Environmental Monitoring

Environment Monitoring for Ongoing Operational Compliance

Demonstrate a state of control to maintain pertinent quality and safety standards with our environment monitoring services. We offer support across all stages, whether you are commissioning new facilities, completing facility remediation, planning a shutdown, or conducting routine, ongoing manufacturing.

Identifying potential contamination sources requires a comprehensive approach that considers air, surface, personnel, water, and compressed gas. Our team is thorough in understanding your unique requirements and providing strategic guidance on cleanroom environmental monitoring.

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Environment Monitoring Services

Cleanroom Qualification

Comply with the engineering design specifications and requirements of your cleanroom environmental monitoring by qualifying your site and equipment. Our team is responsive and adaptable to your needs, and we strive to accommodate your operational requirements and restrictions.

ISO 14644 Certification
BSC / HLF / Fume Hood Certification
HEPA Filter Integrity / Velocity
Room Pressure / ACH
Smoke Study Videos
Surface Contact Plates / Swabs
Temp / Humidity Mapping
Total Particulates
Viable Particulates

Controlled Environment Monitoring

Maintain control under specific conditions and verify adequate compliance with our microbial monitoring services. We offer a variety of sampling methods to meet the unique needs of your environment.

Surface Contact Plates / Swabs
Total Particulates
Viable Particulates

Compressed Air & Gas Systems

Confirm that your controlled environment’s compressed gas and air lines meet regulatory requirements. We perform testing at any step of your process and provide custom reports that include test results and a map of testing locations.

IQ OQ PQ
Moisture
Oil
Pressure
Total Hydrocarbons (Oil)
Total Particle Counts
Viable Particulates
Viable Organism

WFI / Purified Water / Process Water

Ensure your water systems meet the required standards with our variety of water testing services. Because water serves as both a raw material and a cleaning agent, our team carefully considers the unique needs of your program before establishing our approach. We customize each program to test, monitor, and validate your water quality with specific standards in mind, then provide accurate reporting and documentation for your compliance needs.

Bacterial Endotoxins
Conductivity
Microbial Counts
Total Organic Carbon

Cleaning Verification

Demonstrate control by confirming the performance of your cleaning procedures with our verification support. We help validate your processes by testing for a variety of common outliers.

Microbial Assessments
Residual Active Pharmaceutical Ingredients
Residual Detergents

Our Environmental Monitoring Process

Although formulation vehicles are often quite simple, a biologics’ complex structure and composition require tailored formulation for optimum stability and product quality. The components and strategy used to strike this balance include:

Consultation

On-site Sampling

Reporting

Consultation

Our services start with consultation to determine your assessment needs. All our work is performed in strict compliance with current Good Manufacturing Practice (cGMP) requirements following USP, EP, JP, ISO, or client-specified standards.

We perform testing to determine the viable population on surfaces, as well as the total and viable particulates in air and compressed gases.

On-site Sampling

Our services are performed by our qualified technicians, who are experienced in executing on-site sampling in a variety of settings. If preferred, we also supply the necessary materials and instructions to perform your own sampling, which you then send to our lab for incubation and enumeration.

Reporting

After sampling, our experienced technicians customize your final reports to include both test results and a map of the testing locations. If you perform sampling internally, you receive detailed results of the tests performed.

What You Need To Know About Cleanrooms

Comprehensive Cleanroom Services

Trained Technicians

Our highly trained technicians are equipped with specialized instruments to offer support at any point of the certification process.

Experienced Microbiologists

Our experienced microbiologists offer testing performed in compliance with current USP/NF standards, and client-supplied methodologies.

Expert Consultants

Our consulting team supports compliance strategy, master planning, validation, and contract services to ensure your facility satisfies industry standards.

Proven Performance

"The quick service was greatly appreciated!"

"Pace® did a great job working around our production schedule when setting up the appointment. The technician was very professional and completed the certification in a timely manner, sharing observations for improvements to the facility."

"It’s always a pleasure working with Pace® representatives. My concerns and/or questions are answered in a timely manner. My experience with Pace® is positive A++++."

"Pace® employees are professional, timely, and very helpful with questions."

Integrated Laboratory Services  

Maintain compliant, ongoing operations with our array of talented teams. We have the people power to upkeep your facilities and instrumentation, achieve regulatory compliance, staff your projects, and outsource your research and development.

Cleanroom Testing & Certification

Validation Services

Laboratory Relocations

RESOURCES

TERMS
Installation Qualification (IQ)
Operational Qualification (OQ)
Performance Qualification (PQ)

CLEANROOM GUIDES
ISO 14644-1 Cleanroom Standard
EU Guidelines to Good Manufacturing Practice

CERTIFICATIONS
A2LA, BSI, CETA, ISO9001, NEBB

To help ensure compliance with USP General Chapter <797> and USP General Chapter <800>, our CETA National Board of Testing certified staff provide all required pharmacy cleanroom testing and certification.