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Clean rooms

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Clean Room Garment Monitoring 1st edition (Yellow Cover)

25 May 2010In hospital aseptic preparation of pharmaceutical products the operator is an essential part of the production process. To minimise the risk of contaminating products with…

Cleaning and Disinfection Regimens for Clean Rooms 1st edition (Yellow Cover)

24 May 2010The purpose of this document is to provide advice on the principles of cleaning and disinfection regimes used in clean rooms and aseptic suites provided…

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

Sampling Programme for GMP Grade Controlled Environments, Section 10 Unlicensed Units 1st edition (Yellow Cover)

25 May 2010To demonstrate compliance with the microbiological standards required in GMP environments it is necessary to monitor the number of microbes in the air and on…