The delicate process by which drugs are manufactured and shipped requires perfect temperature control. By monitoring temperature and making the necessary adjustments, temperature controllers help maintain a constant temperature in a laboratory or industrial space. This ensures the quality of healthcare products and the smooth operation of pharmaceutical equipment.
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Whether medicines, vaccines, active pharmaceutical ingredients (APIs), biopharmaceuticals or medical devices, all pharmaceutical products are subject to strict regulations to protect patients and guarantee product efficacy and quality.
21 CFR part 11 was established by the FDA to meet the challenges of traceability of electronic temperature records. This standard requires that records be reliable and accurate, in order to ensure the safety of pharmaceutical products. Pharmaceutical companies must therefore use temperature controllers capable of generating accurate and reliable reports. In addition, they must keep records of all alarms and events in electronic format.
PUM series modular controllers can be connected to a PC for programming and data logging. They are linked to easy-to-clean industrial touchscreen HMI displays, for easy data readability. PUM and HMI systems display trend curves and enable temperature measurements to berecorded and traced.
Precise temperature control is essential for successful research. Whether you're growing bacteria in an incubator or drying samples in a vacuum oven, it's important that your equipment is capable of maintaining a constant temperature.
To ensure that equipment is working properly, temperature must be regularly monitored and regulated. This includes ovens, autoclaves, incubators and heating chambers. Vacuum or climatic drying chambers are used to control the environment in which experiments are carried out. They help maintain a constant temperature, which is essential for obtaining accurate results. Crystallization chambers are used to grow crystals for use in experiments. And test chambers are used to simulate real-world conditions.
Temperature controllers and temperature measurement instruments can help improve the accuracy of your laboratory equipment and ensure the success of your research.
Temperature control is an important element of Good Laboratory Practice (GLP).
Any deviation from the ideal temperature can lead to adverse reactions and compromise the validity of the research. By maintaining a stable environment with temperature controllers, test laboratories can guarantee the accuracy of their results, and thus the safety and pharmacological efficacy of new drugs.
Temperature is a critical parameter in pharmaceutical and industrial development, which must be controlled and regulated. When it is too high or too low, reactions can occur, leading to undesirable results.
For example, an increase in temperature in a reactor can cause an increase in the rate of chemical reactions, leading to the formation of undesirable by-products or favoring the creation of micro-organisms likely to contaminate the product. Furthermore, an increase in temperature in a bioreactor can cause denaturation of proteins, leading to changes in their structure and function. Conversely, a drop in temperature can slow down chemical reactions, reduce yields, and even cause product or plant degradation.
Therefore, to produce safe and effective drugs or vaccines, it is essential to measure and control temperature using PT100 temperature sensors, HART temperature transmitters and industrial digital displays, at all stages of chemical or biological development and scale-up.
The quality of manufactured products is highly regulated, as it can have an impact on patient health and even the environment. All manufacturing stages are subject to Good Manufacturing Practices (GMP).
Poor temperature control or contamination, at any stage of the manufacturing process, can have serious consequences: batch recall, production stoppage. Consequently, manufacturers must take every possible measure to ensure the safety of their products. This includes meticulous compliance with GMP guidelines, and real-time temperature monitoring and recording.
PXF series PID controllers are fast, compact and ergonomic. Their large LCD display enables real-time monitoring and control of manufacturing processes, while meeting productivity targets. Only by ensuring that temperatures are maintained in accordance with procedures can manufacturers guarantee product stability and pharmacological efficacy.
High-performance temperature controllers can be installed on all equipment used to manufacture solid, liquid, sterile or non-sterile drugs or biological medicines:
Once healthcare, pharmaceutical or biotech products are produced on a large scale, they need to be distributed.
The packaging, palletization, storage and transport of healthcare products to distributors, wholesalers, hospitals and clinics must comply with Good Distribution Practices (G.D.P.), and with the specific datasheet recorded at the time of marketing authorization.
Storage areas must be kept within acceptable temperature limits.
To maintain the cold chain and prevent product deterioration, vehicles and refrigerated enclosures must also be equipped with temperature measurement and control systems:
The pharmacist in charge is responsible for ensuring that transport conditions guarantee the proper preservation, integrity and safety of heat-sensitive medicines.
During all the steps leading to the patient, the drug follows a highly regulated process where temperature must be monitored and recorded to guarantee product quality and patient health.
Measurement and temperature control from Fuji Electric improve the quality of your pharmaceutical production, save energy and optimize the operation of your laboratories and industrial equipment.
