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C.G. Laboratories, Inc.

Environmental Monitoring Service

  • FDA-registered and ISO 13485:2016 accredited laboratory

  • Medical Device Testing

  • State-of-the-Art Equipment

  • Nationwide Service

  • Proven Track Record

Our Process

We follow a six-step process to ensure precision, compliance, and efficiency in cleanroom environmental service:

Step 1: Initial Assessment

We evaluate your facility’s environmental monitoring needs, identifying key areas requiring cleanroom environmental service.

Step 2: Sampling Plan Development

Based on industry standards, we create a customized laboratory environmental monitoring plan tailored to your requirements.

Step 3: Air and Surface Testing

We conduct comprehensive environmental testing for medical devices and other industries using advanced monitoring techniques.

Step 4: Data Analysis and Reporting

Our team analyzes collected data and provides detailed reports for regulatory compliance.

Step 5: Corrective Actions & Recommendations

If contamination is detected, we assist with mitigation strategies to ensure a sterile environment.

Step 6: Ongoing Monitoring & Support

Our continuous environmental monitoring service helps maintain compliance and operational excellence.

Understanding Environmental Monitoring Service

Environmental monitoring service is a crucial process that ensures the cleanliness and compliance of manufacturing environments, laboratories, and cleanrooms. It helps detect, measure, and control airborne and surface contaminants, safeguarding product quality and regulatory adherence.

At C.G. Laboratories, Inc., we offer a robust cleanroom environmental service, ensuring that pharmaceutical, medical device, and biotechnology facilities meet the highest standards.

Our laboratory environmental monitoring services provide precise assessments, preventing contamination that could compromise research or production.

Additionally, our environmental testing for medical devices is designed to maintain sterility and safety for patient use. With our expertise, you get reliable data and actionable insights to maintain the integrity of your operations.

Our Environmental Monitoring Services

We provide comprehensive solutions tailored to various industry needs. This includes:

Air Monitoring: ISO 14644 (1) (2) (3)

Our environmental monitoring service includes advanced air quality testing to assess airborne microbial contaminants and particulate levels.

  • Microbial Sampling : We use RCS Biotest air samplers and air settling plates to capture viable microorganisms.
  • Non-Viable Particle Monitoring : Our Met One laser particle counter ensures compliance with ISO 14644 standards.
  • Regulatory Compliance : Air monitoring aligns with FDA and industry regulations for cleanroom operations.

Particulate contamination can affect product integrity, making laboratory environmental monitoring essential.

  • Precision Testing : Our state-of-the-art Met One laser particle counter detects dust and non-viable particles.
  • Data-Driven Analysis : We provide detailed reports to help clients maintain a contamination-free environment.
  • Ideal for : Pharmaceuticals, aerospace, and medical device manufacturing, ensuring that even microscopic particles do not compromise product safety.

Maintaining contamination-free surfaces is a key component of cleanroom environmental service.

  • RODAC Sampling : Our RODAC plates collect and analyze viable microorganisms on critical surfaces.
  • Personnel Monitoring : Testing extends to personnel hygiene assessments to maintain cleanroom compliance.
  • Risk Mitigation : Early detection of microbial contamination prevents costly compliance violations

For facilities needing independent monitoring, we provide environmental testing for medical devices and cleanrooms with specialized rental equipment.

  • Air Quality Samplers : Rent our RCS Biotest air samplers for reliable microbial testing.
  • Flexible Rental Terms : Short-term and long-term rental options tailored to client needs.
  • Technical Support : Our experts guide you through setup and data interpretation.
Laboratory Testing

Ready to Get Expert Environmental Testing For Medical Devices?

Expert Guidance

Over 40 years of experience in cleanroom environmental service and laboratory monitoring.

Cutting-Edge Technology

We use state-of-the-art equipment to conduct precise environmental monitoring services.

Regulatory Compliance Assurance

Our environmental testing for medical devices ensures compliance with ISO and FDA regulations.

Tailored Solutions

Customized plans that fit your facility’s specific requirements and operational workflow.

Laboratory Testing Services Offered

The laboratory offers a wide array of testing services, such as:

  • Aging Study/Stability Study Services

  • Aqueous Biocide

  • Bioburden Testing Services

  • Endotoxin Testing

  • Biological Indicator Services
  • Nutritional/Dietary Testing Services
  • Identification Services
  • Validation Services
  • Packaging Integrity Services
  • Product Sterility Services
  • Product Testing Services
  • Water Testing Services
  • Miscellaneous Testing

  • Miscellaneous Testing

  • Environmental Services

  • Dialysis Water Testing

contract packaging

Benefits of Laboratory Environmental Monitoring

Here are some benefits: 

  • Ensures Regulatory Compliance
    Meeting industry standards for cleanliness, particularly for environmental testing for medical devices.
  • Reduces Contamination Risks
    Minimizes microbial and particulate contamination through effective laboratory environmental monitoring.
  • Enhances Product Safety
    Protects pharmaceutical, biotech, and medical device products from contamination.
  • Improves Cleanroom Efficiency
    Our cleanroom environmental service ensures optimal operational performance.
  • Supports Long-Term Quality Control
    Ongoing environmental monitoring service maintains consistency in quality and compliance.

Application of Laboratory Environmental Monitoring

Laboratory environmental monitoring plays a crucial role in maintaining controlled environments across various industries. Here are key applications in different sectors:

  • Pharmaceutical & Biotechnology
    Maintains sterile conditions in drug production, preventing microbial contamination and ensuring regulatory compliance.
  • Medical Device Manufacturing
    Ensures cleanroom standards for contamination-free medical devices, meeting FDA and ISO 14644 regulations.
  • Hospital & Healthcare Facilities
    Controls microbial presence in surgical rooms, ICUs, and laboratories to protect patient safety.
  • Food & Beverage Industry
    Prevents contamination in food processing environments, ensuring compliance with safety standards.
  • Electronics & Semiconductor Manufacturing
    Maintains ultra-clean conditions to prevent particle interference in microchip and circuit board production.

Frequently Asked Questions

Why is laboratory environmental monitoring important?
Laboratory environmental monitoring helps prevent contamination, ensures product integrity, and maintains regulatory compliance for pharmaceuticals, medical devices, and manufacturing facilities.
Monitoring frequency depends on industry standards, risk assessments, and operational needs, with routine testing ensuring compliance with cleanroom environmental service regulations.

ISO 14644, FDA, and GMP guidelines regulate cleanroom environmental service, ensuring compliance with air quality, microbial control, and particle monitoring.

It identifies microbial and particulate contamination risks, ensuring that medical devices are manufactured in a clean, controlled environment.

Cleanroom environmental service includes air monitoring, particulate testing, surface microbial analysis, and equipment validation for contamination control.
If contamination is found, we provide detailed reports and recommendations to address and mitigate contamination risks effectively.