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ENVIRONMENTAL MONITORING / CLEANROOM TESTING
Environmental Monitoring & Cleanroom Testing
Confirm cleanroom particle and microbial conditions before use and during operation.
SOLVE provides cleanroom environmental monitoring services covering viable sampling and non-viable particle testing for initial qualification, periodic requalification, and routine monitoring. We test under defined static and dynamic conditions and compare results with the applicable criteria.
Keep them Clean
Monitoring · Sampling · Trends
Purpose-defined testing
Qualification, requalification or routine monitoring
Traceable sampling
Locations, times, room conditions and activities
Clear scope boundaries
Particle and microbial testing within your protocol
01/ Testing scope
02 / When to test
04/ Deliverables
05/ Pricing & Quote
06/ FAQs
01 TESTING SCOPE
What can we monitor?
Your study is planned around the space, equipment, or vehicle you use and the products you need to protect.
01/ MONITORING AREA
Non-viable particles
Measure airborne particle concentrations at specified sizes using a calibrated particle counter. Report results by location and testing condition.
03/ MONITORING AREA
Surfaces and personnel
Cleanroom surface sampling uses contact plates or swabs. Glove and gown sampling assess personnel at defined points in the operation.
05/ MONITORING AREA
Dynamic conditions
Operational testing evaluates defined activities with equipment running and personnel present. Record occupancy, operations, and relevant interventions.
02/ MONITORING AREA
Viable air
Viable air sampling services use active air sampling and, where specified, settle plates. Record sampled volume or exposure time for the selected method.
04/ MONITORING AREA
Static conditions
At-rest testing evaluates an unoccupied room with HVAC operating and equipment in the protocol-defined state, after the specified clean-up period.
AGREED BEFORE YOUR VISIT
Your room, purpose & conditions
Need onsite environmental monitoring services? Share your room classifications, testing purpose, required conditions, and target dates.
Particle classification and microbial assessment
Our cleanroom testing services combine two distinct measurements. Non-viable particle testing measures particle counts; it does not identify whether particles contain living microorganisms. Viable testing measures microorganisms recovered under the selected sampling and incubation conditions.
Particle classification follows ISO 14644-1 for the agreed class, particle sizes, and occupancy state. Microbial results are assessed against the applicable site-approved criteria. Our qualification scope covers these tests; it does not represent every test needed for complete facility qualification.
02 KNOW WHAT THE RESULT REPRESENTS
Why test both contamination types and conditions?
SOLVE
Static / at rest
Defined unoccupied conditions, with HVAC operating and equipment in its protocol-defined state.
PROCESS OWNERS
Dynamic / operational
Defined activities, equipment state and personnel levels representing the operation being assessed.
Particle counts and microbial results answer different questions. Static testing establishes conditions in the defined unoccupied room; dynamic testing evaluates the effects of people, equipment, and activities. Results should identify the condition tested so comparisons are meaningful.
When do you need cleanroom testing?
Initial qualification
Establish particle classification and microbial conditions for a new room or controlled area under an approved protocol before your team makes decisions about use.
Periodic requalification
Repeat the defined qualification tests at your approved interval, or after relevant changes, repairs, or loss of control. Assess results against the applicable criteria for each condition.
Routine monitoring
Our GMP environmental monitoring services support scheduled viable and non-viable monitoring. The plan defines coverage, frequency, operating conditions, and response to findings.
Excursions and adverse trends
An environmental monitoring excursion investigation reviews exceeded limits or recurring concerns alongside activities, cleaning, personnel, and equipment conditions. Follow-up testing supports investigation and corrective action review.
Before the sampling visit
Agree on the room state and testing plan so results can be interpreted in the right context.
Room list, dimensions, classifications and testing purpose.
Approved protocol or monitoring plan and applicable criteria.
Required static or dynamic conditions and room availability.
Operating schedule, personnel levels and activities to represent.
Access, gowning, cleaning status and laboratory arrangements.
03 FROM PLAN TO RESULTS
How SOLVE performs the work?
01
Define the testing purpose and criteria
Confirm rooms, classifications, applicable requirements, and whether the work supports qualification, requalification, or routine monitoring. Your team approves the protocol and acceptance criteria.
02
Plan locations and testing conditions
Define particle sizes, sample volumes, microbial methods, sampling points, and static or dynamic conditions. Record the rationale, equipment requirements, personnel levels, and activities to be represented.
03
Execute onsite testing
Collect particle counts and viable samples using the approved methods. Document sample IDs, locations, times, room state, equipment details, and any departures from the protocol.
04
Coordinate laboratory analysis
SOLVE arranges laboratory processing for microbial samples, with agreed media, handling, incubation, and identification requirements. Maintain traceability from collection through laboratory reporting.
05
Review results and report conclusions
Compare results with the applicable criteria for each room and condition. Report excursions, limitations, and recommended follow-up. Your quality team approves investigations, corrective actions, and room-use decisions.
SOLVE
Plan & sample onsite
Perform agreed particle testing and viable sampling. Record locations, room conditions, equipment details and departures from the plan.
DESIGNATED LABORATORY
Process microbial samples
Laboratory processing follows the agreed media, handling, incubation, identification and reporting requirements coordinated by SOLVE.
YOUR QUALITY TEAM
Approve & decide
Approve the protocol and criteria, evaluate findings and determine investigations, corrective actions, product impact and room use.
Defined testing scope. Particle classification and microbial assessment form part of qualification evidence. They do not represent every test required for complete facility qualification.
04 RESULTS LINKED TO ROOM CONDITIONS
What you recieve?
Receive traceable test records, particle-count results, laboratory microbial results, and a report identifying excursions and next steps. SOLVE performs onsite sampling and coordinates laboratory incubation and identification within the agreed scope.
Your quotation identifies the scope and review rounds included:
A protocol or monitoring plan defining rooms, sample locations, methods, conditions, and criteria.
Onsite execution records linking particle readings and microbial samples to locations and room activities.
Particle-count results and microbial laboratory reports, with identification results where specified.
A qualification or monitoring report stating results by test and condition, departures from the plan, and conclusions against approved criteria.
Recommendations and a results review, with trend analysis or investigation support when included.
Results describe the locations and conditions tested. Your quality team evaluates the report alongside other applicable qualification evidence and makes room-use and product-impact decisions.
FROM SAMPLING POINT TO REVIEW
ILLUSTRATIVE FORMAT · NOT A CLIENT REPORT
How your results can be organized
Traceable collection
Link sample IDs and readings to locations, methods, times and documented room activities.
Separate result interpretation
Assess particle and microbial results using the criteria and units appropriate to each method.
This outline contains no actual particle counts, microbial recoveries, client data or pass/fail decisions. Your approved plan and quotation define testing and deliverables.
YOUR ONGOING PROGRAM
Support beyond the sampling visit
Build or improve your monitoring program
Environmental monitoring program development defines risk-based locations, methods, frequencies, alert and action levels, reporting, and escalation. Qualification coverage and routine monitoring coverage are planned for their different purposes.
Understand changes over time
Environmental monitoring data trending reviews particle and microbial results by room, location, condition, and time. We examine repeated recoveries and shifts in results, including concerns below action limits.
Sampling matched to your operation
Our pharmaceutical environmental monitoring services support pharmaceutical, biotechnology, and controlled laboratory areas. Microbial air sampling services and viable surface sampling services can be combined with particle testing for a defined qualification or monitoring program.
Environmental monitoring support in California
SOLVE supports cleanroom environmental monitoring in California and provides environmental monitoring services in the San Francisco Bay Area. For cleanroom testing services in California, send your room list and required scope so we can confirm scheduling.
05 SCOPE-BASED PRICING
What does cleanroom testing cost?
Cost depends on room size and number, classification, sampling locations, static and dynamic runs, microbial methods, visit frequency, laboratory analysis, and reporting depth. Identification, trending, and investigation support are defined in your quote.
Start with your rooms and testing purpose.
Send your site location, room sizes and classifications, testing purpose, required conditions, existing protocols or plans, and target dates. Include the operating schedule and expected personnel levels for dynamic testing.
CAT Frequently asked questions
Ready to plan your cleanroom testing?
Tell us which rooms need testing, whether you need qualification or routine monitoring, and the required static or dynamic conditions. We will define the onsite testing, laboratory analysis, and reporting for your project.