Appearance
Regulation and Disinfection: what is the the regulatory framework for biodecontamination?
Metadata
Toggle details
- Necessity confirmation: Y
- Word count
- Raw: 900
- Main: 586
- Effective: 586
- Draft: Done
- Publish: Done
Contents
Title
en
Regulation and Disinfection: what is the the regulatory framework for biodecontamination?zh-Hans
监管和消毒：生物净化消毒的监管框架是什么？Content
en
NFT 72-281, EN 17-272, BPR 528/2012, European Community conformity, ECHA… What are the norms for ASD devices and biocides? What are the latest applicable versions? Three questions today to Devea’s regulatory expert, specialized in Biocides Regulation EU 528/2012, to help you understand the context.
Devea, French specialist in Airborne Surface Disinfection by centrifugation, has been promoting its Phileas® solutions in France and internationally since 2009. Pharmaceutical industry, hospitals, research laboratories, research animal facilities, health, communities, etc
1. First of all, can you remind us of the regulatory framework in which the ASD, Airborne Surface Disinfection operates?
“The ASD involves a device / disinfectant pair; marketing is regulated by several norms and regulation. The biocidal product contains the active substance hydrogen peroxide (H2O2) approved according to the European Regulation on biocidal products BPR (EU) 528/2012 of May 2012. This product is also authorized according to this same Regulation for fogging use under the number FR 2019-0071.
The competent authority that issues authorizations in France is ANSES. Likewise, in each European country in which the product is sold, the Phileas / O2SAFE must be authorized by the local competent authority.
The authorization request must also contain proof that the product operates in accordance with the claims made by the marketer as well as the guarantee of the product’s harmlessness with respect to humans and the environment.
From an efficiency standpoint, the product must demonstrate that it meets the requirements of the EN 17272 standard of April 2020, which also validates the homogeneity of fog diffusion. There are very few authorizations in France for this type of product and DEVEA was a forerunner in this area.”
2. Any recent regulatory changes, and if so, which industry sectors are affected?
“The French norm NFT 72-281, the last version of which dated from 2014, is now outdated. It largely inspired the European standard EN 17-272 which is currently in force for any request for authorization which would be submitted since its date of publication (April 2020).
Two points in particular have been developed in EN 17-272 compared to NFT 72-281:
a) A distribution test to validate the homogeneity of the diffusion of biocide fog, with 8 biological indicators distributed in the corners.
b) Populations of microorganisms and a log reduction in these populations variable according to the target industries.
Specifically for the pharmaceutical industry, the production of sterile drugs, ruled by appendix I of ‘Good Manufacturing Practices’, is evolving towards the promotion of barrier technologies, and a limitation of human interventions in grade A areas. Bioburden control, minimization of aseptic risks and a more structured contamination control strategy are the pillars of this new version 12. This appendix I describes the need to biodecontaminate the most critical areas in sterile production, and to validate the effectiveness of cleaning and disinfection. The ASD is therefore a key step to qualify these areas, and choosing the right ASD partner can make all the difference! High-performing equipment, expert support and time saving in establishing effective protocols, simple yet complete traceability, service provision, maintenance and adapted services, etc.”
3. At the start of the year, should we expect any new changes for 2022?
“The official publication of this version 12 of appendix I of the GMP is expected for the spring, even if the text has been finalized since December 2020. A first draft of version 13 is already circulating…”
Biocides and devices regulations: additional resources
To go further:
EN 17-272 on norminfo
BPR (EU) 528/2012
Contact uszh-Hans
To help improve translation, feel free to suggest through Email.
NFT 72-281、EN 17-272、BPR 528/2012、欧共体准则、ECHA……气载表面消毒设备和消毒剂都有哪些规范，最新适用的版本又是什么？今天，Devea 的法规专家（专研欧盟 528/2012 生化消毒法规）将为您解答这三个问题，以帮助您了解相关情况。
Devea 是法国离心式气载表面消毒专家，自 2009 年起在法国和国际范围内推广其 Phileas® 解决方案，（业务范围涵盖）制药行业、医院、研究实验室、动物研究机构、卫健、社区等。
1. 首先，能否请您回顾一下 ASD（气载表面消毒）所受监管的框架？
“气载表面消毒是一种设备/消毒剂组合；其上市许可受多项规范和法规的监管。该消毒剂产品含有活性物质过氧化氢（H₂O₂），符合 2012 年 5 月颁布的欧洲消毒剂法规 BPR (EU) 528/2012。同样也是遵从该条例，该产品还获准用于雾化用途，编号为 FR 2019-0071。
法国负责颁发许可的主管机构是 ANSES。在销售该产品的每个欧洲国家，Phileas/O₂SAFE 也必须获得当地主管机构的授权。
该授权申请中还必须包含产品运行与销售商声明的证明一致，以及产品对人体和环境无害的保证。
在有效性方面，产品必须证明其符合 2020 年 4 月 EN 17272 标准的要求，该标准还验证了汽雾扩散的均匀度。此类产品在法国的授权非常少，而 DEVEA 是这一领域的先行者”。
2. 近期有什么法规变动？若然，哪些行业部门将受影响？
“最后一版发布于 2014 年的法国标准 NFT 72-281 现已失效。它在很大程度上启发了现行的强制性标准，欧洲标准 EN 17-272；该标准适用于对自其发布之日（2020年4月）起提交的所有上市许可申请。
与 NFT 72-281 相比，EN 17-272 特别在两个方面进行了延伸：
a) 通过分布在角落的8个生化指示器对消毒剂雾扩散均匀性进行验证的分布度测试。
b) 微生物种群数量和这些种群数量的减少对数，（合格标准）取决于具体目标行业。
以制药业为例，《良好生产规范》附录I规定的无菌药品生产，正在朝着提高屏障技术，并在 A 级区域对人工干预进行限制的方向发展。新版（第12版）规定的核心为生物负荷控制、无菌风险最小化和更有条理的污染控制策略。附录I介绍了对无菌生产中最关键区域进行生化消毒，以及验证清洁效果、消毒效果的必要性。ASD 因而成为了在这些方面达成合规的关键步骤，选择合适的 ASD 合作伙伴则成为了关键！高性能的设备、专家支持以及因建立高效流程、简单而完整的可追溯性、服务支持、维护和有针对性的服务等而（为机构）节省的时间”。
3. 在年初这个时间点，我们可以预见 2022 年的哪些变化？
“GMP 附录 I 第 12 版预计将于春季正式发布，尽管该文本已于 2020 年 12 月定稿。第 13 版的起草工作已在进行中......”
消毒剂和设备法规：更多资源
更多信息：
EN 17-272 规范信息
BPR (EU) 528/2012
联系我们