Case Study OSD_131204

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OSD (High Containment) Example

Project Outline

Plant Description

Time Schedule

Scope of work

Conclusions

Size of Modular Plant

Process Capacity

Layouts


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.


Scope of Work

Signing of Contact

Design & Engineering

Procurement

Modules Construction

Installation of equipment

Operator Training

IQ & GMP Inspection

Commissioning IQ OQ

Signing of Contract

Warehouse & Administr. bldg

Foundation and sewage system

Electricity and water supply

Validation/PQ Operation Production

Plant Disassembly

Reassembly of Plant

AT SITE IN ESTONIA

Shipment


Containment in OSD Production

• Risk assesment

• GMP and containment

• Protect the product

• Protect the employees


Potency OEL


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.


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.


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


• 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

Process Plant Description


Dispensing

• API dispensing in isolator

• Excipients dispensing under LAF


Blending and Granulation


Sieving


Tabletting


Coating


Sorting


Blister Packaging


Layout – Ground Floor


Detail design in 3D


Equipment Installations


Containment – Ground Floor


Layout – First Floor


Utility Installations


Transport


Site Assembly


Time Schedule


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.


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€


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 (GMP’s) •Faster Return-on-Investment (ROI)

Case Study OSD_131204

Documents

rights reserved blending

rights reserved scope

granulation keyplants

tabletting keyplants

d keyplants

laf keyplants

employees keyplants

sieving keyplants