DOXPUB 02-0014-SOP

Summary:

Describes methods of liquid exchange, calibration, sanitization and maintenance of the Pharmacia, BioPilot System. Applies to properly trained personnel requiring the use of the pH armacia, BioPilot System for manufacturing purposes. Includes provisions for plumbing mode, liquid exchange, calibration, sanitization, 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:

Biopilot Chromatography System Calibration Worksheet, Equipment Cleaning, Use, and Maintenance Log, and Biopilot Supply List

About This Document:

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