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 predetermined specifications and quality attributes
Monday, January 1, 2018
Medical Device Packaging Validations
Packaging Validations demonstrate the strength, integrity, and microbial barrier properties for porous and non-porous packages. These validations are required by FDA/ISO regulations before products can be sold. Nelson Labs has a streamlined validation process that meets these requirements and complies with the ISO 11607 "Packaging for terminally sterilized medical devices" standard.
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