Bioreactor Calibration

Bioreactors play a critical role in the production of therapeutic proteins, monoclonal antibodies, and other bio-based products in the biopharmaceutical industry. This complex equipment provides an environmental conducive to the growth of cells or microorganisms, allowing for synthesis of desired biomolecules. To maintain high-quality output, bioreactors need to be calibrated regularly. The professional team at GL Technologies is an ISO 17025 company provided calibration and certificated services for biopharmaceutical laboratories throughout California.

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What is a Bioreactor?

Bioreactors are designed to cultivate and grow cells, microorganisms and biological molecules under controlled conditions. It provides the perfect environment for the growth and proudction of various biopharmaceutical products including vaccines, therapeutic proteins, antibodies, and enzymes. These machines consist of a vessel or container in which cells or microorganisms are placed along with a growth medium that provides the necessary nutrients for their growth.

calibration bioreactor

Importance of Bioreactor Calibration

Quality Control and Compliance

For all equipment, calibration is important for maintaining overall product quality and meeting regulatory requirements such as the cGMP (Current Good Manufacturing Practices). Accurate measurements of equipment variables like temperature, pH, dissolved oxygn, and gas flow rates are important to maintain cell growth and product yield.

Improved Processes

Calibration of the bioreactor improvess process flow by providing reliable data for development, scale-up, and tech transfer. Accurate measurements of process parameters allows for the identification of the best operating conditions, which leads to improved productivity and shorter development cycles.

Equipment Reliability

All equipment in a laboratory or manufacturing process needs to be able to provide both reliability and longevity. By identifying and fixing deviations in measurement accuracy, issues can be resolved before they lead to process failures or equipment breakdowns. Which again, minimizes laboratory downtime and production losses.

Bioreactor Calibration Process

Define Requirements

Calibration requirements must be clearly defined to established the needed parameters and performance standards. This will include specifying the range of values that need to be measured including temperature, pH, and dissolved oxygen. The process should outline the frequency of calibration method to be employed, and traceability of calibration standards. When these requirements are defined upfront, the bioreactor can then be properly calibrated to maintain exact control over key variables conducted by the system.

Standards

Calibration standards py an important role in the process by providing reference points for various parameters, including temperature, pH, and dissolved oxygen. These standards are prepared and traceable to internationally recognized measurement standards for accuracy. The bioreactor's sensors are carefully calibrated using the required standards, allowing for exact measurement and control of the key process variables. This will provide consistency and reproducibility of bioprocesses.

Calibration Frequency

How often the bioreactor should be calibrated depends on a few different factors including the exact requirements of the bioreactor, the nature of the process being carried out, and regulatory guidelines. Calibration should be performed at regular intervals to verify and adjust key parameters to minimize the risk of inaccuracies and to verify consistent and reproducible results in the bioreactor.

Perform Calibration

Start by thoroughly cleaning and sterilizing the bioreactor systems and eliminate any contaminants that may interfere with the calibration process. Once complete, verify and calibrate the sensors, probes, and transmitters that are used for monitoring parameters like temperature, pH, and dissolved oxygen. It involves comparing readings obtained by sensors with known standards and making adjustments to align the readings. It's important to calibrate the control system by testing its responsiveness and accuracy in meeting desired setponts.

Documentation

Documentation outlines the step-by-step procedure for calibrating the bioreactor to maintain equipment performance. The documentation should include the dates of the calibration, the process, and who completed the service. Documentation serves both as a guide for laboratory employees and also for audits and inspections to maintain regulatory compliance.

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.