Service Catalogue 2014

Prices valid from April 2014

Robert-Perthel-Str. 49
D-50739 Kln
Tel.: +49-(0)221-957457-0
Fax.: +49-(0)221-957457-25
e-mail: info@compliance-microbiology.de

www.compliance-microbiology.com

Compliance Advice and Services in Microbiology GmbH

Content

Service Catalogue 2014 .................................................................... 1

About us............................................................................................ 4
Your Contacts ................................................................................... 6
Laboratory services........................................................................... 7
Biological Indicators ......................................................................... 7
Determination of resistance in the BIER-Vessel ....................................................................................... 7
Determination of resistance in dry heat ................................................................................................... 9
CFR-Part 11 documentation of process data ............................................................................................ 9
spore suspensions ............................................................................................................................... 10
Additional offers for D-Value determinations ......................................................................................... 10
Manufacture and Certification of customer specific Bio Indicators ........................................................... 11
Surveillance of sterilisers through bioindicators ...................................................................................... 11

Chemical indicators ........................................................................ 12

Microbiological Examination of Pharmaceutical Products according
Ph. Eur. ........................................................................................... 13
Water for Pharmaceutical Purposes; Determination of the Total Viable Count with Membrane filtration ..... 13
Microbiological Examination of Non Sterile Products (Ph. Eur 2.6.12 ) .................................................... 14
Total viable aerobic count .................................................................................................................... 14
Microbiological Examination of Non Sterile Products (Ph. Eur 2.6.13) ..................................................... 14
Combined Examination of Non Sterile Products (according to Ph. Eur. 5.1.4)........................................... 15

Compliance Advice and Services in Microbiology GmbH

Suitability of the Total Viable Count Method in the presence of the product (Ph. Eur.2.6.12 ) ................... 16
Suitability testing: Test for specified microorganisms ............................................................................. 16
(Ph. Eur. 2.6.13) ................................................................................................................................. 16
Efficacy of Antimicrobial Preservation (Ph. Eur. 5.1.3) ............................................................................ 17
Validation of the method for Determination of the Total Viable Count ..................................................... 17
Bacterial Endotoxin Test (LAL-Test, Ph. Eur. 2.6.14) .............................................................................. 18
Environmental monitoring .................................................................................................................... 18
Microbiological Examination of pharmaceutical production and adjacent areas......................................... 19
Qualification of culture media ............................................................................................................... 19
Additional reports ................................................................................................................................ 19

Validation studies ........................................................................... 20

Allowance for individual studies and examinations in the
laboratory ....................................................................................... 20
Microbiological Competence ........................................................... 21
General terms and conditions ......................................................... 26

Compliance Advice and Services in Microbiology GmbH

About us
Service concept
With the foundation of Compliance Advice
and Services in Microbiology, GmbH in
Cologne, Germany in 1999, our mission
was to competently support enterprises
with their microbiological problems and
encounter those with practical solutions.
Our goal is to provide our customers with
a service that not only contains of a
classical
microbiological
laboratory
service, but also microbiological consulting
services. Thus, we offer an approach of a
whole service from the development of
a concept through the execution of
experiments in the laboratory.
We may help you with the realisation of
experiments that have been developed
within a consulting project. This may result in individual project plans, tailored to your needs. On the other
hand, results of laboratory projects may require professional experience to draw the right conclusions. As
all of our projects are scientifically supervised by Dr. Klaus Haberer, we can assure that we posses the
necessary expertise to support you with your problems as well.
Our customers can be sure to receive a complete Service from one source and avoid complicated and
indirect communication and coordination from the beginning. We provide you with personal advice and a
flexible laboratory-service at all times.

Working areas
Besides the standardised testing accoring to Ph. Eur., we were
able to build up great expertise in the field of D-Value
determinations and Biological Indicators. There are few other
laboratories that can match our experiences in this area. For
these experiments, we regularly use our BIER-Vessel (Biological
Indicator Evaluation Resistometer), particularly for tests with
spore preparations on different surfaces and the recertification of
Biological Indicators.
Additionally, we may provide support also for very special and
complex problems within the area of quality assurance. This
contains the planning and execution of a variety of experiments
for example, product specific endotoxin depletion studies or
container closure studies.
Even individual projects with the conception of mechanical
devices to match certain experiment requirements have been
realized in the past. If you need support with individual solutions
for your microbiological problems, come and speak to us.

Compliance Advice and Services in Microbiology GmbH

Microbiological Competence

Good advice is the combination of practical experience and state-of-the art know-how.
All services provided for our clients are technically reviewed by Dr. Klaus Haberer. He combines more than
30 years of practical experience in the pharmaceutical industry with profound know-how in the sector of
microbiological quality assurance in pharmaceutical product manufacturing. He is one of the best recognized
specialists in his area of expertise worldwide. Throughout his professional career, he has supported
numerous companies with a great variety of microbiological challenging projects, including the planning of
sterilization processes and elimination of errors within such processes.
This highly specific expertise helps us to provide high value with consulting, planning and executing our
microbiological services. His advice in specific questions remains exclusively available for our clients. Our
goal is to deliver high-quality results to customers, and our experience assures that we reach it.

If you would like to learn more about Dr. Haberer and his professional experience, you are provided with
more detailed information starting at page 21.

Quality management system

Our mission is to provide our customers with high qualitative services to their satisfaction. Our quality
management system ensures to fulfill this requirement. Together with our great flexibility and the close
cooperation to our customers, we provide convenient solutions for our customers problems.
Our
laboratory
is
inspected
by
our
64 AMG (German pharmaceutical legislation)

regulatory

authorities

in

compliance

with

Compliance Advice and Services in Microbiology GmbH

Do you have further questions about compliance or our services?

Your Contacts
Dr. habil. Klaus Haberer
Managing Director,
Microbiological issues & consultancy

Karl-Heinz Schhlein
Managing Director,
Commercial Issues

Hildegard Haag

Christopher Schhlein

Head of laboratory

Accounting / Controlling

Tel.:
Fax.:
e-mail:

+49-(0)221-957457-0
+49-(0)221-957457-25
info@compliance-microbiology.de

Status: February 2014

Laboratory services

Laboratory services
Unfortunately, we can not provide you with prices in the PDF Version of this catalogue. On your
demand, we will send you a paper version including prices, or provide you with an individual
quotation upon request.

Biological Indicators
For the determination of the resistance of biological indicators in dry heat or in the BIER-Vessel, we will
establish an individual quotation upon your request.

Determination of resistance in the BIER-Vessel

The D-Value determinations (determination of resistance) of spore preparations are being performed in our
Resistometer (BIER-Vessel) for steam sterilization processes. Furthermore, we are able to determine whether
your biological indicator is applicable for your sterilization process or not. Our BIER-Vessel matches the
requirements of AAMI and ISO 11138-3.
We are also able to establish new models for specific problems in close cooperation to our customers.

D-Value calculation
The calculation of the D-Value can be performed through two different methods:
1. Statistical method; FN-method (= Fraction Negative)
2. Enumeration method
For recertifications of bioindicators, we recommend to choose the method, that the manufacturer indicates in
the certificate for the particular bioindicator or spore suspension

On your demand, we can also record the process data according to the requirements of CFR Part 11 and
provide you with a graphic performance on the recorded data.

Laboratory services

Corroboration of D-value for biological indicators (e.g. paper strips, ampoules) in the
BIER-Vessel by use of the FN-Method (up to 7 inactivation times of max. 30 minutes with
10 replicates each run), including initial viable spore count

Corroboration of D-value for biological indicators (e.g. paper strips, ampoules) in the
BIER-Vessel by use of the Enumeration Method (up to 5 inactivation times of max. 30
minutes with 3 replicates each run), including initial viable spore count

Corroboration of D-value for spore suspensions in the BIER-Vessel by use of the FNMethod (up to 7 inactivation times of max. 30 minutes with 10 replicates each run),
including preparation of replicates and initial viable spore count
Corroboration of Survival / Kill-time in the BIER-Vessel, including initial viable spore
count

Prices upon
request

Determination of D-value for spore suspensions on surfaces in the BIER-Vessel by

use of the FN-Method (up to 7 inactivation times at 121 C of max. 30 minutes with 10
replicates each run), including preparation of replicates and initial viable spore count

Determination of D-value for spore suspensions in product in the BIER-Vessel by use

of the FN-Method (up to 7 inactivation times at 121C of max. 30 minutes with 10
replicates each run), including preparation of replicates and initial viable spore count,
growth control of product dilution
(Please note: The D121C-value for spore suspensions provided by Compliance has already
been corroborated.)
Determination of z-value (D-value determination for a spore preparation in product at
3 different temperatures) in the BIER-Vessel, including preparation of replicates and initial
viable spore count

Laboratory services

Determination of resistance in dry heat

Corroboration of D-value for biological indicators (paper strips) in dry heat by use
of the FN-Method (up to 7 inactivation times of max. 30 minutes with 10 replicates each
run), including initial viable spore count.
Determination of D-value of spore preparations (e.g. in product) at various
temperatures in dry heat by use of the FN-Method (up to 7 inactivation times of max.
30 minutes with 10 replicates each run), including preparation of replicates and initial
viable spore count

Prices upon
request

CFR-Part 11 documentation of process data

CFR Part 11 compliant documentation of process data at various positions by use of
the Kaye Validator (CD)

CFR Part 11 compliant documentation of process data at various positions by use of

the Kaye Validator (CD and graphic performance)

mbar
Temp in C

250

2000

200

1500

150

1000

100

500

50

16:01

15:01

14:01

13:01

12:01

11:01

10:01

09:01

08:01

07:01

06:01

05:01

04:01

03:01

02:01

01:01

0
00:01

Temperature (C)

Pressure (mbar)

2500

Prices upon
request

Time (min)
fig:
Temperature- and pressure conditions in the BIER Vessel; defined and reproducable expositionconditions

Laboratory services

spore suspensions
Provision of a independently certified spore suspension of G. stearothermophilus
ATCC 7953 with a spore titer of 1 E8/ml, sufficient for 1-2 D-value determinations
(minimum quantity 2ml*)

Prices upon
request

Further spore suspension can be provided upon request

Additional offers for D-Value determinations

Sporulation of isolates provided by the customer, incl. microscopic control of purity
and initial viable spore count
Identification of aerobic spore-forming bacteria by means of API-System

Evaluation of colony morphology and purity

Growth

Promotion

Test,

inoculation

of

the

testmicroorganism

(e.g.

G.

stearothermophilus) in the product dilution (TSB+sample)

Subculturing on CASO-Agar if a product leads to a turbidity of the media by themself
and a visual evaluation of growth in the enrichment isnt possible (e.g. for emulsions or
suspenions)

Prices upon
request

Inactivation of antimicrobial ingredients with e.g. filtration

Blank & Cooney-study for products with a strong antimicrobial activity
Determination of a spore population, spore suspension provided by the client
(without Determination of Resistance/D-Value Determination)

Note: For products with antimicrobial activities testing procedures have to be agreed on.

10

Laboratory services

Manufacture and Certification of customer specific Bio Indicators

Prices upon request; we will establish an offer adapted to your
individual needs

Inoculated product filled in Ampoules, incl. Provision of a independently certified

spore suspension of e.g. G- stearothermophilus ATCC 7953 with a spore titer of 1 E8/ml,
D-value determination of the spore preparation, initial spore count, growth control of
product dilution
Inoculated stoppers or caps, incl. Provision of a independently certified spore
suspension of e.g. G- stearothermophilus ATCC 7953 with a spore titer of 1 E8/ml, Dvalue determination of the spore preparation, initial spore count, growth control of
product dilution
Inoculated primary package , incl. Provision of a independently certified spore
suspension of e.g. G- stearothermophilus ATCC 7953 with a spore titer of 1 E8/ml, Dvalue determination of the spore preparation, initial spore count, growth control of
product dilution

Other surfaces, incl. Provision of a independently certified spore suspension of e.g. Gstearothermophilus ATCC 7953 with a spore titer of 1 E8/ml, D-value determination
of the spore preparation, initial spore count, growth control of product dilution
Stability test of customer specific Bio Indicators incl. Storage under specified
conditions, determination of the viable spore count after 1 and 3 month storage time,
Corroboration of D-value at the end of the storage time with one exposition time in the
FN-Range

Surveillance of sterilisers through bioindicators

Provision of 10 certified spore strips, additionally 1 strip as positive control, dispensing
in nutrient media and incubation, documentation of results

Upon request

The required number of spore strips depends on the size of the dry heat sterilizer. 10 spore strips are
sufficient for a medium-sized sterilizer.
Please contact us for assisting you to verify the requested count of Bioindicators for your Steriliser!

11

Laboratory services

Chemical indicators
Chemical Indicators are being used for daily controls as well as for the validation of
sterilization processes.
Different types of sterilization demand the use of adapted, particular Chemical Indicators.
Various products are being offered at the market.
Chemical Indicators are classified according to DIN EN ISO 11140-1.
We are able to verify, if the Chemical Indicator used lies within accordance to ISO
11140 classification, using either our BIER-Vessel or our Dry Heat Sterilizer.

Prices upon
request

We may verify the following classes of Chemical Indicators:

class
class
class
class

1(process indicators)
3 (single variable indicators)
4 (multivariable indicators; on the basis of ISO)
5 (steam integrating indicators; on the basis of ISO)

12

Laboratory services

Microbiological Examination of
Pharmaceutical Products according Ph.
Eur.
Water for Pharmaceutical Purposes; Determination of the
Total Viable Count with Membrane filtration
Aqua purificata (purified water)
1 sample (filtration of 100ml)
2-4 samples in one test (per sample)
> 5 samples in one test (per sample)

Prices upon
request

Amount of water needed per test:

Aqua valde purificata (high purified water)

1 sample (filtration of 1 ml and 200ml Probe)
2-4 samples in one test (per sample)
> 5 samples in one test (per sample)

Prices upon
request

Amount of water needed per test:

Aqua ad iniectabilia (Water for injection/WFI)

1 sample (filtration of 1 ml and 200ml Probe)
2-4 samples in one test (per sample)
> 5 samples in one test (per sample)

Prices upon
request

Amount of water needed per test:

13

Laboratory services

Microbiological Examination
(Ph. Eur 2.6.12 )

of

Non

Sterile

Products

Total viable aerobic count

Total Aerobic Microbial Count (TAMC) and Total Combined Yeast and Mould Count
(TYMC)
Membrane filtration* each dilution additional

Prices upon
request

Pour plate method additional

Customer specific tests
Necessary Amount of product per test:

Min. 10 g or ml

* applicable to all products which can be rendered filterable into a suitable solution

Microbiological Examination
(Ph. Eur 2.6.13)

of

Non

Sterile

Products

Detection of specific microorganisms

Bile-tolerant gram-negative bacteria, E. coli, Ps. aeruginosa, S. aureus, per germ
Salmonella
Prices upon
request

Clostridia
Bile-tolerant gram-negative bacteria (quantitativ)
Candida albicans
Necessary Amount of product per test

30 g or ml

14

Laboratory services

Combined Examination of Non Sterile Products (according to

Ph. Eur. 5.1.4)
Oralia (Aequous and non-aequous preparations) TAMC, TYMC and specified
microorganisms (E. coli)
Oralia vegetable or mineral origin for which antimicrobial pre-treatment is not feasible
and with approval of viable count of raw material of > 10 3 cfu per g or ml
TAMC, TYMC and specified microorganisms (E. coli bile-tolerant gram-negative bacteria,
S. aureus and Salmonella)
Rectalia
TAMC and TYMC

Prices upon
request

Preparations for topical use: for oral muclosa (oromucosal)/ gingival (gingival)/
dermis (cutan)/ nose (nasal) and ear (auricular)
TAMC, TYMC and specified microorganisms (S. aureus + Ps. aeruginosa)
Preparation for vaginal use
TAMC, TYMC and specified microorganism (S. aureus + Ps. aeruginosa + C. albicans)
Herbal medicinal products (of whole, reduced or powdered herbal drugs):
... to which boiling water is added before use
Total viable count and specified organism (E. coli (quant.))*
... to which boiling water is not added before use
Total viable count and specified organism (bile-tolerant gram-negatives bacteria (quant.),
E. coli + Salmonella)*
*required amount of product

Prices upon
request

30 g or ml

Note: The suitability of the method must be proved for each product by validation according (Ph.
Eur 5.1.4).

15

Laboratory services

Suitability of the Total Viable Count Method in the presence

of the product (Ph. Eur.2.6.12 )
Method suitability validation per test organism; surface spread
Method suitability validation, surface spread (TAMC with 5 test organisms)

Prices upon
request

Method suitability validation, surface spread (TAMC+TYMC with 7 test organisms)

required amount of product per test organism:

20 g or ml

Suitability testing: Test for specified microorganisms

(Ph. Eur. 2.6.13)
Method suitability validation per test organism; surface spread
Oralia (Aqueous and non-aqueous preparations) specified microorganisms (E. coli)
Oralia vegetable or mineral origin for which antimicrobial pre-treatment is not feasible
and with approval of viable count of raw material of > 10 3 cfu per g or ml specified
microorganisms (E. coli bile-tolerant gram-negative bacteria, S. aureus and Salmonella)

Prices upon
request

Preparations for topical use: for oral mucosal (oromucosal)/ gingival (gingival)/
dermis (cutan)/ nose (nasal) and ear (auricular) specified microorganisms (S. aureus +

Ps. aeruginosa)
Preparation for vaginal use specified microorganisms:(S. aureus + Ps. aeruginosa +

C. albicans)
Herbal medicinal products (of whole, reduced or powdered herbal drugs)
...to which boiling water is added before use specified organism (E. coli (quant.))*
...to which boiling water is not added before use specified organism (bile-tolerant
gram-negatives bacteria (quant.), E. coli + Salmonella)**
Amount of product needed per test organism:

Prices upon
request

20 g or ml

Note: In case the product has antimicrobial properties, dilution, filtration or addition of an
inactivating agent is needed and the suitability of the method needs to be demonstrated in the
method validation. If no inactivating method is known, and a suitable method has to be
developed, the amount of sample needed will be correspondingly higher. The additional cost will
be calculated based on a project plan prepared by Compliance and agreed by the client.

16

Laboratory services

Efficacy of Antimicrobial Preservation (Ph. Eur. 5.1.3)

Determination by surface spread method
Determination of Inoculum per test organism according to Ph.Eur. 2.6.12 by surface
spread method
Each test organism and evaluation time (for products, where extensive sample
preparation is not required)
Parenteral/ophthalmic preparations (4 bacteria, 6 testing times)
Topical preparations (4 bacteria, 5 testing times)
Oral preparations (5 bacteria, 3 testing times) incl. test of specific contaminating
microorganism

Prices upon
request

additional cost membrane filtration* each dilution

additional cost pour plate method**
Customer specific tests
Bentigte Menge fr die Durchfhrung einer Prfung:

150 g o. ml

bzw. bei Prfung im Endbehltnis:

5 Muster

*applicable to all products which can be rendered filterable in a suitable solution

**upon request

Validation of the method for Determination of the Total

Viable Count
Upon
request

Each test organism

Required amount for validation:

150 g o. ml

If tested in the original product container

5 Muster

17

Laboratory services

Bacterial Endotoxin Test (LAL-Test, Ph. Eur. 2.6.14)

Limit value Test (Gel-Clot-Method A)
1 sample
Sample examination of one batch,(3 samples: begin, middle, end)
2-4 samples in one test (per sample)
> 5 samples in one test (per sample)
Validation of the test for bacterial endotoxin (per batch)

Prices upon
request

Semi-quantitative Test (Gel-Clot-Method B)

1 sample
2-4 samples in one test (per sample)
> 5 samples in one test (per sample)

Prices upon
request

If the service you desire is not listed below, feel free to contact us for a customized quote.

Environmental monitoring
Contact plates, Sedimentation plates, active air samples
1 sample
2-4 samples in one test (per sample)

Prices upon
request

> 5 samples in one test (per sample)

(sampling performed by customer)

18

Laboratory services

Microbiological Examination of pharmaceutical production

and adjacent areas
Specific evaluations on occasion (e.g. failure investigations) or during validation of the
manufacturing processes
Determination and characterization of bioburden of raw materials, intermediates and
finished products
Evaluation of Media Fills

Prices upon
request

Trend analysis and interpretation of environmental data including identification data

Biochemical Identification of microorganisms (API-System)

Qualification of culture media

Examination of Nutritivity and Selectivity according Ph. Eur.
per media and test organism
Qualification with additional test organisms and/ or special nutrient media

Prices upon
request

Additional reports
Extra charge for interim report
Subsequent translation of a report
OOS-Report

According
additional
effort

19

Laboratory services

Validation studies
One of our core competences is to develop individual projects and studies for our customers.
These studies are tailored to our customers specific needs and wishes and the corresponding
project-plans are always prepared in close cooperation.
The following list contains a brief overview of different study-types that we are able to perform. If
the study you are looking for is not listed, simply contact us to evaluate the feasibility of the
desired study.

Development and validation of optimized sterilization procedures

simulations of specific depletion methods

qualification of dry-heat and steam sterilization

process specific testing and characterization of biological indicators

microbiological validation of water systems

validation of disinfection methods

Container Closure Integrity Test

endotoxin depletion studies, e.g. within a heat-tunnel validation

Allowance for individual studies and

examinations in the laboratory
Hourly rates
Biological-Technical Assistant
Head of laboratory

Prices upon
request

20

Microbiologcal Competence

Microbiological Competence
Curriculum Vitae Dr. rer. nat. habil. KlausHaberer
Managing Director, Microbiologist

Studies
19661973

Studies of Biology and Biochemistry at the

Universities of Tbingen and Kln, Germany

1973

Ph.D. in physiological chemistry from University of

Kln, Germany Biochemistry (Lipids) of Cell
Membranes

1974-1981

Postdoctoral studies in microbiology at the University of Rochester, USA, and

at the University of Ulm, Germany
Biology of Mycoplasmas and Mycoplasma Viruses; Methods:

1983

Biochemisty of nucleic acids

Electron Microskopy

Characterization of host cells, viruses and proteins

Biology and biochemistry of virus replication

Associate Professor in Microbiology (University of Ulm)

15 years of annual courses to undergraduate students in microbiological analytics
and quality assurance

Professional Career
1981-1982

Project Manager at IPHAR-Institut fr Klinische Pharmakologie, Hhenkirchen,

Germany

1983-1986

Head of Microbiological Quality Control at Hofmann-La Roche-AG, Grenzach,

Germany

1986-1999

Head of Microbiological Quality Control at Hoechst AG and later Director of

Microbiology Global Quality Operations at Hoechst Marion Roussel in Frankfurt,
Germany.

seit 1999

Managing Director of Compliance Advice and Services in Microbiology GmbH at

Cologne, his own consultant company with microbiological laboratory service.

21

Microbiologcal Competence

Professional experienes

clinical pharmacology

Project management of immune pharmacologic clinical studies of Phase 1 and Phase 2

Planning and equipping of a microbiological laboratory for clinical studies according GLP
and GCP guidelines

Microbiological Quality Control and Quality Assurance

Head of microbiological QC/QA department for more than 10 years;

Planning and development of microbiological QA/QC procedures for pharmaceutical

developmental products;

Validation of sterilization procedures and aseptic procedures;

Environmental monitoring and control of plants for production of sterile pharmaceuticals

under GMP conditions;

Pharmacopoeial methods for microbiological quality control under GMP conditions;

Setting of microbiological standards and guidelines in a globally operating pharmaceutical

company;

International auditing practice for many years;

Training in microbiological techniques, methods, practices and their validation worldwide;

Officially recognized Qualified Person under German drug law.

Professional Training

Numerous public presentations in collaboration with professional training organizations

(Publication list upon request);

Regular appearance as speaker, panelist or chairman in international congresses

22

Microbiologcal Competence

Representation of professional committees

1986 - present

Associated German expert for European Pharmacopoeia: Expert Group 1

Microbiology. Expert in various ad hoc working parties and European delegate for
international harmonization of microbiological methods

1987 - 1992

Member of the microbiological working party of APV (Arbeitsgemeinschaft

Pharmazeutischer Verfahrenstechnik)

1987 - 1992

DIN/ ISO: Member of the standardization committees for steam sterilization and
membrane filtration in DIN/NAMed

1994 - 2011

Member
of
the
German
Methods of Sterilization

1994 - 2011

Member of the working group ISO TC 198/WG 9 Aseptic Processing

1998-2009

Chairman of the group

Since 1995

PDA Member of various task forces

1997-1999

Chairman of the task force Parametric release

2000-2005

Member of PDA working group: Validation of Steam Sterilisation

2003-2004

Member of the PQRI working group (by invitation) for discussion of specific
questions of FDA in course of revision of the FDA-Draft (2002) for Aseptic
Processing of Pharmaceuticals

2005- 2012

PDA Member of Scientific Advisory Board

Mirror

Committee

for

CEN:

204:

23

Certification

24

Certification

25

General terms and conditions

General terms and conditions

1. Contractual conditions
1.1 The contractual relations are defined by the
service catalogue of COMPLIANCE Advice and
Services in Microbiology GmbH (hereinafter
referred to as Compliance), the specified
customer quote and the terms and conditions set
forth hereunder. Alternative arrangements are
only valid in writing. Except for the following
general terms and conditions the legal regulations
apply exclusively.
1.2 Services, which are not part of the service
catalogue, e.g. method development, special
expert reports, certificates in other languages than
German, are subject to independent contracts and
price arrangements.
1.3 All orders require written form. Orders sent by fax
or e-mail, fulfil such form requirement.
1.4 In the event that Compliance is not prepared to
accept an order, Compliance will inform the client
hereof without unnecessary delay.
1.5 The confirmation of order by Compliance shall
determine the scope of the services to be provided
by Compliance here under (the "Services"). The
order shall constitute a binding agreement once
the confirmation of order has reached the client.
The order confirmation cannot be amended or
modified without prior written approval by
Compliance. Modifications or amendments of the
scope of the services require written form.
1.6 Costs for the preparation of project plans as part
of offer preparations have to be paid by the client
even if the order does not materialize as a reason
of the client's decision.
1.7 Compliance shall keep secret all the client's knowhow disclosed to Compliance within the context of
the order.
1.8 With
regard
to
potential
supplementary
performance (No. 7.1) the client shall store retain
samples.
2. Additional expenditure
2.1 If additional studies, which were not predictable at
the time of the confirmation of order, are required
in certain cases to obtain or verify results, the
procedure shall be subject to the acceptance by
the client. Any costs resulting from such additional
studies shall be born by the client.
2.2 If additional studies are necessary within the
frame of the tests to guarantee a proper

conduction of the Services, which results in a new

pricing, Compliance shall be entitled to pause their
operations until an agreement with regards to
such additional costs has been reached between
the parties.
2.3 In case a new price arrangement cannot be
reached, the order shall be considered terminated.
In this event, the client shall bear the costs of the
actual attainment. Expenses for OOS clarification
have to be paid by the client unless the reason is a
result of the performance of the Services by
Compliance.
3. Terms of payment/due date
3.1 Invoices are due strictly net within 30 days after
the date or the receipt of the invoice, on which
date funds have to be credited to the account of
Compliance. Alternative terms of payment need to
be agreed in writing.
3.2 For the processing of rush-orders and special
orders, for which definite handling times have
been agreed and warranted, surcharges for the
required additional effort apply.
3.3 Compliance may demand advance payments of up
to 50% of the contract value. Compliance may
also demand part payments for already performed
parts of the Services.
3.4 Additional transport cost resulting from the usage
of a courier company within the frame of an order
will be charged to the client.
3.5 Offer prices are exclusive of VAT; final prices
include VAT at the rate of taxation valid on the
day of conclusion of the contract.
3.6 Invoices to the client must be queried in writing
within 30 days after the date and receipt of such
invoice, otherwise the invoice shall be deemed
accepted.
3.7 Cheques are accepted for payment on account of
performance only. The acceptance is carried out
by itemized bill for collection and discount fees.
3.8 In the event of late payments, the Client shall pay
to Compliance interest of 4 percentage points
above the then valid discount rate of the Deutsche
Bundesbank without further reminder. The
assertion of further damages due to late payments
is reserved. Furthermore, the Client shall refund
any collection costs incurred by Compliance as a
result of any such late payment.
3.9 Arrears or substantial loss of financial standing of
the Client entitle Compliance, subject to further
rights, to request prepayment, cash, or other

26

General terms and conditions

collaterals from the client for further supplies or
services. In such event, Compliance shall have the
right to withdraw from existing agreements and
the client shall not be entitled to damages as a
result of such withdrawal.
3.10
In an event as described in Clause 3.9
above, Compliance shall have the right to demand
immediate payment for all outstanding debts.
3.11
In the event of material or legal defects,
retentions of payments shall be limited to such
amounts as the client may by law and by this
agreement deduct from the total purchase price
for reason of such defects. A more extensive
retention is excluded.
4. Order performance
4.1 Compliance
takes
responsibility
for
the
performance of the tests according to methods
(test procedures) known by and agreed upon with
the Client which are based on the current state of
the art, such as customer methods, methods
taken from literature, pharmacopoeia, OECD, EG,
DIN-, EN and ISO standard. Compliance does not
take responsibility for the methods themselves.
Unless these methods were either developed by
Compliance or adapted and validated for the
equipment of Compliance. The client pays all costs
for
these
developments,
adaptations
or
validations. Otherwise the client bears the
responsibility for the methods used.
4.2 If a known test procedure is not available, a
project plan is developed and arranged with the
client.
4.3 Compliance is not bound to store samples, so that
the client is obliged and bound to check the results
provided by Compliance immediately and notify
defects without delay.
4.4 The client bears the cost of any agreed storage of
samples for a period longer than the investigation
period.
5. Delivery time
5.1 Agreed delivery times shall not commence prior to
the clarification of all technical questions and the
completion of the contractually fixed participation
of the client. Any agreed delivery dates shall be
postponed for such time periods during which the
Service can not be performed due to noncompleted participation of the client.
5.2 In the event that project planning is part of the
Services or a contract is concluded based on a
plan developed by Compliance, the delivery time

starts with the acceptance of the plan by the

client.
5.3 The delivery time starts a new, if any
supplementary modifications of Compliance's
services are arranged.
5.4 In case of an interruption of the operations at
Compliance or our suppliers, which is due to force
majeure, the arranged delivery times shall be
extended by the time of such interruption. The
same applies to any business disruption by nonimputable measurements of industrial conflicts.
Beginning and end of the industrial action shall be
communicated without delay. The agreed delivery
dates shall be postponed accordingly.
5.5 The client may only withdraw from the agreement
due to failure to comply with a delivery period or
delivery date, if an adequate additional period for
performance or cure has been set out before hand
by the client and Compliance is responsible for the
transgression of the delivery period or the delivery
time and the additional period. The limitation of
the right for withdrawal does not apply, if
Compliance seriously and definitively refuses the
services or if there are special circumstances
which, when the interests of both parties are
weighed, justify immediate withdrawal. The
adequate additional period for performance or
cure in terms of this clause shall be at least 3
weeks from the receipt by Compliance of written
notification thereof.
6. Risk assumption
6.1 With the acceptance of the order Compliance shall
bear the risk of appropriate handling of samples
after their receipt by Compliance. If the samples
are not suitable for the Services due to reasons for
which Compliance is not responsible (e.g. climatic
influences or other damages during transport,
improper shipment by the client, wrong sample
identification, non-observance of relevant safety
regulations), Compliance shall inform the client
without delay and the client shall remedy such
deficiencies. Compliance is entitled to charge the
client for performed services based on actual
effort (including costs for return consignments,
disposal e.g. of toxic, carcinogenic substances,
drugs, etc.), if the unsuitability of the delivery was
not or not yet detectable upon service provision.
6.2 With regards to shipments sent via a courier
company, the risk passes to the client with the
transfer of the shipment to the courier company,
thus relieving Compliance of any further liability
for any risk of delay, loss or deterioration.

27

General terms and conditions

7. Warranty / Liability
7.1 Compliance's warranties are limited to the Services
which are fixed in writing in the order. Such
warranties are limited to the rectification of
defects or faults in an adequate period, provided
that the client has notified Compliance of such
defect or fault in writing within 1 month after the
receipt of the test results, expert report etc. In this
case Compliance can chose to cure the defect or
to repeat the service as specified in the order at its
own costs. For this purpose the client shall provide
retain samples (see No. 1.7) free of charge. If
rectification is not performed on time or
insufficient, the client is entitled to a price
reduction of up to 25% of the order value. All
other clients claims for damages are excluded,
save for the liability for injury to life, body or
health or damages caused by grossly negligent or
intentional acts by Compliance.
7.2 Compliance offers a warranty for a period of one
year. The period of warranty starts with the
transfer of the shipment to the courier service.
7.3 If the Services represent a part in another service
provided by the client to a third party, the client
shall arrange an identical liability agreement with
such third party (his customer). The client
indemnifies Compliance against any claims by such
third party, resulting from failure to arrange such
liability agreement with the third party.
7.4 The regulations of the Product Liability Act remain
unaffected.
7.5 Compliance is liable for delay and impossibility in
cases of gross negligence or intention by
Compliance or one of its representatives or
assignees according to the legal regulations.
Compliances liability in cases of gross negligence
is limited to the damage forseeable and typical to
the contract. Compensation for further liabilities
for impossibility and delay of service is limited to
10% of the services value. Further claims against
Compliance - including but not limited to cases of
transgression of the date for service delivery set
by Compliance - are excluded.

the document is marked with the name of an

employee of Compliance.
9. Excess of samples
9.1 If Compliance receives more samples than
necessary for the performance of the tests, the
remainder shall be stored for 2 months and shall
be available for follow-up examination. The
samples shall be stored according to the clients
specifications (cp. 4.4).
10. Prohibition of assignment
10.1
The client may assign to a third party his
claim for execution of due services only with prior
written approval by Compliance.
10.2
The assignment of outstanding debts
againt Coompliance to any third party requires
Compliance's prior written approval.
11. Place of performance and jurisdiction /
Partial invalidity
11.1
The place of performance of all claims
under this agreement is Cologne (Kln), Germany.
The courts of Cologne (Kln) Germany shall have
sole jurisdiction.
11.2
The laws of the Federal Republic of
Germany apply exclusively to this agreement.
11.3
Should any individual provision of this
agreement be or become invalid, the validity of
the remaining conditions shall not be affected.
Instead of ineffective provisions, valid provisions,
which most closely approximate those desired by
the parties, shall come into force respectively.
11.4
Compliance would like to point out, that
clients data is electronically saved and processed.

In the event of any dispute, the German version of

these general terms and conditions shall prevail.

Status: 04.01.2010

8. Copyright
8.1 Results of tests performed on behalf of the client
are the exclusive property of the client. The
publication or reproduction of our results,
certificates, study and expert reports as well as
presentations for marketing purposes and their
usage in extracts for any other application are
subject to the prior written approval by
Compliance. This also applies in all cases in which

28