The importance of temperature control in the pharmaceutical industry
The importance of temperature control in the pharmaceutical industry
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.
Temperature control is crucial for pharmaceutical industries
Medicines, vaccines, Active Pharmaceutical Ingredients (APIs), biopharmaceuticals or medical devices, all drugs are subject to strict regulation to guarantee product safety end quality.
The FDA's 21 CFR part 11guidance addresses the traceability challenges of electronic temperature records. Records must be reliable and accurate to ensure the drug safety. Pharmaceutical companies must therefore use temperature controllers that can generate accurate and reliable reports. In addition, they must keep the electronic records of all alarms and events.
For monitoring and data acquisition, themulti-loop controllers - PUM series can be connected to a computer. They are connected to easy-to-clean touch screens HMI, for easy data display. The PUM and HMI systems display trend curves and allow temperature measurements to be recorded and traced.
Discover PUM modular controllers and HMI touch screens
Temperature regulation during drug discovery process
Accurate temperature control is essential for successful research. Whether you are growing bacteria in an incubator or drying samples in a vacuum oven, it is important that your equipment can maintain a constant temperature.
To ensure that the equipment is working properly, the temperature must be regularly monitored and regulated. This includes ovens, autoclaves, incubators, and heating test chambers. Vacuum, or climate, drying chambers are used to control the environment in which experiments are conducted. They help maintain a constant temperature, which is essential for accurate results. Crystallizers are used to grow crystals for use in experiments and the test chambers are used to simulate real-world conditions.
Temperature controllers and temperature measuring instruments can help improve the accuracy of your laboratory equipment and guarantee the success of your research.
Temperature monitoring during preclinical trials
Temperature control is an important requirement of Good Laboratory Practice (GLP) for preclinical laboratory studies.
Any deviation from the temperature specification may lead to adverse effects and compromise the study's result. By maintaining a stable environment with temperature controllers, CROs and research lab can assure the accuracy of their results and the safety of new drugs.
Temperature control during drug development process
Temperature is a critical parameter in process development, which must be controlled and regulated. When it is too high or too low, reactions can occur with unwanted outcomes.
For example, a temperature increase in a reactor can accelerate the chemical reactions, leading to the development of undesirable by-products or the growth of micro-organisms that can contaminate the product. In addition, a temperature raise in a bioreactor can cause the denaturation of proteins, leading to alterations in their structure and function. Furthermore, a drop in temperature can slow down chemical reactions, reduce yields, and even cause product degradation or plant damage.
Temperature control and regulation during pharmaceutical manufacturing process
The quality of the manufacturing products is highly regulated, as it can impact on the public health and even the environment. All manufacturing steps are subject toGood Manufacturing Practices (GMP).
Poor temperature control or contamination at any stage of the manufacturing process can have serious consequences, including batch recalls and production stoppages. Therefore, manufacturers must take all possible measures to guarantee the safety of their drugs. This includes complying with GMP guidelines and making real-time temperature checks and records.
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.
Discover the digital temperature controllers - PXF series
High-performance temperature controllers can be installed on all equipment for the manufacture of solid, liquid, sterile or non-sterile drugs or biological drug:
Weighing
Mixing
Compression
Drying
Milling
Coating
Bioreactors
Fermentation
Viral inactivation
Purification
Polishing chromatograpy
Pharmaceutical water control (PW and UPW)
Cleaning In Place (CIP)
Once healthcare, pharmaceutical, or biotechnological products are produced on a large scale, they need to be distributed to wholesalers, hospitals, and clinics.
Identify temperature excursion during pharmaceutical storage and delivery
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 datasheet particulars recorded at the time of marketing authorization.
Warehouse should be maintained within acceptable temperature limits.
Vehicles and transport refrigeration units must also be equipped with temperature measurement and control systems to maintain the cold chain and prevent product deterioration:
The Pharmacist is in charge to ensure that the shipping conditions guarantee the proper preservation, integrity, and safety of Temperature Sensitive Pharmaceutical Products (TSPP).
Why temperature control is critical for pharmaceutical companies?
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.
Fuji Electric's measurement and control solutions temperature control Fuji Electric solutions improve the quality of your pharmaceutical production, save energy and optimize the operation of your laboratories and industrial equipment.
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