EO product group and processing group
In actual work, there may be many types of products that need to be sterilized with ethylene oxide. Due to the long and high cost of sterilization confirmation, it is not economical to confirm the sterilization of each product separately, and in many cases it is even unrealistic. In order to realize the problem of multiple products being confirmed together and sterilized together, a common practice is to divide the products into EO product families or treatment groups. After confirming representative products or PCDs in the EO product families or treatment groups, you can All products in the product family or treatment group are routinely sterilized.
4.1 EO product line
The EO product family refers to a series of products that are similar or equivalent for confirmation. When classifying a product into a product family, the main factors considered are product design and function, production method, production environment or area, material composition, packaging material, sterile barrier or protective packaging mode, density, size, and/or surface area , And bioburden, etc.
4.2 Processing Group
The concept of EO product family is further extended to get the concept of treatment group: a treatment group refers to a series of products or product families that can be sterilized by the same EO sterilization process.
It can be seen from the above definition that the treatment group covers a wider range than product families and can include different product families.
The products contained in the treatment group may be different in terms of materials, structure, packaging, etc. This is a different concept from the product family. But the products within the treatment group are consistent in that they can all use a certain PCD to represent their microbiological challenges.
4.3 Application of EO product family and processing group concepts
The concepts of EO product family and processing group have important guiding significance for actual work, making it possible to verify different types of products with less work at the same time, which can save a lot of time and cost. The following is a specific method used:
(A) Divide the products to be verified into different EO product families;
(B) Determine the PCD of each EO product family and compare their relative resistance;
(C) Choose the PCD with the strongest relative resistance as the main PCD of the treatment group;
(D) Confirm sterilization with the main PCD of the treatment group;
(E) After the confirmation is completed, all products in the treatment group can be subjected to routine treatment at the same time in the same sterilization process.
Process equivalence
For the sterilization process, running on different sterilization equipment may have different output (ie sterilization effect) due to the differences in the sterilization equipment itself. Therefore, even for a completely consistent sterilization process, when running on different sterilization equipment, sterilization confirmation needs to be performed separately. This principle is consistent with the production and packaging of medical equipment.
However, for manufacturers with multiple similar sterilization equipment, the time and economic cost of comprehensive sterilization confirmation for the same products and parameters on each sterilization equipment are relatively high, and may not be necessary, so here we introduce the process The concept of equivalence.
The evaluation of process equivalence is usually divided into two parts: process analysis and evaluation, and microbiological evaluation. In addition to the sterilization cabinet, process analysis and evaluation also need to consider other related equipment of the sterilization process, such as the pretreatment room and the analysis room. One focus of the evaluation is to compare the similarities and differences of each system in detail, such as manufacturers, brand models, power levels, etc., and another focus is on the process effects, such as vacuum rate, temperature and humidity distribution, etc. The microbiological assessment is mainly to run part of the cycle or half cycle, etc., to prove that the sterilization process can reach the specified minimum SAL (sterile assurance level).
Conclusion
In summary, the confirmation of ethylene oxide sterilization involves many aspects such as microbiological challenge equipment, residual quantity detection, products, and processes. There may be many problems encountered in actual work, but some methods are used reasonably. It is possible to economically perform sterilization confirmation on a scientific and reasonable basis.
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