Pharmaceutical Industry

Pharmaceutical Industry
Within the pharmaceutical industry the quality level is of great concern as the products may influence the health of their customers. It is therefore essential to control the process and storage areas according to prescribed rigid regulations and FDA standards. We specialize in producing several instruments for temperature, pressure, and process calibration. From digital test gauges and data recorders, to high accuracy dry block temperature calibrators, we have a variety of equipment to help you do your job.

Sterilizing in Autoclaves – Medicine producers are sterilizing ampoules or other containers to hold medicine prior to filling them. This process is controlled to be within specific temperature and pressure. Temperature range can be up to 150° C and pressure op to 3,5 bar absolute. The temperature and pressure sensors controlling this process are calibrated on a regular basis. The most commonly used temperature calibrators for this application is RTC156 and PTC155 and on the pressure side the nVision serves the purpose perfectly. RTC, PTC

Freeze Drying – Medicine and food producers are very often freeze drying their products to preserve and prolong the lifetime and ease the transportation. Freeze drying is a process where al water content is removed from the product. The process consists of several steps. First the product is being frozen to low temperature from -80 to -50°C and the pressure is lowered in the chamber. By this process the water in the product sublimates (directly from ice to vapor). The sensors controlling this process are calibrated to run the process. Due to the very low temperatures RTC159 and PTC125 are used for the temperature calibration. RTC, PTC 

Validation – Sterilizers and freeze dryers are controlled for having a homogenous temperature distribution. This is done by having a lot of temperature sensors in the chamber during a loaded test-run. All the sensors used for this validation need to be calibrated. For this purpose we have developed special validation inserts to calibrate all the validation sensors in one run. These inserts fit to RTC156, RTC157, RTC159 and PTC125 calibrators. RTC, PTC 

Depyrogenation – In processes were sterilization is not enough a special depyrogenation process is used This process run at 350°C and makes sure the all material is burned leaving no germ left. Calibrators like PTC, and ITC are used for calibration of the temperature sensors controlling the process. PTC, ITC 

Super Freezers – Medicine Producers often keep their product in super freezers at temperatures from -95 to -60°C.  The purpose is to keep the product inactive and stable. Since the value of these  drugs are normally very high it is imperative to keep them chilled at a controlled and documented temperature. This is where the calibration comes in. For generating and calibrating in these very low temperatures we have developed two temperature calibrators, RTC159 and PTC125. RTC, PTC

Conductivity Sensors – Conductivity sensors are used to prove that a proper Clean-in-place, CIP, has been performed on a tank or a tube system. After having used 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 prove that the system is clean. A conductivity sensor holds a temperature sensor since this measurement is very dependent on the temperature. The temperature sensors have to be calibrated and an RTC158 is the perfect solution. RTC

pH Sensors – These are widely used in medicine production using fermentation. A pH measurement give different results in the same fluid if the fluid changes temperature. The pH measurement Is therefore referred to a reference temperature to make comparisons. A pH electrode holds a temperature sensor to make this possible. To make the correct calculation to the reference temperature pH value, the temperature sensor is calibrated. Calibration can be carried out in a RTC158-bath model with ion-exchanged water. RTC

Storage Tank Level – Producers store their inventory in holding tanks, and an accurate pressure and temperature measurement of each storage vessel creates a record of their inventory on-hand. The nVision offers an easy and fast way to record accurate pressure measurements and the RTC measures and calibrates temperature. nVision, HPC40 Series, XP2i, RTC

Datalogging/Data Recording – Record pressure, temperature, current, and voltage at up to 10 readings per second using the nVision. The battery-optimizing, Ultra Low Power (ULP) mode, allows an entire year of continuous recordings on one set of batteries. nVision, XP2i

Direct Pressure Measurement – Various places throughout pharmaceutical facilities will require direct measurement of pressure. This could involve permanently mounting an instrument or completed periodic checks. Our intrinsically safe instrumentation provides the flexibility and accuracy to confidently measure pressure. nVision, HPC40 Series, XP2i, 30 Series, ASC-400

Barometric Pressure Measurement – Some applications, such as calibrating absolute pressure gauges, will require the reference gauge to read directly in barometric pressure. The nVision and the HPC40 series, with the optional barometric reference will indicate pressure in the absolute scale. You can even toggle between gauge and absolute pressure on the same device. nVision, HPC40 Series, ASC-400

Humidity Measurement – Humidity measurement is an important parameter in many industrial processes, but measuring it correctly can be tricky. Relative humidity is a term used to describe amount of water vapor present in air expressed as a percentage of the amount needed for saturation at the same temperature. It is crucial that temperature is precisely determined to get an accurate relative humidity measurement. If the room temperature measured is off by only 1°C, the humidity measurement can vary by up to 3-4%. The RTC Reference Temperature Calibrator provides the high accuracy needed to calibrate humidity measurement. RTC Series

Maintenance of Calibration Standards and Test Equipment - Portable calibrators and test equipment requires periodic checks and calibration. Having local standards on site for calibration of these instruments offers a savings in cost and downtime of instruments: calibrate the field instruments locally and then send only the standard in for regular calibration. The nVision and HPC40 Series are small, light-weight instruments that have the accuracy required to calibrate pressure in the field or in a lab. 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. The DTI Series with an STS may be used as high accuracy temperature references. The RTC and PTC series are excellent standards for the verification and calibration of handheld thermometers. There is no better pressure standard than a deadweight tester for calibrating pressure instruments and our deadweight testers are designed to be highly accurate but durable. nVision, HPC40 Series, DTI-050, DTI1000, AMC-910, APM CPF, RTC, PTC, Deadweight Testers