They aim to guarantee the safety and efficacy of medicinal products through the appropriate qualification of materials in contact with them.
What is the purpose of the BPOG guidelines?
Single-use technologies and components, such as bags, tubes, valves and other bioprocessing equipment, are playing an increasing role in the industry due to their efficiency and benefits. However, it is crucial to demonstrate their regulatory compliance and compatibility with production processes to ensure the safety and efficacy of the final biologics. Extractables testing is therefore an essential part of the design of such equipment.
The analyses recommended by the BioPhorum Operations Group (BPOG) for the assessment of extractables and leachables in the context of the use of single-use plastic (SUS) systems in biopharmaceutical manufacturing focus on a comprehensive risk-based approach. The main techniques and methodologies recommended by BPOG are as follows:
Analysis of Volatile and Non-Volatile Compounds
BPOG recommends the use of various analytical techniques to detect and quantify volatile, semi-volatile, non-volatile and inorganic compounds.
The FILAB laboratory can help you analyse your products in accordance with BPOG
Why choose FILAB for BPOG analysis?
The FILAB laboratory has the experience and specific analytical equipment to support pharmaceutical companies in the analysis of plastic materials used in the manufacture of pharmaceutical and biopharmaceutical products in accordance with the BPOG, through tailor-made support.
The support of an expert plastics analysis laboratory such as FILAB enables you to better understand the strategic challenges and changes in the pharmaceutical sector.