Worst case selection and acceptance criteria

GOOD VALIDATION PRACTICE (cGVP) CLEANING VALIDATION
1

Dear Forum,

We manufacture majorly three types of products by aseptic filling

  1. Sterile Contact Lens Cleaning solutions

  2. Eye and Ear drops

  3. Nasal drops

All the products are for external use and there is no fixed theraupetic daily dosage.

Actives are soluble in water and the amount of actives is less than 0.1%

What should be the cleaning method adopted?( Rinse or Swab)

What is the selection criteria?

What limits can I fix for my CV?

Can you please guide.

Thanks

Narahari

2

First of all select the worst case…which product gives the maximum difficulty for cleaning.

If data is not available for phamacological dose method then use the simplest one i.e limits from 10ppm to 0.1% of an individual unkown or 0.5% of total unknown.

Sampling technique depends upon the design of equipment and method (CIP, COP, manual, etc). Swab sampling doesnot cover the entire surface area while rinse method covers the entire surface area including the points inacessible to swabs. A combination of both is a better choice.