Radiation Sterilization: Validation and Routine Operations by Anne Booth

By Anne Booth

This entire instruction manual is meant to supply a framework for the validation and regimen operation of irradiation sterilization approaches. It defines easy methods to help you within the interpretation and figuring out of ancillary criteria and guidance. It bargains sensible tactics for the validation and regimen tracking of your particular radiation sterilization approach. even though the scope of the factors refers to scientific units, the necessities and tips can be acceptable to different health and wellbeing care products.
The suggestions provided complies with:
ANSI/AAMI/ISO 11137-1: 2006: Sterilization of well-being care items Radiation half 1: standards for improvement, validation and regimen keep an eye on of a sterilization procedure for scientific devices;
ANSI/AAMI/ISO 11137-2: 2006: Sterilization of future health care items Radiation half 2: setting up the sterilization dose;
ANSI/AAMI/ISO 11137-3: 2006 Sterilization of future health care items Radiation half three: assistance on Dosimetric points.

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In addition, the contractor is responsible for the following: (1) Documenting the quantity of product and test samples received (2) Processing and reporting any deviations from specification 24 CONTRACT STERlLlZATlON (3) Segregating product to avoid mixing sterile and nonsterile product (4) Documenting material damage ( 5 ) Reviewing records to ensure compliance with specification (6) Recording the effect of process interruptions (7) Dose monitoring-placement and retrieval (8) Shipping product loads with identifying labels on each pallet containing the designation: "Sterilized-Awaiting test results" (9) Providing the following documentation: test sample (if used) and dosimeter placement and retrieval information lot number, quality received, sterilized, and shipped sterilization batch number and date specified dose received and maximum dose written release or acceptance of the sterilization processing records documentation of any damage, deviations, and changes that could affect the process On receipt of the routine batch information from the contractor, the manufacturer should review the processing documentation to ensure that the validated specifications were met.

PBT not as stable at PET resins. HD not as stable as MD and LD. LCPs; natural LCPs are not stable. lrradation causes embrittlement. Color changes have been noted (yellow to green). (continued). Polyimides Polyphenylene sulfide Polypropylene, natural Polypropylene, stabilized Comments Radiation Stability Excellent Excellent Poor-fair Physical properties are greatly reduced when irradiated. Radiation stabilizes grades utilizing high MWand copolymerized and alloyed with polyethylene, should be used in most applications.

EX~MPLEI . Sample # Product-Lancet Batch 1 (Plastic plus Metal). 1. Verification test results: 4 positives = failure. Average using spikes: 31. Test result using spikes: 1 positive = pass. p - EXAMPLE 2. Sample # Cotton Gauze Bandage (Large). Batch l Average 5750 Batch 2 2916 Batch 3 3642 Overall average: 4103. Verification test results: 15 positives = failure. Average using spikes: 17,333. Test result using spikes: 1 positive = pass. EXAMPLE 3. Sample # Foam Equipment Handle Cover. Batch 1 Batch 2 1 2 3 4 5 6 7 8 9 10 Average Overall average: 196.

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