The Elsmar Cove Wiki More Free Files The Elsmar Cove Forums Discussion Thread Index Post Attachments Listing Failure Modes Services and Solutions to Problems Elsmar cove Forums Main Page Elsmar Cove Home Page
Google
  Web Elsmar.com
*Please be aware that SOME RECENT forum threads may not yet be indexed by Google.

View Full Version : Swab, Rinse and Visual Cleaning Validation


raghu_1968
12th April 2009, 12:55 PM
While performing the cleaning validation is it required to evaluate the cleaning method all the times by Swab, Rinse and Visual?

The reason why the above question came is:

we are having a kilo lab facility where we can able to manufacture the material with low volume (where regulatory filing is also possible/happened from this facility). The facility consist of small glass vessel where in some cases it is not possible to perform swab sampling.

In such cases can we go by Rinse and visual? (by avoiding swab)

Also it will be helpful if there is any regulatory reference for this.

Thanks,

Regards / Raghu

Jennifer Kirley
12th April 2009, 10:08 PM
Is this a pharmaceutical, food production, or some other regulated industry?

When on ship, eons ago, we did basic particulate checks with a black light. The black light would pick up film contamination as well. However, this would only be acceptable in certain industries and applications. We'd need to start by understanding what this cleanliness is for.

raghu_1968
13th April 2009, 12:41 AM
It is an API (Active Pharmaceutical Ingredient) industry.

Regards / Raghu