Flex Concepts, Inc.

Flexible Disposable Single Use Containment Systems for Bio-Pharmaceutical Applications

• Secure Storage and Transport of Sterile Liquids
• Flexible Bioprocess Systems
• Replacement Rocker Style Bio Bags
• Easy Freeze / Thaw Solution Applications
• Solutions Transfers to Bioreactors
• Full Traceability and Leachables & Extractables Data

Disposable Single Use Containment Systems

Flex Concepts, Inc. offers more than 20 years experience in engineering, design and customization of flexible products for the demanding biopharmaceutical industry. Flex specializes in “A Single Use Concept” with unlimited applications for your company’s liquid solution and powder handling needs. Flex's sterile Bio Bag and solution containment products are manufactured using USP Class VI materials under full FDA compliance guidelines with strict adherence to cGMP standards. All products are designed, developed and tested in house and manufactured in Class 10,000 clean rooms. Extensive materials leachable and extractable data and test results are available for all product contact films.

Flex’s 200 Series Film

• Contamination Free; Tensile Strength and Elongation Tested
• Radiation Tolerant to 40 kGy (4.0 mrad)
• Sterility Assurance Levels (FLA) of 10-6
• Meets USP Class VI Testing Specifications
• Base Film = 3 mils Thickness
• Raw Film Materials Strictly Controlled
• FTIR Identified

Flexible Chamber Construction Options: Double Layer Bio Bags: = 8 mils Thickness:

• EVOH/Nylon Strong Outer Barrier
• Flex 200 Sterile Contact Layer

Triple Layer Bio Bags: = 11 mils Thickness:

• EVOH / Nylon Strong Outer Barrier
• Flex 200 Security Layer
• Flex 200 Sterile Contact Layer

Product Highlights

• All Bio Bags and Components are Manufactured in Class 10,000 Clean Rooms and Gama Irradiated
• All Product Contact Surfaces are USP Class VI Tested Materials
• Value Added and Custom Bioprocess Bags are never a problem!

Single Use Solutions provide:

• Elimination of Cross Contamination Problems
• Reduced need for Stainless Steel Equipment & Systems
• Processing Times are Minimized and Turnarounds are faster!
• Reduced Labor, Downtime and Manufacturing Costs