How often to wash the Blender

GOOD VALIDATION PRACTICE (cGVP) CLEANING VALIDATION
1

Hello,

please help me for this confusion matter, actually is it necessary to wash V-blender after production of each batch, assumed that we use V-blender for the same batch but after each batch we only clean the Blender and not washing with water and detergent, is that okay with GMP or we need to wash before making the new batch of the same product !!??

thank you all.

2

When you have same product manufacture on the shopfloor, you need not wash the blender. You must have a fixed schedule for it based on cleaning validation. You can wash after every 3 batches once. Its because of the same product.

In certain casses where if you find a particular batch OOS during manufacturing and for the next batch you need to wash even though schedules say NO. The reason is that some contaminents or overages or unwanted materials do not pass to new batch. Its basically a risk reduction strategy.

If you change any component in the blender or any gasket is worn out and you replace with new gasket or if you see the blender is too much soiled inside–its advisable to clean it even though schedules say you can use for X number of batches.

Both Q.A and Production Executives must keep in mind what is best for production systems. They have to come to a proper conclusion regarding this. A tussel is found on these issues all the time and Production folks think Q.A is policing and Q.A wants to execute their authority.These issues should be taken on a compliance and risk basis.

3

Hi,

Thank you , please clearify this. is there any guideline which is mentioned for the same product after how many times to wash the equipments (like V-blender) or we can use the Blender for many times for the same product and batch ? or we must wash it afetr a certain of use or we must validate that during the cleaning validation study?

I await for your knidly response.

thank you,

4
  1. Validation can be done by taking swabs after each product run.
  2. You should have a proof that the existing trace materials represent true compounds or compound present in the earlier batch and batch that you are supposed to run.
    3.Find out there are no degrading materials formed after batch is performed. Some compounds may have oxidative changes and temerature changes. You must prove that the trace compounds are representative of the batch but not new compounds for degradation.
    4.Normally after 3 runs the blender looks soiled. This is very common. In such casses it must be cleaned. In this case a constant interaction with QA is required and you can take photos from batch to batch. You must compare the photos.

These are all scientific strategies or methods which proves that the bender can be used to certain point of time.You must combine all these methods and come to a rational conclusion.

As far as the guideline is concerned it all depends up on the API you are using and senstivity.Guidelines always do give a guidance. The proof of them must be provided with a strong scientific rationale when auditor comes and inspects your facitilities, Practices and procedures.