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Clean rooms

4 results

Applied filters

Design, Build and Maintenance of Pharmacy Aseptic Units (Yellow Cover)

3 November 2021Originally published in 2010, information in this yellow cover document remains useful

Guidance for Aseptic Transfer Processes in the NHS: Addressing Sporicidal Issues

31 July 2015  Following a series of patient deaths in 2014 linked with Bacillus cereus infections (MHRA, 2014) and observations of practice and microbiological monitoring made during…

Measurement of HEPA filter performance using the dispersed oil particle aerosol test for leak detection in filter installations ed 3

20 December 2018This test protocol is supplementary to Quality Assurance of Aseptic Preparation Services, Fifth edition, Edited by Alison M Beaney, Pharmaceutical Press, 2016.
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Responding to Annex 1 EU GMP changes

10 August 2023A summary of the August 2022 changes to Annex 1 EU GMP, including responses from the MHRA, and QA committee guidance