Autoclave Validation and Calibration Program (AVCP)

Biomedical waste management and disposal is strictly regulated at the federal, state and local level.  Autoclaves are used to sterilize waste and clean materials associated with biomedical research at MIT.  The Autoclave validation and calibration program (AVCP) oversees compliance at the state level (Massachusetts State Sanitary Code Chapter VIII 105 CMR 480.000) and national level (AAALAC- Association for Assessment and Accreditation of Laboratory Animal Care).

 

Validation of autoclaves is required as a measure to check the effectiveness of the equipment in deactivating a biological indicator used as a standard under regulatory guidance. Calibration of autoclaves is required annually as a parametric monitoring of the temperature function of the equipment.  The ACVP requires all autoclaves, including bench-top laboratory-owned equipment, used for sterilization of waste and clean materials to be validated quarterly.

 

In addition, ACVP requires that all autoclaves designated for sterilization of waste to be calibrated annually and recommends all other autoclaves to be calibrated when necessary, as a good practice.  The ACVP also provides training and information associated with the proper and safe use of autoclaves, types of equipment recommended, basic user maintenance, and guidance on level II inspection of autoclaves, working closely with DLC assigned EHS coordinators and facilities managers.  Operationally, ACVP, is under Biosafety Program management and applies campus wide oversight with local coordination and operational collaboration. For more information, see the roles and responsibilities table below.

 
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Roles and responsibilities

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Validation testing using biological indicator device

 

Biological indicators are a device designed to monitor the parameters and adequacy of the sterilization process.  The device consists of a standardized population of bacterial spores (Geobacillus stearothermophilus) known to be the most resistant to the monitored sterilization mode. The microorganisms are packaged in a carrier with a protective container.  Biological indicators show that all the parameters necessary for sterilization were present. Subsequent bacterial growth or failure to grow under suitable conditions indicates the adequacy of sterilization.

 

Biological indicators are recognized by most authorities as being closest to the ideal monitors of the sterilization process because they measure the sterilization process directly by using the most resistant microorganisms (i.e., Bacillus spores), and not by merely testing the physical and chemical conditions necessary for sterilization.  

 

Validation test procedure

  • ACVP provides the biological indicator vials and other supplies. Please visit the VWR Office located in 56-022 or contact your EHS coordinator for pickup of needed fresh test vial, bag and label.

  • Validation runs are classify per autoclave usage function as described below.

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Validation and Sterilization of waste

 

PPE: safety glasses, long sleeves or lab coat and gloves rated for hot items should be worn when handling waste and especially when handling hot waste.  Please see the biological contaminated waste page for additional safety information.

  • Waste should be collected and placed in clear bag in marked (biohazard labeled) floor transfer container.

  • When bag is full, place completed autoclave tag firmly on bag (tags are provided by EHS office. To request tags please send email to bsp@mit.edu or call 2-3477). Tags are required by law to be attached to waste bag.

  • Place biological indicator vial in the waste bag near the center of the load. Attach the vial to a string (also found in 56-022) and then loop the string around the end of a long serological pipet which can be used to place the vial in the center of the waste load, pull the pipet out leaving the end of the string visible to be able to reach it and pull the vial out of the bag after the run has cooled down.

  • Leave bag OPEN for effective steam penetration during autoclaving.

  • Place waste bag with tag in a secondary autoclave-proof container and run waste cycle (121oC, 15 psi, 60 minutes).

  • After the run, allow waste to cool for at least 10 minutes. Caution: The waste is hot. Wear appropriate PPE when handling hot waste (safety glasses, long sleeves or lab coat and gloves rated for hot items). Failure to allow sufficient cooling time may result in injury.

  • Enter waste run in autoclave log binder, usually near equipment. Documentation must include tag I.D. number (sequentially numbered).

  • Place treated and tagged waste bags into regular waste for custodial pickup.

  • Place rescued biological indicator vial in provided plastic bag and attached label. Drop off at 56-022 or per previous arrangement, with your EHS coordinator.

  • Results will be communicated through your EHS coordinator as they become available.

    • Negative results indicate all parameters passed validation.

    • Positive results indicate a failure of the sterilization process and re-test is required. The users of the autoclave are advised to stop using failing equipment for decontamination of waste and find other validated autoclave to continue proper waste inactivation. Please consult your EHS coordinator or ACVP for questions and concerns.

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Validation and Sterilization of clean materials

 

  • Clean materials (wrapped, liquids, etc.) should be collected and placed in autoclave-proof tray (for supplies information click here).

  • Place biological indicator vial with the load. Vial can be placed in a beaker or taped to a wrapped material.  For liquids, leave cap slightly OPEN for effective steam penetration during autoclaving and to prevent pressurization of the container and spills inside the autoclave.

  • Run appropriate cycle (121oC, 15 psi, at least 15 minutes).

  • After the run, allow load to cool for at least 10 minutes. Caution: The waste is hot. Wear appropriate PPE when handling hot waste (safety glasses, long sleeves or lab coat and gloves rated for hot items). Failure to allow sufficient cooling time may result in injury.

  • Place rescued biological indicator vial in provided plastic bag and attached label. Drop off at 56-022 or per previous arrangement, with your EHS coordinator.

  • Results will be communicated through your EHS coordinator as they become available.

    • Negative results indicate all parameters passed validation.

    • Positive results indicate a failure of the sterilization process and re-test is required. The users of the autoclave are advised to find other validated autoclave to continue sterilization. Please consult your EHS coordinator or ACVP for questions and concerns.

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How do I calibrate my autoclave?

 

  • Contact your EHS coordinator or the ACVP manager to borrow a data logger. Note: Please run data logger without delay. The logger records continuously, memory capacity is limited.

  • Once you have the data logger, check that cap is tightly closed and place it in the autoclave and run waste cycle (121 oC, 15 psi, 60 minutes). Note: no need to run real waste with the logger.

  • After the run, allow logger to cool as needed. Caution: The metal logger is very hot. Wear appropriate PPE when handling hot equipment (gloves rated for hot items). Failure to allow sufficient cooling time may result in injury.

  • Note the following information with the logger and return to EHS coordinator or bring personally to EHS Office (N52-496)
    • Logger number (etched) used in corresponding autoclave
    • Date
    • Your name, email and phone number
  • Data will be downloaded and posted under each autoclave in the system. No further communication needed.

  • If anomalies are detected in data, communication will go to EHS coordinator to contact service. Once autoclave is back in service, data logger should be run again and results recorded.

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What should I do if my autoclave breaks?

 

If your autoclave breaks you should contact your facilities manager and/or EHS coordinator depending on your DLC.

 

Broken autoclaves are expected to be identified with signage indicating their status and warning users. Users affected may need to find another autoclave. Users sterilizing waste must not use a broken autoclave and you should contact your EHS coordinator or BSP contact to find alternative equipment or to check that is OK to dispose of such waste through a biowaste box.

 

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Is there any safety training on autoclave use?

 

Online training on autoclave safety is available through the MIT Atlas Learning Center.  Please go to course catalog and search for course name “autoclave use and safety” (EHS00254w).  Your lab or DLC might also require in person training.  This is typically done by your EHS representative, experienced researcher, or your EHS coordinator.  Please check with your EHS representative for details.  Please see the Biosafety Specific Training Webpage for further details on registering for online training.

 

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Frequently Asked Questions

 

  • How do I know if I can autoclave waste in an autoclave?

Autoclaves are designated and labeled “for waste”, not all DLCs have autoclaves designated for waste, if you are not sure if you should autoclave your waste please consult with your Biosafety contact.

The “for waste” designation means that the particular piece of equipment has been validated quarterly and calibrated annually. The information can be found on the autoclave log binder.

 

  • Can I autoclave waste?

MIT disposes of biological/medical waste using biowaste boxes, primarily.  Biological/medical waste is autoclaved under certain conditions (permit requirements, only effective method of waste inactivation, per specific approved risk assessment, etc.). Please consult with your Biosafety contact if you have questions or concerns.

 

  • What supplies do I need to autoclave waste and clean materials?

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