validation refers to establishing documented evidence that a process or system, when operated within established parameters, can perform effectively and reproducibly to produce a medicinal product meeting its pre-determined specifications and quality attributes
Tuesday, January 2, 2018
Ethylene Oxide Sterilization Validations
Ethylene Oxide sterilization is well known in the industry and is accepted as a sterilant by the FDA. It is one of the most popular ways of sterilizing medical devices. It is a great form of sterilization for medical devices that are heat sensitive or sensitive to radiation- such as polymers and plastics that can melt, become brittle or deteriorate. http://bit.ly/fuza5C Nelson Labs provides the EO validation testing. www.nelsonlabs.com.
Subscribe to:
Post Comments (Atom)
Pharmaceutical Validation Documentation Requirements
Pharmaceutical validation is a critical process that ensures that pharmaceutical products meet the desired quality standards and are safe fo...
-
K. Dashora, D. Singh, Swarnlata Saraf and S. Saraf *. Institute of Pharmacy, Pt.RavishankarShuklaUniversity, Raipur 492 010. *Author for ...
-
Validation of the Autoclave is classified into the following 1.0 OQ – Operational Qualification 2.0 PQ – Performance Qualification The valid...
-
Cold storage is a relatively simple cold room that is commonly used to store material between 2[degrees] to 8[degrees]C. Such cold rooms a...
1 comment:
Wonderful explanation in your video.
medical device prototyping services
Post a Comment