Swab, Rinse and Visual Cleaning Validation Requirements

raghu_1968

Involved In Discussions
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
 

Jen Kirley

Quality and Auditing Expert
Leader
Admin
Re: Swab, Rinse and Visual Cleaning Validation

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

Involved In Discussions
Re: Swab, Rinse and Visual Cleaning Validation

It is an API (Active Pharmaceutical Ingredient) industry.

Regards / Raghu
 
R

radhia

Cleaning Validation

i am drawing up the initial validation protocols for a pharmaceutical company. do i need to seggregate the protocols into iq/oq/pq format or can i just put all the information on a single document without indicating the qualification phases
 

Ronen E

Problem Solver
Moderator
Re: Cleaning Validation

i am drawing up the initial validation protocols for a pharmaceutical company. do i need to seggregate the protocols into iq/oq/pq format or can i just put all the information on a single document without indicating the qualification phases

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070336.pdf

Also have a look at ICH guidline Q7, ch. 12:

http://www.ich.org/fileadmin/Public.../Guidelines/Quality/Q7/Step4/Q7_Guideline.pdf
 
L

lindseyc

Re: Cleaning Validation

you can not prove by a visual that the vessel is clean you still need to swab and analytically test for proof as every API is different. also for the actual validation you dont need to use the actual vessel, a plate of the same material will do spiked at expected value. cleaned with swab extract API from swab and test for full extraction repeat x 6 for meaningful data. but I wouldnt expect the authorities to let you do a visual for normal clean down either. hope this helps
 
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