Describe about swab and rinse sampling? : Pharmaceutical Guidelines

Describe about swab and rinse sampling?

Swab: Areas which are reasonably accessible & hardest to clean can be evaluated, leading to a level of contamination or residue per given surface area.
  • Take the clean swab having surface area of 10mmX10mm
  • Put the swab in the test tube containing 10 ml suitable solvent and squeeze the swab along the sides of the test tube to remove the excess of water from it.
  • Identify the locations for swab sampling
  • Take out the wet swab from the test tube without touching the tip of swab.
  • Place the one side of swab over the identified location and apply it on the 10 X 10 sq. cm area first in vertical fashion without changing face of the swab
  • Turn the swab to other side and apply it on the area in horizontal fashion covering all the areas
  • Place the swab stick in to the test tube having 10 ml suitable solvent without touching the tip.
  • Lave the test tube with the location
Rinse: Large area or parts of equipments which could not be swabbed should be rinse sampled or directly extracted by solvent. The areas which are not reasonably accessible for direct surface sampling have to be rinsed with suitable solvent.

  • Use specified volume of suitable solvent for rinsing
  • Rinse the identified locations using the following procedure
  • Take specified quantity of suitable solvent in a graduated bucket
  • Use a clean mug to splash the solvent in the reactor
  • Close the bottom valve of the reactor
  • Take solvent in the mug splash at all side of the reactor
  • Attention to be applied particularly on the blind sides in the inside top of the reactor
  • Splash the solvent at the agitator shaft and blades
  • Open the bottom valve and collect the washed solvent in a clean bucket. Collect about 100 ml (specified quantity in the protocol) in a sample bottle from the bucket. Close the lid and label it properly.
  • When more than one equipment is involved (equipment chain) for rinsing, suitable quantity of solvent shall be used and the rinse volume shall be measured.

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