AseptiCel™ Bioreactors
mdi AseptiCel™ disposable single use bioreactors have been validated for various functional as well as regulatory requirement such as sterility, integrity, bioburden, bacterial endotoxin, extractables and biosafety.
Mammalian cell culture is a highly critical process and the disposable bioreactor is required to be validated to provide the requisite reliability in terms of robustness and consistent performance.
These complex bioreactors with sampling systems, sparger, vent filters etc. are designed to ensure high viable cell densities and high product titre.
mdi AseptiCel™ disposable single use bioreactors are designed for manufacture of high value monoclonal antibodies by mammalian cell culture.
Designed for your High Value
- Monoclonal Antibodies (mAbs)
- Viral Vectors
- Vaccines
| Film Material | AseptiFlex™- I |
| Impeller | Polypropylene |
| Sparger Disc | High Density Polyethylene (HDPE) |
| Spargers | SS 316L |
| Adapter for Sensors | Silicone |
| Biosafety | Passes Biological Reactivity test, In-Vivo, as per USP<88> for Class VI plastics. Passes the Biological Reactivity Tests, In Vitro for Cytotoxicity as described in USP<87>. |
| Sterilization | mdi AseptiCel™ bioreactors are Gamma Sterilizable upto 50 kGy. |
| Sterility | The gamma sterilization process has been validated as per ISO 11137 to ensure a sterility assurance level (SAL) of 10-6. |
| Bioburden Testing | Bioburden level is < 1000 cfu/device as per ISO 11737-1:2018 |
| Endotoxin Testing | Aqueous extracts exhibit <0.25 EU/ml as established by Limulus Amebocyte Lysate (LAL) Test as per USP <85>. |
| Particle Release | Complies with USP <788> test for particulate matter in injections and USP <790> for visible particulates in injections |
| Extractables | The Extractable profile of all the components used in AseptiCel™ is available as per BioPhorum Best Practices Guide for Extractable Testing of Polyemric Single Use Components used in Biopharmaceutical Manufacturing. |
| File Type | Download |
|---|---|
| Datasheet | Download |
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