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SOP for Bioburden Test for Clean Area

OBJECTIVE
To determine Viable and Non-viable particle count in the air of a Clean Area.

SCOPE
The SOP is applicable to the Sterility Testing and Parenteral product manufacturing area.

PRECAUTIONS
  • The personnel must wear an apron, mask, cap, hand gloves, and working sandals during the operation.
  • All glass wares and utensils must be sterile.
  • All operations must be done aseptically.

RESPONSIBILITY
Microbiologist
QC authorized personnel

ACCOUNTABILITY
Quality Control Manager

PROCEDURE

For Viable Particle count:

Settling Plate Count Method:
  • Ensure that the area to be monitored for Viable particle count must be thoroughly cleaned as per SOP.
  • Place at least 4 sets of Petri dishes (Dia: 90 mm) containing sterile Nutrient Agar Media in different grade clean areas.
  • Aseptically expose the Petri dishes for 2 hours.
  • After the lapse of the period covered the Petri dishes aseptically.
  • Keep the petri dishes invertly in the Incubator and incubate at 37°C for 18 to 24 hours.
  • Observe the growth and count the cfu per Petri dish and determine an average.
  • Record the results in Annexure-I.
  • Observe the count is within the limit for the specified area.
  • Frequency: The next day after fumigation.


For Non-viable Particle count
  • Ensure that the area to be monitored for Non Viable particle count must be thoroughly cleaned as per SOP.
  • The instrument used: Met one Instrument.
  • Operate the instrument as per SOP.
  • Sample the air at the rate of 1ft3/minute.
  • Take Air sample from a location concerned operation.
  • Repeat and take two (02) such readings and determine the average.
  • Record the results in Annexure-I.
  • Observe the count is within the limit for a specified area.
  • Frequency: Operation to be done before going to production or sterility testing.

ANNEXURE

ABBREVIATION
SOP: Standard Operating Procedure
QC: Quality Control

REVISION HISTORY
Nil

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