Testing Procedures: The Unrivaled Quality of our SUBs

Looking to ensure that your product is crafted to the highest standards possible? Look no further than our unbeatable #SUBs and their unparalleled quality. With our rigorous testing procedures, you can trust that our products are not only the safest around, but also the most reliable. Rest easy knowing that your manufacturing process is in good hands, and let us take care of the rest. We do:

Integrity Testing:

Our customers have unique requirements, and we offer integrity testing of our #SUBs as per their request. Our procedures are validated and adhere to industry standards to ensure the highest level of quality.

Physico-Chemical Testing:

All lots of our SUBs undergo Physico-Chemical Testing as per USP <661> for plastic containers. This testing ensures that our #products meet the appropriate physical and chemical requirements and are safe for use.

Pressure and Temperature Endurance:

Our SUBs are designed to endure a wide range of operating pressure and #temperature conditions that they may encounter during use. We validate our products for burst pressure with liquid to ensure user and product safety in case of inadvertent pressure build-up.

Extractables:

Our highly qualified and trained personnel perform characterization of our SUBs for volatile, semi-volatile, and non-volatile extractables. We use multiple extraction media under different conditions of time and temperature to ensure the highest quality and safety standards.

Sterilization:

We use gamma irradiation to sterilize our SUBs, and our sterilization process has been validated as per #ISO 11137-2, including dose verification, dose mapping, and quarterly dose audits.

Our #sterilization dose of 25 kGy has been narrowed down through careful studies of test samples, bioburden testing of multiple lots of selected test samples, calculation of verification dose, and sterility testing ensure the maximum acceptable dose for our products. When treated with the maximum acceptable dose, our products meet their specified functional requirements throughout their defined lifetime.

Bacterial Endotoxin Testing:

Our SUBs meet the specification of <0.25 EU/ml for endotoxins, established by Limulus Amebocyte Lysate (LAL) Test as per USP <85>. This ensures that our products are free from harmful bacterial endotoxins.

Biosafety:

Our 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>. This ensures that our products are safe and free from any biological reactivity that may be harmful to users.

Certificate of Analysis:

We take quality assurance seriously, and each lot of our #singleuse 2D Bags undergoes a rigorous quality assurance release process. We provide a Certificate of Analysis with each lot to ensure that our customers receive a product that meets their unique requirements.

In conclusion, at AranBiotech Single Use Technologies , we strive to provide world-class testing facilities that ensure the quality and safety of our Single-Use Bioreactors. Our rigorous testing procedures, combined with our commitment to quality, make our products stand out in the industry.

We are dedicated to providing the highest level of customer satisfaction, and we guarantee that our products will meet your unique requirements.

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AranBiotech Single Use Technologies ; Eran Kurtz