 A successful environmental monitoring program begins with the appropriate qualification and certification activities that will lay the groundwork for routine testing. Our team is well-versed in the current industry and regulatory standards and can assist with the following qualification and certification activities:
Room Recovery Studies
Cleanroom Qualification Activities
At Rest (Static) Performance Qualification
Operational (Dynamic) Performance Qualification
Cleanroom Certificationper ISO 14644-1:2015, ISO 14644-2:2015, and EU Annex 1
Utilities Qualification Activities per ISO 8573-1:2010 and USP<1231>
Qualification activities require a significant time commitment and resource strain that Alcami can assist with...
Sr Manager, Laboratory Operations
Qualification discussions include a risk evaluation as it is critical to understand the intent behind your cleanroom: what will the environment be used for? what environmental control systems will be in place? what are the gowning and material transfer processes going to look like? ...
After this initial discussion takes place, our team develops the proper qualification protocols that can either be used by your team or Alcami’s experienced and qualified analysts...
The qualification protocols will establish the appropriate acceptance criteria based on ISO and EU regulations as well as define the microbial identification strategy...
All results are evaluated, and a comprehensive summary report is issued upon completion of activities.