DOXPUB 12-0034-SOP

Summary:

Describes the procedures, equipment, personal protective equipment and work practices necessary to protect personnel from the potential health hazards presented by biohazards in medical device, biologic and drug establisments. Includes provisions for handling human or primate tissue/blood/fluids/aerosols, working with sharps, pipetting/centrifugation/transport of potentially infectious fluids, documentation requirements, decontamination, equipment disinfection, disinfection agents, liquid waste disposal, and Hepatitis B vaccination and post-exposure evaluation.

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 7-page procedure that was actually created and used in the Environmental Health & Safety 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:

• Laboratory Personnel
• Facilities Managers
• Material Control Personnel