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 inverted in the Incubator and incubate at 37°C for 18 to 24 hours.
• Observe the growth count of 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 an 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

ALSO READ: SOP for Growth Promotion Test