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Environmental Monitoring

Professional Services / Facilities / 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:
1
Consultation
2
On-site Sampling
3
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

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.

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.