To prepare for airborne particle testing we require the following information:
- We will require confirmation of the cleanroom/s ISO/GMP cleanroom rating one week prior to the test date.
- All building work must be completed.
- All Air Handling Units and supporting plant equipment is installed and commissioned.
- All Building Management Systems (If applicable) is installed and commissioned.
- All cleanroom suite fixtures (lighting, windows, doors and power etc.) are installed and functioning correctly.
- All supply/extract filters are fitted and diffuser in place.
- All cleanroom equipment (MBSC’s LAF, Fume Cupboard etc.) is commissioned and functioning correctly.
- Cleanroom suite pressure regime is balanced and commissioned.
- All GMP Drawings have been approved and made available for use.
- All design and installation drawings are complete and signed off as-fitted.
- All pre-OQ works were successful and any issues addressed and corrected.
- Installation Qualification Report is complete.
- Cleanroom suite gowning regime is in effect and relevant gowning and training provided to contractors.
- Access to the area under test will be limited to APT test operatives and the site representative throughout the test period.
- We will require a site representative who knows how to operative the whole cleanroom environment. They will need to be available throughout the duration of the testing.
- Due to potential contamination issues, we will require the client to supply each operative with a full set of the appropriate cleanroom clothing prior to the test.
- High rise ceilings greater than 3 meters will require a podium or MEWP or other safe means of access. (Filter integrity tests and Air Change Rates)
- A witness/QA will need to be appointed and made available. (If required)
If you would require further information, please check out our informative airborne particle testing checklist to help you prepare for the cleanroom testing.