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The cool code: making sense of regulatory guidelines governing refrigeration disciplines
The coolest day of the year is fast approaching… World Refrigeration Day! Taking place every year on the 26th of June, World Refrigeration Day is designed to raise awareness of the importance of the refrigeration, air conditioning and heat pump sectors.
As temperature and humidity specialists, we’re keen to contribute to this international campaign and facilitate raising awareness of the importance of refrigeration, cold storage, ultra-low temperature control and climatic testing.
This year, the campaign specified its theme as #CoolSkills, intended to honour the human expertise that makes cooling and heating of all environments possible. Spanning multiple disciplines, refrigeration is a key aspect of product safety, stability and consumption, however, it is also only achievable in line with industry-specific standards.
The practical knowledge required to manage temperatures effectively is hard to obtain. One cool skill that is prevalent across our team, in commercial and technical roles, is the ability to navigate the varying regulatory expectations of proper, compliant refrigeration. Mastering the elements is simple with Withnell Sensors.
In this first blog dedicated to the World Refrigeration Day movement, we will explore and detail the stringent standards that govern refrigeration/cold storage/climate control and much more in each sector.
Five key disciplines deploying refrigeration daily
The commercial and industrial sectors are continuously evolving to ensure the highest standards of safety, one such factor that has always remained a crucial aspect of product safety and consumption though, is the refrigeration process.
Originally brought to life by ‘the father of refrigeration’ Jacob Perkins was granted the first patent for vapour compression refrigeration cycles in 1835. His predecessors’ innovations and plans had input into the first model he created, along with many further creators following on to lead to the modern-day fridge.
As refrigeration entered the commercial and industrial landscapes, in the 19th century, there wasn’t much change to its basic principles. It hasn’t been until the last decade that we’ve seen brands like FARRAR, Kambic and Haier unlock energy-efficient technology, smart interfaces, sustainable materials, cold chain logistics and much more.
Now, whether it’s drug development companies refrigerating biological samples ahead of clinical trials, or your local restaurant operating a walk-in chamber with ambient to low temperatures for raw ingredients, cold storage has and will remain essential.
Becoming increasingly complex has made refrigeration a suitable stage in various product processing, manufacturing and distribution lines. Sectors such as the below now couldn’t function without refrigeration:
- Food
- Healthcare
- Pharmaceutical
- Transport
- Commercial refrigeration
Commercial vs Industrial refrigeration
Commercial refrigeration is the umbrella term used for any kind of cold storage deployed across customer-facing sectors, including hospitality, supermarkets etc. Industrial refrigeration is designed for large-scale operations, like processing plants, manufacturing and production and warehouse storage. This is where we can divide the more common industrial applications into food, healthcare, pharmaceutical and transportation:
Your guide to meeting refrigeration regulatory compliance
Let’s start with food
- The Food Safety Regulations 1995 mandate a storage temperature of 8C or below
- The Food Standards Agency (FSA) advises regular monitoring of fridge temperatures
- The EU refrigeration and cold storage laws and Regulation EC cover temperature control requirements and proper management of appropriate temperatures
- Appropriate temperatures are typically 0 – 5C in cold rooms and below -18C for frozen goods
Moving onto crucial healthcare
- The Health and Safety Executive (HSE) governs workplace temperature regulations for healthcare worked
- EU GDP guidelines strictly enforce proper temperature monitoring for storage and transport
- EN 12830 standards will also regulate temperature recording devices
- In the US, the FDA requires pharmaceutical storage to meet USP Good storage and distribution practices
- In the UK and EU, the MHRA and EMA publish guidance on Good manufacturing practices (GMP) which strictly requires 2C – 8C for refrigerated pharmaceutical materials
- ISO 20387:2018 governs the general requirements for biobanking
- The MHRA and FDA guidelines governs medication storage in pharmacies
- Overseeing third party healthcare service providers is the Care Quality Commission (CQC) which mandates environmental compliance
And what about the pharmaceuticals
- Eudralex Volume 4 established temperature control for manufacturing and storage facilities which can transcend pharma applications
- EN 12830 standards are what govern the monitoring and recording devices of temperature in pharmaceutical refrigeration
- ISO 14644 regulates cleanroom environments specifically which are crucial for manufacturing and finished product testing
- The FDA provides specific guidance on the management temperature properly during manufacturing
How all the above get transported
- The MHRA mandates Good Distribution Practice (GDP) compliance for medicine materials which must be kept at 2C – 8C during transit
- Providing guidelines for cold chain logistics is the World Health Organisation (WHO) which governs healthcare transport, specifically vaccines & drugs
- IATA sets the standards for air cargo that must be temperature controlled
- The FSA (food standards agency) regulates food transportation
- Temperature monitoring is unnegotiable for any and all cold chain transport
- The Environmental Protection Agency (EPA) is an additional body that specifies the responsible use of refrigeration use in cold chain systems
Additional regulatory compliance expectations and best practices
Calibration requirements
Temperature calibrations are expected to be performed at least annually and to UKAS-accredited standards in order to comply with MHRA, FDA and EMA. The same calibration service/performance needs to be compliant with ISO 17025 to ensure accurate results and reliable performance.
Expected from food, pharmaceutical, healthcare and transport sectors.
Servicing & maintenance requirements
Preventative maintenance and leak detection are two crucial aspects of servicing that are mandated since they have a significant impact on the environment and carbon footprints.
Mapping requirements
The MHRA, GDP, FDA, WHO and ISPE all expect storage validation to be completed by conducting a complaint temperature mapping protocol. UKAS accredited temperature mapping that conforms with ISP 17025 is paramount to meeting regulatory expectations.
This is especially true for biobanks, hospitals, pharmaceutical warehouses and food storage.
Our teams #coolskills are undisputed
We are well versed in working alongside a variety of different customers and clients. Not only do we focus on ensuring your business can comply with regulatory expectations, but we aim to provide long term support and routine maintenance in order to help you upkeep accreditations, certifications and high-quality operations.
Refrigeration isn’t a simple process, instead, it requires time and dedication to ensuring that you are reliably and traceably accountable for public and product safety. If you’re looking to test our #coolskills and need to navigate the various regulatory expectations prevalent in your sector, get in touch with us today!
To celebrate this World Refrigeration Day, we'd like to give our customers a plushie Chilly or Billy! Our #cool experts are well-versed in crisis aversion and can help protect your refrigeration processes to uphold regulatory compliance.
Want to secure your plushie Chilly or Billy? Get in touch here!
