Cleanroom airborne particulate limits and 70% isopropyl alcohol: a lingering problem for pharmaceutical manufacturing?
Seventy percent isopropyl alcohol (70% IPA) in water for injection is extensively utilised within pharmaceutical cleanrooms for glove and surface disinfection. When supplied in pressurised containers and delivered as an aerosol, it has been demonstrated that large quantities of 70% IPA particles are generated that remain airborne for substantial periods of time. Within non-unidirectional airflow cleanroom areas, such particles are likely to be recorded by the particle monitoring system. Consequently, the derived operational limits for particles will almost certainly be at "artificially high" levels and any particle generating activities with contamination potential may be masked. These high particle levels may not comply with the requirements of Annex 1 of the European Unions Guide to Good Manufacturing Practices (EU GGMP) and the United States Food and Drug Administration (FDA) Aseptic Processing Guideline. This is the case predominantly for the larger particles (> or =5 microm), the monitoring of which is exclusively required by the Annex 1 guide. However, by using canisters that deliver the 70% IPA as a stream, large quantities of particles are not generated and more meaningful and compliant operational levels can be obtained. Additionally, the EU GGMP's Annex 1 continuing requirement to monitor particles > or =5 microm appears to have little value or scientific justification and restricts further harmonisation of the European guide with the US FDA Aseptic Processing Guideline.
Eaton
Tim
T
AstraZeneca, UK Operations, Macclesfield, Cheshire, England. tim.eaton@astrazeneca.com
D019840:2-Propanol / Q000032:analysis* / Q000737:chemistry; D016902:Air Pollution, Indoor / Q000032:analysis*; D001207:Asepsis / Q000379:methods; D004202:Disinfectants / Q000032:analysis* / Q000737:chemistry; D004345:Drug Industry / Q000379:methods; D004780:Environment, Controlled; D004784:Environmental Monitoring / Q000379:methods; D004866:Equipment Contamination / Q000517:prevention & control; D005062:European Union; D017575:Gloves, Protective; D017408:Guidelines as Topic; D006801:Humans; D010316:Particle Size; D052638:Particulate Matter / Q000032:analysis; D014481:United States; D014486:United States Food and Drug Administration
D004202:Disinfectants; D052638:Particulate Matter; D019840:2-Propanol