Quality Control in the Pharmaceutical Industry

Quality level is of great concern within the pharmaceutical industry as the products can affect the health of their customers. So, it is crucial to control the storage and process areas according to prescribed rigid regulations and FDA standards.

Quality Control in the Pharmaceutical Industry

Ametek Calibration specializes in producing numerous instruments for pressure, temperature, and process calibration. From high accuracy dry block temperature calibrators to digital test gauges and data recorders, a variety of equipment is provided to help you do your job.

Sterilizing in Autoclaves

In order to hold medicine prior to filling them, medicine producers sterilize ampoules or other containers. This process is controlled to be within certain pressure and temperature. Pressure op to 3,5 bar absolute and the temperature range can be up to 150 °C.

The pressure and temperature sensors controlling this process are calibrated regularly. The most frequently utilized temperature calibrators for this application are RTC156 and PTC155 and for pressure the nVision serves the purpose perfectly.

Freeze Drying

Food and medicine producers are frequently freeze drying their products to ease their transportation and to preserve and prolong their lifetime. Freeze drying is a process in which all of the water content is removed from the product. The process is made up of a number of steps.

  1. The product is frozen to low temperature between -80 °C and -50 °C and the pressure in the chamber is lowered
  2. Using this process the water in the product sublimates (directly from ice to vapor)
  3. The sensors controlling this process are calibrated to run the process
  4. Due to the extremely low temperatures RTC159 and PTC125 are utilized for the temperature calibration

Conductivity Sensors

Conductivity sensors are employed to confirm that a proper clean-in-place, CIP, has been carried out on a tank or a tube system. After using caustic or acid solution to clean the system, it is flushed with Water-for-injection (WFI) water.

This flush process is repeated until the conductivity of the water is low enough to confirm that the system is clean. Since this measurement is extremely dependent on the temperature, a conductivity sensor holds a temperature sensor. The temperature sensors must be calibrated and an RTC158 is the perfect solution.

Datalogging/Data Recording

The nVision can be used to record pressure, current, temperature, and voltage at up to 10 readings per second. The battery-optimizing, Ultra Low Power (ULP) mode, permits an entire year of continuous recordings on one set of batteries.

Direct Pressure Measurement

A number of places throughout pharmaceutical facilities will need direct measurement of pressure. This could involve completed periodic checks or permanently mounting an instrument. Ametek Calibration provides intrinsically safe instrumentation for flexibility and accuracy to measure pressure confidently.

Validation

Freeze dryers and sterilizers are controlled to have a homogenous temperature distribution. This is carried out by utilizing a large number of temperature sensors in the chamber during a loaded test-run.

All of the sensors which are utilized for this validation must be calibrated. For this purpose Ametek Calibration has developed special validation inserts to calibrate all the validation sensors at once. These inserts fit to RTC156, RTC157, RTC159 and PTC125 calibrators.

pH Sensors

pH sensors are widely employed in medicine production utilizing fermentation. If the fluid changes temperature a pH measurement gives different results in the same fluid. For that reason, the pH measurement is referred to a reference temperature to make comparisons.

To make this possible a pH electrode holds a temperature sensor. The temperature sensor is calibrated to carry out the correct calculation to the reference temperature pH value. Calibration can be performed in a RTC158-bath model with ion-exchanged water.

Barometric Pressure Measurement

Some applications will require the reference gauge to read directly in barometric pressure, such as calibrating absolute pressure gauges. The nVision and the HPC40 series, with the optional barometric reference will show pressure in the absolute scale. You can even toggle between absolute pressure and gauge on the same device.

Depyrogenation

In processes where sterilization is not sufficient, a special depyrogenation process is employed. This process is performed at 350 °C and ensures that all material is burned, eradicating all germs. Calibrators like PTC, and ITC are utilized for calibration of the temperature sensors controlling the process.

Super Freezers

Medicine producers usually store their product in super freezers at temperatures between -95 °C and -60 °C. The purpose of this is to keep the product stable and inactive. It is crucial to keep the drugs chilled at a controlled and documented temperature, since the value of these drugs tends to be extremely high. This is where calibration is useful. For producing and calibrating in these extremely low temperatures Ametek Calibration has developed two temperature calibrators, RTC159 and PTC125.

Storage Tank Level

Producers store their inventory in holding tanks, and a precise temperature and pressure measurement of each storage vessel creates a record of their inventory on-hand. The nVision provides a quick and easy method to record accurate pressure measurements and the RTC measures and calibrates temperature.

Humidity Measurement

Humidity measurement is a crucial part of many industrial processes, but measuring it accurately can be challenging. Relative humidity is a term which is used to describe the amount of water vapor present in air expressed as a percentage of the amount required for saturation at the same temperature.

It is important that temperature is established precisely to attain an accurate relative humidity measurement. If the room temperature which is measured is off by at little as 1 °C, the humidity measurement can change by up to 3-4%. The RTC Reference Temperature Calibrator supplies the high accuracy needed to calibrate humidity measurement.

Maintenance of Calibration Standards and Test Equipment

Test equipment and portable calibrators require periodic checks and calibration. Having local standards on site for calibration of these instruments provides savings in cost and downtime of instruments: calibrate the field instruments locally and then only send the standard in for regular calibration. The HPC40 Series and nVision are light-weight, small instruments that have the accuracy needed to calibrate pressure in the field or in a lab.

The RTC and PTC series are excellent standards for the verification and calibration of handheld thermometers. The DTI Series with an STS may be used as high accuracy temperature references. The AMC-910 offers capabilities for local calibration of electrical signals and with the APM CPF and an STS probe may be used for pressure and temperature calibration.

There is no better pressure standard than a deadweight tester for calibrating pressure instruments and the deadweight testers from Ametek Calibration are designed to be highly accurate but durable.

This information has been sourced, reviewed and adapted from materials provided by AMETEK Sensors, Test & Calibration.

For more information on this source, please visit AMETEK Sensors, Test & Calibration.

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