{"id":1944865,"date":"2023-02-07T05:00:00","date_gmt":"2023-02-07T10:00:00","guid":{"rendered":"https:\/\/platoaistream.com\/plato-data\/how-to-select-and-help-validate-the-best-sterilization-method\/"},"modified":"2023-02-07T05:00:00","modified_gmt":"2023-02-07T10:00:00","slug":"how-to-select-and-help-validate-the-best-sterilization-method","status":"publish","type":"station","link":"https:\/\/platoaistream.com\/plato-data\/how-to-select-and-help-validate-the-best-sterilization-method\/","title":{"rendered":"How to select and help validate the best sterilization method?"},"content":{"rendered":"
Posted by Rob Packard<\/a><\/span> on February 7, 2023<\/span> <\/span> <\/p>\n The FDA eSTAR includes a list of eight different options for a sterilization method, but how do you select the best method and validate it?<\/span><\/p>\n <\/p>\n The Sterilization Packaging Manufacturers Council (SPMC) founded Sterile Packaging Day<\/span><\/a> in 2021 to recognize and thank all of the companies in the supply chain who work together to deliver innovative, safe, and sterilized devices to provide excellence in patient care. Sterile Packaging Day is February 8, 2023, and this year\u2019s celebration theme is \u201cDesigned to Protect.\u201d SPMC provides four tips for celebrating Sterile Packaging Day:<\/span><\/p>\n [embedded content]<\/p>\n Several factors determine the best sterilization method to use for your device. The first factor is whether your device will be delivered sterile or will the end user sterilize the device. If the end user is responsible for sterilizing the device, the most common methods used by hospitals are:<\/span><\/p>\n The popularity of the third method is declining due to environmental restrictions on hazardous emissions from the ethylene oxide sterilization process. Hydrogen peroxide is gaining popularity because it can be used for heat-sensitive materials, and hydrogen peroxide vapor reacts with moisture to form a harmless aqueous solution. Steam is the most common sterilization method used by doctors, dentists, and hospitals because steam sterilizers are relatively inexpensive, and no hazardous chemicals are required.<\/span><\/p>\n The second factor to consider when selecting a sterilization method is whether there are any heat-sensitive components. Plastics will melt and degrade in dry heat sterilization cycles, and some plastics cannot withstand the temperature of a steam sterilizer. Therefore, if your device is constructed from plastics for cost reduction, weight, magnetic resonance (MR) compatibility, or other reasons, you may need to use a sterilization method with a lower temperature process.<\/span><\/p>\n The third factor to consider when selecting a sterilization method is whether any long, narrow tubes require sterilization. These design features are difficult to sterilize for any vapor-based sterilization process, such as steam, hydrogen peroxide, or ethylene oxide. There are a few process control strategies that can be used to sterilize with gas:<\/span><\/p>\n The fourth factor to consider when selecting a sterilization method is whether the device includes a liquid. A liquid cannot be sterilized with hydrogen peroxide, ethylene oxide, or dry heat. In some cases, the liquid may be a sterilant (i.e., ISO 14160:2021 for liquid chemical sterilizing agents). There are three popular solutions for the sterilization of a device that includes liquid:<\/span><\/p>\n eBeam and Gamma are also used for sterilizing products where cross-linkage of ultra-high molecular weight polyethylene (UHMWPE) is desired, or it is impossible for a gas sterilant to penetrate all areas of a device.<\/span><\/p>\n As shown in the FDA eSTAR screen capture above, eight possible sterilization methods can be selected for sterilizing a medical device in a 510k or De Novo submission. Each sterilization method has a different applicable standard that should be used to validate the sterilization process, but in all cases, the sterilization process must result in a sterility assurance level (SAL) of 10-6<\/sup>.<\/span><\/p>\n The FDA feels that the Established A (Est A) methods of sterilization have a long history of safe and effective use, while the FDA has not recognized a dedicated consensus standard for the Established B (Est B) sterilization methods. However, there are examples of devices that have received FDA 510k clearance using each of the non-traditional sterilization methods (i.e., Est B methods). Manufacturers will generally adapt existing international standards for sterilization validation to validate the non-traditional methods. There is published information on the development, validation, and routine control for these non-traditional sterilization processes.<\/span><\/p>\n Links to each of the recognized standards are provided below:<\/span><\/p>\n Novel sterilization methods should only be used when none of the traditional (Est A) and non-traditional (Est B) sterilization methods will not work. For example, aseptic filling combined with filtration of liquids is a common strategy for pre-filled syringes if the liquid is sensitive to radiation sterilization. Sterilization with peracetic acid has been used for a long time, but the sterilization method has not gained widespread popularity. Peracetic acid can also be combined with hydrogen peroxide. There is also a low-temperature steam and formaldehyde validation standard (i.e., ISO 25424:2019). Sterilization with UV light is a process that is sometimes used where materials are sensitive to high temperatures and where all surfaces can be penetrated with UV light. Nitrogen dioxide was developed as a more environmentally friendly sterilant similar to ethylene oxide. X-Ray is a new type of radiation sterilization that is being developed as a high-speed alternative to Gamma and eBeam, but X-Ray sterilization also has the advantage of being able to control a narrower dose range than Gamma and eBeam processes. <\/span><\/p>\n There are also additional supporting standards that you will need for validation of your sterilization process. The following is a partial list of the standards you might consider:<\/span><\/p>\n The current standard for accelerated aging studies is ASTM F1980:2021<\/span><\/a> \u201cStandard Guide for Accelerated Aging of Sterile Barrier Systems and<\/span> Medical Devices has been revised and recently released to include medical devices.\u201d Jan Gates explains that the \u201cand\u201d used to say \u201cfor.\u201d The language was updated with more information on product humidity effects to go with the title. Jan was kind enough to write a Shelf-life Testing Protocol<\/span><\/a> for us based on this new version of the standard. The protocol includes requirements for real-time and accelerated age testing of a product. If you need basic training on how to validate the shelf-life of your device, we have a webinar for sale<\/span><\/a> on sterility and shelf-life. We also recorded an updated webinar on January 19, 2023, as part of the FDA eSTAR updates to our 510(k) Course<\/span><\/a>.<\/span><\/p>\n There are also standards for distribution conditioning tests (i.e., ASTM D4169-22<\/span><\/a>). Jan Gates was kind enough to write a 20-page Distribution Conditioning Shipping Qualification Protocol<\/span><\/a> for Medical Device Academy based upon the ASTM standard. The protocol is available for purchase at the link above. Jan also wrote an 18-page Packaging Performance Testing Protocol<\/span><\/a> for our customers in accordance with ISO 11607-1 <\/span><\/a>and ISO 11607-2<\/span><\/a>.<\/span><\/p>\n ISO 13485:2016, Clause 7.5.7 is specific to the \u201cParticular requirements for validation of processes for sterilization and sterile barrier systems.\u201d This clause includes the requirement to establish procedures for sterilization validation and validation of your sterile barrier systems. Even if your company uses a protocol and procedures established by a contract manufacturer, you still need to establish an internal procedure(s) to meet this requirement if you have sterile products. The following is a list of procedures sold by Medical Device Academy:<\/span><\/p>\n Most device manufacturers do not sterilize their devices in-house. Instead, sterilization is outsourced to a contract sterilizer. The process flow diagram below is a hypothetical process flow diagram for a contract sterilization process. The only step not included in this process flow is the incubation of biological indicators because gamma and eBeam sterilization processes use dosimeters instead of biological indicators. The nature of biological indicators is also changing rapidly because manufacturers are developing \u201crapid test\u201d biological indicators. In 2008 I worked extensively with self-contained biological indicators that eliminated the need to use an aseptic technique to transfer biological indicators into culture media. In addition, I complete an incubation reduction study to validate a shorter 48-hour incubation cycle instead of the typical 7-day sterility test. Terragene<\/span><\/a> is one of the manufacturers developing next-generation technology for biological indicators that allows the results to be read within seconds instead of 48 hours. This next-generation technology also incorporates barcode readers and networked readers to ensure traceability to each biological indicator and reader.<\/span><\/p>\n <\/p>\n In the \u201colden days\u201d (c. 2005), I used to print out labels for each pallet that we shipped to the Isomedix facility in Northboro, MA. The label identified who the product was from and what we wanted Isomedix to do with the product (e.g., gamma sterilize at 25-40 kGy). At the time, we were just beginning to incorporate barcodes into on-demand labeling to facilitate traceability. 18 years later, companies are still stalling the implementation of on-demand barcoded labels. Almost every shipping dock has a barcode reader, and the technology is inexpensive. Therefore, you should consider creating a template for on-demand barcoded labels with all the information listed below. This will reduce the risk of errors by the contract sterilizer and enable you to identify when a mistake was made quickly. Contract sterilizers should also demand this information on product labeling as an added risk control. All biological indicators and dosimeters are labeled with UDI barcodes<\/span><\/a> now. Therefore, contract sterilizers should be able to create robust process controls that ensure traceability between barcodes on your labeled product with barcodes on the biological indicator or dosimeter.<\/span><\/p>\n <\/p>\n <\/p>\n Posted in:<\/strong> Sterilization Validation<\/a>, Validation<\/a><\/p>\n<\/p><\/div>\n <\/p>\nWhat is Sterile Packaging Day?<\/span><\/strong><\/span><\/h2>\n
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Thank you to Jan Gates!<\/span><\/strong><\/h3>\n
How to select the best sterilization method<\/span><\/strong><\/span><\/h2>\n
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What are the applicable sterilization validation standards for each sterilization method?<\/strong><\/span><\/h2>\n
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When should you use a novel sterilization method?<\/span><\/strong><\/span><\/h2>\n
Consensus Standards for Sterilization Validation<\/span><\/strong><\/span><\/h2>\n
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Aging and Shelf-life Testing<\/span><\/strong><\/span><\/h2>\n
Distribution Conditioning Tests & Packaging Performance Tests<\/span><\/strong><\/span><\/h2>\n
Where can you find a procedure for each sterilization method?<\/strong><\/span><\/h2>\n
What is the process flow for contract sterilization?<\/span><\/strong><\/span><\/h2>\n
What information should serialized labels include for contract sterilizers?<\/span><\/strong><\/span><\/h2>\n
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