Vikrant Chadawar, Sr Technical Account Specialist, West Pharmaceutical Services, India | FDD Conclave 2022

In this video:
Vikrant Chadawar, Sr Technical Account Specialist, West Pharmaceutical Services, India
Topic: Overview on new USP <382> and its impact to parenteral product packaging and delivery systems

Key Highlights:
+ <382> was released in December 2020 with five-year implementation grace period

+ It is mandated to perform Container Closure Integrity Testing (CCIT) USP <1207>

+ Needle self-sealing capacity is important, so that any random particle doesn’t enter into the product

+ Packaging specifications will continue to evolve with advancing therapies and novel delivery systems

+ Testing standards helps in discovering risks and closing knowledge gaps