AranBiotech has invested in procuring the strong analytical capabilities needed to set the gold standard in Bioflex film and
SUS equipment. Testing is either carried out in-house or by qualified and approved external testing laboratories.
Bioflex film
Undergoes extensive testing for various properties that satisfy ASTM standard like Gauge, Bond Strength, Seal Strength, Gelbo test, Puncture Resistance, Tensile Strength (MD & TD), Elongation at Break (MD & TD), Coefficient of Friction, Oxygen, Transmission Rate, Water Vapor Transmission Rate, CO2 Transmission Rate and Haze. The film is also tested for biocompatibility.
Single Use Bags
Our 2D and 3D Single Use Bags also are subject to all Quality Control Tests conducted as per release specifications, regardless
of the target market, i.e whether they are used for Bioprocessing or other purposes. Our tests are validated and performed
by skilled and trained staff in state of the art facilities to ensure accuracy of results.
Key Tests
Some key test that our products undergo are:
• Integrity Testing
AranBiotech SUBs are tested for seal strength integrity and component/ assembly integrity, using validated procedures.
• Physio-Chemical Testing
Raw materials used for the production of our SUSs are subject to Physio-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 air to ensure user and product safety in case of inadvertent
pressure build-up.
• Extractables and Leachables
Testing of extractables and leachables supports the use of Single-Use bags for biopharmaceutical manufacturing operations.
We work with international well known approved and certified laboratories on characterizing our SUBs for volatile, semivolatile
and non-volatile extractables with multiple extraction media under different conditions of time and temperature.
• Sterilization and Sterility testing
AranBiotech SUS are sterilized by gamma irradiation. The sterilization process has been validated as per ANSI/AAMI/ISO
11137:2006 which includes dose verification, dose mapping and periodical dose audits.
Our bags are sterilization at a dose range of 25-40 kGy and verified by 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 SUSs meet the specification of <0.25 EU/ml for endotoxins, as established by Limulus Amebocyte Lysate (LAL) Test
as per USP <85>.
• Biosafety
AranBiotech SUSs 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>.
• Leak Test
All AranBiotech 2D SUBs upto 50L size pass leak test conducted using state of the art, qualified Decay Test Machine.
