CLEANROOM ENVIRONMENTAL MONITORING and TESTING SERVICES

On-Site and Laboratory-Based Testing for Controlled Environments

Environmental monitoring programs are required to maintain classified cleanrooms and support aseptic processing, sterile manufacturing, and regulatory compliance. BA Sciences provides comprehensive cleanroom environmental monitoring and testing services, with support for both on-site sample collection and subsequent analytical characterization.

If you are looking for cleanroom services, contact BA Sciences. We use the latest technology, equipment and software to give you fast, accurate results. We are also committed to providing the highest quality analytical testing services to life science companies throughout the world. You can rely on us to conduct all necessary testing quickly and expertly while meeting all regulatory/compliance requirements. Contact us today to get started.

Monitoring Services for Cleanroom Operations

We offer a full range of environmental monitoring services to assess microbial and particulate contamination in classified environments. Monitoring plans are developed based on facility classification, regulatory expectations, and internal quality requirements.

Core services include:

  • Microbial air and surface monitoring using active air samplers, swabs, and RODAC plates
  • Viable and non-viable particle testing in support of USP <797> compliance, ISO classifications, and internal action limits
  • Aseptic environmental monitoring during production, cleaning, and maintenance activities
  • Compressed gas testing for air viable, particulate, hydrocarbons, and water vapor, per USP, EP, and JP guidelines
  • Disinfectant efficacy testing in accordance with USP <1072>
  • Pharmaceutical-grade water collection & testing (TOC, Endotoxin, Conductivity, Bioburden)

We also support on-site water quality sample collection, and monitoring of purification systems.

Protocol Development, Qualification, and Support

In addition to routine monitoring, BA Sciences assists with facility setup, remediation, and requalification. Services include:

  • Cleanroom qualification (environmental monitoring performance qualification) and initial baseline testing
  • Protocol development based on USP <1116>, PDA technical reports, and ISO 14644 standards
  • Layout assessment and risk-based sampling plan design
  • SOP development and training for in-house environmental monitoring teams
  • Disinfectant efficacy studies to support cleaning validation programs
  • Investigation support following excursion events or contamination findings

All services are performed on-site by trained personnel with the appropriate materials, equipment, and documentation protocols.

Why Work with BA Sciences

We provide specialized cleanroom testing services to pharmaceutical, biotech, and medical device manufacturers operating in regulated environments. Our environmental monitoring team works within the framework of your facility classification, cleanroom design, and process requirements.

What we provide:

  • Support for both initial qualification and ongoing environmental monitoring
  • Testing aligned with USP, EP, and ISO guidance
  • Staff trained in aseptic techniques, trending analysis, and cleanroom compliance
  • Consistent documentation and communication to support internal audits and regulatory inspections

Our microbiology testing services and bioburden and sterility testing programs complement our cleanroom monitoring capabilities, supporting end-to-end contamination control.

Start a Project

To request a quote or discuss how our cleanroom environmental monitoring and testing services can support your facility, contact us. Our team can assist with qualification, routine monitoring, or protocol development tailored to your operational needs.

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