Production of pharmaceuticals is so complex and requires such precision, the last thing pharma manufacturers need is vital equipment that may not be performing to its top specification and full compliance. The tiniest error in temperaturemonitoring could result in batch failures and recalls, costing huge amounts in terms of both replacement and damage to reputation.
It’s vital to control and optimize the freeze-drying process all the while ensuring the highest level of accuracy and data integrity. Typically the last stage of a production process, lyophilization helps to preserve and extend the shelf life of products such as vaccines, diabetes treatments and multiple other pharmaceuticals. This is where validation technology using flexible wireless data logging comes into its own, ensuring compliance across the board.
Maintaining a sterile environment
Data loggers will optimize the freeze-drying process and can be easily flipped to a different product without significant downtime and with as little operator interaction as possible. A sterile environment is crucial – the less human intervention with production and testing, the better.
Products must be qualified and validated. Documenting the entire process is crucial to assuring drug quality and that it is verifiably safe to use. The loss of a batch due to errors in the freeze drying process can carry a heavy price tag, so monitoring the whole process could essentially save pharma companies a lot of waste – and a lot of money.
That’s where major suppliers of validation solutions, like the Ellab Group, can help pharma companies large and small to meet the strict criteria from government bodies. Learning how a product behaves during the process allows you to optimize future runs, while monitoring helps to minimize potential product loss.
Understanding biologically active molecules
There is new innovative technology on the market that offers the ultimate solution for validating the process from pilot to production. However, ‘there is no one size fits all’. As mentioned, different formulations require knowledge of the behaviour and characteristics of complex biologically active molecules during freeze-drying. These should be taken into account when designing a lyophilization cycle.
Ensuring the safety of your freeze-drying process is crucial to the quality and reliability of the final product – there’s no two ways about it. The real question is when should your freeze dryer go through qualification? And additionally, how often and with what equipment?
Jakob Mieritz. Product Manager Lyophilization at the Ellab Group explains: “Validation is typically required annually or when there have been major changes like the introduction of new major equipment. Having the right equipment to do the job can be a science in itself, however it doesn’t have to be with reliable products like LyoPro data loggers and interchangeable sensors. Correct measurement of product and shelf temperature ensures no downtime and the process is kept under perfect control.”
Filling the data gaps
Another major challenge for pharma businesses is vial sizes. It is difficult to measure the product temperature in very small vials. However, there are now wireless data loggers that will cover all vial size ranges used in production and testing from one adaptable base.
Ellab’s Jakob Mieritz, says: “Our systems can cover up to 128 data loggers in one session whatever the vial sizes, transmitting live data as well as having an internal memory. This capacity covers the typical requirement for data points for a complete freeze-drying study.
“It’s quite difficult to measure the product temperature in the very small vials often used. The LyoPro data loggers with thermocouple sensors are flexible and with fittings they will fit any size vial and enable very consistent and accurate positioning. This enables the temperature to be measured at the same position in all sample vials every time. The loggers provide accurate memory functionality with no gaps which is in compliance with FDA.”
As there is an increased focus from government bodies like the FDA on product and process control, it’s ever more important that vital equipment performs to its highest possible efficiency level and is completely reliable year after year. That can be achieved with a supply partner that pharma companies can trust.
As well as its world-renowned validation, monitoring and calibration solutions and services, Ellab also provides class-leading GMP consulting and ancillary products to life science and food manufacturing companies globally.