Temperature and quality: the critical connection for pharmaceutical production

Compliance with GxP quality guidelines

The production of pharmaceuticals is one of the most tightly regulated of all the manufacturing processes. Every aspect of production is carefully controlled, with each of the key factors that could affect product quality or efficacy being monitored in real-time to ensure full traceability and compliance with industry regulations, industry-wide good practice (GxP) guidelines and quality procedures that are specific to each organisation or process.

Ideally, the tight controls imposed within the boundaries of each manufacturing site should also extend through the cold chain – the logistics process that delivers drugs to the point of use. The nature of distribution and storage, however, inevitably introduces a number of variables that can make it difficult to guarantee that pharmaceutical products are maintained in perfect condition once they have left the factory gate. Problems can, for example, arise due to the failure of refrigeration systems, delays to transport services, errors in handling or disruption caused by extreme weather events.

In this context, precise temperature control is the most important factor to ensure that product quality is maintained at all times – both during manufacture and, in particular, through the length of the cold chain.

Degradation, risk and waste

Most modern drugs need to be stored and transported under carefully controlled conditions, to prevent degradation due to temperature-induced changes in drug chemistry. Degradation can lead to the formation of impurities that may affect the safety or efficacy of the product, potentially putting patients’ lives at risk. It may also affect the physical characteristics of the drug, changing its colour, taste or smell. In each case, products can rarely be used or recycled, leading to a loss of revenue and possible reputation damage.

In 2019, the life sciences company IQVIA estimated that the biopharmaceutical sector lost around $35 billion every year from failures in temperature-controlled logistics (quoted in the 2019 Biopharma cold chain logistics survey). This results in major volumes of products to be destroyed.

This finding is supported by the World Health Organisation, which reports that around a third of all vaccines worldwide are wasted due to spoilage, largely down to temperature excursions and incorrect storage. Additionally, a recent survey by Accenture highlighted that half of pharmaceutical executives thought that ‘security and temperature reporting had the greatest impact in managing supply chain performance’.

Although improvements have been made in recent years, especially with the development of a new generation of cold chain packaging materials, the scale of the challenge is still significant. Clearly, more needs to be done, which is where the importance of accurate temperature management and control becomes a key consideration.

Technology, experience and knowledge

In common with many critical process parameters, changes in temperature may appear simple to detect and adjust. In reality, the science of temperature management and control requires expert knowledge if pharmaceutical products are to be produced, stored and distributed safely and profitably.

This is where working with a leading industry specialist is vital. At Rotronic, we have many years of experience in applications across the pharmaceutical manufacturing and cold chain sectors. Just as importantly, we have one of widest range of temperature products and technologies, enabling us to provide solutions that match your exact needs, without compromise.

The product range includes modular, scalable instruments, plus our RMS advanced environmental monitoring system, which has been designed specifically to meet the demands of highly regulated pharmaceutical applications; these include FDA 21 Part 11, EU Annex 11 and GxP quality guidelines (Good Laboratory Practice, Good Storage Practice, Good Manufacturing Practice and Good Distribution Practice).

Calibration and data integrity

One of the key aspects of effective and reliable temperature management is data integrity – the ability to be able to trust that the data you’re capturing is consistently accurate.

In part, this is determined by the quality of the equipment you choose; in part, by the design and installation of the system, and by the experience of your equipment providers; and, most importantly, by regular maintenance and, where appropriate, sensor calibration.

These points are especially important when developing and allocating the temperature stability budget. This governs every aspect of the production and distribution operation, with temperature stability studies being used as the basis of a management system that underpins the safety, quality and efficacy of each pharmaceutical product.

Temperature monitoring applications

As experts in the science of temperature monitoring we have extensive experience across many different pharmaceutical applications. These include:

• Cryogenic monitoring
• Ultra-low temperatures monitoring (including with dry ice)
• Fridge/freezer monitoring
• Stability testing.
• Incubators monitoring.
• Storage monitoring.
• Warehouse monitoring.
• Distribution centre monitoring.
• Cleanroom monitoring.
• Transport monitoring (trucks, airplanes, containers, trains…)
• Healthcare sales point monitoring (pharmacies, vets, dentists, hospitals…)
• Blood bank monitoring
• Tissue bank monitoring
• Biobank monitoring
• Calibration laboratory monitoring

Product Range

Our Rotronic range of temperature monitoring instruments has been designed for use throughout the pharmaceutical and associated sectors.

Advanced temperature monitoring to meet GxP guidelines

The Rotronic Monitoring System (RMS) is a world-class environmental monitoring system, which has been developed specifically for regulated applications. Our latest RMS software and hardware is designed for stricter FDA 21 CFR Part 11 and EU Annex 11 regulations and will enable you to comply with all GxP quality guidelines.

The GxP guidelines

Our solutions:

• Temperature monitoring in action - Learn how pharmacies are using our latest RMS systems to ensure product and data integrity.
• Learn more about our innovative Rotronic Monitoring System (RMS)

Surveys and Reports:

• Biopharma cold chain logistics survey 2019
• Accenture report on the pharmaceutical supply chain

WHO estimate of vaccine waste:

• Optimized cold chains saving billion covid vaccines
• Reasons for wasted vaccines