A Systematic Approach To Extractables And Leachables: A Review Of Guidance From The Industry

By Aryo A. Nikopour

Aryo A. Nikopour, Senior Vice President of Scientific and Technical Services with Nitto Avecia Pharma Services, discusses the basic definitions of extractables and leachables and why it is important to reference the vast amount of reference material available to ensure that you are meeting industry standards. Understand the role of the supply chain, what departments/positions within your company need to be involved, as well as many other factors to consider such as the machine, drug substance, material, water, and container closure system environment when designing your extractable/leachable study.

The presentation also includes details from case studies done using prefilled syringes and a second using a single-use bag. The case studies give insight into variables and challenges in real situations and how applying specific methods and techniques can allow you to detect extractables and/or leachables.

Speaker

Aryo A. Nikopour,
Senior Vice President of Scientific and Technical Services
Nitto Avecia Pharma Services

Nitto Avecia Pharma Services is your single solution for premier contract development and manufacturing services. Nitto Avecia Pharma Services supports the pharmaceutical, bio pharmaceutical, and medical device industries with a complete package of cGMP services, small to large molecules including, formulation and processing development, parental manufacturing, analytical development, analytical chemistry, stability, structural chemistry, microbiology, and drug delivery device testing.