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Autoclave and Sterilizer Validation Solutions

Installation, Operation and Performance Qualification for Autoclaves and Sterilizers

Autoclaves and sterilizers are essential to any lab, medical, and industrial setting as they clean lab equipment from bacteria, viruses, fungi, and more. These chambers must work properly because nonsterile equipment could seriously interfere with experimentation, lab results, manufacturing, patient well-being, and many more processes.

Alcami is an elite provider of validation and qualification services, specializing in several areas, including:

  • autoclaves and sterilizers
  • steam-in-place in bioreactors and lyophilizers
  • vacuum ovens
  • depyrogenation ovens

With our extensive experience and fierce commitment to quality, Alcami executes comprehensive validation and qualification testing to determine if your autoclaves and sterilizers are working correctly.

Autoclave and Sterilizer Validation Done Right

The Alcami validation team specializes in sterilization applications including autoclaves, steam-in-place in bioreactors and lyophilizers, vacuum ovens and dehydrogenation ovens. We supply all the test equipment which has been tested and calibrated in our NVLAP ISO/IEC 17025:2017 accredited metrology laboratory to ensure the utmost accuracy (NVLAP lab code 200904-0). Equipment and supporting devices include:

  • thermocouples
  • wireless dataloggers
  • baths and standards
  • biological indicators
  • flanges
  • validation clamps
  • gaskets

We come to your project equipped with the right tools for sterilizers including smart gaskets with our own sanitary fittings and feed-through mechanisms, correct thermocouples for your application (Teflon or Kapton). And we always choose the right dry-block before performing your autoclave or sterilizer validation.

Our validation team is highly experienced with both EN 285 and HTM 2010 guidelines and will work with your team to identify the best way to demonstrate sterility assurance. We also perform steam quality tests to verify dryness, superheat, and non-condensable gas in your clean steam supply. If you’re looking for additional information to determine whether you should be performing this test, contact us for more information. We’re always happy to help and provide guidance.

Protocol Development for Validation Projects

Alcami provides assistance with protocol generation, and our experts can demonstrate a written explanation describing how loads and products were selected for qualification testing. The test equipment is prepared and calibrated in advance. When test execution is ready to start, the testing can start immediately with no delays. We can perform the cycle development for the sterilizer, so it satisfies the requirements of the guidelines and standards set for the industry. Supported standards include:

  • 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

European Directives

European Directives also apply to sterilizers used in the pharmaceutical, biotechnology, and medical devices industries. These must be adhered to as well for maximum compliance. These 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)

Industry-Leading Autoclave and Sterilizer Validation Practices

Helping the life sciences industry deliver safe and effective products to their patients is our priority. That’s why we offer high-quality autoclave and sterilizer validation services that benefit your organization and your end users. When you choose Alcami for your validation projects, you choose efficiency, integrity, and excellence.

Time is valuable in a high-demand, fast-paced industry. Alcami creates time and money-saving efficiencies in the validation process by conducting pre-qualification procedures before beginning a project. Pre-qualification assesses your equipment’s performance before validation begins and determines if the equipment will likely pass or fail validation – helping you make the most informed decision before moving forward with further testing.

All certified validation and calibration equipment used at customer sites is verified upon return to our NVLAP accredited metrology laboratory to confirm accuracy. We complete your project by providing a clear, comprehensive validation report, confirming your equipment is fit for use for your requirements. 

Reducing equipment downtime is critical to meeting the needs of patients. Masy is fully equipped with an in-house validation team and the largest validation equipment inventory to consistently meet or exceed your project and time-frame requirements, while never sacrificing quality or accuracy.

Your Comprehensive Pharma Services provider

Alcami is a comprehensive Pharma Services partner, offering services for Metrology & Calibration, Commissioning, Qualification & Validation, Environmental Monitoring and Cleanroom Services and GMP Pharma Storage. Improve the efficiency of your operations and quality of your products when you choose Alcami as your single-source Pharma Services partner.