Biopharma Group supply freeze dryers designed to put data traceability and scalability at the forefront of development.
The company’s range features the Line of Sight suite of lyo/freeze drying technologies, which encompasses process analytical technologies (PAT) designed to help achieve drug commercialisation objectives – whether scale-up to GMP production or scale-down to R&D.
Data traceability is an essential aspect of the freeze-drying process. Within R&D, it helps to establish a baseline for process parameters and quality attributes, including information on the starting materials, processing conditions, and final product characteristics. By collecting such data, researchers can identify critical process parameters that affect product quality – such as drying time, temperature, and pressure – and optimise the process for maximum yield and quality. It also enables scientists to know from the outset of an R&D programme whether a technology can be successfully applied on a commercial scale.
As the process moves from R&D to GMP production, strict guidelines must be followed to ensure any product meets regulatory requirements. Data traceability provides a record of all process steps and quality control measures, which can be reviewed and audited by regulatory agencies.
Equally important to the gathering of data is its integrity at all stages. Information gathered must be accurate, complete, and reliable to ensure that the product meets quality standards. This can be achieved through electronic records and signatures, which are compliant with regulatory requirements. By using the correct tools, equipment and protocols, data traceability can be achieved and maintained throughout the product lifecycle.
To discuss your freeze dryer requirements, please contact Biopharma Group’s specialists.
