BPOG analysis laboratory
Would you like to carry out a BPOG analysis of the plastic materials used in your pharmaceutical products?
What is the BioPhorum Operation Group (BPOG)?
The BioPhorum Operations Group (BPOG) has developed important guidelines for the assessment of extractables and leachables (E&L) associated with the use of single-use components in biopharmaceutical manufacturing. These guidelines include the “Best Practice Guide for Leachate Risk Assessment” and the “Standardised Extractibles Testing Protocol”,
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 guidelines published by the BPOG are intended to provide guidelines for the characterization of plastic materials and systems used in the production, processing and packaging of pharmaceutical products.
What analyses does BPOG recommend?
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.
Analytical Threshold Analysis (AET)
The AET is an important value in the assessment of extractables and leachables, representing the minimum concentration at which a compound must be quantified to meet safety requirements. Analytical methods are designed to meet or exceed this sensitivity.
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.
FILAB can also help you analyse your plastic materials in accordance with USP 665.
Our technical resources for analysis in accordance with BPOG guidelines
To provide you with reliable analyses and interpretations, FILAB has a complete range of analytical equipment, adapted to the analysis. These include
