Swabbing difficult area's

GOOD VALIDATION PRACTICE (cGVP) CLEANING VALIDATION
1

In our factory we perform swab testing for determening contamination by swabbing a predefined (100 cm2) area. I think that smooth surfaces will only have a limited contribution to contamination of equipment. Problem area’s are seals, sharp edges etc etc. These surfaces are very difficult to swab, and to interpret. How do you deal with this problem?

2

Dear ROb,

This is good way that you have selected the 100 sq cm for swabbing, there is no binding or restriction for selecting specified area in CLV, if there is any problem for swabbing due to small area, you can take the swab at this subjected small area and measure the sampling area, and in your calcultaion you put microgram/ area instead of microgram/100 sqcm , and after get the require result you will calculate and applicable on whole equipment product contact area. So don’t you worry.

Thanks

3

Rob,

You can adopt one more method i.e. collect 1cm x 1cm swab in 10 locations of that component (seal, sharp edges, etc.), if the swabbing is not possible with 10cm x 10cm.

Or else

Apply the concept of Rinse Sampling, for such type of areas, where swab is not possible by using 10cm x 10cm coupon.

Generally, for sharp edges, applying swab concept won’t give adequate result.

Regards,
Sudarshan Reddy
ys.sudarsan@gmail.com

4

i think rinse sampling is the best option,for this kind of problem
or u can use swab 5cmx5cm area for swab sampling.

there is no guideline which says u can only stick to 10x10cm swab.

Prasad
Nicholas piramal

5

you can select 5-10 unapprochable points of equipment for example inner side of the top cover of the reactor close to the man hole, inner shell of the equipment opposite to the man hole or interface or recation mixture volume etc. and analysis. Afeter receiving the three runs reports you can decisde difficult to clean area.

regards