E&L considerations for injectables and FluroTec closures

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Summary
Speakers

Extractables and leachables (E&L) is a very popular and very important topic for the pharmaceutical industry. If E&L are not assessed thoroughly and mitigated, they can cause serious adverse events such as product recalls, or worse, compromising on safety and even causing deaths. There are many information available on the topic such as in the USP chapters <1663> and <1664>. Although these documents provide detailed guidance and recommended best practices regarding assessment of E&L, they provide no specifications. This is because E&L needs to be assessed according to the specific drug application (Drug product, dosing, target population, etc.). Therefore, E&L remain as the hot topic for the industry especially for high risk applications such as injectables.

Boo Jia Min

Technology Manager. West Pharmaceutical Services

Jia Min, Boo is the Technology Manager for Asia Pacific from West Pharmaceutical Services. She is based in the Singapore office. She joined West as a Technical Account Specialist in Technical Customer Services (TCS) and later progressed to the role of Senior Technical Account Specialist. In her TCS role, she provides technical support to pharmaceutical companies in the AP region through product recommendations, technical trainings and consultations to ensure smooth and easy uptake of West’s wide product portfolio for customers' drug product applications. As Technology Manager, in addition to providing TCS support to customers in Australia, she works closely with relevant stakeholders to develop in-depth knowledge of industry and technology. By understanding the technical regulatory requirements, she transforms these into scientific insights for customers and the industry. Additionally, she is also managing the AP Technical Services Lab, which mainly supports West internal projects. Jia Min holds a Bachelor degree in Material Science Engineering from Nanyang Technological University in Singapore.