Standard Guide for Validating Cleaning Processes Used During the Manufacture of Medical Devices
ASTM E3106 applies to the lifecycle approach to cleaning process validation, which includes the development, qualification, and verification of cleaning processes. It is applicable to pharmaceuticals—including active pharmaceutical ingredients (APIs); dosage forms; and over-the-counter, veterinary, biologics, and clinical supplies—as well as to other health, cosmetics, and consumer products. The ASTM E3106 standard provides considerations for validating cleaning processes for medical devices during initial fabrication and assembly, prior to initial use. Validated cleaning processes are important for achieving consistency in both function and biocompatibility. The considerations for these include, but are not limited to, validation approach, equipment design, procedure and documentation, analytical methods, sampling, development of limits, and other issues.
Both ASTM E3106 and ASTM F3127 prescribe using risk management for cleaning processes and to assess the impact of contaminants (including cleaning agents) on the next product. They describe the identification of contaminants (active ingredients, drug substances, degradants, excipients, other components of the manufacturing process, cleaning agents, etc.), setting science- and risk-based residue limits (How clean is clean?), and a set of clearly defined sampling methods and techniques.
The ValGenesis VLMS is equipped with modules to manage risk assessment, risk control, and risk review as lifecycle processes, as well as impact assessment and manage validation deliverables in a 100% paperless solution to manage the entire cleaning validation lifecycle process. The functions provided by these modules allow for a level of cleaning validation project planning that includes necessary risk evaluation and impact assessment as required by ASTM E3106 and ASTM F3127. This means our clients can effectively plan/manage cleaning validation projects while simultaneously tracking all factors for individual cleaning steps. All of our solution’s tools and features combine to make a robust system that allows for our clients and users to readily meet and comply with all ASTM E3106 and ASTM F3127 standards.