GXP Environmental Monitoring
Environmental Monitoring & Performance Qualification
Flexible EMPQ support
From complete execution to laboratory analysis — wherever you are in the process.
PlumGXP provides scalable environmental monitoring performance qualification services for new, expanding, and operating controlled facilities in accordance with USP <797>, USP<1116>, FDA Aseptic Processing Guidance EU GMP Annex 1, ISO 14644, 21 CFR part 210 and 211. Whether you need a complete qualification team, laboratory support for your internal samplers, or experienced guidance while building in-house microbiology capabilities, we adjust our level of service to fit your facility, personnel, and project timeline.
Our support may include EMPQ planning and readiness assessments, protocol development or technical review, sampling-location and study-design support, viable air and surface sampling, nonviable particle monitoring, sampling equipment and qualified materials, media incubation and enumeration, microbial isolate identification, data review and technical reporting, routine environmental monitoring, and personnel training and method transition.
Four flexible service models
Choose the level of support that fits your team.
PlumGXP adjusts across four service models — from complete execution to laboratory-only support for your own sampling team.
01
PlumGXP-Executed
We coordinate the complete sampling and laboratory workflow — personnel, materials, equipment, and laboratory services required to support EMPQ execution.
Full service →
02
PlumGXP-Equipped, Client-Sampled
PlumGXP supplies the required materials and sampling equipment. Your qualified personnel perform the sampling; recovered samples return to PlumGXP for incubation, analysis, and reporting.
Equipped →
03
Client-Sampled, PlumGXP-Analyzed
Use your own personnel, equipment, and materials, with PlumGXP as your microbiology laboratory. Samples are delivered or shipped to PlumGXP for laboratory processing.
Lab-only →
04
Transition-to-In-House Support
PlumGXP can initially support EMPQ and routine monitoring while your personnel, procedures, and microbiology laboratory are being developed, transitioning responsibilities in planned stages.
Transition →
One partner, start to finish
From EMPQ through ongoing routine monitoring.
EMPQ establishes important information about your facility under defined conditions, but environmental control doesn’t end when qualification is complete. PlumGXP can continue supporting the facility through routine sampling and analysis, personnel monitoring support, sampling materials and equipment, technical consultation, and overflow laboratory capacity.
Ready to discuss your EMPQ program?
Tell us about your facility, personnel, and project timeline,
and we’ll help determine the right service model for you.