A Review of Sterile Connectors - Many factors must be considered when choosing a sterile connector for a given process. - BioPharm International

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A Review of Sterile Connectors
Many factors must be considered when choosing a sterile connector for a given process.


BioPharm International Supplements


Conclusion

Sterile connectors make operation easier and faster than other methods of connections in an aseptic environment, such as open manipulations and tube welding, while completing the path of a sterile closed system. Nonetheless, due diligence is required to ensure that an appropriate connector type is selected and tested to satisfy the user, product requirements, system integrity, and safety.

Kirsten A. Strahlendorf is a process development scientist and Kevin Harper is a platform director, both at Sanofi Pasteur, Toronto, Canada, 416.667.2700,

REFERENCES

1. Steinmetz R, Brown NG, Allen DL, Bigsby RM, Ben-Jonathan N. The environmental estrogen bisphenol A stimulates prolactin Release in vitro and in vivo. Endocrinol. 1997;138(5)1780–6.

2. Current revision of Code of Federal Regulations, Title 21: Food and Drugs, PART 189—Substances Prohibited from Use in Human Food, 189.5 Prohibited cattle materials.

3.Note for guidance on minimizing the risk of transmitting animal spongiform encephalopathy agents via human and veterinary medicinal products (EMEA 410/01 Rev. 2 – Oct 2003) adopted by the Committee for Proprietary Medicinal Products (CPMP) and by the Committee for Veterinary Medicinal products (CVMP) Official J EU C 24, 28.1.2004, p. 6.


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