• AseptiBag™ HV

AseptiBag™ HV

mdi AseptiBag™ HV are specially designed for minimizing losses of high value drug substances and drug products in transfer and filling applications due to negligible hold up volumes.

Physical Properties of Film
Storage Temperature -20°C to 45°C
Materials of Construction
Bag Film AseptiFlex™ D film
Sterilization Gamma Sterilizable upto 50 kGy
100% Integrity Tested Each AseptiBag™ HV is tested for integrity to comply with validated Acceptable Integrity Test Specifications.
Bacterial Endotoxin Aqueous extracts exhibit < 0.25 EU/ml as established by Limulus Amebocyte Lysate (LAL) Test as per USP <85>
Bioburden Device bioburden is tested as per ISO 117 37-1 and assured to be <1000 cfu/bag.
Fiber Release Passes microscopic test for fibers
Particle Release Complies with USP <788> test for particulate matter in injections
Endotoxin Testing Aqueous extracts exhibit <0.125 EU/ml as established by Limulus Amebocyte Lysate (LAL) Test as per USP <85>
Extractables The Extractable study was performed as per Biophorum Best Practices Guide for Extractable Testing of Polymeric Single-Use Components used in Biopharmaceutical Manufacturing.
Sterility The gamma sterilization process has been validated as per ISO 11137 to ensure a sterility assurance level (SAL) of 10-6
Passes the Biological Reactivity Tests, In Vivo for Class VI plastics as described in USP <88>.
Passes the Biological Reactivity Tests, In Vitro for Cytotoxicity as described in USP <87>.

mdi AseptiBag™ HV is only available as part of mdi single use systems

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