Preventative Maintenance for Pharmaceutical Refrigeration Systems

Maintaining strict temperature control is critical in the pharmaceutical industry. The Medicines and Healthcare products Regulatory Agency (MHRA) requires medicinal products to be stored within strict temperature ranges. For example, many vaccines and drugs must be kept between 2°C and 8°C at all times. Any excursion outside the approved range can render an entire batch unusable – a loss that can cost an organisation millions in wasted product and lost revenue.

In the UK, cold chain failures have led to significant financial losses and compromised vaccine efficacy. In 2022 alone, the NHS reported £5.7 million in vaccine wastage due to cold chain breaches, with half of these incidents resulting from preventable issues like equipment malfunctions and power outages. Furthermore, the UK Health Security Agency reported that 16% of vaccine wastage was due to avoidable cold chain failures, such as fridge malfunctions and improper storage practices. In fact, healthcare facilities collectively lose an estimated $20 million every year due to cold-chain failures, and around 35% of vaccines are discarded because of improper refrigeration americanbiotechsupply.com. Preventative maintenance directly combats these failures by ensuring equipment reliability and early issue detection.

Regulatory compliance is another major driver. MHRA guidelines (as well as GDP and GMP standards) expect that refrigeration equipment is properly maintained and calibrated to safeguard product quality. Likewise, F-Gas regulations mandate regular leak checks and refrigerant management for refrigeration systems. Non-compliance can lead to hefty fines and even legal action, not to mention environmental harm. A robust maintenance program addresses these concerns by incorporating scheduled leak detection and thorough record-keeping as part of every service visit.

Perhaps most importantly, proactive maintenance prevents the nightmare scenario of a sudden breakdown. A failed compressor or a refrigerant leak in a walk-in freezer can cause temperatures to rise rapidly. For pharmaceutical firms, even a minor temperature deviation can mean quarantining or discarding stock – think of high-value biologics, vaccines, or cell cultures that might be destroyed in hours if the cold chain falters. By investing in regular maintenance, companies avoid the risk of such catastrophic losses and ensure continuous MHRA compliance (since no excursions means no reportable deviations).

In the following sections, we outline a step-by-step guide to preventative maintenance for walk-in pharmaceutical fridges and freezers. These steps are derived from Industrial Cooling Equipment (ICE) Ltd’s proven maintenance process – the same process that has kept some client coldrooms running without a single deviation for over 20 years. By adhering to these steps, you can significantly extend your equipment’s life, maintain regulatory compliance, and protect the integrity of your valuable products.

Preventative maintenance isn’t just a theoretical best practice – it delivers real, measurable results. Anonymously, we can share that one of ICE’s pharmaceutical clients operates a walk-in coldroom that was installed in 2005 and has been under our maintenance program ever since. In the 20 years that followed, this critical cold store has never deviated outside its required 2–8°C range. Despite the system aging, regular preventive upkeep (cleanings, timely parts replacements, calibration, etc.) has ensured continuous compliance. This kind of track record is not luck; it’s the result of rigorous maintenance and prompt attention to any issues.

There are plenty of other success stories just like this. In multiple instances, our maintenance visits have caught issues early – from condenser fan motors about to fail, to door gaskets starting to crack – and addressed them before any temperature excursions occurred. In one case, a routine maintenance check uncovered that a backup battery for the alarm system had died; a simple replacement during maintenance meant that when a power outage hit a month later, the coldroom’s alarm still functioned and the client was able to respond in time. Without that foresight, the outcome could have been very different.
The takeaway is that preventative maintenance pays for itself many times over. It’s not just avoiding downtime and product loss (as important as those are), but also maintaining the trust of patients and partners that the medicines and vaccines will always be stored correctly. An unbroken cold chain protects patients’ well-being and a company’s reputation.

In the high-stakes world of pharmaceutical storage, preventative maintenance is not an expense, but an investment in quality assurance, compliance, and risk management. A step-by-step maintenance regimen – from leak detection and coil cleaning to control verification and data review – ensures that your walk-in fridges and freezers continue to perform flawlessly when it matters most. The cost of these regular check-ups is trivial compared to the potential losses from a single catastrophic failure or regulatory breach.

By following the guide above, you can develop a maintenance plan that keeps your equipment in top shape. Even better, consider partnering with specialists like ICE who can bring industry-specific expertise and an added layer of service to your program. Our real-world track record shows that with the right maintenance approach, it’s possible to achieve zero unplanned downtime and zero temperature excursions year after year.

Your pharmaceutical products and patients depend on the cold chain being unbroken. With diligent preventative maintenance – and a reliable service partner to support you – you can confidently assure that your cold storage will hold its temperature, protect your stock, and meet every regulatory standard. In short, staying cool and compliant is a sure path to peace of mind and operational success.
Remember: when the products you store are worth millions and lives may ultimately depend on them, there’s no such thing as too much care for your refrigeration systems. Preventative maintenance is the key to safeguarding that value, one step at a time.