$162
PDA TR 48
2010
Technical Report No. 48 (TR 48) Moist Heat Sterilizer Systems: Design, Commissioning, Operation, Qualification and Maintenance
- Format:
- Language(s) :
- Published :
- English
- 05/01/2010
PDA's Moist Heat Sterilization Systems Task Force has developed a scientific technical report that will help you design and operate moist heat sterilizers. Advise is offered on the following areas:
- Setting User Requirements and Specifications
- Design Qualification (DQ)
- Equipment and Control System Design
- Functional Requirements for the moist heat sterilizer and expectations for utilities supporting the sterilizer
- Equipment Operation, including calibration and maintenance
- Equipment Qualification, which may include Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), and commissioning
- On-going control requirements
- Cycle Development
This Technical Report addresses moist heat sterilizers intended for use in the pharmaceutical, medical device and biotechnology industries. This technical report focuses on the design and operation of moist heat sterilizers, from the development of User Requirements Specifications (URS) through equipment qualification (Installation Qualification (IQ) / Operational Qualification (OQ)) and culminating with ongoing maintenance requirements. The focus of this report does not include Performance Qualification (PQ). The reader is directed to PDA Technical Report No. 1 (2007 Revision) for discussion of load cycle development and process Performance Qualification.
| PDA TR 48 | |
|---|---|
| STANDARD INFO: | |
| Standard Name | PDA TR 48 |
| Scope | Technical Report No. 48 (TR 48) Moist Heat Sterilizer Systems: Design, Commissioning, Operation, Qualification and Maintenance |
| Publisher | PDA - Parenteral Drug Association |
| Languages | English |
| State | |
| Publication Year | 2010 |
| Most recent Version | MOST RECENT |
| Whether to be replaced | |
| Addendum | |
| FILE INFO: | |
| File Size | 1 file , 2.8 MB |
| ISBN(s) | 9780939459292 |
| Number of Pages | 64 |
| Product Code(s) | 01048 |
| Published | 05/01/2010 |
| PDA TR 48 | ||
|---|---|---|
| History | Publisher Year | |
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