Implementation Strategies for Validating Alternative Methods

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Celsis for Sterility

Most QC labs agree that evaluating and selecting an alternative method is a complex and sometimes confusing process, as it must be suitable with their current methods, samples, and improvement goals. However, many of these labs, despite knowing how important the subsequent implementation and validation project will be, fail to consider ease of implementation as a criteria in their selection process.

The availability, in addition to ease, of implementation strategies and statistical methods for a specific alternative method or technology should be considered in a buying process. After all, the real work begins after the box arrives. The lab must then create validation documents, train personnel, and perform tests. However, rather than feel overwhelmed and as though a degree in mathematics is necessary for success, labs should look to their industry colleagues, as well as cross-industries, as a resource for proven strategies.

Industry conferences, such as those organized by EDQM in Europe or PDA in North America, are events where the sharing of these ideas can become a wellspring of knowledge among peers. Most recently, Stefan Gartner of Labor L+S AG presented at EDQM Europe on the statistical approach they used for implementing a rapid sterility test. Labor L+S AG, a German contract testing laboratory, is one of the largest suppliers of sterility testing services in Europe. As a service-based laboratory, the perspective they have on implementing a rapid sterility test is based on validating a wide variety of sample types in an efficient manner based on customer needs.

To learn more about how Labor L+S AG successfully validated its 7-day rapid sterility test for membrane filtration, watch a webinar replay with their Head of Sterility Testing.