Ethylene oxide (EO) is mainly used to sterilize items that are sensitive to moist heat or radiation. EO is a toxic, flammable and explosive substance, listed in a schedule 1 of the Canadian ...

Process validation is crucial for ensuring the quality of final products and the safety of these processes for manufacturing personnel and consumers in the pharmaceutical, medical device, and ...

The authors outline a validation approach for the manufacture of a “legacy product,” taking into consideration recent guidelines. The aim is to demonstrate the validity and capacity of the ...

Process validation is an extension of biologics development processes. When it comes to outsourcing process validation of biologics, Abel Hastings, director of process sciences at FUJIFILM Diosynth ...

Dublin, June 27, 2024 (GLOBE NEWSWIRE) -- The "Process Validation Training Course (FDA and EU Annex 15: Qualifications and Validation)" training has been added to ResearchAndMarkets.com's offering.

The "Process Validation Training Course (FDA and EU Annex 15: Qualifications and Validation)" training has been added to ResearchAndMarkets.com's offering. This training program will illustrate how ...

Moist heat sterilization is widely used for aqueous-based products. It's not used in instances where it results in product/material or packaging degradation. You must fully evaluate and document any ...