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C.G. Laboratories, Inc.

Sterilization Validation Service

  • FDA, AAMI, and ISO 11137 Certified
  • Laminar Flow Hood-controlled Environment
  • Custom Testing Solutions
  • Regulatory Compliance Assurance
  • Fast & Reliable Results

Our Sterilization Validation Process

At C.G. Laboratories, Inc., we follow a structured sterilization validation process to guarantee effectiveness and compliance:

Step 1: Initial Assessment

Identifying the appropriate sterilization method based on device materials and intended use.

Step 2: Bioburden Testing

Measuring the microbial load before sterilization to determine baseline contamination levels.

Step 3: Sterilization Cycle Development

Establishing sterilization parameters for effective microbial elimination.

Step 4: Verification & Dose Audits

Conducting radiation dose verification or cycle validation to ensure consistent sterility.

Step 5: Sterility & Residual Testing

Confirming the absence of viable microorganisms and ensuring no harmful residue remains.

Step 6: Final Report & Certification

Providing comprehensive documentation for regulatory submission and quality assurance.

Understanding Sterilization Validation Service

Sterilization validation service is a critical process that ensures the sterility of medical devices by verifying that sterilization methods effectively eliminate microbial contamination. This validation is essential to meet regulatory requirements and protect patient safety.

At C.G. Laboratories, Inc., we specialize in sterilization validation service for medical devices, ensuring full compliance with FDA regulations and industry standards. We use industry-approved methods to assess and validate sterilization effectiveness, helping medical device manufacturers bring safe and sterile products to market.

Sterilization Testing For Medical Devices Methods We Offer

We offer a range of sterilization testing for medical devices methods to ensure that devices meet industry standards:

AAMI 11137 Method 1 (Gamma & E-Beam Radiation Validations)

  • Validates sterilization using gamma or electron beam (E-Beam) radiation.
  • Ensures consistent sterility for single-use medical devices.

  • Determines microbial contamination levels before sterilization.
  • Essential for assessing sterilization efficacy.

  • Confirms the required radiation dose for effective sterilization.
  • Ensures that devices receive the correct sterilization exposure.

  • Evaluates final product sterility after undergoing sterilization.
  • Conducted in a controlled environment to prevent contamination.

  • Tests for microbial inhibition effects in sterilized medical devices.
  • Ensures accurate sterility test results.

  • Routine dose verification for radiation-sterilized products.
  • Ensures ongoing compliance with AAMI 11137 standards.

  • Validates sterilization using EtO gas for heat-sensitive devices.
  • Confirms effective microbial elimination without damaging materials.

  • Tests autoclave sterilization efficiency for reusable medical devices.
  • Ensures complete sterility without material degradation.
Laboratory Testing

Get Expert Sterilization Validation Testing For Medical Devices

Expert Team

Our trained microbiologists perform tests under controlled conditions using state-of-the-art equipment

Regulatory Compliance

We ensure that all sterilization validation testing aligns with FDA and AAMI guidelines.

Comprehensive Testing Solutions

From radiation validation to steam and ethylene oxide testing, we cover all sterilization methods.

Quick Turnaround Time

Efficient sterilization validation testing to meet your production timelines.

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

Why is Medical Device Sterilization Validation Important?

  • Ensures Regulatory Compliance
    Meets FDA, AAMI, and ISO 11137 standards, preventing legal issues and ensuring medical devices are safe for patient use.
  • Protects Patient Safety
    Eliminates harmful microorganisms, reducing infection risks and ensuring medical devices remain sterile throughout their intended use.
  • Verifies Sterilization Effectiveness
    Confirms sterilization processes work consistently, preventing contamination and ensuring product reliability in medical and pharmaceutical applications.
  • Supports Product Quality & Longevity
    Maintains product integrity by validating sterilization methods that do not compromise materials or device functionality over time.
  • Facilitates Market Approval & Trust
    Proper sterilization validation provides documented proof of safety, boosting confidence among healthcare providers, regulators, and end-users.

Facility Process and Environmental Validations

We offer sterilization validation testing for manufacturing environments. Our environmental validations ensure that sterilization facilities maintain controlled conditions that prevent contamination.

Our Environmental Validation Services Include:

  • Facility Air Quality Testing
    Ensuring compliance with cleanroom standards.
  • Surface Microbial Contamination Testing
    Evaluating the sterility of production areas.
  • Sterilization Equipment Validation (IQ/OQ/PQ)
    Installation, operational, and performance qualification for sterilization equipment.

Frequently Asked Questions

How often should sterilization validation be conducted?

It should be performed initially for new products and routinely audited (e.g., AAMI quarterly dose audits) to ensure ongoing compliance.

Yes, we provide sterilization validation for reusable devices, ensuring they meet safety and hygiene standards after repeated sterilization cycles.
The timeline varies depending on the sterilization method and regulatory requirements, but we prioritize efficient testing without compromising accuracy.

Yes, our services comply with FDA, AAMI, and ISO regulations to ensure your medical devices meet global sterilization standards.

Absolutely! We tailor sterilization validation testing based on your product’s materials, intended use, and sterilization method.

Yes, we provide detailed reports, test results, and certification documents to support FDA and ISO compliance.

Sterilization validation prevents contamination, preserves material integrity, and ensures sterilized products remain safe and effective throughout their shelf life.