Issue 43 2020 Number Three ISSN 2042-3268 Real-time optimisation of VPHP bio-decontamination cycles GMP-compliant EM systems in stem cell and tissue laboratories Known unknowns: 4. Airlocks The risks of using ineffective hand sanitisers in cleanrooms Test results and methodology in validation Events and Training courses
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Issue 42 2020 Number Two ISSN 2042-3268 The science of airborne viruses Impact of coronavirus in cleanroom operations Known unknowns: 3. Positive pressure vs negative pressure An innovative AAS for continuous viable air monitoring Update on 14644 cleanroom standards: Parts 3 and 4 A new European standard for Biocontamination Control Vaporised hydrogen peroxide:...
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Issue 41 2020 Number One ISSN 2042-3268 Known unknowns: Cleanroom monitoring Critical parameters H2O2 bio-decontamination Microbiological risks following cleanroom shut-downs New draft of EU GMP Annex 1 Update on ISO 14644: Parts 8, 9, 10 and 16 Update on ISO 14644: Parts 14, 15 and a PWI “Honey I shrunk the cleanroom” Is log 6 overkill for an...
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Issue 40 2019 Number Four ISSN 2042-3268 Standards for pharmaceutical isolators ISO 16890 – Air filters for general ventilation EN 1822 and EN ISO 29463 – High efficiency air filters Known unknowns: Source strength Decommissioning a biological containment facility
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Issue 39 Summer/Autumn 2019 ISSN 2042-3268 Clean build protocols Monitoring and controlling of vaporized hydrogen peroxide bio-decontamination cycles Risk and sciencebased validation of cleanroom garments Cleanroom Technology Conference 2019 News, Events and Training courses
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Performance of cleanroom garments Nanoscale particle standard – outreach article Protective gloves standard New energy Standard A review of FDA warning letters Clarity on GMP from PHSS – a critique
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Air quality indices and cleanroom ventilation equations, Part one: theoretical considerations Things that shouldn’t happen in a cleanroom Selection criteria for protective garments Recent cleanroom standards and changes to filter standards Events and Training courses
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Statistical treatment of sampling in ISO 14644-1:2015 H2O2 surface sterilization: a robust process Cleanroom monitoring and data integrity Risk Assessment E-learning module: Annex 1 disinfection requirements ISCC’18 and Cleanzone reports
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Issue 35 | July/August 2018 ISSN 2042-3268 - Removal of macroparticles and MCPs by surface deposition and mechanical ventilation - Getting rid of 95% UCL calculations in ISO 14644-1:2015 - Removal of airborne contamination using hydrogen peroxide vapour - VHP (Vapour Hydrogen Peroxide) fragility - Review of ‘Advances in Cleanroom Technology’ by Bill Whyte - Cleanroom Technology...
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Issue 34: October 2018 Main features ISO/TC 209 launches new cleanroom standards and outreach projects, Roberta Burrows, David Ensor Abstract, US-led outreach task team will foster promotion and education of the expanding body of ISO/TC 209 Standards. Keywords: ISO, TC 209, 14644, 14698, cleanroom, particle deposition rate, cleanroom consumables. Standards update...
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