Tuesday March 24, 2020
12:00 Noon – 1:30 pm EDT
Instructor: Richard Forsyth
This Web Seminar will present a comprehensive overview of the product grouping and equipment grouping for cleaning validation (CV) for product contact surfaces of equipment in the pharmaceutical industry. Grouping of products and equipment are necessary in a multi-product facility to develop a comprehensive, understandable, executable and maintainable cleaning validation program.
Product grouping is used to identify the product(s) for CV execution. The selection criteria are critical to justify a defendable product grouping. Although a number of criteria are available, the two recommended criteria to use are: hardest-to-clean product and the product with the lowest cleaning limit.
The hardest-to-clean criterion is based on the physical properties of the formulation components and the proportion of each component in the formulation. In an aqueous or detergent based cleaning medium, hydrophilic, water soluble components are relatively easy to clean, whereas hydrophobic formulation components are more difficult to clean.
The hardest-to-clean formulation can be determined through operator experience, analysis of the physical properties of the formulation components, testing of formulation samples for cleanability or a combination of the three approaches.
Equipment grouping is based on the design, function, geometry, complexity, degree of disassembly and how the equipment is cleaned.
The most basic equipment grouping are those pieces of equipment that are manually cleaned and those that are cleaned by an automated process: either clean-in-place (CIP) or cleaned out-of-place (COP).
Most equipment grouping is defined by the functionality of the equipment unit operation: for example, tablet presses, film coaters, fluid bed driers, tanks, bins or totes. Defining the equipment group parameters is up to the site but the more restrictive the grouping parameters, the more complex the cleaning validation.
Combining the product grouping and the equipment grouping into a coherent matrix for cleaning validation is a strategic exercise that can result either in a well-defined, executed, maintained and defendable CV program, or an overly complex, unsustainable program that will not stand up to regulatory scrutiny.
Teaching objectives for this presentation include:
- Understand regulatory expectations for grouping
- Grouping criteria for products
- Paper-based evaluation of formulations
- Laboratory cleanability of formulations
- Importance of operator experience
- Determination of cleaning limits
- Combining hardest-to-clean and lowest cleaning limit
- Equipment grouping criteria
- Effective design of equipment grouping
- Strategic matrixing of products and equipment
Fee:
- $385 for one person
- $700 2-5 people
- $999 6-10 people
Questions? support@eccwebinars.com
ECC-179