Protect Your Cleanroom. Strengthen Compliance.
Contamination Monitoring Solutions for 503A & 503B Facilities
For compounding pharmacies and outsourcing facilities, contamination control isn’t optional—it’s essential to patient safety, regulatory compliance, and operational efficiency.
Particle Measuring Systems (PMS) helps 503A and 503B facilities take control of their cleanroom environments with complete, integrated contamination monitoring solutions that support cGMP and USP <797> compliance.
Built for the Realities of Compounding Pharmacies
Whether you’re managing a single cleanroom or scaling a 503B operation, PMS solutions are designed to help you:
- Maintain sterile compounding environments
- Meet USP <797> environmental monitoring requirements
- Support cGMP inspection readiness
- Reduce risk of contamination events and batch loss
- Simplify documentation for audits
Complete Environmental Monitoring—All from One Partner
PMS delivers end-to-end solutions for contamination control:
- Particle monitoring (non-viable)
- Microbial monitoring (viable)
- Environmental monitoring systems (EMS)
- Data management & compliance software
One integrated system, designed to support your entire environmental monitoring program
Particle Monitoring: Stay in Control of Air Quality
Airborne particles are the first indicator of risk in your cleanroom.
PMS particle monitoring solutions include:
- Portable particle counters for:
- Clean Room certification
- Routine sampling
- Investigations
- Continuous particle monitoring for:
- ISO 5 / critical areas
- Real-time alerts and trending
What this means for your pharmacy:
- Quickly identify contamination issues
- Maintain ISO classifications required by USP <797>
- Confidently document air quality for inspections
Microbial Monitoring: Verify Sterility Assurance
USP <797> requires ongoing evaluation of microbial contamination risk.
PMS microbial solutions include:
- Portable microbial air samplers for routine EM programs
- Remote/continuous samplers for critical environments
Key benefits:
- Capture viable organisms accurately
- Support trending and root-cause analysis
- Strengthen sterility assurance programs
Continuous + Portable Monitoring = Smarter Compliance
Modern regulatory expectations are shifting toward continuous monitoring and data trending.
PMS supports both approaches:
- Portable monitoring
- Flexible, easy to deploy
- Ideal for routine compliance sampling
- Continuous monitoring
- Real-time visibility into critical operations
- Immediate detection of excursions
- Supports proactive contamination control
Combine both to align with risk-based monitoring strategies
Environmental Monitoring Systems (EMS)
Move beyond disconnected data and manual tracking.
PMS EMS solutions provide:
- Centralized monitoring across your facility
- Real-time alarms for out-of-spec conditions
- Automated data collection and reporting
- Scalable systems—from small pharmacies to large 503Bs
Integrates with:
- LIMS and internal reporting systems
- Isolators and controlled environments
- Facility automation platforms
Data Management Built for Audits
Documentation and data integrity are critical for compliance.
PMS software solutions help you:
- Automate environmental monitoring records
- Maintain 21 CFR Part 11-compliant data integrity
- Generate audit-ready reports instantly
- Reduce manual errors and paperwork
Result:
- Faster batch release decisions
- Reduced compliance risk
- Confidence during inspections
Designed to Support cGMP & USP <797>
PMS solutions are trusted by compounding pharmacies to:
- Monitor viable and non-viable contamination
- Maintain controlled, ISO-classified environments
- Ensure traceable, compliant data
- Support continuous improvement in EM programs
Helping you meet cGMP expectations, including USP <797>, with confidence
Why Pharmacies Choose PMS
- Proven expertise in sterile environments
- Solutions designed specifically for compounding workflows
- Flexible systems that grow with your facility
- One partner for monitoring, data, and compliance
Take Control of Your Environmental Monitoring Program
Reduce risk. Simplify compliance. Protect patients.
Connect with a PMS expert to evaluate your current monitoring strategy and identify opportunities to strengthen compliance.
