The pharmaceutical industry is very familiar with the use of sanitary systems in production with their predominant use of stainless steel and glass. These materials are being replaced for convenience and efficiency reasons by single use polymer based systems. The replacement plastics can be a source of contamination and assessment of this is essential.
Single use technology is more efficient for small batch production, it removes cleaning requirements and the equipment is delivered sterile. This allows flexibility and more efficient line clearance between production of different formulations. It is the method of choice for biopharmaceuticals.
Extractables and leachables is stated as the most significant negative factor by the many users1. However assessment of leachables in a drug product analysis is also a requirement according to FDA (21 CFR 211.65), and EMEA (EMEA/CVMP/205/04). It is also stated in 21 CFR 211.65 (a) that “Equipment used in the manufacture of drug product shall be constructed so that surfaces that contact components, in-process materials, or drug products shall not be reactive, additive, or absorptive so as to alter the safety, strength, quality, or purity of the drug product beyond the official or other established requirements.”
MET’s support service is designed to make the analysis of migrating materials as simple as possible for you. We can examine and understand your process and design specific analytical programs to investigate only the relevant environments for impurities. We will take the formulation into account and the steps required to produce it. In addition, consideration is given to non-active molecular variants of a biologic. BPOG protocols can also be applied.
These analytical services follow ICH Q6B and EMA guidelines. Validation of test methods and GMP quality control is available for production lot release.