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## Turning

Yo u r

Vision

to

Realit y

Biopharmax Group

\[Link\]

BIOPHARMAX PROFILE  
Introduction

Regulatory Compliance

## Biopharmax is a global leading design and construction group

specializing in the Biopharmaceutical market segment. Our group has  
been active for over 40 years and has executed over hundreds of  
projects worldwide. We have provided services to the leading  
pharmaceutical companies in Europe, US, Israel, China and India. Our  
clients include world leaders like TEVA Pharmaceuticals, Johnson &  
Johnson, Merck Serono, Sigma-Aldrich, Abbott and many others. Our  
group staff has over 150 engineers in all related disciplines: process,  
validation, mechanical, software & control, HVAC & CR, laboratories,  
industrial fields, etc.

## Biopharmax is committed to comply to

the highest standards:  
Fully automated plants, compliant to 21  
CFR Part 11 and GAMP V  
Experience with constructing facilities  
globally which are approved and  
complied by USFDA and/or EMEA,  
Canadian FDA, WHO, China FDA and  
Indian FDA.

GENERAL

## TURNKEY SOLUTIONS: URS TO VALIDATION

## Biopharmax has an excellent track record for the best customer

satisfaction including; "Abbott Business Performer of the Year 2014"  
award and J&J Certificate of Appreciation for the leading design of the  
project in Omrix. We never compromise on the quality and the  
services provided to the customer. We strive to deliver our customers  
a competitive advantage through a resourceful and innovative thinking  
process. We therefore take deep interest in our customer's business  
and fear not to challenge all assumptions.

## OMRIX Johnson & Johnson

Services  
Turnkey Projects from Design to Supply, Commissioning and Qualification  
Master Planning, Conceptual, Basic and Detailed Design  
Project Management Consultancy (PMC) Services  
Trouble shooting, Inspection, Retrofit & fix works  
cGMP Gap Analysis and Gap Closure

## Process Skids and Systems Expertise-CIP/SIP, Fermentation, PW/WFI

Technology Sourcing

Services

## OMRIX Johnson & Johnson

## BIOPHARMAX PROJECT EXAMPLES

HTBT

OMRIX J & J

## Biotechnology production plant, Insulin crystals and

other recombinant products

## Fibrin sealant sterile production plant from Human

Plasma

## 7,500 SQM building

Process equipment, fermentors  
Upstream, Downstream and final purification  
Clean utilities and general utilities  
Warehouses, laboratories, offices  
Software as per CFR 21 part 11

## Production lines, process equipment clean rooms

Filling suite, packaging department  
Clean & general utilities  
Warehouses, laboratories, offices  
Raw material Human plasma  
FDA, EMEA compliant  
Total size: Cap. 10,000 SQM

## Complete commissioning and validation

HTBT

## OMRIX Johnson & Johnson

ABBOTT

PLURISTEM

## Process Skids- Feno Penta

## Stem cell processing facility

Human Placenta source, EMEA Compliant

Detail engineering  
Process Skids ASME BPE compliant  
Process Piping  
CE certified electrical control  
21 CFR compliant Automation and control

## Integration of Process Skid paraphernalia

Equipment & Utility

ABBOTT

## 1,400 SQM production site

## Upstream, downstream and filling

Clean utilities  
Software as per CFR 21 part 11  
Complete commissioning and validation  
Laboratories and Offices

PLURISTEM

EXAMPLES

EMEA compliant

Our Clients

## Mr. Ramchandra Bhat

Business development  
Biopharmax India  
Office-020-66768837  
Mobile-08378992064  
ram@\[Link\]  
\[Link\]

On Time!  
On Budget!  
No Compromises on Results!

Biopharmax India Pvt Ltd, 2 Floor, Survey No.253/1, Plot No.4, Tirumala Industrial Estate, Hinjewadi, Pune, Cont-.020-66768840