Annales pharmaceutiques francaises · 2022
[Qualification of low temperature vaporized hydrogen peroxide sterilization: Towards greater harmonization of practices?].
Аннотация на английскомСтатьяНазвание и аннотация: Перевод в очереди
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Van Den Broucke R, Maurin A, Tilleul P, Combeau D
Аннотация
OBJECTIVES: Comparing performance qualification procedures for low temperature vaporized hydrogen peroxide sterilization. Assessing conformity with draft standard ISO/DIS 22441.
METHODS: Qualification reports from several providers have been compared according to specific criteria: choices of cycles, loads, sterile barrier systems, probes, biological and chemical indicators; checking of packaging integrity and exposure to sterilizing agent.
RESULTS: Six out of 8 reports based on 4 distinct sterilizers have been performed by third-party providers. Routine and process challenge devices are respectively used in 6 and 3 of these reports. Sizes and masses are never mentioned whereas load configuration is always specified. All reports use at least one biological indicator and 50% of them use one chemical indicator at a minimum. Most frequent wrapping materials are Ultra® and Tyvek® bags (respectively 50% and 37.5% of reports). Each qualification monitors per process pression and temperature, and 37.5% of them also quantify hydrogen peroxide concentration. Packaging integrity and environmental exposure are checked in respectively 50% and 12.5% of all reports. All reports have received providers approval.
CONCLUSION: Qualification procedure is based on steam sterilization NF EN 14937 standard, which seems unsuitable for low temperature process. The lack of autonomy, the heterogeneity of loads and measurement choices reveal a low harmonization of practices. New standard should dispel the doubts about this heterogeneity.
METHODS: Qualification reports from several providers have been compared according to specific criteria: choices of cycles, loads, sterile barrier systems, probes, biological and chemical indicators; checking of packaging integrity and exposure to sterilizing agent.
RESULTS: Six out of 8 reports based on 4 distinct sterilizers have been performed by third-party providers. Routine and process challenge devices are respectively used in 6 and 3 of these reports. Sizes and masses are never mentioned whereas load configuration is always specified. All reports use at least one biological indicator and 50% of them use one chemical indicator at a minimum. Most frequent wrapping materials are Ultra® and Tyvek® bags (respectively 50% and 37.5% of reports). Each qualification monitors per process pression and temperature, and 37.5% of them also quantify hydrogen peroxide concentration. Packaging integrity and environmental exposure are checked in respectively 50% and 12.5% of all reports. All reports have received providers approval.
CONCLUSION: Qualification procedure is based on steam sterilization NF EN 14937 standard, which seems unsuitable for low temperature process. The lack of autonomy, the heterogeneity of loads and measurement choices reveal a low harmonization of practices. New standard should dispel the doubts about this heterogeneity.