AranBiotech has strong analytical capabilities. Testing is either carried out in-house or by qualified and approved external testing laboratories.
AranBiotech SUBs are integrity tested as per the customer request, using validated procedures.
All lots of SUBs are subject to Physico-Chemical Testing as per USP <661> for plastic containers.
Pressure, Temperature Endurance
SUBs are validated to endure a wide range of operating pressure and temperature conditions that may be encountered during use. They are also validated for burst pressure with liquid to ensure user and product safety in case of inadvertent pressure build-up.
Well qualified and trained personnel characterize our SUBs for volatile, semi-volatile and non-volatile extractables with multiple extraction media under different conditions of time and temperature.
AranBiotech SUB are sterilized by gamma irradiation .The sterilization process has been validated as per ISO 11137-2 which includes dose verification, dose mapping and quarterly dose audits.
Our sterilization dose of 25 kGy has been narrowed down through careful studies of the test samples, bio-burden testing of multiple lots of the selected test samples, calculation of verification dose and sterility testing. These studies also establish the maximum acceptable dose for the product and conclude that when treated with the maximum acceptable dose, the product shall meet its specified functional requirements throughout the defined lifetime.
Bacterial Endotoxin Testing
Our SUBs meet the specification of <0.25 EU/ml for endotoxins, as established by Limulus Amebocyte Lysate (LAL) Test as per USP <85>.
AranBiotech SUBs pass Biological Reactivity test, In-Vivo, as per USP <88> for Class VI plastics. They also pass the Biological Reactivity Tests, In Vitro for Cytotoxicity as described in USP <87>.
Certificate of Analysis
Each lot of our Single-Use 2D Bags undergoes rigorous quality assurance release process and will be accompanied by a Certificate of Analysis.