Surface monitoring or swab sampling

Swab technique.

Sample an approximate area of 25 cm². (as per USP 24-30 cm²) The irregular surfaces used swab stick method.

which are directly in contact with product. Closure surface sample should be done only after completion of filling activity, after taking the swab sample.

production personnel shall be informed to dismantle the machine parts for cleaning and sterilization.

After taking the swab sample, mop the surface with 70% IPA with a lint free sterile mop.

Perform sampling in  (Grade-D) controlled area once in a week for the locations. Incubate the monitored swab samples at 20-25⁰C for 72 hrs & 30-35^oC for 48 hrs.

1.    Contact plate method

2.    Swab method or Flexible films

1.  Contact Plate method:

Use RODAC (Reflicated Organism Detecting And Counting)

Open the lid select the location Gently Light Compression. (impression 5 secounds)

If required Contact plate may be rolled for sampling of curved surfacec (irregular surfaces) Cover an area of approximetaly 5cm X 5 cm = 25cm²

  

2.  Swab Technique Or Flexible Films:

Put the swab sticks (Tex wipe’s) individually in test tubes containg 5ml of 0.1% peptone /saline and plug the test tube with PP (polyPropylene)caps.

Keep the tubes in stand double wrap the stand with butter paper and sterilized.

Sampling Procedure:

Carry the swab tube for sampling location.

Remove the swab stick from the test tube and perfrom the swab sampling.

Perfrom the sampling by rotating the swab through equipement surface to be sampled. Cover an area of approximetely 25 cm2(5 cmx 5cm)

Then transfer the swab stick again the test tube plug the tubes and bring lab. After sampling disinfectant the sampled area with filtered 70% IPA.

Plating procedure:

Add 10 ml sterile 0.1% peptone water in to each tube containig the swab. Gently vortex in the tubes.


Membrane filtration.

Rinse the swab twice with 10 ml of 0.1% peptone. After filtration, place the membrane SCDA plate. Incubate 20-25⁰C-3 days, then 30-35⁰C –for 2 days.

sterile swabs are avalabile in USP-grade cotton, polyurethene foam, and medical grade spun polyster.

       Sterile cotton swabs:

1.    Sterile cotton polyster handle.

2.     Sterile cotton wood handle. Steility assurence limit =10^-6

SWAL= SAL  X Area swabbed X RF

RF = recovery factor (assume 50%)