SOP FOR STERILITY TESTING

1. OBJECTIVE:

To lay down a procedure for Sterility Testing.

• SCOPE:

This procedure is applicable for procedure for sterility testing.

• RESPONSIBILITY:

Microbiologist

• ACCOUNTABILITY:

QC Manager.

• PROCEDURE:
  • Medium for Sterility Test Method

Soybean Casein Digest Medium (SCDM): Prepare the medium as per manufacturer instructed or as per SOP.

Fluid Thioglycollate Medium (FTGM): Prepare the medium as per manufacturer instructed or as per SOP.

• General Instructions & Precautions:
  • Follow SOP, for entry and exit procedure to microbiology testing and sterility testing area.
  • Check the physical parameters (temperature, Relative humidity and pressure differential) of the area and ensure they are within limits before starting the testing / activity.
  • During each sterility test session, perform the environmental monitoring as per SOP.
  • Insure the all instrument cleaned by IPA 70%.
  • ON the UV light and LAF before 30 minute from start testing.
  • Insure the during testing highly precaution on cross contamination.
  • Sterilization Procedure

All medium (SCDM & FTGM), 100 ml of water with containing 2 ml of Polysorbate 80 for one product, filtration assembly with filter paper, filtration flask, gloves, scissors & forceps are sterile by steam sterilization at 121⁰C  and 15 lbs pressure for 20 minute.

• Testing Method
  • Enter in microbiology testing as per SOP & follow the gowning procedure as per SOP.
  • OFF the UV light.
  • Mop the LAF bench with IPA 70%.
  • Take the sample (about 20 applicap) wash with upper side of capsules with 70% IPA.
  • Cut the upper side of capsules one by one by using sterile scissors and ointment take in sterile 100 ml of water; mix the ointment and then filter with membrane filtration method.
  • After completion of filter wash the filter paper with 100 ml of other sterile water.
    Cut the filter by using sterile scissors and take the one part of filter paper by using forceps in sterile SCDM medium and one part is in sterile FTGM medium; close the tube immediately and prevent the cross contamination.
  • Incubate the SCDM tube at 20-25⁰C for 14 days and FTGM tube at 30-35⁰C for 14 days.
  • Positive and negative test should be performing during testing.
  • Observed the tubes on daily basis for sample is fail or OK and maintain the record.
  • After completion of 14 days; check tubes and fill the report and report submit in QC department.
  • Sample Qty.

Take about 20 applicap for testing.

• Acceptance Criteria
• For bacterial Observation
• For SCDM Tube: SCDM tube should not be turbid.
• Positive tube should be turbid and negative tube should not be turbid.
• For bacterial Observation
• For FTGM Tube: FTGM tube should not be turbid and pink colour should not be removed.
• Positive tube should be turbid and negative tube should not be turbid.
• If any acceptance criteria is not match; so re analysis the product.
• TRAINING:

Trainer   : Manager – Quality Control

Trainees : Staff of the microbiology departments

• DISTRIBUTION:

Master Copy                  :           QA Department

Controlled Copy            :           Microbiology Department

Display Copy                 :           Microbiology Department (If Required)

• REFERENCES:

In-House

1. ABBREVIATIONS:

Abbreviations	Extended Form
SOP	Standard Operating Procedure
NA	Not Applicable
MB	Microbiology
Sr. No.	Serial Number
QA	Quality Assurance
DEPT.	Department
IPA	Isopropyl Alcohol
%	Percentage
SCDM	Soybean Casein Digest Medium
FTGM	Fluid thioglycollate medium