Process Validation & Cleaning Validation

Dear All,

Is it required to perform the different cycles of Cleaning and process validation for same product in a different capacities of equipment, like we are having two fermentors with different design and process parameters but batch size and process is same.Please suggest me on this and is there any guidelines saying that these requirements:).



FDA states that it expects written validation protocols prepared in advance,addressing issues such as sampling and analytical methods for residues, including the sensitivity of these methods. Sampling and analytical methods are at the heart of the validity of any cleaningvalidation protocol, so one can expect special attention to these issues in any inspection.

The FDA also states that “ideally, a piece of equipment or system will have one process for cleaning.” However, the context clearly recognizes that this will depend on the individual situation. This does not preclude having different cleaning processes on the same piece of equipment for different manufactured products.

FDA also states that Individual equipments even when used from same product must have a Validated cleaning method.For Equipment to Eqquitment it differes as size or area increases.

“In your case you might have scaled up your fermentation by 3fold or 10 fold or 100 fold.As far as regulators are concerned it is a new piece of equipment even though the product might be similar.You have to have a Validated Cleaning procedure along with your scale-up documentation”.


С 1 января 2011 года в Рф подорожают сильные спиртные. Как извещает Интерфакс, указом Росалкогольрегулирования малая розничная стоимость на водку устанавливается в размере 98 рублей за 0,5 литра.
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I also do agree with Mr. Durga, You should go with the validation for both fermentors.

You should use a risk analysis then a matrix of the equipment and their respective surface areas in determining the ‘maximum safe concentration (MSC was MACO)’. Your analytical method must evolve. In developing the method (use in a pharmasuite) you must 1st select the instrumentation, perform specificity, and linearity. It is not until you know the the surfaces areas of the full manufacturing process train do you know whether the LOQ meets the MSC minimum requirement.