Checking personnel hygiene by dab test method-SOP

1.0 OBJECTIVE :
  • To describe procedure for Microbial Count on Hands by using dab test method.
2.0 SCOPE :
  • It applies to the all staff and workers who are coming in direct contact with product during Manufacturing/processing.
3.0 RESPONSIBILITY :
  • Microbiologist
4.0 ACCOUNTABILITY:
  • Head of Department
5.0 PROCEDURE :
  • Prepare SCDA plate and keep in incubator for preincubation at 30°C to 35°C for 24 hours.
  • Those people who directly come in contact to product, this people  first wash the hand with help of water and then disinfect the hand with 70% IPA.
  • Take the impression of finger on plate of media.
  • After pressing the finger keep the plate in incubator for incubation at 20°C to 25°C for 3 days for fungal count and then 30°C to 35°C for bacterial count for 2 days.
  • Observe the colonies after incubation and record.
  • FREQUENCY:
    • Once in month.
  • LIMITS:
    • Alert limit              : 60 cfu/hand
    • Action limit           : 80 cfu/hand
    • Maximum limit     : 100 cfu/hand
  • In case of failure of result, give the proper training to all worker and staff to disinfect hand using 70% IPA.
6.0 ABBREVIATIONS:
AbbreviationExpanded form
SCDASoybean Casein Digest Agar
SOPStandard Operating Procedure
IPAIsopropyl Alcohol
cfuColony Forming Unit
%Percentage

7.0 ANNEXURES
Annex. No.Title
01Format for Checking Personnel Hygiene By DAB Test Method 

8.0 SOP REFERENCES
  • United States Pharmacopoeia

END OF THE SOP


ANNEXURES :

Annex. No. 01 Format for Checking Personnel Hygiene By DAB Test Method