What Are Validated Sterile Wipers?


TO BE USED in a sterile environment, production consumables, like wipers, must conform to high standards and be documented as validated sterile.

 

Meeting Manufacturing & Documentation Standards

This Technical Brief presents an overview of:

  • The concept of sterility.
  • Good Manufacturing Practices (cGMPs).
  • Validated procedures for sterile manufacturing.
  • ANSI / AAMI / ISO standards for sterility.
  • Sterility Assurance Levels (SALs) and Gamma Irradiation.
  • Certificates of Sterility (COSs).

 

Get briefed on all these points, by submitting the form below for PDF download.


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