DOXPUB 02-0058-SOP

Summary:

Provides the procedures and documentation for cleaning and sterilizing materials used in aseptic filling using the AFSM, MQ-018. Applies to the materials used in the aseptic filling of sterile products intended for clinical or commercial distribution. Covers cleaning procedures for glass vials, stoppers, receiving vessels, forceps, caps and AFSM change parts, filtration and filling tubing, aluminum seals, dry heat sterilization and depyrogenation, and steam sterilization.

Included Sections:

Purpose, Scope, Responsibility, References and Applicable Documents, Materials and Equipment, Health and Safety Considerations, Documentation Requirements, and Procedures

Included Attachments/Appendices:

Aseptic Fill Materials Cleaning Record, Aseptic Fill Materials Dry Heat Sterilization Record, Aseptic Fill Materials Steam Sterilization Record

About This Document:

This is not a generic template, it's a 13-page procedure that was actually created and used in the Bioprocessing operations of a FDA-regulated establishment. The company-specific information (names, addresses, some images, proprietary product information, etc.) has been redacted but the content and format have been largely preserved.

Reasons to Buy:

• Use it as a starting point for your own documentation project
• Compare the quality of your documents against your industry peers
• Learn what other companies in your industry are actually doing

Who Will Benefit:

• Biologic Manufacturing Personnel
• Process Development Personnel
• Method Development Personnel