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C.G. Laboratories, Inc.

Air Microbial Monitoring

  • 40 Years of Experience

  • Precision Air Sampling

  • ISO 14644 Compliance

  • Expert Support & Reporting

  • RCS Biotest Air Sampler for Rental

Our Process

At C.G. Laboratories, we follow a six-step process to ensure accurate and reliable air microbial monitoring:

Step 1: Site Assessment & Planning

We evaluate cleanroom environments and determine the optimal sampling strategy based on industry regulations.

Step 2: Deployment of RCS Biotest Air Sampler

The RCS Biotest Air Sampling system is set up to collect air samples efficiently from designated areas.

Step 3: Microbial Sample Collection

Airborne microorganisms are captured using specialized environmental plates and media.

Step 4: Incubation & Microbial Enumeration

Collected samples undergo controlled incubation to promote microbial growth for precise enumeration.

Step 5: Data Analysis & Reporting

We provide detailed reports, highlighting microbial counts and contamination risks.

Step 6: Corrective Actions & Compliance Support

If contamination is detected, we assist with remediation strategies to maintain cleanroom integrity.

Understanding Air Microbial Monitoring

Air microbial monitoring is a critical process for assessing airborne contamination in controlled environments such as cleanrooms, pharmaceutical facilities, and medical device manufacturing plants. Airborne microorganisms, including bacteria, fungi, and mold, can compromise product sterility and lead to regulatory non-compliance.

At C.G. Laboratories, we utilize advanced RCS Biotest Air Sampling methods to detect and quantify microbial presence in the air. This ensures that facilities meet strict FDA, ISO 14644, and GMP guidelines for environmental monitoring.

Our microbial enumeration service provides detailed analysis of air samples, offering essential data for contamination control and risk assessment.

Our Air Microbial Monitoring Methods

We use multiple air microbial monitoring techniques to ensure a comprehensive evaluation of airborne contamination. Our methods include:

RCS Biotest Air Sampling

Utilizes the RCS Biotest Air Sampler, a highly efficient system designed to collect airborne microbes from cleanrooms and controlled environments. It supports air sampling volumes ranging from 1 to 2000 liters.

Our lab analyzes collected samples, incubates them under controlled conditions, and enumerates microbial colonies to determine contamination levels. This process ensures precise microbial assessment.

Involves drawing a known volume of air through a specialized sampler, such as the RCS Biotest Air Sampler, and capturing microorganisms on a culture medium for further analysis.

Uses open petri dishes placed in critical areas to capture settling microorganisms over a set period. This method helps assess airborne microbial load without active air movement.

Complements air sampling by assessing microbial contamination on surfaces and personnel within controlled environments. This ensures comprehensive monitoring and contamination control
Laboratory Testing

Ready To Get Reliable Air Microbial Monitoring?

Regulatory Expertise

We ensure compliance with ISO 14644, FDA, and GMP standards.

Cutting-Edge Technology

We utilize RCS Biotest Air Sampling for accurate microbial detection.

Comprehensive Services

We offer microbial enumeration services, environmental monitoring, and compliance support.

Flexible Rental Solutions

Our RCS Biotest Air Sampler for Rental provides cost-effective air sampling options.

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 Air Microbial Monitoring

Our advanced air microbial monitoring offer multiple benefits, including:

  • Ensures Regulatory Compliance
    Helps businesses meet ISO 14644, FDA, and GMP standards for cleanroom and controlled environments.
  • Prevents Contamination
    Detects airborne microbial threats early, reducing the risk of product contamination in industries like pharmaceuticals and medical device manufacturing.
  • Enhances Product Quality & Safety
    Maintains a sterile production environment, ensuring the integrity of medical devices, pharmaceuticals, and other sensitive products.
  • Supports Risk Management
    Provides data-driven insights that help identify contamination sources and implement corrective actions before issues escalate.
  • Improves Environmental Monitoring Programs
    Offers a structured approach to monitoring cleanrooms, laboratories, and production areas, ensuring continuous air quality assessment.
  • Protects Human Health
    Reduces exposure to airborne pathogens in hospitals, research facilities, and food production areas, safeguarding both workers and consumers.
  • Increases Operational Efficiency
    Early microbial detection allows businesses to implement proactive contamination control measures, minimizing downtime and costly recalls.

Application of Air Microbial Monitoring

Here are key applications in different sectors:

  • Medical Device Manufacturing
    Ensures sterile production environments by detecting airborne microbial contamination.
  • Pharmaceutical Industry
    Helps maintain contamination-free drug production and ensures regulatory compliance.
  • Hospital Cleanrooms & Labs
    Protects sensitive environments from airborne pathogens, ensuring patient and staff safety.
  • Food & Beverage Industry
    Prevents microbial contamination in food processing and packaging areas.
  • Biotechnology & Research Facilities
    Supports controlled environments in research labs to prevent microbial interference.

Frequently Asked Questions

What is the RCS Biotest Air Sampler used for?
The RCS Biotest Air Sampler is a specialized device designed for air microbial monitoring. It captures airborne microbes for enumeration, helping industries assess and maintain cleanroom air quality.

The frequency depends on industry regulations and facility requirements. High-risk environments, such as pharmaceutical and medical device manufacturing, may require daily or weekly monitoring, while other industries may conduct it monthly or quarterly.

By detecting airborne contaminants, microbial air sampling prevents microbial growth in medical devices, pharmaceuticals, and food products, ensuring safety and regulatory compliance.

Yes, CG Laboratories offers the RCS Biotest Air Sampler for rental, allowing businesses to perform air microbial monitoring without the high cost of ownership.

The RCS Biotest Air Sampling system can collect air volumes ranging from 1 to 2000 liters, ensuring flexibility for different cleanroom classifications and monitoring needs.

It can detect bacteria, fungi, yeast, and mold that may pose contamination risks in controlled environments.