Summary:

Describes the certification, repair and replacement procedures for HEPA filters. Applies to HEPA filter units use in TAFs (terminal air filters) in classified clean rooms, biosafety cabinets, laminar flow hoods, laminar flow benches, and manufacturing support areas surrounding the clean corridor in building. Includes provisions for DOP leak testing, airflow velocity testing for unidirectional or laminar flow devices, airflow volume testing for non-unidirectional airflow devices, differential pressue testing, HEPA filter replacement, HEPA filter leak repair, and service reporting.

Included Sections:

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

Included Attachments/Appendices:

None

About This Document:

This is not a generic template, it's a 6-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