Commissioning, Qualification and Validation (CQV)

Autoclave & Sterilization Validation

Pharma Services
Pharma Storage & Services
Validation

Comprehensive Autoclave and Sterilization Validation Services

Autoclaves and sterilizers are indispensable in laboratory, medical, and industrial environments, ensuring equipment is free from harmful bacteria, viruses, fungi, and more. The proper functioning of these devices is critical, as non-sterile equipment can significantly impact experiments, lab results, manufacturing processes, and patient safety.

At Alcami, we provide elite validation and qualification services, with specialized expertise in:

  • Autoclaves and sterilizers
  • Steam-in-place systems in bioreactors and lyophilizers
  • Vacuum ovens
  • Depyrogenation ovens

With extensive experience and a steadfast commitment to quality, Alcami conducts thorough validation and qualification testing to ensure your autoclaves and sterilizers operate flawlessly.

Precision Autoclave and Sterilization Validation

Alcami’s validation team is skilled in a range of sterilization applications, including autoclaves, steam-in-place systems in bioreactors and lyophilizers, vacuum ovens, and depyrogenation ovens. We use meticulously tested and calibrated equipment to guarantee precise results.

  • Precision Autoclave and Sterilization Validation Devices

    Thermocouples

  • Wireless dataloggers

  • Baths and standards

  • Biological indicators

  • Flanges

  • Validation clamps

  • Gaskets

We arrive at your project equipped with the right tools, such as smart gaskets with sanitary fittings, feed-through mechanisms, and application-specific thermocouples (Teflon or Kapton). We also ensure the correct dry-block is selected before initiating your autoclave or sterilizer validation.

Our team is well-versed in both EN 285 and HTM 2010 guidelines and will collaborate with your team to determine the best approach for sterility assurance. Additionally, we conduct steam quality tests to assess dryness, superheat, and non-condensable gas levels in your clean steam supply, offering expert guidance on the necessary testing for your application.

  • Tailored Protocol Development for Validation Projects

    Our experts assist in the creation of validation protocols, providing a detailed explanation of how loads and products were selected for qualification testing. With our test equipment prepared and calibrated in advance, your testing can begin without delays. We also handle cycle development for sterilizers, ensuring compliance with industry standards such as:

  • EN 285, ISO 17665-1:2006

  • Choice Framework for local Policy and Procedures (CFPP) 01-01-part C

  • PDA Technical Report no. 1, and PDA Technical Report no. 48

  • Compliance with European Directives for Sterilization

    Alcami ensures that your sterilization processes adhere to relevant European Directives, which are crucial for compliance in the pharmaceutical, biotechnology, and medical device industries. These directives include:

  • Medical Device Directive (93/42/EEC and 2007/47/EEC) Class II a

  • Electromagnetic Compatibility Directive (2004/108/EEC)

  • Low-voltage Directive (2006/95/EC)

  • Pressure Equipment Directive (97/23/EEC)

  • Machinery Directive (98/37/EEC and 2006/42/EEC)

  • Leading the Industry in Autoclave & Sterilization Validation

    Alcami is dedicated to helping the life sciences industry deliver safe and effective products to patients. We offer top-tier autoclave and sterilization validation services designed to enhance the efficiency and quality of your operations. By partnering with Alcami, you benefit from our commitment to efficiency, integrity, and excellence.

    Pre-Qualification for Enhanced Efficiency

    In a fast-paced industry, time is of the essence. Alcami streamlines the validation process by performing pre-qualification assessments to evaluate your equipment’s performance before formal validation. This step allows you to make informed decisions, potentially saving time and resources.

  • Post-Qualification Verification and Documentation Delivery

    After using certified validation and calibration equipment at customer sites, we verify its accuracy upon return to our ISO/IEC 17025:20 accredited metrology laboratory. You will receive a detailed validation report, confirming that your equipment meets all necessary requirements.

  • Rapid Turnaround to Minimize Downtime

    Minimizing equipment downtime is crucial for patient care. Alcami’s in-house validation team and extensive equipment inventory enable us to meet or exceed your project deadlines without compromising quality or accuracy.

  • Alcami: Your Comprehensive Pharma Services Partner

    Alcami is your all-in-one Pharma Services partner, offering solutions in Metrology & Calibration, Commissioning, Qualification & Validation, Environmental Monitoring and Cleanroom Services, and GMP Pharma Storage. Choose Alcami to optimize your operations and improve the quality of your products.

Related Topics
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Commissioning, Qualification and Validation (CQV)
Contact Alcami
Summary

Alcami provides comprehensive autoclave and sterilization validation services, ensuring that equipment in laboratory, medical, and industrial settings operates at peak efficiency. Our expert team follows stringent guidelines, conducts pre- and post-qualification assessments, and delivers detailed documentation to guarantee compliance and accuracy. Partnering with Alcami means benefiting from our commitment to quality, efficiency, and regulatory adherence.

Related Topics
Metrology & Calibration
Exploring FDA Findings Around Calibration
Why the FDA General Calibration Requirements are Not Enough
Commissioning, Qualification and Validation (CQV)
Contact Alcami
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