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Biopharmax Group

www.biopharmax.com

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@biopharmax.com
www.biopharmax.com

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