In the United States, for instance, 21 CFR 211.65 states, “Equipment 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, identity, strength, quality, or purity of the drug product beyond the official or other established requirements.” 1 TWO WORDS, TWO PERSPECTIVES In fact, regulations on single-use-technologies (SUT) do not exist yet, although the basis for such regulation exists. This paper presents risk-based approaches for evaluating E&L from SUS. Our goal is to propose consensus E&L guidelines for all industry stakeholders, using risk management and quality by design (QBD) approaches, and supporting single-use development and market promotion. The objective of this article is to clarify and highlight the importance of distinguishing between extractables and leachables when evaluating SUS. Bridge the gaps between end user expectations and supplier capabilities by defining the limit of responsibilities and the scope of operations for both.Prevent misinterpretation of regulatory requirements for E&L as they are used on finished product containers by applying them to process contact materials as well.The pharmaceutical industry’s challenges are: This makes it difficult for end users to select suitable single-use components. Lack of standardization, however, leads to incomplete E&L studies that do not cover the conditions encountered throughout the process train. With the integration of single-use systems (SUS)* into downstream processing and thus closer to the final drug product, considerations of extractables and leachables (E&L) have become a critical issue within the industry.
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