DOXPUB 02-0014-SOP

DOXPUB 02-0014-SOP
DOXPUB 02-0014-SOP English PDF Calibration, Sanitization and Maintenance of the BioPilot Chromatography System

standard published 08/01/2007 by Doxpub, Inc.

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Full Description

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:

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Who Will Benefit:

Biologic Manufacturing PersonnelProcess Development PersonnelMethod Development Personnel

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