Case Studies

Alternatives’ Cold Chain Expertise: Case Study
Clinical Research Organizations:

Monitoring Clinical Drug Products at Anapharm
Anapharm
Your Natural Choice !
Early-phase Development Services
Anapharm is an industry leader in early-phase drug development, providing a wide range of services
to the pharmaceutical, biotechnology, and generic-drug markets. Anapharm offers a vast array of
bio-analytical laboratory services, as well as services in Phase I clinical development,
bioequivalence, and regulatory affairs.
As a PharmaNet Development Group company, Anapharm has access to a global network of

resources for Phase I–IV consulting and clinical drug development.
Anapharm’s expertise is well reputable in Europe, North-America, South-America, Oceania and

Africa. In Canada, Anapharm’s clinical activities are spread among multple facilities that are
located in Quebec-city, Trois-Rivières, Montreal and Toronto.
Temperature-controlled Environments
for Clinical Drug Products
Early-phase and clinical drug products must be
preserved from drastic environmental condition
changes as described by the Health Canada’s Guide-
0069 guidelines on Drug products storage and
transportation.
Similarly, the temperature preservation of clinical
specimens and collected samples shall be assured
during storage and transportation.
Clinical Research Organizations (CROs) are
responsible for the cold chain management during the
storage and transportation of clinical drug products
and collected specimens and samples. Drug products,
Blood and Biological products are current within
CROs’ business operations.
• Cold Chain Analysis

Alternatives Technologie Pharma realized a
thorough analysis of the existing cold chain
management system at Anapharm.
The goal of the analysis and the auditing of its
documentation was to verify the concordance
between the cold chain regulations that are
applicable to Anapharm, and the existing storage and
shipping environment.
Verifications were made through a close collaboration
between Quality Assurance, Quality Control and
Shipping/Receiving departments. Upon the
completion of the cold chain and gap analysis,
specific recommendations and advices worked out by
Alternatives Technologie Pharma were suggested to
Anapharm.
• Temperature Mapping of Storage areas
Alternatives Technologie Pharma realized a complete temperature
mapping study of the storage area of each of the 5 clinical centers in
Canada. The mapping was performed using Alternatives’ ATP-
ThermoProfile™ monitoring system.
Alternatives Technologie Pharma provided mapping protocols,
prepared the mapping missions, and performed the gathering and
analysis of all temperature data as well as the publishing of well
documented reports.
• IOQ Qualification of thermal equipments

Alternatives Technologie Pharma performed the pre-qualification,
the enhancement, the writing, the execution and the approval of IOQ
protocols of all thermal equipment at every Anapharm clinical
center.
Cold
Cold Chain
Chain Solutions
Solutions for
for Clinical
Clinical Research
Research
• Installation of ATP-Mirador™ Monitoring System in every storage Organizations (CROs)
Organizations (CROs)
area
All storage areas at Anapharm’s clinical centers in Canada were
equipped with Alternatives’ ATP-Mirador™ centralized monitoring •• Cold
Cold Chain
Chain Management
Management Analysis
Analysis
system. Alternatives Technologie Pharma prepared and provided the •• Training
User Specification Requirements (URS), the design and installation of Training (Cold
(Cold Chain)
Chain)
the ATP-Mirador™ monitoring system for each clinical center, •• IOQ
IOQ of
of Thermal
Thermal Equipment
Equipment
including the training, the IOQ qualification and SOPs. •• Implementation
Implementation of of ATP-Mirador™
ATP-Mirador™ Monitoring
Monitoring
The installed ATP-Mirador™ monitoring systems included wired System
System for
for Laboratory
Laboratory && Equipment
Equipment
temperature sensors. It made possible the simultaneous monitoring of
thermal equipment and of the warehousing zones. Each ATP-
•• Implementation
Implementation of of ATP-ThermoProfile™
ATP-ThermoProfile™ DataData
Mirador™ system was equipped with customized floor plan interfaces Loggers
Loggers Management
Management System
System
as required. The ATP-Mirador™ monitoring systems were qualified at •• Cold
Cold Chain
Chain Shipping Containers, ATP-
Shipping Containers, ATP-
Anapharm’s sites by ATP’s Validation and Compliance Team. HemoThermal™
HemoThermal™
•• Design
Design && testing
testing of
of packout
packout and
and packaging
packaging
• Installation of ATP-Thermoprofile™ Data Loggers Management configurations.
configurations.
System
ATP-ThermoProfile™ data loggers and logging missions management
system was installed at Anapharm. It enables Anapharm to perform
ongoing environmental temperature recordings, temperature
mappings and IOQ protocol executions. The ATP-ThermoProfile™
system is a database version, centrally installed at Anapharm.
The ATP-ThermoProfile™ system was qualified at Anapharm’s sites
by ATP’s Validation and Compliance Team.
Benefits to Anapharm
The storage and transportation environmental conditions of clinical drug products and
collected clinical specimens must comply with Health Canada’s Guide-0069. Through
temperature mapping, IO Qualifications, and helped by the installation of ATP-Mirador™ and
ATP-ThermoProfile™ solutions, Anapharm was able to address Health Canada’s requirements
on cold chain management as well as implementing temperature-controlled environments for
the storage of clinical drug products and specimens.
Our Compliance Services and Monitoring Solutions helped Anapharm to assure and protect
their product integrity and efficacy whilst addressing Health Canada regulatory requirements.
3100 de la Concorde East, Suite 211

Laval (Quebec) H7E 2B8 Canada
T. (450) 661-5966 / 1-866-661-5966 / F. (450) 661-7966
courrier@alternatives-tech.com
www.alternatives-tech.com
© Copyright Alternatives Technology Pharma 2008

Transportation of Blood Products:
Environmental Conditions Monitoring at Héma-Québec
Héma-Québec
Blood Donation, Blood Collection, Blood Banking, Stem Cells, Human Tissues
Héma-Québec was incorporated as a non-profit organization on March 27, 1998, and subsequently
governed by special legislation, Bill 438, adopted by the National Assembly of Québec, Canada, on
June 20, 1998.
Héma-Québec's mission is to efficiently provide adequate quantities of safe, optimal Blood
components, substitutes, and human tissues and cord Blood to meet the needs of all Quebeckers;
provide and develop expertise along with specialized and innovative services and products in the
fields of Transfusion medicine and human tissue Transplantation.
As a consequence, Héma-Québec is one major interlocutor for all Blood banks, Hospitals and
Healthcare institutions in the province of Québec.
Ensure the Héma-Québec’s Cold Chain Management during Blood

Collection, Banking and Dispatching.
Alternatives Technology Pharma has been mandated by Héma-

Québec for a two-step program, where:
• First, Alternatives evaluated the Héma-Québec’s needs and

requirements in regard to the cold chain management during the
Blood collection, banking and dispatching process as well as to the
standards and guidelines that apply to Héma-Québec’s operations.
• Secondly, Alternatives developed and provided customized

solutions, that included procedures, monitoring software and
hardware and equipment addressing Héma-Québec’s needs and
requirements concerning the cold chain preservation during the Blood
collection, banking and dispatching process.
Ultimately, Héma-Québec equipped its two sites of Quebec-city and

Montréal and its truck fleet with Alternatives‘ technological
solutions, which ensured an optimal cold chain management of its
Blood products intended to hospitals and healthcare institutions:
• Héma-Québec’s Blood products must be preserved within the temperature range of 2-8ºC
(1-10ºC ). Héma-Québec uses ATP-ThermoProfile™ as their monitoring solution for its
cord -blood products bank. Although they were using qualified packaging, Héma-Québec
performed the monitoring of temperature conditions of their products during shipments
using ATP-ThermoProfile™. They were able to address two purposes. The software allowed
temperature monitoring and was able to demonstrate full documentation of historical
temperature conditions to regulatory authorities as well.
• Héma-Québec also installed the ATP-Sentinel™ system to monitor their cargo

environment of blood and other products. Trucks carrying blood collected from donor
clinics were equipped with the ATP-Sentinel™ solution . A PDA was installed on each dash
board and allowed the real-time temperature readings of the cargo space. The PDA was
equipped with an alarm that goes on whenever a temperature excursion occurs.
• ATP-Sentinel™ solution for monitoring 6 vehicles
carrying Blood products Cold
Cold Chain
Chain Solutions
Solutions for
for preserving
preserving Blood
Blood
The ATP-Sentinel™ enables real-time monitoring of the environmental
Products
Products during Storage and Transportation
during Storage and Transportation
conditions of air-conditioned cargo, such as:
- The transportation and distribution of sensitive products, biological
products, drug products or equivalents, •• Training
Training (Cold
(Cold Chain
Chain && CSA
CSA Z904.02)
Z904.02)
-The collection and transportation of biological products and other •• IOQ
medical samples.
IOQ of
of Thermal
Thermal Equipment
Equipment
The ATP-Sentinel™ solution includes a configuration station, a PDA and a
Monitoring
temperature data logger. The temperature-data is secured into data System
System for Laboratory && Equipment
for Laboratory Equipment
loggers as well as in the internal memory card of the PDA. It includes a •• Implementation
Implementation of of ATP-Sentinel™
ATP-Sentinel™ Monitoring
Monitoring
secured database system (SQL server). System
System for Transportation (Cargo)
for Transportation (Cargo)
The ATP-Sentinel™ solution enables various functionalities and features
related to transportation temperature, truck fleet and transportation
•Implementation
•Implementation of of ATP-ThermoProfile™
ATP-ThermoProfile™ datadata
loggers
loggers management system
management system
routes:
-The monitoring and recording of temperatures between -40oC and 85oC, •• Portable
Portable Insulated
Insulated Packaging Containers, ATP-
Packaging Containers, ATP-
-The alarms notification and auto recording of alarms received by the HemoThermal™
HemoThermal™
driver into a database,
-Management of delivery truck fleet and delivery routes creation
capabilities;
-Advanced reports and graph generating system ; ATP-Sentinel™ PDA support on
The data logger calibration is compliant with national measurements vehicle console
standard. It comes with a worry-free calibration plan (loggers are
calibrated before calibration expires); Main PDA interface (ATP-Sentinel™)
The software is compliant with CFR21 part 11 requirements (electronic
data and signatures). Furthermore, engineering, validation and operating
instructions documentation is available.
• ATP-ThermoProfile™ solution for monitoring Blood

Product Shipments
Complete reports and graphics
solution was installed at Héma-Québec. It enabled Héma-Québec to
monitor Blood product shipments, environmental temperatures as well as
to perform temperature profile mapping and the execution of
qualification protocols.
Benefits to Héma-Québec
Being one of the major players in Blood products collection and supply, Héma-Québec has to protect and ensure the integrity and
quality of Blood products to be transported and distributed to Healthcare institutions and Blood banks.
By installing ATP-Sentinel™ and ATP-ThermoProfile™ monitoring solutions, Héma-Québec addressed the Canadian regulatory
requirements on environmental conditions and their documentation during storage and transportation of Blood products.
Furthermore, Héma-Québec is now able to provide optimal assurance and reliability to its business partners, suppliers or customers:
donors, governmental agencies, blood banks, hospitals, long-term care clinics and other institutions, and most of all to end-users.

T. (450) 661-5966 / 1-866-661-5966 / F. (450) 661-7966

Shipping and Conditioning of Drug products:
Cold Chain Monitoring & Packaging at Sandoz
Sandoz Canada
A world leader in Generics
In 2004, Sandoz acquired Sabex, headquartered in Boucherville, Canada. This strategic

acquisition allowed Sandoz to establish a new presence for Sandoz in Canada, the sixth largest
generics market worldwide, to gain an attractive global growth platform in the fast-growing
injectable generics business and to get an FDA-approved manufacturing facility.
Sandoz Canada develops, manufactures and distributes injectable and ophthalmic generic
pharmaceutical products for hospital and retail markets. It employs over 600 people countrywide,
and are mostly located at the Boucherville facilities. Injectables and ophthalmic products are a
special category of generics involving unique processes that require specific expertise. This
distinction has enabled Sandoz Canada to become the internationally renowned Sandoz Centre of
Excellence for injectable products. They currently have 85 molecules and 350 SKUs produced
under various dosage forms: injectables, ampoules and vials; ophthalmic solutions, suspensions
and ointments; suppositories; oral and topical forms.
Since 2004, Sandoz Canada has acquired RhoxalPharma and increased production in Boucherville
(Quebec) by about 40 per cent. Since 2006, it has boosted its work force beyond 600 with the
creation of 100 jobs. The labour force is expected to grow by another 100 and production
increase by 66 per cent by the time the work is completed in 2008.
To make health accessible to all
Sandoz generates value and wealth by developing, manufacturing and selling off-patent and
patent free pharmaceuticals, biopharmaceuticals, active ingredients and intermediates.
Through worldwide operations Sandoz understands customers’ needs and is adding value to their
business by offering attractively priced, high-quality products and services.
As a leader in generic products Sandoz enhances access to medical treatments and helps
healthcare systems through significant cost savings. Sandoz aims to improve the lives of the
people all over the world.
Cold Chain Compliance at Sandoz Canada
Sandoz has decided to outsource the distribution of their products to UPS,

Supply (chain) services. Sandoz distributes 14 products with 26 different
codes. Sandoz is shipping their products to UPS in Toronto, via ground
transportation services. Then, UPS is shipping from Toronto to the final
destinations in Canada, by selecting and using the appropriate transportation
modes and services. Sandoz wants to be compliant with Health Canada
guidelines (guide-0069) “Guidelines for Temperature Control of Drug Products
during Storage and Transportation” edited by the Health Products and Food
Branch Inspectorate of Health Canada.
• Installation of ATP-Mirador™ Monitoring System for Conditioning

Equipment Cold
Cold Chain
Chain Compliance
Compliance Services
Services and
and
At Sandoz Canada, six (6) freezers used for the conditioning of packaging gels Solutions
Solutions for the Pharmaceutical Industry
for the Pharmaceutical Industry
were temperature-mapped and installed with the ATP-Mirador™ monitoring
system.
First-off, freezers were temperature-mapped by Alternative Technologie •• Gap
Gap Analysis
Analysis
Pharma’s team, which included the writing of protocols, the execution and •• Training
Training
the issuance of well documented mapping reports.
•• Prequalification
Prequalification of of Thermal
Thermal Equipment
Equipment
The ATP-Mirador™ monitoring system was installed centrally at Sandoz’s
warehouse. Each freezer was equipped with two (2) calibrated wired sensors: •• Temperature
Temperature Mapping of Warehouses &&
Mapping of Warehouses
one fixed at the internal freezer wall, and the other being mobile to be Equipment
Equipment
installed within the conditioning gels stock. The ATP-Mirador™ system •• I/O
enables ongoing temperature monitoring and recording of the conditioning I/O Qualification
Qualification of of Thermal
Thermal Equipment
Equipment
gels that are used for the shipping of temperature sensitive products. •• Implementation
Monitoring
System
System for
for Warehouse
Warehouse && Storage
Storage areas
areas
• Temperature profile Analysis in Transport •• Implementation
ATP-ThermoProfile™ data data
Sandoz needed realistic ambient temperature profiles of its shipments for loggers
loggers management
management systemsystem
summer and winter. Shipping routes and related ambient temperature profiles •• Ambient
Ambient Temperature
Temperature Profile
Profile Analysis
Analysis of
of
were analyzed by Alternatives Technologie Pharma during 3 weeks in both Shipping
seasons. For this ambient temperature profile analysis, four (4) worst-case
Shipping Lanes
Lanes
destinations and six (6) standard destinations were selected in Canada. The •• Design
Design && test
test of
of Packaging
Packaging && Packout
Packout
temperature profile analyses were performed after Alternatives Technologie Configurations
Configurations
Pharma prepared the regulatory documentation and the data collection was •• Qualification
Qualification ofof Packout
Packout Configurations
Configurations
done.
• Cold Chain Packaging Methods

Sandoz wanted to design and qualify new 2 to 8ºC packaging configuration for
the shipping of small and large payloads in winter with a duration of 36 hrs.
Also, a pallet shipper was proposed for shipping 2 to 8ºC products. Through
our packaging laboratory services, Alternatives Technologie Pharma
performed the design of the 2 to 8ºC configuration, -the qualification, the
writing of the configuration report of the SOP packaging method and the
training program for the personnel.
Benefits to Sandoz Canada

Being a key component of the health product supply chain in Canada, Sandoz Canada has to protect and ensure the integrity and
quality of drug products to be transported and distributed through its pan Canadian network.
By implementing its 2@8ºC shipping methods plan, and by installing the ATP-Mirador™ monitoring system in its warehousing, Sandoz
Canada ensured to fulfill the Canadian regulatory requirements for the temperature control of drug products during storage and
transportation.

T. (450) 661-5966 / 1-866-661-5966 / F. (450) 661-7966

Storage and Distribution of Drug products:
Ensuring Cold Chain Compliance at AmerisourceBergen
AmerisourceBergen Canada
AmerisourceBergen Corporation is based in Valley Forge, PA and is distributing products
throughout the U.S.A, Puerto Rico, Canada, and the U.K.
In the US, AmerisourceBergen handles the distribution of 20% of all pharmaceuticals that are
sold in the country. In addition to delivering pharmaceuticals on a just-in-time basis to tens of
thousands of healthcare providers every day, AmerisourceBergen provides business support and
consulting services to help their customers focus on their key strength—caring for patients.
AmerisourceBergen is committed to the safety and security of the nation’s pharmaceutical
supply chain. AmerisourceBergen purchases all branded and generic pharmaceuticals only
directly from the manufacturer, except in the rare instance that AmerisourceBergen is required
to do otherwise either by the manufacturer or a government agency.
Pharmaceutical Distribution & Services: AmerisourceBergen Drug Corporation also provides
consulting services to help healthcare providers improve their businesses and focus on their
strengths.
Specialty Distribution & Services: AmerisourceBergen Specialty Group (ABSG) delivers
specialty pharmaceuticals and related services to physician offices, including reimbursement
consulting and physician education. AmerisourceBergen Specialty Group provides
commercialization and other services to specialty drug manufacturers.
AmerisourceBergen and Alternatives Technologie Pharma partnered to address stringent Cold Chain
Management and Compliance requirements throughout their warehousing and distribution network in
Canada. This plan involved:
• Cold Chain Management Analysis

Alternatives Technologie Pharma performed a complete analysis of AmerisourceBergen’s existing
cold chain management. The purpose of the cold chain analysis and its documentation audit was to
verify the concordance between the cold chain regulations that were applicable to
AmerisourceBergen, and the existing environment in which products were handled, stored and
shipped.
Verifications were made through a close collaboration between Quality Assurance, Quality Control and
Shipping/Receiving departments. Through this cold chain quality and gap analysis audit, specific
recommendations and advices worked out by Alternatives Technologie Pharma were made to
AmerisourceBergen.Upon the completion of the cold chain and gap analysis, specific recommendations
were suggested by Alternatives Technologies Pharma
• Temperature Mapping of AmerisourceBergen’s sites
Alternatives Technologie Pharma performed a complete temperature
mapping study for each of their 8 Canadian facilities. Temperature mappings
of warehouses were made using Alternatives’ ATP-ThermoProfile™ software
and data loggers monitoring system. Alternatives Technologie Pharma
provided mapping protocols, prepared mapping missions, performed the
gathering and analysis of temperature data as well as the publishing of well
documented reports.
• Engineering on thermal equipments

Alternatives Technologie Pharma performed engineering work on 11 double-
door refrigerators and enhanced their cold-storage performance.

Alternatives Technologie Pharma performed pre-qualifications and
qualifications, the writing, the execution and the approval of IOQ protocols
for all thermal equipment at AmerisourceBergen‘s warehouses.
Cold
Cold Chain
Chain Compliance
Compliance Services
Services and
and
•Installation of ATP-Mirador™ Monitoring System in 8 Solutions provided to AmerisourceBergen
Solutions provided to AmerisourceBergen
Warehouses
All AmerisourceBergen Canada’s warehouses and DCs in Canada were •• Gap
Gap Analysis
Analysis && Training
Training
equipped with Alternatives’ ATP-Mirador™ central monitoring system.
Alternatives Technologie Pharma prepared and provided the User
•• Engineering
Engineering & Qualification (IOQ)
& Qualification (IOQ) of
of Thermal
Thermal
Specification Requirements (URS), the design and installation of the ATP- Equipment
Equipment
Mirador™ monitoring system for each warehousing and DC, including the •• Temperature
Temperature Mapping
Mapping ofof Warehouses
Warehouses
training, the IOQ qualification and SOPs. The installed ATP-Mirador™
monitoring systems incorporated both wired temperature sensors and RF
Monitoring
acquisition systems, and enabled the simultaneous monitoring of the thermal System
System for
for Warehouse
Warehouse (by(by DC)
DC)
equipment and the warehousing zones. Each ATP-Mirador™ system was •• Temperature
Temperature Profile
Profile Analyses
Analyses during
during Transport
Transport
equipped with customized floor plan interfaces as required. (Sameday
(Sameday && 2424 hrs)
hrs)
•Cold
•Cold Chain
Chain Packaging
Packaging Methods,
Methods,
• Temperature Profile Analyses ATP-HemoThermal™
ATP-HemoThermal™
A study on temperature profiles of shipping lanes was conducted from
AmerisourceBergen‘s DCs to determine ambient temperature profiles in
Winter and Summer that were used as benchmarks to evaluate thermal
performance of packaging configurations. Temperature profiles were analyzed
for Sameday and 24-hr transport and distribution.
• Cold Chain Methods, ATP-HemoThermal™

AmerisourceBergen selected portable and reusable insulated shippers from
our ATP-HemoThermal™ series of containers. These containers were used to
carry drug products at 2 to 8ºC. The ATP-HemoThermal™ series include 6L,
15L, 22L and 66L containers, and are provided with appropriate conditioning
material ensuring a temprature range of 2 to 8ºC.
Benefits to AmerisourceBergen
By implementing a Cold Chain Management and Compliance plan, mainly through the installation of ATP-Mirador™ systems,
AmerisourceBergen addressed the Canadian regulatory requirements for the cold chain compliance as well as assuring the integrity and
efficacy of products during distribution.
Furthermore, AmerisourceBergen is now able to provide maximal guarantees to its business partners, suppliers or customers:
manufacturers, retail pharmacies, hospitals, long-term care, clinics and other institutions.

T. (450) 661-5966 / 1-866-661-5966 / F. (450) 661-7966

Storage and Distribution of Drug products:
Ensuring Cold Chain Compliance at McKesson Canada
McKesson Canada
McKesson Canada plays a pivotal role in the Canadian health care

supply chain, by providing solutions to manufacturers, pharmacies,
hospitals, and various health care institutions who serve the needs of
Canadian patients every single day. McKesson Canada is the leading
provider of logistics as well as information products and services within
the Canadian health care marketplace.
McKesson Canada is a wholly owned subsidiary of McKesson
Corporation of San Francisco, one of the world's leading health care
supply management and information Technology companies.
Distribution is what we are known for, but McKesson Canada does much
more than logistics and order-fulfillment. The truth is that
manufacturers and health care providers count on us for a full range of
services that contribute to the quality and safety of care for Canadian
patients.
McKesson Pharmaceutical:
McKesson Canada carries more than 35,000 products in 15 distribution
centres (DCs), provides logistics and distribution to over 800
manufacturers, and delivers to 6,800 retail pharmacies, 1,150
hospitals, long-term care centres, clinics, and over 200 institutions
across Canada.
Operating units of McKesson Pharmaceutical assure the supply and
distribution of pharmaceutical, over-the-counter (OTC) and front shop
products to Quebec and the Atlantic provinces, to Ontario and the
Western provinces.
McKesson Specialty Pharmaceutical Solutions:

The McKesson Specialty Pharmaceutical Solutions division of McKesson
Canada offers a range of solutions designed to effectively respond to
manufacturers' evolving needs. These include patient assistance and
support services, customized distribution programs and specialty
prescription services.
The McKesson Specialty Pharmaceutical Solutions division offers
customized services to manufacturers of high value pharmaceuticals,
including cold chain, information management, and controlled
distribution programs.
McKesson Canada partners with Alternatives Technologies

Pharma to address Cold Chain Compliance
McKesson Canada and Alternatives Technologie Pharma partnered to implement a plan for Cold
Chain Management and Compliance of the entire McKesson Canada warehousing and distribution
network. This plan includes:
• Personnel Training
Alternatives Technologie Pharma provided complete personnel training sessions for each
warehouse and distribution center in Canada. The training focused on Health Canada’s Guide
0069 Guidelines for Temperature Control of Drug Products during Storage and Transportation.
The program also included equipment qualification, warehouse mapping and SOPs.
• Temperature Mapping of 15 McKesson facilities.
Alternatives Technologie Pharma performed a complete temperature
mapping study for each of site the 15 Canadian facilities. The warehouse
mapping study was performed using Alternatives’ ATP-ThermoProfile™
software and data loggers monitoring system. Alternatives Technologie
Pharma provided mapping protocols, prepared the mapping missions, and
performed the collecting and analysis of all temperature data as well as the
warehouse mapping reports.

Alternatives Technologie Pharma performed the pre-qualification and
qualification, the writing, the execution and the approval of IOQ protocols for
all thermal equipment at McKesson Canada’s warehouses and DCs.
•Installation of ATP-Mirador™ Monitoring System in 15

Warehouses and DCs
All McKesson Canada’s warehouses and DCs in Canada were equipped with Cold
Alternatives’ ATP-Mirador™ centralized monitoring system. Alternatives
Cold Chain
Chain Compliance
Compliance Services
Services and
and
Technologie Pharma prepared and provided the User Specification
Solutions
Solutions provided
provided to
to McKesson
McKesson Canada’s
Canada’s
Requirements (URS), the design and installation of the ATP-Mirador™ Distribution
Distribution Network
Network
monitoring system for each warehousing and DC, including the training, the
IOQ qualification and SOPs. The installed ATP-Mirador™ monitoring systems
included both wired and RF temperature acquisition systems, and enabled the •• Gap
Gap Analysis
Analysis (per
(per DC)
DC)
simultaneous monitoring of both thermal equipment and warehousing zones. •• Training
Each ATP-Mirador™ system was equipped with customized floor plan Training (per
(per DC)
DC)
interface(s) as required by the site. Throughout Canada, ATP-Mirador™ •• Prequalification
Prequalification ofof Thermal
Thermal Equipment
Equipment (per
(per DC)
DC)
monitoring systems were installed in 16 warehouses and DCs of both •• Temperature
Temperature Mapping of Warehouses (per DC)
Mapping of Warehouses (per DC)
McKesson Pharmaceutical (14) and McKesson Specialty Pharmaceutical
Solutions (1) business units. •• IOQ
IOQ of
of Thermal
Thermal Equipment
Equipment (per
(per DC)
DC)
•• Implementation ATP-Mirador™
Implementation of ATP-Mirador™ Monitoring
of Monitoring
System
System for
for Warehouse
Warehouse (per
(per DC)
DC)
• Installation of ATP-Thermoprofile™ as a data logger
management system accessible by all sites •• Implementation
ATP-ThermoProfile™ data data
loggers
loggers management
management system
system (centralized)
(centralized)
ATP-ThermoProfile™ data logger and logging mission management system
was installed at McKesson Canada. It enabled McKesson Canada to perform •• Ambient
Ambient Temperature
Temperature Profile
Profile Analyses
Analyses of
of
ambient temperature recordings, temperature mapping and execution of IOQ Shipping
Shipping Lanes
Lanes
protocols. ATP-ThermoProfile™ system was a database version, installed
•• Design
Design && testing
testing of
of Packaging
Packaging && Packout
Packout
centrally but securely accessible by all McKesson Canada’s DCs.
configurations
configurations
• Temperature Profile Analyses and Cold Chain Methods
A study on temperature profiles of shipping lanes was conducted from all
McKesson Canada ‘s DCs to determine ambient temperature profiles of in
Winter and Summer with shipping durations of 24-hr and 48-hr. It resulted in
design of pack out configurations for 2@8oC temperatures of small and
medium payload sizes that were tested and qualified at ATP’s laboratory.
Benefits to McKesson Canada

By implementing a Cold Chain Management and Compliance plan, mainly through the installation of ATP-Mirador™ and ATP-
ThermoProfile™ systems, McKesson Canada addressed the Canadian regulatory requirements for the cold chain compliance as well as
assuring the integrity and efficacy of products during distribution.
Furthermore, McKesson Canada is now able to provide maximal guarantees to its business partners, suppliers or customers:
manufacturers, retail pharmacies, hospitals, long-term care clinics and other institutions, and most of all to end-users.

T. (450) 661-5966 / 1-866-661-5966 / F. (450) 661-7966

Cell-based and Biological Products:
Compliance and Monitoring at Royal Victoria Hospital
Royal Victoria Hospital (MUHC)
The McGill University Health Center’s most important Hospital in Montréal

(Québec, Canada)
The Royal Victoria Hospital of Montréal was founded in 1893, and became with time one major
center for Health care, teaching and scientific research in Quebec and Canada. It joined the McGill
University Health Center (MUHC) in 1992. Its complex of six pavilions houses a bed complement of
517.
The Royal Victoria Hospital has annual inpatient admissions of over 22,000, and ambulatory services
visits of over 400,000.
The MUHC is a merger of five teaching hospitals affiliated with McGill University —The Montreal
Children's Hospital, the Montreal General Hospital, The Royal Victoria Hospital, and The Montreal
Neurological Hospital as well as The Montreal Chest Institute.
Producing Biological Drugs from

Donor Patients…
The Apheresis Laboratory and Stem Cell

Laboratory of the MUHC are involved in
producing haematopoietic stem cells from Blood
and Bone marrow collected from patients.
These MUHC laboratories are concequently

collecting human Blood and Bone marrow from
donor patients, executing separation processes
to isolate the Biological materials, then
preserving and storing such Biologicals up to its
further dispatching to the various MUHC’s
Transplantation departments.
In Canada, both the Apheresis Laboratory and

Stem Cell Laboratory fall into current and future
Health Canada (HC) regulations for Drugs and
Biologicals as well as current and future
Canadian Standard Association (CSA) standards.
Furthermore, the MUHC’s Apheresis Laboratory

and Stem Cell Laboratory wanted to fully comply
with the standards issued by United-States
Foundation for the Accreditation of Cellular
Therapy (FACT).
• Compliance with Health Canada Regulations and FACT
Standards.
To comply with Health Canada (Health Products and Food Branch
Inspectorate, HPFBI), CSA and FACT regulations and standards, the
Apheresis Laboratory and Stem Cell Laboratory, jointly with other
departments of the MUHC, have initiated a complete regulatory levelling,
and have mandated Alternatives Technologie Pharma for the validation
and qualification of its equipment, instruments and software.
The MUHC laboratories had to comply with the Health Canada’s HPFBI
guidelines, GMPs parts 1 and 2, guideline-0069, to the FACT standard
(Standard for Haematopoietic Progenitor Cell Collection, processing and
Transplantation), and to the CSA Z902-04 (Blood and Blood Components)
standard.
Alternatives Technologie Pharma proposed a gap analysis and a
directing plan for the validation and qualification of equipment,
instruments and software. This mission included
-The Identification of the critical elements; Cold
Cold Chain
Chain Solutions
Solutions for
for preserving
preserving Cell
Cell
-The Writing of Validation Plan and Protocols; Therapy
Therapy and Biological Products during
and Biological Products during
-The Installation Qualification (IQ); Storage
Storage and
and Transportation
Transportation
-The Operational Qualification (OQ).
It assisted Royal Victoria Hospital in its efforts to comply with both
Health Canada and FACT regulations. Furthermore, Alternatives
•• Training
Training (Cold
(Cold Chain,
Chain, CSA
CSA Z902-04
Z902-04 && FACT)
FACT)
Technologie Pharma provided IO Qualification services to Royal Victoria •• IOQ
IOQ of
of Thermal
Thermal Equipment
Equipment
Hospital to qualify equipment such as refrigerators, freezers,
centrifuges, laminar hoods... Alternatives Technologie Pharma provided
Monitoring
System
System for Laboratory && Equipment
for Laboratory Equipment
IO Qualification protocols and reports and executed IO Qualifications.
ATP-ThermoProfile™ data
data
• ATP-ThermoProfile™ solution for monitoring Blood
Product Shipments
•• Portable
Portable Insulated Containers, ATP-
Insulated Containers, ATP-
HemoThermal™
HemoThermal™
ATP-ThermoProfile™ data logger and logging mission management
solution was installed at Royal Victoria Hospital. It enabled the Royal
Victoria Hospital to monitor cells-based and biological product
shipments, environmental temperatures and to perform temperature the
required profile mapping and qualification protocols execution.
• ATP-HemoThermal™ container for Sensitive Products

Transportation
Royal Victoria Hospital is using portable and reusable ATP-
HemoThermal™ containers that have been specially designed for the
temperature-controlled transportation of Blood products, Biological
products and Clinical specimens. It enabled the Royal Victoria Hospital
to preserve cells-based and biological product during intra-hospital and
inter-hospital transports.
Benefits to Royal Victoria Hospital

Cell therapy laboratories at the Royal Victoria Hospital have to comply with Health Canada and FACT guidelines regarding the quality
process and the preservation of temperature-sensitive products and materials during storage and shipment.
Our Compliance Services helped the Royal Victoria Hospital’s laboratory to obtain its cell therapy oriented FACT accreditation. By
installing ATP-Thermoprofile™ and ATP-HemoThermal™ solutions, the Royal Victoria Hospital ensured to maintain and document a
temperature-controlled environment during storage and transportation.

T. (450) 661-5966 / 1-866-661-5966 / F. (450) 661-7966

Temperature Controlled Transportation:
Compliance of temperature-controlled Transportation at
Skelton Truck Lines ltd.
Skelton Trucks Line Ltd.
Temperature-controlled Shipping
Skelton Truck Lines is a specialized, expedited, satellite tracked, over the road carrier. Founded in
1962, Skelton Truck Lines offers customers a powerful and comprehensive distribution system
throughout Canada and the United States.
Skelton’s head office is located in Newmarket, Ontario and includes a 65,000 square foot warehouse
Skelton currently operates over 50 trucks and 75 trailers. Trucks are all kept in excellent condition
with a stringent maintenance program that is second to none.
Skelton has various types of trailers including refrigerated trailers, dry vans, and rack and tarps (flat
beds).
Skelton ships a variety of temperature sensitive products including pharmaceuticals and plasma
using insulated vans with single, double-reefer trailers. These shipments are monitored closely using
the Brandstadt temperature controller and depending on the product, can be kept within a range of
plus or minus 3 degrees Celcius. The temperature recorder is directly linked to in-cab alarm system
which notifies the driver of any sudden temperature change.
Skelton Truck Lines offers very attractive temperature-controlled
shipping solutions for pharmaceutical and biological products, thus
enabling to reduce temperature extremes applied onto products during
transportation, and to soften the external temperature profile.
Temperature-controlled transportation is certainly a must to ship

temperature-sensitive products such as pharmaceuticals and drug
products.
• Ensure Compliance to Health Canada (Guide-0069)

guidelines
To comply with Health Canada, Skelton needs to qualify and re-qualify
its temperature-controlled truck-trailers. The re-qualification of
temperature-controlled trailers are done every three years at Skelton.
The qualification applies to each truck and each Brandstadt temperature Cold
Cold Chain
Chain Compliance
Compliance for
for Logistics
Logistics and
and
recording device as well. Transportation Companies
Transportation Companies
This Qualification work includes:

•• Cold
Cold Chain
Chain Process
Process Analysis
Analysis
•• Training
Training
-The Writing of Validation Plan and Protocols;
•• IOQ
IOQ of
of Thermal
Thermal Equipment
Equipment
-The Installation Qualification (IQ);
-The Operational Qualification (OQ). •• Implementation
Implementation ofof ATP-Mirador™
Monitoring
System
System for
for Laboratory
Equipment
Alternatives Technologie Pharma assisted Skelton in its efforts to •• Implementation
Implementation ofof ATP-ThermoProfile™
ATP-ThermoProfile™ Data
Data
comply with Health Canada guidelines. Alternatives Technologie Logging
Logging Management
Management system
system
Pharma had the responsibility to provide protocols, to execute them and
to generate IQ/OQ qualification reports.
For Skelton, Alternatives Technologie Pharma performed re-

Qualification and Qualification of a total of 17 trucks for 2-8ºC and 2-
8ºC/15-25ºC (24 hrs). Verification of calibration reports of each
temperature recording device and of existing personnel training
programs was undertaken.
Trailers were temperature-mapped (2-8ºC/15-25ºC) for a 24-hr period at

empty and full load. Temperature mapping of trailers was done using our
ATP-ThermoProfile™ solution and 15 calibrated data loggers for each
trailer.
Benefits to Skelton Truck Lines

The storage and transportation of drug and blood products must comply with Health Canada guidelines (Guide-0069). By providing
temperature-controlled trucks and trailers for the transportation of pharmaceutical and medicinal products, Skelton uses thermal
equipment. As a consequence, qualification of such temperature-controlled equipment is required just like any other thermal
equipment in the highly-regulated pharmaceutical industry.
Our Compliance Services helped Skelton Truck Lines to qualify its fleet of temperature-controlled trailers, thus ensuring the
compliance of its fleet with Health Canada’s regulations.

T. (450) 661-5966 / 1-866-661-5966 / F. (450) 661-7966

Laboratory Services:
Controlling & Monitoring Storage & Transportation
Temperatures
Laboratoire Médical Biron
Analytical Laboratory
Laboratoire Médical Biron’s mission is to offer health care professionals high-quality laboratory
services.
Since it was first founded in 1952, Laboratoire Médical Biron has made it a priority to deliver a
quick and efficient personalized services.
Its initial objectives have always been to offer health care professionals accurate and have remained
unchanged: offer health care professionals a better laboratory service, providing accurate and
reliable test results more quickly than a hospital or CLSC.
Laboratoire Médical Biron was founded in 1952 by a visionary entrepreneur, Denis Biron. Since
1970, Mr Biron has relied on the relentless support of his wife, Eve, an active contributor to the
success of the company. Since the early 1990's, the Biron's three daughters, Eve-Lyne, Caroline and
Geneviève have brought new insights into the corporation's direction and have, since 1995,
participated in a successful transition to the second generation.
Determined and perseverant, the three sisters are hard at work into their father's footsteps, making
sure the corporation remains the leader of this industry in the province of Quebec and bringing new
vision and goals for the future. By relying on ambitions and competent human resources, they are
confident that they will be able to raise to the occasion.
Laboratoire Médical Biron provides more than 300 tests, including tests in Hematology,
Biochemistry, Virology, Endocrinology, Drug testing, Microbiology, HIV, Spermogram, Detection of
STD through urinalysis (PCR), Range of molecular medicine tests, Electrocardiogram, Spirometry,
Sleep Laboratory, Complete and simplified polysomnography, etc. Laboratoire Médical Biron is also
a business partner of more than 150 companies in the province of Quebec and in Canada in the
management of health at work.
Temperature-controlled Environments
Being a services laboratory for health customers,

Laboratoire Médical Biron wishes to maintain a
temperature-controlled environment for the storage and
shipping of specimens and samples.
To establish a well-controlled temperature-controlled

environment, Laboratoire Médical Biron asked Alternatives
Technologie Pharma for its regulatory expertise and
environmental monitoring solutions:
• Installation, Operational & Performances Qualification of

Storage Refrigerators and Freezers;
• Monitoring of the Storage Temperature Conditions in
Refrigerators and Freezers.
• IOPQ Qualification of thermal equipments
Alternatives Technologie Pharma performed the pre-qualification,
the writing, the execution and the approval of IOPQ protocols of all
thermal equipment at Laboratoire Médical Biron laboratory.
A total of 3 refrigerators and 2 freezers were qualified at Laboratoire
Médical Biron.
• Installation of ATP-Mirador™ Monitoring System in storage areas

The laboratoire Médical Biron’s laboratory were equipped with
Alternatives’ ATP-Mirador™ centralized monitoring system. The ATP-
Mirador™ system was installed to monitor 18 storage equipments
(refrigerators and freezers).
Specification Requirements (URS), the design and installation of the
ATP-Mirador™ monitoring system for each clinical center, including
the training, the IOQ qualification and SOPs.
The installed ATP-Mirador™ monitoring systems included wired Cold
Cold Chain
Chain Solutions
Solutions for
for Analytical
Analytical &
& Clinical
Clinical
temperature sensors. It renders possible the simultaneous monitoring Laboratories
of thermal equipment. It was equipped with a floor plan interface Laboratories
customized to the Laboratoire Médical Biron’s
The ATP-Mirador™ system was equipped with customized floor plan •• Cold
Cold Chain
Chain Management
Management Analysis
Analysis
interfaces as required. The ATP-Mirador™ monitoring systems were
qualified at Laboratoire Médical Biron’s laboratory by ATP’s
•• Training
Training (Cold Chain)
(Cold Chain)
Validation and Compliance Team. •• IOQ
IOQ of
of Thermal
Thermal Equipment
Equipment
Monitoring
• Installation of ATP-Thermoprofile™ Data Loggers Management System
System for
for Laboratory
Equipment
System •• Implementation
Data
The ATP-ThermoProfile™ data loggers and logging missions Loggers Management
Loggers Management SystemSystem
management system was installed at Laboratoire Médical Biron. •• Cold
Cold Chain
This system enables Laboratoire Médical Biron to record the product HemoThermal™
HemoThermal™
or specimen temperature during all collecting, transportation or
delivery processes. It also enables Laboratoire Médical Biron to •• Design
Design && testing
testing of
of packout
packout and
and packaging
packaging
perform ongoing environmental temperature recordings, temperature configurations.
configurations.
mappings and IOQ protocol executions.
The ATP-ThermoProfile™ system installed at Laboratoire Médical
Biron is a standalone version.
The ATP-ThermoProfile™ system was qualified at Laboratoire
Médical Biron’s laboratory by ATP’s Validation and Compliance Team.
Benefits to Laboratoire Médical Biron
The storage and transportation environmental conditions of clinical and

sensitive products or samples and collected medical specimens should
be controlled and documented. Through IOP Qualifications, and helped
by the installation of ATP-Mirador™ and ATP-ThermoProfile™
solutions, Laboratoire médical Biron was able to address good cold
chain management as well as implementing temperature-controlled
environments for the storage of products and specimens.
Our Compliance Services and Monitoring Solutions helped Laboratoire
Médical Biron to assure and protect their product integrity and efficacy
whilst addressing the various regulatory requirements.

T. (450) 661-5966 / 1-866-661-5966 / F. (450) 661-7966

Pharmacies:
Controlling & Monitoring Storage & Transportation
Temperatures
Galenova, Gentès & Bolduc Pharmacists

Galenova (previously Denis Giroux Laboratories Inc.) is a company that specializes in the
distribution of chemical and pharmaceutical products, material, equipment and supplies.
Galenova and Gentès & Bolduc Pharmacists and its team of close to 50 people, pharmacists and
other professionals, are working hard to offer high quality products and exceptional service.
Gentès & Bolduc Pharmacists (previously Denis Giroux M. Sc., Pharmacist) is the only pharmacy
entirely dedicated to serving community pharmacists, health institutions, veterinarians and
agricultural producers.
Gentès & Bolduc Pharmacists apply the following manufacturing principles and standards: USP 795
and 797; they conform to standard 95.01 of the “Ordre des Pharmaciens du Québec” and they follow
the Canadian cGMP (Good Manufacturing Practices) for a number of our processes. They are also
certified ISO 9001:2000. Gentès & Bolduc Pharmacists take orders and deliver throughout Canada.
Gentès & Bolduc Pharmacists prepare and deliver Prescriptions such as Oral Pharmaceutical
Formulations, Uro-genital Pharmaceutical Formulations, Rectal Pharmaceutical Formulations,
Topical Pharmaceutical Formulations, Ear, Nose and Throat (ENT) Formulations, Modification of
Pharmaceutical Formulations, Preparation of Medications for Clinical Trials, but also Sterile Products
such as Antibiotherapy and Home Care (Preparation of Intravenous Antibiotherapy at Home,
Parenteral Products for Post-Operative or Palliative Care, Preparation of All Other Injectable
Products) and Antineoplasic Products (Ophthalmic Solutions, Oral Formulations, Creams, Ointments
or Topical Solutions, Injectable Formulations) and Veterinary Medicines (Commercial Medications,
Veterinary Supplies, Prescriptions).
Temperature-controlled Environments & Cold

Chain Compliance
Being a products & services company and specialty

pharmacists, Galenova and Gentès & Bolduc Pharmacists
must comply with Health canada guidelines and regulations,
and maintain a temperature-controlled environment for the
storage and shipping of specimens and samples.
To establish a well-controlled and compliant temperature-
controlled environment, Galenova and Gentès & Bolduc
Pharmacists asked Alternatives Technologie Pharma for its
regulatory expertise and environmental monitoring
solutions:
• Levelling of Cold Chain Compliance;

• Installation, Operational & Performances Qualification of
Storage Refrigerators and Freezers;
• Monitoring of Environmental Conditions in Equipments;
• Cold Chain packaging Methods.
• Installation of ATP-Mirador™ Monitoring System
The Galenova and Gentès & Bolduc Pharmacists ’s laboratory were
equipped with Alternatives’ ATP-Mirador™ centralized monitoring
system. The ATP-Mirador™ system was installed to monitor equipments
including refrigerators, freezers, sterilizers and clean rooms. More than
40 temperature sensors, relative Humidity sensors, and differential
pressure sensors were connected to the ATP-Mirador™ system.
Specification Requirements (URS), the design and installation of the
ATP-Mirador™ monitoring system for each clinical center, including the
training, the IOQ qualification and SOPs.
The installed ATP-Mirador™ monitoring systems included wired
temperature sensors. It renders possible the simultaneous monitoring of
equipment. It was equipped with a floor plan interface customized to
the Galenova and Gentès & Bolduc Pharmacists’s laboratory.
The ATP-Mirador™ system was equipped with customized floor plan
interfaces as required. The ATP-Mirador™ monitoring systems were
qualified at Galenova and Gentès & Bolduc Pharmacists ’s laboratory Cold
by ATP’s Validation and Compliance Team.
Cold Chain
Chain Solutions
Solutions for
for Laboratories
Laboratories &
&
Specialty
Specialty Pharmacies
Pharmacies (Compounding)
(Compounding)
• Installation of ATP-Thermoprofile™ System
The ATP-ThermoProfile™ data loggers and logging missions •• Cold
Cold Chain
Chain Management
Management Analysis
Analysis
management system was installed at Galenova and Gentès & Bolduc •• Training
(Cold Chain)
Pharmacists.
•• IOQ
IOQ of
of Thermal
Thermal Equipment
Equipment
This system enables Galenova and Gentès & Bolduc Pharmacists to
record the product or specimen temperature during all collecting, •• Implementation
Monitoring
transportation or delivery processes. It also enables Galenova and System
System for
for Laboratory
Equipment
Gentès & Bolduc Pharmacists to perform ongoing environmental •• Implementation
Data
temperature recordings, temperature mappings and IOQ protocol
Loggers Management
Loggers Management SystemSystem
executions.
The ATP-ThermoProfile™ system installed at Galenova and Gentès &
•• Cold
Cold Chain
Bolduc Pharmacists was a standalone version and will be levelled to a HemoThermal™
HemoThermal™
database version. •• Design
Design && testing
testing of
of packout
packout and
and packaging
packaging
configurations.
configurations.
• Cold Chain Packaging Methods
Alternatives Technologie Pharma also supplied Galenova and Gentès
& Bolduc Pharmacists laboratory with qualified cold chain packaging
methods, and supplies. Qualified packaging methods were developed
for -20ºC products with two different packaging models.
Benefits to Galenova & Gentès & Bolduc Pharmacists
The storage and transportation environmental conditions of clinical and

sensitive products or samples and collected medical specimens should be
controlled and documented. Through IOP Qualifications, and helped by
the installation of ATP-Mirador™ and ATP-ThermoProfile™ solutions,
Galenova and Gentès & Bolduc Pharmacists was able to address good
cold chain management as well as implementing temperature-controlled
environments for the storage of products and specimens.
Our Compliance Services and Monitoring Solutions helped Galenova and
Gentès & Bolduc Pharmacists to assure and protect their product
integrity and efficacy whilst addressing the regulatory requirements.

T. (450) 661-5966 / 1-866-661-5966 / F. (450) 661-7966

Biotech Company: Theratechnologies
Preparation of Cold Chain and Pedigree Management for
a Clinical Biotech Drug products
Theratechnologies
Theratechnologies is a Canadian biopharmaceutical company that discovers innovative drug

candidates in order to develop them and bring them to market. The Company targets unmet medical
needs in financially attractive specialty markets. Its most advanced program is tesamorelin (TH
9507), now in a confirmatory Phase 3 clinical trial for a serious metabolic disorder known as HIV-
associated lipodystrophy. The Company also has other projects at earlier stages of development.
Theratechnologies ‘s products pipeline is oriented toward:
• HIV-associated lipodystrophy
• Growth hormone deficiency in abdominal obesity (GHDAO)
• Acute renal failure
Tesamorelin (TH9507) is a stabilized analogue of the growth hormone-releasing factor (GRF) that
induces growth hormone (GH) in a specific and physiological manner. To date, the studies suggest
that tesamorelin has several beneficial features: it reduces VAT, without reducing SAT and without
compromising glycemic control (blood glucose), it increases muscle mass and improves the lipid
profile. These characteristics make it an ideal candidate for the treatment of excess VAT, an
important aspect of HIV-associated lipodystrophy.
HIV-associated lipodystrophy is a metabolic disorder that afflicts a significant percentage of HIV
patients. Caused by several factors including the antiviral regimen and the virus itself, HIV-
associated lipodystrophy is characterized by changes in body composition, dyslipidemia and glucose
intolerance.
The changes in body composition include: accumulation of excess visceral adipose tissue (VAT) and
loss of subcutaneous fat tissue also known as SAT, generally in the limbs and facial area.
Excess VAT is believed to be a risk factor for cardiovascular disease and type 2 diabetes. In addition
to the direct health risks, the resulting body abnormalities can stigmatize patients and discourage
compliance with their HIV treatments.
Theratechnologies expects to submit its NDA by the end of 2008.
Preparing Cold Chain and Pedigree Compliance for Commercial

Tesamorelin
Throughout its Commercial Supply Chain, the Marketing, Sales & Distribution of Tesamorelin face
important compliance challenges in terms of Cold Chain Management and Pedigree Requirements.
Theratechnologies aims at defining its strategy in regard to Commercial launching of
Tesamorelin, this strategy being focused onto:
• Defining the best-suited Commercial Storage conditions and the related Stability Program for
the Tesamorelin;
• Ensuring the Cold Chain Compliance of the Manufacturing and Supply Chain of the Tesamorelin;
• Preparing the Compliance of the Supply Chain with Pedigree and other Security guidances.
• Defining the Commercial Storage Conditions of the Tesamorelin
The Tesamorelin has been clinically tested (Phases I-III) as a frozen Drug
product (-20ºC±5ºC). However it would be highly attractive to
commercially supply Tesamorelin as a refrigerated Drug product
(+5ºC±3ºC).
First the manufacturing and supply chain has been redefined from the
API supplier up to the end-user.
• Preparing the Stability Studies Program for the Tesamorelin

Based upon the previous stability testing, a novel Stability Studies
Program has been established to validate the future Storage conditions
of the Tesamorelin (+5ºC±3ºC). This Stability Studies Program takes into
considerations:
•The long-term Stability testing ((+5ºC, 12 months minimum)
•The accelerated Stability testing (+25ºC/60% RH, 6 months)
•The Temperature excursion Stability testing (+40ºC/75%RH, 48 hrs)
•The Thermal cycling Stability testing (Cycling at +5ºC and +25ºC) New
New Commercial
Commercial Drugs
Drugs
A deep knowledge of the Stability testing of a novel Drug products is
important for a good Storage and Transport conditions throughout the
Supply Chain. •• Cold
Cold Chain
Chain Gap
Gap Analysis
Analysis
The Stability results have to be provided for the NDA submission of the •• Stability
Stability Studies
Studies
Tesamorelin.
•• Environmental
Environmental Monitoring
Monitoring during
during Storage
Storage &&
Transport
Transport
• Defining and Implementing a Cold Chain validation Plan for the
Tesamorelin Supply Chain •• Mapping,
Mapping, I/OI/O Qualification
Qualification Studies,
Studies,
The commercial supply chain has been defined from the API supplier up Temperature
Temperature Profile
Profile Analysis
Analysis during
during Transport
Transport
to the end-user, including the manufacturer / packager, the wholesaler •Design & testing of packout and packaging
•Design & testing of packout and packaging
/ distributor, the specialty pharmacies, the transport providers… configurations
configurations
Each component of the Tesamorelin supply chain are visited for a •• PDMA
PDMA Compliance
Compliance && Pedigree
Pedigree Requirements
Requirements
regulatory gap analysis and audit focused on the Storage, Handling and
Transport conditions. •• VAWR
VAWR Accreditation
Accreditation (NABP)
(NABP)
The temperature profiles during transport as well as the packaging
methods are also reviewed for all supply chain steps:
• API supplier to manufacturer/ packager;
• Manufacturer to Wholesaler / Distributor;
• Wholesaler to Speciality Pharmacies;
• Specialty Pharmacies to End-users.
• Compliant Marketing & Sales for the Tesamorelin

The Marketing and Sales and the Supply Chain of the Tesamorelin are
reviewed and analyzed in terms of compliance with the pedigree and
other requirements, such as the FDA’s Prescription Drug Marketing Act
(PDMA), US National Association of the Boards of Pharmacy (NABP) and
US state pedigree requirements.
Benefits to Theratechnologies
Theratechnologies is a Biotech company focusing on the development of

Drug products. At the Clinical study III, Theratechnologies has to develop
its compliance strategy in terms of cold chain and pedigree requirements.
This strategy should encompass the Stability Studies, the Cold Chain
Compliance throughout the Supply Chain and the Compliance of the
marketing and Sales activities.

T. (450) 661-5966 / 1-866-661-5966 / F. (450) 661-7966

Pharmacies:
Ensuring Cold Chain at the Pharmacy Distribution Level
(shoppersdrugmart)
MATRIX
Shoppers Drug Mart / Matrix Logistics Services
Logistics & Transportation at a Pharmacy Banner level
Built on a foundation of professional expertise and personal service, Shoppers Drug Mart has been
meeting Canadians' health care needs for over 40 years. What was once a small pharmacy in Toronto
has grown into an organization of over 1,035 stores from coast to coast, becoming an indelible part
of the lives of Canadians, young and old. Yet despite their growth, they have never forgotten our
origins. They have always remained true to the belief that the personal satisfaction of each and
every customer is at the root of success - and it can only be ensured by the commitment of people
who realize that success is built one customer at a time.
Partnerships between Shoppers Drug mart and Matrix Logistics Services
Shoppers Drug mart and Matrix Logistics Services partnered for the distribution and supply of
pharmaceutical products to the pharmacies and institutions. The partners decided to implement the
cold chain management and control over the pharmacy supply chain.
• Cold Chain Gap Analysis

Alternatives Technologie Pharma realized a complete cold chain process analysis at
Shoppers/Matrix. The goal of the cold chain quality and gap analysis audit and its documentation
was to control the concordance between the cold chain related regulations that may apply to
Shoppers/Matrix, and the working environment at Shoppers/Matrix. Through this cold chain quality
and gap analysis audit, recommendations and advices worked out by Alternatives Technologie
Pharma were made to Shoppers/Matrix.
• Temperature Mapping of all Warehouses and DCs
Alternatives Technologie Pharma realized complete storage area mapping
for distribution centers in Canada. The storage area mapping was
performed using Alternatives’ ATP-ThermoProfile™ software and data
loggers monitoring system. Alternatives Technologie Pharma provided
mapping protocols, prepared the mapping missions, and performed the
collecting and analysis of all temperature data as well as the warehouse
mapping reports.
• I/O Qualification of thermal equipments

Alternatives Technologie Pharma performed the pre-qualification and
levelling up for all thermal equipment, and the redaction, execution and
approval of I/O Qualification protocols for all thermal equipment at
Shoppers/Matrix’s clinical centers (5 sites).
• Installation of ATP-Mirador™ Monitoring System in all DCs

All DCs and storage areas at Shoppers/Matrix’s clinical centers in Canada
were equipped with Alternatives’ ATP-Mirador™ central monitoring system.
Specification Requirements (URS), the design and installation of the ATP-
Mirador™ monitoring system for each clinical center, including the training,
the IOQ qualification and SOPs.
The installed ATP-Mirador™ monitoring systems incorporated wired
temperature sensors, and enabled the simultaneous monitoring of the
thermal equipment and the warehousing zones. Each ATP-Mirador™ system
was equipped with personalized floor plan interface(s) as required by the
site. The ATP-Mirador™ monitoring systems were qualified at
Shoppers/Matrix’s sites by our validation and compliance team.
• Installation of ATP-Thermoprofile™ Data loggers management System

ATP-ThermoProfile™ data loggers and logging missions management Cold
Cold Chain
Chain Solutions
Solutions for
for Pharmacies
Pharmacies
system was installed at Shoppers/Matrix.
It enables Shoppers/Matrix to perform environmental temperature •• Cold
Cold Chain
Chain Process
Process Analysis
Analysis
recordings, temperature mapping and IOQ protocols execution. ATP-
ThermoProfile™ system was a database version, installed centrally at •• Training
(Cold Chain)
Shoppers/Matrix. The ATP-ThermoProfile™ system was qualified at •• IOQ
IOQ of
of Thermal
Thermal Equipment
Equipment
Shoppers/Matrix’s sites by our validation and compliance team. •• Implementation
Implementation ofof ATP-Mirador™
Monitoring System
System
for
for Laboratory
Equipment
• Ambient Temperature Profiles during Transport •• Implementation
Implementation ofof ATP-ThermoProfile™
data loggers
loggers
Temperature Profile Analysis was performed with Shoppers/Matrix‘s DCs management
management system
system
(Moncton, Mississauga, Calgary) to determine the external temperature •• Cold
Cold Chain
Chain Shipping Containers, ATP-HemoThermal™
Shipping Containers, ATP-HemoThermal™
profiles during transport in Summer and Winter. •• Design
Design && test
test of
of Cold
Cold Chain
Chain Packaging
Packaging
Following the Temperature Profile Analyses, 48-hr Packaging Methods for
small and medium 2@8oC payloads were designed, tested and qualified at
Alternatives Technologie Pharma ‘s laboratory.
Benefits to Shoppers Drug mart and Matrix Logistics Services
Being a key component of the health product supply chain in Canada, Shoppers/Matrix has to protect and ensure the integrity and
quality of drug products to be transported and distributed to its pharmacies network.
By implementing a Cold Chain Management and Compliance plan, and by installing the ATP-Mirador™ and ATP-ThermoProfile™ systems
in its warehousing and distribution centers, Shoppers/Matrix ensured to fulfill the Canadian regulatory requirements for the temperature
control of drug products during storage and transportation.
Furthermore, Shoppers/Matrix is now able to provide maximal guarantees to its business partners, suppliers or customers:
manufacturers, retail pharmacies, hospitals, long-term care centres, clinics and other institutions.

T. (450) 661-5966 / 1-866-661-5966 / F. (450) 661-7966

Veterinarian Drugs Supply Chain:
Cold Chain Compliance for Veterinary Drug Products
Vétoquinol / CDMV
Vétoquinol
Vétoquinol was born in Lure, France, at the beginning of the 1930's, from Joseph Frechin's vision.
Since then, the company has always remained a family-owned business and experienced a sustained
growth that brought it to it's current position as a leader in the animal health market in Europe.
In 1990, Vétoquinol N.-A. Inc. was founded in Canada, to cater to the needs of the entire North
American market.
The Head Office, located in Lavaltrie, Québec, regroups the corporate administration for North
America as well as the Customer Service for Québec and the Maritimes. Two other locations, in
Cambridge, Ontario and Edmonton, Alberta, complete the Customer Service network.
The state-of-the-art manufacturing facilities located in Princeville, Québec, meet GMP and FDA
standards and manufacture products for our customers in Canada and the rest of the world.
CDMV
CDMV is a leading distribution provider for animal health products in Canada. With three major
distribution centers in canada, at St-Hyacinthe, Halifax and Calgary, CDMV stores and maintains
ambient, refrigerated and frozen animal health products. Distribution centers comprise warehousing
areas, loading/unloading docks, cold room, freezers (-10ºC/ -30ºC), narcotic vaults and quarantine
areas.
Guidelines for Temperature Control of Drug Products during Storage and

Transportation
GUIDE 0069, Guidelines for Temperature Control of Drug Products during Storage and Transportation
(HPFBI, Health Canada), aims at regulating the temperature control during storage and
transportation of Drug products for either human or veterinary uses. As a consequence, temperature-
sensitive Veterinary and Animal Health products shall be stored and transported following the
guidelines for Human Drug products.
These guidelines target the following points:
-Standard Operating Procedures (SOPs)

-Temperature monitoring in warehouse
-Validation of freezer and refrigerators
-Product storage conditions
-Temperature control during transport
-Packaging Methods
-Procedure for investigations and actions in the case
of temperature excursion from the set parameters
• Temperature Mapping of all CDMV’s Warehouses and DCs
Alternatives Technologie Pharma realized complete storage area
mapping for distribution centers in Canada. The storage area mapping was
performed using Alternatives’ ATP-ThermoProfile™ software and data
loggers monitoring system. Alternatives Technologie Pharma provided
mapping protocols, prepared the mapping missions, and performed the
collecting and analysis of all temperature data as well as the warehouse
mapping reports.
• Installation of ATP-Mirador™ Monitoring System in all CDMV’s DCs

All warehouses and storage areas at CDMV’s DCs in Canada were equipped
with Alternatives’ ATP-Mirador™ central monitoring system. Alternatives
Technologie Pharma prepared and provided the User Specification
Requirements (URS), the design and installation of the ATP-Mirador™
monitoring system for each clinical center, including the training, the IOQ
qualification and SOPs.
The installed ATP-Mirador™ monitoring systems incorporated wired
temperature sensors, and enabled the simultaneous monitoring of the
thermal equipment and the warehousing zones. Each ATP-Mirador™
system was equipped with personalized floor plan interface(s) as required
by the site. The ATP-Mirador™ monitoring systems were qualified at
CDMV’s sites by our validation and compliance team.
• Installation of ATP-ThermoProfile™ Data loggers management System

at Vétoquinol
system was installed at Vétoquinol.
Cold
Cold Chain
Chain Solutions
Solutions for
for Veterinary
Veterinary and
and
It enables Vétoquinol to perform environmental temperature recordings,
temperature mapping and IOQ protocols execution. ATP-ThermoProfile™
Animal Health Products
Animal Health Products
system was a Web version, installed centrally at Vétoquinol. The ATP-
ThermoProfile™ system was qualified at Vétoquinol’s sites by our •• Cold
Cold Chain
Chain Process
Process Analysis
Analysis
validation and compliance team. •• Training
(Cold Chain)
•• IOQ
IOQ of
of Thermal
Thermal Equipment
Equipment
• Ambient Temperature Profiles during Transport for Vétoquinol •• Mapping
Mapping of
of Storage
Storage && Warehousing
Warehousing area
area
Temperature Profile Analysis was performed from the Vétoquinol‘s DC to •• Implementation
Monitoring System
System
determine the external temperature profiles during transport in Summer for
for Laboratory
Equipment
and Winter.
data loggers
loggers
management
management system
system
• Design and Qualification of Vétoquinol’s Packaging Methods •• Design
Design && test
test of
of Cold
Cold Chain
Chain Packaging
Packaging
Following the Temperature Profile Analyses, 2@8oC Packaging Methods for
three different-size payloads were designed, tested and qualified for 24-
hr periods in Summer and Winter.
Benefits to Veterinary and Animal Health products Company
Being a key component of the Animal Health product supply chain in Canada, CDMV and Vétoquinol has to protect and ensure the
integrity and quality of products to be transported and distributed to veterinary clinics and animal health product stores.
By implementing a Cold Chain Management and Compliance plan, and by installing the ATP-Mirador™ and ATP-ThermoProfile™ systems
in its warehousing and distribution centers, CDMV and Vétoquinol ensured to fulfill the Canadian regulatory requirements for the
temperature control of drug products during storage and transportation.
Furthermore, CDMV and Vétoquinol is now able to provide maximal guarantees to its business partners, suppliers or customers:
manufacturers, veterinary offices, veterinary hospitals, clinics and other institutions.

T. (450) 661-5966 / 1-866-661-5966 / F. (450) 661-7966

Cold Chain Telemonitoring System:
Telemonitoring Services for Storage areas in Pharmacies
The Pharmacist and the Cold Chain
The concept of the cold chain is all the necessary means to maintain therapeutic products
within the temperature limits specified by the manufacturer during the distribution, the
manufacturing and up to the patient administration, including the transportation and the
storage.
The pharmacy is the utimate link of the Life Science products supply chain to deliver
therapeutics and drug products to patients.
Even if more stringent cold chain guidelines and regulations apply onto the pharmaceutical
industry and its first supply chain components, the entire pharmaceutical supply chain
including pharmacies is concerned by such guidelines and regulations.
Several communication and official notices have been already edited in order to inform and
sensitize the pharmacists to the crucial importance of cold chain.
However, many community pharmacies do not have the resources to operate complex and
performant cold chain monitoring systems onsite to control the storage conditions in
officines, storage areas and thermal equipment. Current automated monitoring systems
require hosting capabilities and trained staff to be operated and maintained efficiently.
To cope with such concerns, Alternatives Technologie Pharma Inc. proposes a cold chain
telemonitoring system as a Solution as a Service (SaaS) that is specially tailored for
pharmacies and small laboratories, thus providing the advantages of real-time continuous
monitoring system but avoiding the need of too heavy staff and resources.
This cold chain telemonitoring system has been successfully installed in several community
pharmacies of the Proxim pharmacy banner (a major Quebec pharmacy chain).
Cold chain telemonitoring system provides many advantages:
• Remote Cold Chain Monitoring

ATP-Mirador™ Express
• Vendor hosted & Internet Access Software and Database
• Adaptable RF (wireless) Sensors Network (Vendor-hosted)
• Enhance your Quality and Productivity

• Controlled by Cold Chain Compliance Specialists
• Ideal Solutions for:
-Retail Pharmacies,
-Specialized Pharmacies,
-Blood banks,
-Laboratories,
-Small-scale Facilities
WEB
A COLD CHAIN TELEMONITORING KIT FOR CONTROLLING
TEMPERATURES IN YOUR PHARMACY AND STORAGE AREAS,
The web telemonitoring service ATP-Mirador™ Express provides a

continuous monitoring of the temperatures in your various storage areas and
equipments. You receive automatic alarm signals in case temperature
excursions occur in your storage rooms or refrigerators.
ATP-Mirador™ Express provides features such as Remote Cold Chain
Monitoring, Web hosting & Internet Access, Adaptable RF Sensors Network,
Enhance your Quality and Productivity, Control by Cold Chain Compliance
Specialists.
Telemonitoring features:
• Easy Installation: ATP-Mirador™ Express includes your telemonitoring

device and account registration notice. Install your telemonitoring devices
and register your account on our ATP-Mirador™ ExPress Web portal. You are
ATP-Mirador™ Express Solution:
Solution:
ready to perform telemonitoring of your facilities !
• Internet-Enabled Access (Web Hosting): Web application, you can access -Laboratories,
-Laboratories, Storage
Storage areas
areas and
and Storage
Storage and
and Thermal
Thermal
your account and data from any computer with an internet (web) access, and equipment
equipment (refrigerators,
(refrigerators, freezers…)
freezers…)
you can monitor multiple sites. The past or current information remains -21
-21 CFR
CFR part
part 1111 Compliant
Compliant (electronic
(electronic records/signatures)
records/signatures)
always available. -Application
-Application hosted
hosted and
and managed
managed by by Alternatives
Alternatives
• Wireless Network: Cold chain telemonitoring is performed wirelessly Technologie
Technologie PharmaPharma
through a network of Radio-Frequency sensors and readers (no wiring). You -Web
-Web Access
Access && Account
Account
can move your equipment around while maintaining the temperature -Wireless
-Wireless Readers
Readers and and Sensors
Sensors (RF)
(RF)
monitoring.
-Temperature
-Temperature Sensors,
Sensors, Temperature
Temperature monitoring
monitoring from:
from:
• Sophisticated Alarms: Sends alarms by email, SMS and pager; Set yourself
Standard
Standard :: -30ºC
-30ºC toto +60ºC
+60ºC (0,50ºC
(0,50ºC accuracy)
accuracy)
low and high alarm limits and recipient parameters.
External
External sensor
sensor :: -40ºC
-40ºC toto +80ºC
+80ºC (0,50ºC
(0,50ºC accuracy)
accuracy)
• Regulatory Compliance: Generate reports and graphs under regulatory
formats, audit trail on the system. Sensors are calibrated annually via a -Sensors
-Sensors calibrated
calibrated annually
annually
unique exchange program. You can demonstrate your facility complies with -«No-Worry»
-«No-Worry» Exchange
Exchange Program
Program
the most stringent cold chain regulations and guidelines. -Calibration
-Calibration status isis checked
status checked andand manage
manage byby Vendor
Vendor
• Scalable & Adaptable Architecture: The use of optimized sensors networks -Secured User Access; Multi-levels
-Secured User Access; Multi-levels
enables to build up scalable system architectures that adapt to small storage -Configurable
-Configurable && parametrable
parametrable by by user
user
areas as well as large warehouses. You can add new equipment to the system -English/French
according to your schedule and budget. The system conforms to your needs -English/French languages
languages
and can integrate new equipments. -Ideal
-Ideal for
for small
small scale
scale site
site
-System
-System isis scalable
scalable toto new
new needs
needs
• Multi-Equipments: Telemonitoring and recording of temperatures (-30ºC@
+70ºC). All your equipment are regularly monitored in one place. -Alarm
-Alarm types:
types: E-mail
E-mail (SMS)
(SMS) notification
notification
• Customizable: Multi-users access managed by access rights, alarms are -Provided
-Provided with
with User
User Manual
Manual
manageable (by equipment, day, time and type), French/English, C/F. Adapt -Qualification
-Qualification (I/O) at Alternatives
(I/O) at Alternatives Technologie
Technologie Pharma
Pharma
your monitoring system to your needs and activities.
Benefits to Pharmacies and Laboratories
The ATP-Mirador™ Express telemonitoring system as a Solutions as a Service (SaaS) is a ideal way to have an automated central monitoring
system that provides you with a efficient and sophisticated temperature monitoring system. However, ATP-Mirador™ Express telemonitoring
system avoids the pharmacy or laboratory to invest in heavy monitoring hardware and server or to require specialized IT staff.
ATP-Mirador™ Express provides a Vendor qualified and hosted monitoring system that is managed by highly skilled cold chain compliance
and IT specialists. It gives access to configurable user account and system parameters (alarms, units…) and can be expandable and adaptable
to your needs.
With ATP-Mirador™ Express telemonitoring system, you combined the features of a central automated monitoring system with the
advantages of a Solutions as a Service.

T. (450) 661-5966 / 1-866-661-5966 / F. (450) 661-7966

Monitoring System for Pharmaceutical
Facility:
Wired and Wireless Networks of Sensors at Roche
About Roche Canada
From its approach to clinical trials for new drug therapies, to industry partnerships and community
involvement, Roche is a leader in providing pharmaceutical and diagnostic solutions that make a
profound difference in people's lives.
At Roche, there are committed to improving the effectiveness and efficiency of the healthcare
system in the diagnosis, treatment and management of acute and long-term disease. Roche is
focused on a number of key critical therapeutic and diagnostic areas, including oncology,
rheumatoid arthritis, virology and transplantation.
Roche is also committed to supporting leading research and development — including clinical
research, clinical trials and genetic research — by pursuing innovative approaches in our search for
superior healthcare products.
More than 75 years of business in Canada, Roche employs over 500 people across the country.
Operations are centered in Mississauga, Ontario (pharmaceuticals) and Laval, Quebec (diagnostics).
Roche serves a broad base of healthcare facilities and practitioners across the country, working in
partnership with them to ensure that the diagnostics and therapies Roche delivers meet the medical
needs of today and of the future.
Monitoring System for Roche’s Pharmaceutical facility
Roche wanted its main operational center (pharmaceutical) in Mississauga (Ontario) to be fully
monitored, including receiving, packaging and retain areas, computer rooms as well as all
refrigerators/freezers and cold room. The environmental conditions monitoring at Roche’s facility
enables compliance with Health Canada’s guidelines and regulations.
Roche selected the ATP-Mirador™ central monitoring system proposed by Alternatives Technologie
Pharma to monitor its facility at Mississauga, Ontario.
The ATP-Mirador™ central monitoring system at

Roche’s facility has the following characteristics
and features:
• Automated monitoring system, installed centrally

at Roche’s site
• Compliant with CFR21 part 11
• Web environment
• Access in real-time through Roche’s intranet
• Multiple configurable Alarm types
• Monitor Temperature and Relative Humidity
• Monitor Water level
• Incorporate Wired and Wireless Sensors
• Qualified onsite (IQ/OQ); Provided with Training
and Regulatory Documentation
• Technical Support and Service Plan
• « No Worry » Calibration Plan
REAL-TIME MONITORING SYSTEM FOR FACILITIES, ATP-Mirador™
Web Applications to Monitor Environmental Conditions

The ATP-Mirador™ Web applications are real-time monitoring systems that

provide compliant monitoring solutions. This platform is available in different
configurations for multiple applications of environmental conditions
monitoring during the various Storage and Transportation steps.
The ATP-Mirador™ Web applications are specifically designed to monitor
environmental conditions of thermal equipment and storage facilities, such
as laboratories, manufacturing, packaging and storage areas, but also of
transportation vehicles. It fully complies with regulatory requirements of Life
Science and Healthcare sectors and is an essential and valuable tool for the
management of your cold chain that is by the same token contributing to the
temperature assurance, the integrity and the efficacy of environmentally
sensitive products.
Wired with daisy chain configuration
A highy-effective Monitoring System using Wired and
Wireless Networks of Sensors
The ATP-Mirador™ Web monitoring system installed at Roche’s facility

incorporates both wired and wireless sensors by combining a wired with daisy
chain configuration and a RadioFrequency (RF) with star configuration. This
architecture allows to monitor highly complex facilities including storage
areas and Equipments.
At Roche’s facility, the ATP-Mirador™ Web monitoring system incorporates

more than 35 sensors, including 11 radio-Frequency temperature sensors
(ambient temperature in storage areas), 21 wired temperature sensors (for
equipment), 2 wired Relative Humidity sensors and 1 Water level sensor. All
such sensor networks were connected and managed through the ATP- RadioFrequency (RF) with star configuration
Mirador™ Web application software.
Sensors for Temperature monitoring can monitor from -196ºC to +125ºC

(0,25ºC to 1,00ºC accuracy), and Sensors for Relative Humidity can monitor
from 10 to 90% R.H. (1,5 to 3% accuracy).
Sensors for differential pressure in Cleanrooms and other sensor types (e.g.:
water level, CO2 level…) can be installed on the ATP-Mirador™ Web
monitoring system.
The ATP-Mirador™ system is programmed according to Roche‘s needs and

layouts (interface) and provided a secure but highly configurable
environment to Roche’s users. Alarms are typically sent using emails or SMS.
The ATP-Mirador™ system is also equipped with a relay that can be used to
activate audible alarms, visual alarms or to trigger an alarm panel).
Benefits to Roche
By installing the ATP-Mirador™ Web monitoring system in its main pharmaceutical facility, Roche can automatically monitor and record
the environmental conditions that prevail within its facility, from the packaging area to the computer room, and including all refrigerators
and freezers. This provides an unique and sophisticated tool to ensure the temperature-sensitive products are maintained under adequate
conditions during all storage, handling and transport steps, thus helping Roche to comply with the recent Health Canada’s guidelines and
regulations.

T. (450) 661-5966 / 1-866-661-5966 / F. (450) 661-7966

Monitoring System for Laboratories and
Facilities:
Wireless Sensors Network with Mesh Configuration
About SGS Life Science Services
SGS Life Science Services is a leading contract service organisation providing clinical research and
quality control testing services.
Specifically, SGS Life Science Services offers drug development services for Phase I to IV clinical
trials, biostatistical management services, regulatory affairs services and bioanalytical laboratory
services, as well as comprehensive high quality testing capabilities in microbiology, analytical
chemistry, biocompatibility, toxicology, microbiology, sterility, method development and stability
testing to pharmaceuticals, biotechnology, medical devices and cosmetics companies worldwide.
SGS Life Science Services operates a network of more than 30 laboratories and offices as well as 3
clinical research units in Europe, Asia and the Americas.The business line employs about 1,200
physicians, scientists, investigators, technicians, nurses, and analysts to offer best in class services
to our clients.
In Canada, SGS Life Science Services has its laboratories in Mississauga, Ontario.
Monitoring System for Roche’s Pharmaceutical facility
SGS Life Science Services wanted its newly-built laboratory (pharmaceutical) in Mississauga
(Ontario) to be fully monitored, including all refrigerators/freezers and cold roomused to store
medicines, drugs and clinical specimens. The environmental conditions monitoring at SGS Life
Science Services ’s facility enables compliance with Health Canada’s guidelines and regulations.
SGS Life Science Services selected the ATP-Mirador™ central monitoring system proposed by
Alternatives Technologie Pharma to monitor its facility at Mississauga, Ontario. This ATP-Mirador™
monitoring system has the new Wireless with Mesh Configuration system.
The ATP-Mirador™ central monitoring system at SGS Life

Science Services’s facility has the following characteristics
and features:
• Automated monitoring system, installed centrally at SGS

Life Science Services’s site
• Compliant with CFR21 part 11
• Web environment
• Access in real-time through SGS Life Science Services’s
intranet
• Multiple configurable Alarm types
• Monitor Temperature and Relative Humidity
• Monitor Water level
• Incorporate only Wireless Sensors (Mesh configuration)
• Qualified onsite (IQ/OQ); Provided with Training and
Regulatory Documentation
• Technical Support and Service Plan
• « No Worry » Calibration Plan
REAL-TIME MONITORING SYSTEM FOR FACILITIES, ATP-Mirador™
Web Applications to Monitor Environmental Conditions

The ATP-Mirador™ Web applications are real-time monitoring systems that

provide compliant monitoring solutions. This platform is available in different
configurations for multiple applications of environmental conditions
monitoring during the various Storage and Transportation steps.
The ATP-Mirador™ Web applications are specifically designed to monitor
environmental conditions of thermal equipment and storage facilities, such
as laboratories, manufacturing, packaging and storage areas, but also of
transportation vehicles. It fully complies with regulatory requirements of Life
Science and Healthcare sectors and is an essential and valuable tool for the
management of your cold chain that is by the same token contributing to the
temperature assurance, the integrity and the efficacy of environmentally
sensitive products.
A Monitoring System using Wireless Network of Sensors in

Mesh Configuration
The ATP-Mirador™ Web monitoring system installed at SGS Life Science

Services’s facility incorporates a new configuration and hardware version Temperature
comprising a network of 100% Wireless sensors (Radio-Frequency with Mesh
configuration). This new Wireless configuration provides key advantages:
- Really unexpensive to install and manage (it minimizes The costs related to
wiring)
- Can move equipment easily (Mesh Network realigns by itself)
- Sensors act as relays (Mesh) which gives Better Reliability and Efficiency to
the Sensors Network Temperature
- Can be applied on Fixed or Mobile Monitoring System

- From Rafio-Frequency (RF) to WiFi (IEEE802.15.4, 2.4Gz antenna)
At SGS Life Science Services’s facility, the ATP-Mirador™ Web monitoring

system incorporates more than 40 wireless sensors, including 25 temperature
sensors (-15ºC to +60ºC), 10 RTD temperature sensors (-80ºC to -10ºC ), and RH
10 Relative Humidity sensors. All such sensors communicates and are
managed through the ATP-Mirador™ Web application software. All Wireless
sensors incorporates internal memory (data storage).
The ATP-Mirador™ system is programmed according to SGS Life Science

Services‘s needs and layouts (interface) and provided a secure but highly
configurable environment to SGS Life Science Services’s users. Alarms are
typically sent using emails or SMS.
Benefits to SGS Life Science Services
By installing the ATP-Mirador™ Web monitoring system in its laboratory, SGS Life Science Services can automatically monitor and record
the environmental conditions that prevail within its facility, from storage areas to all refrigerators and freezers. This provides an unique
and sophisticated tool to ensure the temperature-sensitive products are maintained under adequate conditions during all storage, handling
and transport steps, thus helping SGS Life Science Services to comply with the recent Health Canada’s guidelines and regulations.

T. (450) 661-5966 / 1-866-661-5966 / F. (450) 661-7966

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Alternatives’ Cold Chain Expertise: Case Study

Clinical Research Organizations:

Early-phase Development Services

As a PharmaNet Development Group company, Anapharm has access to a global network of

Anapharm’s expertise is well reputable in Europe, North-America, South-America, Oceania and

• Cold Chain Analysis

• IOQ Qualification of thermal equipments

3100 de la Concorde East, Suite 211

© Copyright Alternatives Technology Pharma 2008

Ensure the Héma-Québec’s Cold Chain Management during Blood

Alternatives Technology Pharma has been mandated by Héma-

• First, Alternatives evaluated the Héma-Québec’s needs and

• Secondly, Alternatives developed and provided customized

Ultimately, Héma-Québec equipped its two sites of Quebec-city and

• Héma-Québec also installed the ATP-Sentinel™ system to monitor their cargo

• ATP-ThermoProfile™ solution for monitoring Blood

3100 de la Concorde East, Suite 211

© Copyright Alternatives Technology Pharma 2008

In 2004, Sandoz acquired Sabex, headquartered in Boucherville, Canada. This strategic

To make health accessible to all

Sandoz has decided to outsource the distribution of their products to UPS,

• Installation of ATP-Mirador™ Monitoring System for Conditioning

• Cold Chain Packaging Methods

Benefits to Sandoz Canada

3100 de la Concorde East, Suite 211

© Copyright Alternatives Technology Pharma 2007

• Cold Chain Management Analysis

• Engineering on thermal equipments

• IOQ Qualification of thermal equipments

• Cold Chain Methods, ATP-HemoThermal™

3100 de la Concorde East, Suite 211

© Copyright Alternatives Technology Pharma 2008

McKesson Canada plays a pivotal role in the Canadian health care

McKesson Specialty Pharmaceutical Solutions:

McKesson Canada partners with Alternatives Technologies

• IOQ Qualification of thermal equipments

•Installation of ATP-Mirador™ Monitoring System in 15

Benefits to McKesson Canada

3100 de la Concorde East, Suite 211

© Copyright Alternatives Technology Pharma 2008

Royal Victoria Hospital (MUHC)

The McGill University Health Center’s most important Hospital in Montréal

Producing Biological Drugs from

The Apheresis Laboratory and Stem Cell

These MUHC laboratories are concequently

In Canada, both the Apheresis Laboratory and

Furthermore, the MUHC’s Apheresis Laboratory

• ATP-HemoThermal™ container for Sensitive Products

Benefits to Royal Victoria Hospital

3100 de la Concorde East, Suite 211

© Copyright Alternatives Technology Pharma 2008

Skelton Trucks Line Ltd.

Temperature-controlled transportation is certainly a must to ship

• Ensure Compliance to Health Canada (Guide-0069)

This Qualification work includes:

For Skelton, Alternatives Technologie Pharma performed re-

Trailers were temperature-mapped (2-8ºC/15-25ºC) for a 24-hr period at

Benefits to Skelton Truck Lines

3100 de la Concorde East, Suite 211

© Copyright Alternatives Technology Pharma 2008

Laboratoire Médical Biron

Being a services laboratory for health customers,

To establish a well-controlled temperature-controlled

• Installation, Operational & Performances Qualification of