OSD (High Containment) Example

Project Outline

Size of Modular Plant

Scope of work

Process Capacity

Time Schedule

Layouts

Plant Description

Conclusions

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Background & Project Outline

Effective reproductive health care services must be given primacy to
ensure the birth and care of healthy children and to promote
responsible parenting
The supply of a turn-key OSD facility for the tableting of oestradiol as
a oral contraceptive
The facility is recommended as a modular facility in order to ascertain
predictability, quality and delivery time
The facility meet the regulatory requirements of WHO & EMA
It is a green field arrangement to be set up at site within a time
period of 14 months.
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Scope of Work

Design &
Engineering
Signing of
Contact

IN ESTONIA

AT SITE

Procurement
Modules
Construction
Installation of
equipment
IQ & GMP
Inspection
Plant
Disassembly

Signing of
Contract
Warehouse &
Shipment
Administr. bldg
Reassembly
Foundation and
of Plant
sewage system
Operator
Electricity and
Training
water supply
Commissioning
IQ OQ
Validation/PQ

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Operation
Production

Containment in OSD Production

Risk assesment
GMP and containment
Protect the product
Protect the employees

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Potency OEL

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Specific for High OEL

American and European personal safety
requirements at high product Operating
Exposure Levels (OEL levels) the process shall
be closed in isolators or the operator should
have full protection breathing suites.

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General Recomendations

Detailed Design documents needs to show

clearly how the requirements for both product
protection and containment are fulfilled.
Documents that support this are:
Gowning procedures
HVAC Zoning drawings, showing on layout which
area each AHU is serving
Pressurization drawings showing the relative room
pressure on the layout.

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OSD Project Example

Design of a contained hormone facility comprising of:

Production (Process) area

Clean utilities
IPC lab
QC lab
Warehouse and packaging
Lockers

Delivery time 14.5 months after start of Detailed

Design
Earthquake safe

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Process Plant Description

Two storied modular building, in total: 540 m2 (9 modules),
(Ground floor: 300 m2, first floor: 240 m2)
Contained OSD facility (Oestradiol Hormon)
HVAC and utility generation and distribution
Stand alone facility (all process and utility equipment incl.)
Adjacent support functions: Emergency Power & Process
Waste Water Treatment

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Dispensing
API dispensing in isolator
Excipients dispensing under LAF

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Blending and Granulation

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Sieving

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Tabletting

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Coating

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Sorting

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Blister Packaging

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Layout Ground Floor

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Detail design in 3D

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Equipment Installations

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Containment Ground Floor

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Layout First Floor

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Utility Installations

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Transport

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Site Assembly

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Time Schedule

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Important features

Short delivery time (6 - 10 months faster than alternatives)

Predictable schedule
Fixed price
Process and project experience
Modular construction guarantee earthquake safe
pharmaceutical production buildings
Risk with contractor
Guaranteed quality through off-site construction
IQ majority finalised off-site
Possibility for tech transfer training off-site

= over-all very favourable (VPN value)/total project economy.

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Example: profit from earlier start up

Product annual sales

20 M (10M x 2) with a Gross Margin of 50%
Production Up-Time 48 weeks/year
20 M/48 weeks = 0,42 M/week
50% GM = 0,21 M/week

Incremental Revenue with faster delivery

6 Months = 24 weeks = 5 M
12 Months = 48 weeks = 10 M

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Value proposition
Time
Shorter time to market
(6-24 months faster than conventional)
Deferred investment decision
More time for process development

Optimized cGMP Process Solutions & Lay-out

Predictability
On Budget
Completion as scheduled
Limited customer resources

Quality & Documentation (GMPs)

Faster Return-on-Investment (ROI)

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