AramusTM Bag Assembly
Validation Guide 

Aramus™ single-use 2D bag assemblies are made of a high-grade, gamma-stable fluoropolymer that provides higher purity, greater compatibility, and increased safety for critical process fluids and final products. With a new single-layer technology that does not contain curing agents, antioxidants, plasticizers, or adhesives, the number of potential contaminants is greatly reduced. These assemblies have a wide operating range and are durable in frozen applications (-85° to 40°C [-121° to 104°F] or lower). This guide pertains only to Aramus gamma-stable, fluoropolymer 2D pillow-style assemblies.

Table of Contents

  1. Introduction ......................................................................................................................................... 2
  2. Scope ..................................................................................................................................................... 2
  3. Regulatory Overview .......................................................................................................................... 3
  4. Certificate of Analysis ......................................................................................................................... 4
  5. Manufacturing Environment ............................................................................................................ 4
  6. Materials of Construction ................................................................................................................. 4
  7. Country of Origin ................................................................................................................................ 6
  8. Animal Derivative Content and TSE/BSE Risk .............................................................................. 6
  9. U.S. Food and Drug Administration ............................................................................................... 6
  10. Shelf Life ............................................................................................................................................... 6
  11. Gamma Sterilization .......................................................................................................................... 7
  12. USP <71> Sterility Testing ................................................................................................................ 7
  13. USP <87> Biological Reactivity Tests, In Vitro ............................................................................. 7
  14. USP <88> Biological Reactivity Tests, In Vivo, Class VI Test ..................................................... 7
  1. USP <85> Bacterial Endotoxins Test, EP 2.6.14, JP .................................................................... 8
  1. USP <661.2> Physiochemical Test, Plastic Packaging System for Pharmaceutical Use ... 8
  2. USP <788> Particulate Matter in Injections ................................................................................ 9
  3. ISO 10993-4 Hemolysis: Direct Contact ....................................................................................... 9
  4. ISO 10993-4 Hemolysis: Indirect Contact .................................................................................... 9
  5. Extractables ....................................................................................................................................... 10
  6. Design Validation .............................................................................................................................. 11
  7. Leak Testing ....................................................................................................................................... 20
  8. Process Validation ............................................................................................................................ 20
  9. Packaging–Shipping Validation ..................................................................................................... 22

   Limited Warranty ..................................................................................................................................... 23

   For More Information ............................................................................................................................. 23

   Terms and Conditions of Sale .............................................................................................................. 23