Biomedical Freezers 101
Finished products in biopharma: the freeze-thaw cycle
As we all know, the journey from lab to shelf is a notoriously long and rigorous one. After drug identification, conceptualization and development, manufacturers are left to complete their next task, and it’s not an easy one.
Although arduous, drug testing is the most vital part of the drug development process, as of course, no manufacturer would want to commercialize a product that’s quality, structural integrity, and behavioral aspects are largely unknown, right?
To expedite the process, manufacturers rely on an indispensable and specialized range of tools, with one of the most important being the climatic chamber. Fundamental in determining the quality of a pharmaceutical product, climatic chambers pilot a ‘survival of the fittest’ assessment, using its simulated environment tests.
A manufacturer’s desired requirements and commercial goals can be made easier through the acquisition of a bespoke, purpose-built, chamber solution. Here, a tailored chamber can meet project specifications with ease whilst facilitating the drug development journey.
Climatic chambers for pharmaceuticals
Drug qualifications ensure that a product meets specified testing conditions and environmental manipulations. Used with both APIs and finished products, the climate chamber is an essential tool in the evaluation of drug quality, reliability, stability and overall performance.
For stability assessments, manufacturers need precise temperature, humidity and light-controlled chambers to deliver desired conditions. This process can then determine the product’s shelf life and storage requirements for the future. A climatic or environmental test chamber which is purpose-built is becoming an increasingly preferred choice for simulating particular conditions such as extreme climate changes, ageing and stress testing.
Identifiable chamber requirements
It goes without saying, compliance with GMP and ICH standards is of unnegotiable importance when determining a climatic chamber for pharmaceutical use. Design must be reflective of a robust and corrosion-resistant nature, easy to clean, and simple to manage.
Customisable commodities include max capacity, humidity range, wattage, lighting and of course, budget. That being said, there are many more design considerations that can be captured with a bespoke solution:
Integral specifications
Vital specifications which must be accounted for include over and under-temperature and humidity protection, an alarm system with blower and compression trips, a control panel for the precision measurement setting, calibratable internal sensors and a detailed diagnostic system, to name a few.
Arguably one of the most fundamental attributes is, of course, the range of temperature and humidity the chamber can provide. Offering a varying range of customizable solutions, Withnell Sensors offer a customizable chamber range of -75°C to +180°C, ensuring all temperature requirements are met with their standard, low, and ultra-low solutions.
All climate zones are easily simulated with our comprehensive climatic chamber product range, accommodating all needs from temperature and humidity testing, simulation and exposure to weather, temperature cycles, ageing and stress testing.
We have been supplying chambers and bespoke solutions for over 10 years, so we’re highly knowledgeable in the specifications needed to maximize your chamber through a range of additional and customizable features. These can range from a glass door, USB port for data download, chamber LED illumination, and more.
Automation, programming and data collection
Climatic chambers are also programmable to conduct automated environmental conditions respective of the desired output. The program can reflect this through automated temperature control and simulation processes, including functions such as jump, stop, start, soak and more.
FDA-compliant data logging is also essential in providing end-to-end documentation for all relevant parameters of temperature and humidity. Incorporated within your custom-built solution, Withnell Sensors can integrate additional software for direct communication with the chamber controller, this includes PC control and in-depth data history.
Adding our data logging systems provides compliant monitoring depending on your varying needs, which can again be tailored to meet specific requirements!
Achieving your commercial goals with custom-built chamber solutions
Not only can custom chambers be configured to embody internal specification requirements, but particular custom solutions can also be built with commercial business goals in mind too:
Process optimization
Often forgotten as a result of habituated processes, optimised workflows can easily be achieved through the evaluation and improvement of your current climatic set-up. Manufacturers can reflect on current practices prior to briefing their custom specifications:
- Are we regularly outsourcing testing processes?
- Are we wasting valuable time on freezing and thawing?
- Are our storage capabilities too limited?
A custom solution therefore can allow the pharmaceutical sector to strategically classify an optimal solution based on specific business needs. For example, choosing a unit of scalable quality, or prioritizing a solution with unsurpassed heating and cooling ability. A unit such as the Kambic ultra-fast climatic chamber would be the perfect solution, boasting world-class metrology and a heating and cooling rate of 10°C per minute.
Achieving sustainability goals through reduced energy consumption
Did you know that laboratories typically consume around 5 to 10 times more energy per square foot than office buildings? Energy-intensive equipment has meant labs are now opting to integrate more sustainable, carbon-reducing methods within their current processes.
Climatic chambers and their energy efficiency is highly dependent on their unique design, manufacture and control, which can be manipulated to best benefit your sustainability goals. Lower energy-consuming chambers are available that don’t compromise on high precision accuracy and reliability, using our ALS product range as an example. These units utilize an R290 refrigerant, a highly desirable, eco-friendly feature given its low global warming potential (GWP) rating of 3.
Our commitment to providing the right chamber solution
At Withnell Sensors, we utilize our exclusive partnerships, extensive product ranges and engineering expertise to provide the pharmaceutical industry with the exact custom climatic chamber solution.
Ranging in size, function, performance and more, we work with you to design and manufacture a bespoke solution that’s reflective of your business needs and commercial goals. Not only this, but as we form long-standing partnerships with our clients, you can benefit from our full installation service, continuous support, emergency recovery and aftersales care.
Looking for a custom chamber solution for your pharmaceutical needs? Get in touch with a member of our team today.
