Sterilization Validation and Routine Operation Handbook (2001)


The validation and radiation sterilization process for biomaterials and medical devices requires careful planning to ensure regulatory compliance followed by precise accuracy in execution and documentation. Les mer
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The validation and radiation sterilization process for biomaterials and medical devices requires careful planning to ensure regulatory compliance followed by precise accuracy in execution and documentation. This in-depth guide details all steps from prevalidation planning to final report and ongoing monitoring and control. Sterilization Validation & Routine Operation Handbook: Radiation provides a framework for the validation and routine operation of an irradiation sterilization process. The guidance presented complies with ANSI/AAMI/ISO 11137: 1994, Sterilization of health care product-Requirements for validation and routine control-Radiation sterilization and the newly published AAMI substantiation of 25 kGy using VDmax procedure. The author discusses methods to aid in comprehending the requirements in these standards. She also provides practical procedures for the validation and routine monitoring and control of specific gamma and electron beam radiation sterilization processes.

Background chapters provide needed information on radiation sterilization technologies, sterilization microbiology, validation approaches and working with a radiation sterilization contractor. Much of the information in this new book is presented in convenient tables and charts, with diagrams and other schematics that simply illustrate appropriate validation methodologies. Sterilization Validation & Routine Operation Handbook: Radiation brings together in one resource information scattered throughout many documents and will be useful to all those involved in the sterilization of medical materials, drugs and devices.



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
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

Om forfatteren

Anne F.Booth President Booth Scientific, Inc
An experienced quality and sterilization professional with an in-depth knowledge of quality systems and sterilization process design, validation, cycle development and routine operation; of environmental monitoring and control and regulatory compliance issues. Detailed knowledge of FDA QSR requirements (21 CFR 820 and 210/211), as well as ISO 13485, ICH, EU MDD and Canadian requirements. Experienced in project and laboratory management. Skilled in process design and validation for a wide variety of medical devices, packaging, and pharmaceutical raw materials. Good troubleshooting, auditing and time management skills. Track record of significant contributions to improved operating efficiency, cost reduction, and profit enhancement.

Specialties: sterilization design and validation, quality systems, environmental monitoring, microbiology evaluations and testing, auditing