Autoclave Calibration

The sterilization of equipment and instruments in the biopharmaceutical laboratory is extremely important to main safety and quality in the production process. Autoclaves play an important role in this process, but the effectiveness of these instruments depends on accurate calibration. GL Technologies works with biopharmaceutical organizations throughout California for all their equipment calibration needs, including autoclaves. As an ISO 17025 company, we provide both calibration and certification not only to maintain the highest quality research and manufacturing procedures, but also to help our clients maintain compliance with government agencies.

To speak with the experts about your autoclave calibration needs, please fill out our online form or give us a call!

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What Does an Autoclave Do?

An autoclave is a specialized piece of equipment that is used to steam under high pressure and temperature to eliminate microorganisms like bacteria and viruses from the laboratory equipment and supplies. It creats a controlled environment that destroys any potential contaminants to preserve the integrity and safety of the biopharmaceutical processes and products. When biopharmaceuticals maintain strict sterilization protocols, the autoclave works to prevent cross-contamination which preserves the purity of cultures and meets quality standards.

The Importance of Autoclave Calibration

Autoclaves are designed to use high-pressure steam to eliminate microorganisms, including bacteria, viruses, and fungi, from equipment and materials.

Regulatory Compliance

The biopharmaceutical industry is under strict guidance and regulations by agencies such as the FDA to maintain cGMP (Good Manufacturing Practices) that require evidence of calibration for the equipment used in the production process, including autoclaves. With regular calibration and documentation, these organizations are able to show compliance and prevent any fines or regulatory issues.

Quality and Safety

Autoclaves are used to sterilize a variety of components like vials, syringes, and equipment, which directly has an impact on product quality AND safety. If a calibration isn't done properly it can lead to ineffective sterilization which in turn can affect the final product which could pose a risk for patient safety.

Key Considerations for Autoclave Calibration

For accurate autoclave calibration, the following factors should be considered:

Calibration Frequency

Calibration frequency depends on a variety of factors including regulatory requirements, how often the equipment is used, and the importance of maintaining sterilization conditions. Autoclaves should be calibrated at least 1 time a year (more frequently if used extensively or critical loads are being sterilized). With regular calibration, biopharmaceutical companies can verify the temperature, pressure, and accuracy of the autoclave, showing the equipment consistently meets the required sterilization results.

Calibration Procedures

There are a series of steps to verify and adjust the temperature, pressure, and time parameters to meet the required standards. The process starts by comparing the readings of the autoclave's sensors with traceable reference standards such as calibrated thermocouples and pressure gauges. If deviations are record then adjustments are made using the autoclave's control system by modifying equipment components. Multiple calibration points are then checked across the operating range to verify consistency and repeatability. After the adjustments are done, the autoclave undergoes a final verification to confirm that it meets the needed accuracy. The autoclave calibration process guarantees the equipment's reliability in achieving the sterilization of the materials and equipment processed in its chamber.

Documentation

Documentation provides the necessary steps and procedures that need to be followed including the verification of temperature, pressure, and time parameters. It highlights the importance of using calibrated equipment and maintaing records for compliance with regulatory requirements. The document points out the need fo regular calibration schedules, periodic performance checks, and qualified personnal to verify the exact functioning of autoclaves. With the right documentation, organizations are able to have verifiable proof that equipment is meeting all compliance standards.

Why GL-Tec?

The GL Technologies team has the experience and equipment to calibrate all types of display equipment accurately. We understand the importance of accurate measurements in your specific industry, and we're committed to providing you with reliable, traceable calibration services.

Our calibration services are ISO 17025 accredited, and we follow strict quality control procedures. Your equipment is calibrated to the highest standards. We also provide fast turnaround times, so you can get back to work with minimal downtime.