DOXPUB 11-0139-SOP

Summary:

Describes the procedures for the operation and maintenance of the M&O Perry Industries Model P1500-I Automatic Filling and Stoppering Machine (AFSM). Applicable to the AFSM used to aseptically fill and stopper vials. Includes an equipment description and provisions for installation, sanitization, setup, operation, fault conditions, and maintenance.

Included Sections:

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

Included Attachments/Appendices:

AFSM Logsheet

About This Document:

This is not a generic template, it's a 10-page procedure that was actually created and used in the Facilities & Equipment 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:

• Manufacturing Personnel
• Facilities Managers
• Laboratory Personnel