Effects of different air change rates on cleanroom ‘in operation’ status

References

• European Commission. Volume 4 – Good Manufacturing Practice (GMP) guidelines; 2021 [Internet] [cited 2021 Jan 26]. Available from: https://ec.europa.eu/health/documents/eudralex/vol-4_de
   Google Scholar
• European Commission. Annex 1: manufacture of sterile medicinal products (corrected version); 2009. Brussels, Belgium.
   Google Scholar
• Food and Drug Administration. Sterile drug products produced by aseptic processing – current good manufacturing practice. Rockville (MD); 2004.
   Google Scholar
• European Commission. Annex 1 draft 2020 – manufacture of sterile medicinal products. Brussels, Belgium; 2020 [Internet] [cited 2021 Jan 26]. Available from: https://ec.europa.eu/health/sites/health/files/files/gmp/2020_annex1ps_sterile_medicinal_products_en.pdf
   Google Scholar
• DIN EN ISO. ISO 14644-1 cleanrooms and associated controlled environments–part 1: classification of air cleanliness by particle concentration. Berlin: Beuth; 2021.
   Google Scholar
• Whyte W. The application of the ventilation equations to cleanrooms – part 2: decay of contamination. Clean Air Contain Rev. 2014;20:4.
   Google Scholar
• World Health Organization. WHO Expert Committee on specifications for pharmaceutical preparations: forty-fifth meeting report. (technical report series). Geneva: World Health Organization; 2011.
   Google Scholar
• Fedotov A. Saving energy in cleanrooms. Cleanroom Technol. 2014;22:14.
   Google Scholar
• Tschudi W, Benschine K, Fok S, et al. Cleanroom energy benchmarking in high-tech and biotech industries. Berkeley (CA): Lawrence Berkeley National Lab; 2001.
   Google Scholar
• Tschudi W, Mills E, Xu T, et al. Measuring and managing cleanroom energy use. Berkeley (CA): Ernest Orlando Lawrence Berkeley National Laboratory; 2005.
   Google Scholar
• Faulkner. Energy savings in cleanrooms from demand-controlled filtration. J Inst Environ Sci. 1996;39:21.
   Google Scholar
• Tschudi W. Cleanroom energy benchmarking results. ASHRAE Trans. 2002;109:733.
   Google Scholar
• Molenaar P. Ventilation efficiency improvement in pharmaceutical cleanrooms for energy demand reduction. Eindhoven: Eindhoven University of Technology; 2017.
   Google Scholar
• Loomans M, Molenaar P, Kort H, et al. Energy demand reduction in pharmaceutical cleanrooms through optimization of ventilation. Energy Build. 2019;202:109346.
   Web of Science ®Google Scholar
• Loomans M, Ludlage T, van den Oever H, et al. Experimental investigation into cleanroom contamination build-up when applying reduced ventilation and pressure hierarchy conditions as part of demand controlled filtration. Build Environ. 2020;176:106861.
   Web of Science ®Google Scholar
• VDI. VDI 2083 part 4.2: cleanroom technology: energy efficiency. Berlin: Beuth; 2011.
   Google Scholar
• ISPE. Baseline pharmaceutical engineering guide: volume 3: sterile product manufacturing facilities. 3rd ed. Tampa (FL): ISPE; 2018.
   Google Scholar
• ISPE. Baseline pharmaceutical engineering guide: volume 3: sterile product manufacturing facilities. 2nd ed. Tampa (FL): ISPE; 2011.
   Google Scholar
• Sun W, Mitchell J, Flyzik K, et al. Development of cleanroom required airflow rate model based on establishment of theoretical basis and lab validation. ASHRAE Trans. 2010;116:87.
   Google Scholar
• Behrens D, Bachhofer J, Zipp B, et al. Abreicherung von partikeln im Reinraum in Abhängigkeit der Luftwechselrate Pt.1 [Decrease of particles in cleanrooms in dependancy of air-change-rate]. Technopharm. 2020;10:284–288.
   Google Scholar
• Behrens D, Bachhofer J, Zipp B, et al. Abreicherung von partikeln im Reinraum in Abhängigkeit der Luftwechselrate Pt.2 [Decrease of particles in cleanrooms in dependancy of air-change-rate]. Technopharm. 2021;11:94–99.
   Google Scholar
• Merck M. Tryptic soy agar + LTHTh-ICR: technical data sheet [Internet]. Darmstadt; 2019 [cited 2021 Apr 19]. Available from: www.merckmillipore.com/biomonitoring
   Google Scholar
• Merck M. Hycon® agar strips TSM: technical data sheet [Internet]. Darmstadt; 2018 [cited 2021 Apr 19]. Available from: www.merckmillipore.com/biomonitoring
   Google Scholar
• Merck M. RCS® High flow touch: microbial safety at your fingertips [Internet]. Darmstadt; 2021 [cited 2021 Apr 19]. Available from: www.merckmillipore.com/biomonitoring
   Google Scholar
• Pinpoint Scientific. ImpactAir_IS0-90_Brochure [Internet]. Bridgend (UK); 2020 [cited 2021 Feb 23]. Available from: https://www.pmtgb.com/fileadmin/Datasheets_UK/ImpactAir_IS0-90_Brochure.pdf
   Google Scholar
• Whyte W, Hejab M, Whyte WM, et al. Experimental and CFD airflow studies of a cleanroom with special respect to air supply inlets. Int J Vent. 2010;9(3):197–209.
   Web of Science ®Google Scholar
• Lenegan N. Diffuser performance. Clean Air Contain Rev. 2014;18:8.
   Google Scholar
• Parat S. Contribution of particle counting in assessment of exposure to airborne microorganisms. Atmos Environ. 1999;33(6):951–959.
   Web of Science ®Google Scholar
• Whyte W, Agricola K. Comparison of the removal of macroparticles and MCPs in cleanrooms by surface deposition and mechanical ventilation. Clean Air Contain Rev. 2018;35:4–10.
   Google Scholar
• Ludlage T. Optimizing energy demand during the non-operational hours in a cleanroom. Eindhoven: Eindhoven University of Technology; 2019.
   Google Scholar
• Molenaar P, Loomans M, Joosten P, et al. Demand controlled filtration, a high potential energy savings measure for cleanrooms? REHVA J. 2019;2019:54–57.
   Google Scholar
• Birks S. Opinion ACRs – time for change? Cleanroom Technol. 2013;21:23.
   Google Scholar
• Slack N, Chambers S, Johnston R. Operations management. 6th ed. Harlow (UK), New York (NY): Financial Times Prentice Hall; 2010.
   Google Scholar