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).