DuPont™ Tyvek® 1421B for In-Process Pharmaceutical Applications
Tyvek® 1421B is specifically developed for in-process pharmaceutical applications to protect surfaces of cleanroom equipment, components and accessories from particle and microbial contamination. Made from HDPE using DuPont proprietary flash-spinning technology, Tyvek® 1421B is softer and more fabric-like compared to other healthcare packaging styles of Tyvek® used in sterile packaging. This makes Tyvek® 1421B ideal for pharmaceutical cleanroom and controlled environment covers and bags. Typical product examples include cleanroom equipment covers, stopper bowl covers, sterilization wrapping and autoclave component bags and covers.
Preparing for the Emerging Regulations
Manufacturing processes for pharmaceutical products require strict quality practices. These requirements will further increase with the introduction of the revised European Good Manufacturing Practice (EU GMP) Annex 1 that describes principles applied for manufacture of sterile products. Special focus is on the systematic implementation of quality risk management (QRM) to ensure prevention of microbial and particulate contamination in the final product. Anticipating these GMP changes, the recently published ISO/DIS 13408-1 provides guidance on how to manage quality risks and on developing an adequate contamination control strategy for aseptic processing of healthcare products.