Dear colleagues,
I am looking for some guidelines on how to implement glassware cleaning validation in an analytical laboratory. Any kind of information will be highly appreciated.
Thanks in advance,
Nur
Dear Sir. Concerning your issue about the guidelines on how to implement glassware cleaning validation in an analytical laboratory . Validationis vitalto pharmaceutical processes because it assuresquality, consistency, and keeps your operationscompliant with GMPs. The FDA provides guidance for proper cleaning validation, howeverchallengesoccur because interpretation of those procedures vary between facilities. To better understand the validation and qualification process, we turned to Miele’s James Espiritu. In his 12 years with Miele, Espiritu’s expertise has included glassware washer use in pharmaceutical, wastewater treatment, forensics, and research facilities. In this Q&A, he covers nine fundamentalsto keep in mindfor labwasher validation—including important validation guidelines to follow, issues that may occur, and the benefits you’ll experience when you properly validate your labwashers. Labwasher cleaning validation has two components: a) the validation of the cleaning process itself and b) the qualification of the labwasher equipment that carries out the process. Validation, as defined originally by the FDA in 1987, is “establishing documented evidence which provides a high degree of assurance that a specific process or analytical method will consistently produce a product meeting its pre-determined specifications and quality attributes.” In the contextof laboratory glassware washers, labwasher cleaning validation is the “documented evidence proving that a cleaning process will consistently result in laboratory glassware that are washed to an acceptable predetermined level of cleanliness.” Qualificationmeans “assuring, through inspection, testing and documentation that: a) the correct equipment has been installed, b) the equipment has been installed properly, and c) the equipment performs according to pre-established, written specifications. Residue identification in a pharmaceutical manufacturing environment involves; the cleaner, primary ingredients, excipients, decomposition products, and preservatives. This document is intended to help with the cleaner residue identification. Residue detection method selection for cleaners can involve specific methods for specific cleaner ingredients such as; high performance liquid chromatography (HPLC), ion selective electrodes, flame photometry, derivative UV spectroscopy, enzymatic detection and titration, or it can involve non-specific methods that detect the presence of a blend of ingredients such as: total organic carbon, pH, and conductivity. The FDA prefers specific methods, but will accept non-specific methods with adequate rationales for their use. For investigations of failures or action levels, a specific method is usually preferable. I think the following below links and the attached file may help you in your analysis:
https://www.scholarsresearchlibrary.com/articles/analytical-methods-for-cleaning-validation.pdf
https://zdoc.site/basics-of-labwasher-cleaning-validation.html
https://community.learnaboutgmp.com/t/glassware-cleaning-validation/223
Thanks
There are none! Cleaning validation guidelines refer to the production process only not the laboratory. As long as you do not samples back into the production process they are not relevant.
However, you must prove your laboratory dishwashers perform adequately and to not interfere in your lab analysis. TOC analysis is usually used.
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