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Cleaning Validation

Good cleaning and disinfecting – cleaning – is essential in the preparation of (bio)pharmaceutical products. The inspectors strictly verify the correct cleaning and ensure that organisations take proper measures to prevent cross-contamination and infection of these products. Good cleaning programmes are therefore essential. Progress-PME helps companies set up efficient and cost-effective cleaning programmes for both equipment and the environment.

Cleaning programmes
(Bio)pharmaceutical cleaning processes vary from the daily GMP facilities and washing machine cleaning to process cleaning, often through Cleaning-In-Place (CIP) or Sterilisation-In-Place (SIP). In this field, Progress-PME has already successfully completed various projects. An example is the development of optimal washing programmes based on worst-case contamination models. For the detection of residual material, we use validated analytical methods. Several customers have started using washing machines for cleaning small production equipment and CIP installations for fermenters and mixing tanks and are satisfied with the results. 

 

How can Progress-PME help you with this?
Progress-PME can develop and implement a totally new GMP cleaning routine. An important success factor in these projects is to incorporate the limiting conditions required for efficient and cost-effective cleaning in the design phase of a new facility. These might include water taps and discharge outlets, storage room and optimal cleaning of the rooms. After a successful pilot, a brand new GMP cleaning method can be introduced based on microfiber cloths, resulting in much less moisture introduction in the cleanrooms. Progress-PME can extensively train the cleaning staff during the start-up phase in the new working methods and the do's and don'ts in the clean rooms. At the start of production, they can therefore immediately implement the cleaning work in compliance with GMP.

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