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T u r n i n g Y o u r V i s i o n t o R e a l i t y
Biopharmax Group
www.biopharmax.com
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G E N E R A L
BIOPHARMAX PROFILE
Regulatory Compliance
Biopharmax is committed to comply to
the highest standards:
Fully automated plants, compliant to 21
CFR Part 11 and GAMP VExperience with constructing facilities
globally which are approved and
complied by USFDA and/or EMEA,
Canadian FDA, WHO, China FDA and
Indian FDA.
OMRIX Johnson & Johnson
Services
Introduction
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 leadingpharmaceutical 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 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 thinkingprocess. We therefore take deep interest in our customer's business
and fear not to challenge all assumptions.
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
OMRIX Johnson & Johnson
T U R N K E Y
S O L U T I O N S
: U R S
T O V A L I D
A T I O N
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HTBT
E X A
M P L E S
BIOPHARMAX PROJECT EXAMPLES
OMRIX J & J
Fibrin sealant sterile production plant from Human
Plasma
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
ABBOTT
HTBT
Biotechnology production plant, Insulin crystals and
other recombinant products
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
Complete commissioning and validation
EMEA compliant
ABBOTT
Process Skids- Feno Penta
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
OMRIX Johnson & Johnson
PLURISTEM
Stem cell processing facility
Human Placenta source, EMEA Compliant
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
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Biopharmax India Pvt Ltd, 2 Floor, Survey No.253/1, Plot No.4, Tirumala Industrial Estate, Hinjewadi, Pune, Cont-.020-66768840
Mr. Ramchandra Bhat
Business development
Biopharmax India
Office-020-66768837
Mobile-08378992064
www.biopharmax.com
On Time!
On Budget!
No Compromises on Results!
Our Clients
