What You Should Know About Sterilizations

Special requirements apply to the production of sterile products and pharmaceuticals to minimize the risk of contamination with microorganisms and particles. Much depends on the sterilization process. Which sterilization method (e.g., steam, gas, radiation, or filtration) is used? Are you familiar with the regulatory requirements?

For example, the EMA Guideline on the sterilization of the medicinal product, active substance, excipient, and primary container.

What does the new Annex 1 require regarding sterilizations? How must the sterilized goods be packaged to generate as few particles as possible? What needs to be considered in sterilizing filtration? How are sterilizing filters sterilized? How are sterilizing filters tested? What are the requirements for PUPSIT?

What should you consider regarding hot air sterilization, depyrogenation, or steam sterilization? How does the authority inspect sterilizations? These are just some of the points that our experts will present at the seminar. Come with your questions to us.