Cleanroom Envoirnmental Monitoring Services

PAL provides environmental monitoring services for BioPharma, medical devices and compounding pharmacies cleanrooms, and GMP utilities such as water systems and compressed gasses as per USP, ISO, EU, and FDA standards. PAL is an FDA-registered laboratory, GMP compliant, and ISO/IEC 17025:2017 accredited. We have over 35 years of experience testing GMP cleanroom environments.

Cleanroom Environmental Monitoring

  • ISO 14644-1 certification
  • HVAC PQ validation support
  • Cleanroom consulting
  • Risk assessment
  • Training
  • EM Sampling Services
    • Non-viable air particulate sampling
    • Viable air particulate sampling
    • Surface sampling– Contact Plates and Swabs.
    • Temperature, RH & air velocity testing
  • Supplies– air and surface sampling media.
  • USP growth promotion of media
  • Media incubation, inspection, and reporting
  • 7 days a week sampling
  • Water Systems sampling & testing
    • Total organic carbon (TOC)
    • Microbial bioburden
    • Endotoxin
    • Nitrates
    • Heavy metals (ICP-MS)

Compressed Gasses

  • CDA, Nitrogen, CO2, O2
  • Protocol and SOP preparation.
  • CG Testing services
    • Bioburden
    • Non-viable particles
    • Oil contamination
    • Water vapor
    • USP incoming QC tests