Elastomer Change Out—Justification for Minimizing the Removal of Elastomers To Prevent
Cross-Contamination in a Multiproduct Facility | PDA Journal of Pharmaceutical Science and …

Compendia methods have historically been used to assess heavy metals in both drug
products and packaging material extracts. However, these methods have been found to be …

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An emerging trend in the biotechnology industry is the utilization of plastic components in
manufacturing systems for the production of an active pharmaceutical ingredient (API) or a …

Due to their unique physical and chemical properties, elastomers have been used as
closures for pharmaceuticals since the early 1900's. Over the years, however, extractables …

This chapter explains migration of extractables/leachables from plastic material into a
contact medium such as a pharmaceutical drug product. It depicts the regulatory landscape …

BioPharm International spoke with John Ward, vice-president of Engineering at Patheon,
about the potential for cross contamination in the manufacture of biopharmaceuticals. Ward …

In addition to making technical developments, vendors are also looking at ways to improve
supply-chain security. By offering standard, off-the-shelf products, vendors are able to …

In Pharma application various elastomeric components are used as primary packaging and
fluid transportation. Several methods are available for sterilization and among all steam & …

Pharmaceutical packaging has allowed the widespread distribution of drugs; without it there
would be no pharmaceutical industry and the quality and quantity of life we have come to …