By René Brecht (auth.), Regine Eibl, Dieter Eibl (eds.)
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Additional resources for Disposable Bioreactors
The use of sterile connectors as well as sterile welding technologies enables the production in fully closed containment. Thus, several products or product candidates can be developed and manufactured in the same suite, being physically segregated only by use of closed systems. The risks of cross contamination due to insufficient cleaning or airborne contamination are eliminated. Despite the flexibility to integrate and operate different technologies and scales in the pilot plant, the overall scalability is still limited in comparison to stainless steel bioreactors.
Several parameters are tested for the evaluation of the overall system robustness regarding mechanical load and permeability . The tensile properties describe the material strength and ductility. The test procedures can be found in the American Society for Testing and Materials (ASTM) standard D882. In principle, the material is mechanically stressed to fracture or to be permanently deformed and the strength or percentage of elongation is measured. The puncture resistance and puncture strength measures the energy that can be absorbed by the material to resist damage or inhibit deformation.
Anti-oxidants, heat stabilisers, plasticisers). As well as the culture container itself, the plastic tubing is also a potential source and has to be carefully evaluated . Whereas leachables migrate spontaneously from the equipment under recommended conditions of use and storage, extractables are extracted under exaggerated temperature and time conditions . 4 Fig. 7 Cross section through the different bag layers, Polyester (dark grey filled square), Tie (light grey filled squares), EVOH (open square), PE (filled square) The potential risks associated with these compounds are toxicity, immunogenicity (acting as adjuvants), product impurities and direct interaction with the drug by affecting its structure, activity or stability.