This article discusses two longstanding ASTM standards on cleanability testing for use in the oxygen service industry that have been updated for use in cleanability testing for the pharmaceutical and medical device manufacturing industries.
By Todd Owens and Raghu Vadlamudi,Donatelle
Process validation is critical in medical device manufacturing, but it often doesn’t get the attention it requires. This article offers guidance for creating validation processes and helps identify the personnel who should create and maintain them.
Application Note |
By Dr. Theresa Bankston,BD Medical - Pharmaceutical Systems
The growing complexity and regulatory rigor of combination products have called for increasingly innovative delivery devices. This article looks at the advantages of using an integrated system for these drug-device combination products rather than sourcing components from different suppliers.
By Mike Driscoll,Carclo Technical Plastics
When developing a part or device for the medical or optic industries, the goal is always to get that part to market as quickly as possible. The key to doing just that: developing a strong relationship with a molder early in the part design process.