Sterilization validation and routine operation handbook : radiation /: radiation. (2014)

• Record Type: Book
• Further Information: Note: By Anne Booth.
• Authors: Booth, Anne F
• Contents: Rationale for Validating Sterilization Processes; Characterization of Radiation Processes; o Physical Characteristics of Radiation; o Facility Design; o Effects of Radiation on Microorganisms; o System Operations; o Critical Process Parameters; o Dose Distribution; o Dosimeters; o Dose Mapping; Contract Sterilization; o Selection of the Sterilization Facility; o Obtain a Written Contract; o Verification of Validation; o Routine Processing; Prevalidation Planning; o Product and Package Materials Evaluation; o Accelerated Aging; o Establishment and Maintenance of Product Families; o Grouping into Product Families; o Selection of Family Representative; o Selection of a Sample Item Portion (SIP); o Sterility Assurance Levels (SAL); Microbiological Considerations; o Evaluation of Product Bioburden; o Evaluation of Bioburden Data; o Bioburden Isolates; o Product Sterility Testing; o Troubleshooting Microbiological Failures; Sterilization Support Testing; o Selection of a Test Laboratory and Test Methods; o Environmental Monitoring and Control; o Biocompatibility Testing; o Bacterial Endotoxin and Pyrogen Testing; The Validation Protocol; Outline of the Sterilization Validation; o Product and Packaging Materials Evaluation; o Equipment Qualification and Documentation; o Sterilization Dose Selection; o Dose Audit; o Dose Augmentation; o Selection of a Sterilization Dose for a Single Production Batch; o Alternate Sampling Plans for Dose Verification and Audit; Final Report; Routine Monitoring and Control; o Adopting a Device into a Validated Sterilization System; o Dose Audit Failure; o Frequency of Sterilization Dose Audits; Appendices; o Contract Radiation Sterilization Facilities in the United States; o Method 1 Dose Verification; o Method 1 Quarterly Dose Audit; o Worked Example for Method 1; o Method 2A Dose Validation; o Worked Example for Single Product Batch (SIP
• Edition: 1st
• Publisher Details: Boca Raton : CRC Press
• Publication Date: 2014
• Extent: 1 online resource
• Subjects: 614.4; Radiation sterilization
• Languages: English
• ISBNs: 9781482296471
• Notes: Note: Description based on CIP data; resource not viewed.
• Access Rights: Legal Deposit; Only available on premises controlled by the deposit library and to one user at any one time; The Legal Deposit Libraries (Non-Print Works) Regulations (UK).
• Access Usage: Restricted: Printing from this resource is governed by The Legal Deposit Libraries (Non-Print Works) Regulations (UK) and UK copyright law currently in force.