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.