Building Environmental Monitoring System Calibration

With the implementation of a trusted environmental monitoring system (EMS), biopharmaceuticals are able to maintain standards of quality. The EMS works to identify and control sources of to prevent contamination in the production process and protects the quality of pharmaceutial products. Calibration plays an important role in maintaining accurate measurements of the equipment to make sure the equipment is performing as needed and directed by both regulations and the manufacturer's specifications. GL Technologies works with a variety of biopharmaceutical organizations throughout California for their equipment calibration and certification needs. We have a quality team of professionals that work hard to keep our clients both compliant with regulations and cGMP, and their equipment working as required.

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Environmental Monitoring Systems (EMS)

The EMS is used to monitor and control the environment in which biopharmaceutical products are manufactured. The process involves regular sampling and analysis of the critical parameters such as air quality, surface cleanlinesses, temperature, and differential pressure. When baseline measurements are established and the appropriate alerts in order, an EMS has the ability to detect any deviations from the needed conditions.

Why is Calibration Important?

Calibration in the biopharmaceutical is one of the most important aspects for the equipment, it involves comparing the measurements obtained from an instrument against a known reference. For EMS, calibration makes sure the monitoring instruments that are being used to measure various environmental parameters are both reliable and accurate. It's very important to calibrate instruments regularly to maintain the monitoring system.

Key Parameters to Calibrate

In a biopharmaceutical EMS, several parameters require calibration, including:

Temperature and Humidity Sensors

The sensor's sensitivity must be calibrated to determine the response to changes in temperature. This process involves the measuremetn of the voltage output or current as a function of known temperature variations. The offset of the sensor should be determined and adjusted to reduce any system errors. Linearity verifies that the sensor's output corresponds linearly to the temperature being tested and measured.& Hysteresis accounts for any lag or delay in the sensor's response and should be accounted for during calibration. The stability of the sensor's output over the course of time must be checked for accuracy.

Particle Counters

The flow rate of the particle counter needs to be calibrated to provide consistent and representative volume of the air being sampled. The parameter is important for obtaining accurate particle concentration readings. The instrument's sensitivity should also be calibrated to detect and classify particles within the needed size range. By adjusting the sensitivity of the particle counter accurately differentiates between varying particle sizes. The particle's 0-count level should be calibrated to establishment a baseline measurement in the absence of particles. This particular calibration eliminates false readings and maintains accurate measurements.

Differential Pressure Sensors

The 0 point calibration makes sure that the sensor outputs 0 pressure when there is no differential pressure being applied. It works to eliminate any offset errors. The span calibration establishes the sensor's response over the entire measurement range so that the sensor accurately represents the applied pressure differentials in the specified range. Linearity calibration verifies the sensor's abiliy to return to the baseline reading after experiencing any pressure variations. Temperature compenstation calibration is important for accurate readings, as it acounts for the influencers of temperature on the sensor's performance.

Calibration Frequency and Documentation

How frequent calibration is done depends on a variety of factors including the instrument stability, regulatory requirements, and manufacturer's recommendations. For biopharmaceutical companies it's important to establish a calibration schedule and maintain detailed documentation of the calibration activities. The documentation should include information like the date of calibration, reference standards used, the results, and any adjustments that were made.

GL Technologies Calibration and Certification

GL Technologies is comprised of a team of professionals with deep knowledge in the biopharmaceutical research and manufacturing industry. We work with clients throughout California for all their equipment calibration and certification requirements to keep equipment perfoming to manufacturer's standards and keep our clients compliant with federal regulations.