ISO 11737 22009 Sterilization Of Medical Devices Pdf
Delmiro Fain
ISO 11737-2:2009 specifies the general criteria for tests of sterility on medical devices that have been exposed to a treatment with the sterilizing agent reduced relative to that anticipated to be used in routine sterilization processing. These tests are intended to be performed when defining, validating or maintaining a sterilization process.
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The appropriateness of the PCD used for process definition, validation or routine monitoring and control shall be determined. The PCD shall present a challenge to the sterilization process that is equivalent or greater than the challenge presented by the natural bioburden at the most difficult to sterilize location within the product.
The key to the selection of an appropriate IPCD is the demonstration that the IPCD shall present a challenge to the sterilization process that is equivalent or greater than the challenge presented by the natural bioburden at the most difficult to sterilize location within the product.
Section 7.3.1 of ISO 11135:2014 requires that medical device manufacturers have a system that specifies and maintains the microbiological quality and cleanliness of the product presented for sterilization in a manner that does not compromise the effectiveness of the sterilization process. The manufacturing controls typically result in consistent bioburden levels comprised of microorganisms lower in population and D value than that of biological indicator organism, Bacillus atrophaeus.
The D value curves above illustrate that the PCD presents a greater challenge to the sterilization process than that of the product bioburden, meeting the requirements set out in section 8.6 of ISO 11135:2014.
Selection of an appropriate PCD based on comparison against the relative resistance of the product bioburden using test of sterility allows manufacturers optimize the EO concentration and dwell when qualifying the required SAL of 10-6. Designing a PCD that presents a greater challenge to the process, for example, by placing a BI in a single, worst case location in the product should be avoided, where possible. Selection of an overly challenging PCD may far exceed the microbiological challenge of the product bioburden. This in turn may in the process requiring additional lethality (EO concentration and / or dwell time) to achieve the required kill in half cycles.
Finally, Figure 2 illustrates the evolution to a practical approach of establishing an appropriate internal PCD (IPCD) to minimize over-processing while still meeting a minimum sterility assurance level (SAL) of 10-6
Q: What is the Ethylene Oxide (EO) Sterilization Master File Pilot Program? A: In an effort to advance innovation in medical device sterilization with ethylene oxide (EO) and reduce the threat of shortages of EO-sterilized medical devices by providing
Products are generally filtered through a membrane in a closed system if they are liquids, and for solid medical devices and other such products a direct inoculation method is used to test the product for sterility. All products are tested for sterility in our clean-room facility.
The pharmacopoeia methods advocate wherever possible that the membrane filtration method be used to test the product. Where there are solubility issues or antibiotic suspensions that are unable to be filtered, it is allowable to directly inoculate the product into the test medium as the test method.
Whichever method is selected it is necessary to qualify the procedure by demonstrating the ability of a prescribed range of microorganisms to grow in the media after the product has been set-up for test.
It is necessary to qualify the procedure by demonstrating that the test articles to do not impart any anti-microbial growth properties to the test medium. This is done by inoculating a representative proportion of the test media with low numbers of prescribed microorganisms to demonstrate their ability to grow in the media after the required incubation period has completed.
Please contact our laboratory for assistance on sampling requirements. This can vary according to the nature of the product, batch size, sterilization method, etc as shown below.
Table 2 below shows the sampling schedule that clients will need to provide. (Table is taken from TGA Guidelines for Sterility Testing of Therapeutic Goods - 2006)
Table 3 below shows the minimum quantity that needs to be tested by the testing laboratory. (Table is taken from TGA Guidelines for Sterility Testing of Therapeutic Goods - 2006)
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General
5 Selection of product
6 Methods for performing tests of sterility
7 Assessment of the method for performing tests of sterility
8 Maintenance of the method for performing tests of sterility
Annex A (informative) Guidance on tests of sterility performed in validation and maintenance of a sterilization process
Annex B (informative) Typical assignment of responsibilities
Bibliography
This document specifies the general criteria for tests of sterility on medical devices that have been exposed to a treatment with the sterilizing agent which has been reduced relative to that anticipated to be used in routine sterilization processing.
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