DOXPUB 11-0035-SOP

Summary:

Describes the standard operating and maintenance procedures for the manufacturing and development facility HVAC Systems. Applicable to Clean Suite HVAC, Manufacturing Support HVAC, General Office and QA/QC HVAC, and Aseptic Filling Suite HVAC. Includes provisions for documentation requirements, general HVAC considerations, system operation, system shutdown, system startup, bi-monthly preventative maintenance, semi-annual preventative maintenance, annual preventative maintenance, semi-annual HEPA and air flow certification, balancing of HVAC systems, and monitoring and alarm handling.

Included Sections:

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

Included Attachments/Appendices:

HVAC Systems Logsheet, Example of Floor Plan HVAC System Zones

About This Document:

This is not a generic template, it's a 16-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