drug products manufactured in-house and intended for release after sterility testing at [Company Name] microbiology laboratory.

3. Responsibilities

• Microbiology Analyst: Performs sterility testing following aseptic techniques and documents the observations.
• Quality Control Manager: Reviews and approves sterility test records and results.
• Quality Assurance: Ensures compliance with regulatory requirements and reviews final reports.

4. Accountability

Head – Quality Control shall be accountable for execution and compliance of the sterility testing process.

5. Procedure

5.1 Pre-Test Preparations

1. Verify cleanliness and calibration status of the sterility test isolator or laminar air flow workbench.
2. Check environmental monitoring results prior to test initiation.
3. Ensure media (FTM and SCDM) are clear, not expired, and pass growth promotion tests.
4. Label test containers with sample code and media type.

5.2 Sampling and Media

• Use Fluid Thioglycollate Medium (FTM) for anaerobic and aerobic bacteria.
• Use Soybean Casein Digest Medium (SCDM) for fungi and aerobic bacteria.
• Samples shall be tested within 24 hours of sampling. If delayed, store at 2–8°C (not exceeding 72 hours).

5.3 Sterility Test Methods

5.3.1 Membrane Filtration Method (Preferred)

1. Assemble sterile filtration apparatus and membrane units inside isolator/LAF under Grade A conditions.
2. Filter product through 0.45 µm or finer filter.
3. Rinse filters with sterile fluid (minimum three rinses of 100 mL).
4. Transfer one filter to FTM and another to SCDM.
5. Incubate FTM at 30–35°C and SCDM at 20–25°C for 14 days.

5.3.2 Direct Inoculation Method (If Filtration Not Feasible)

1. Inoculate a measured quantity of the product directly into FTM and SCDM media.
2. Observe for signs of turbidity or microbial growth over 14 days.

5.4 Controls and Monitoring

• Include negative controls with media only (no product) in every run.
• Perform growth promotion test on positive control organisms (B. subtilis, C. albicans, etc.) periodically.
• Document incubator temperature, media lot, test environment, and analyst details.

5.5 Observation and Results

1. Visually inspect test media daily for turbidity or sediment formation.
2. Record observations in the Sterility Test Log (Annexure-1).
3. If microbial growth is observed, isolate, identify the organism, and initiate an OOS investigation.

6. Abbreviations

• SOP: Standard Operating Procedure
• FTM: Fluid Thioglycollate Medium
• SCDM: Soybean Casein Digest Medium
• OOS: Out of Specification
• LAF: Laminar Air Flow

7. Documents

1. Sterility Test Log – Annexure-1
2. Growth Promotion Test Records – Annexure-2
3. Sterility Test Report Format – Annexure-3

8. References

• USP <71> Sterility Tests
• EP 2.6.1 Sterility
• WHO TRS 1010, Annex 6

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation	QC Analyst	QC Manager	Head QA
Department	Quality Control	Quality Control	Quality Assurance

11. Annexures

Annexure-1: Sterility Test Log

Date	Batch No.	Product Name	Media Used	Observation	Analyst
17/06/2025	IVINJ0234	Inj. Ceftriaxone	FTM/SCDM	No Growth	Neha Verma

Annexure-2: Growth Promotion Test Record

Media	Organism	Inoculum	Result	Date	Analyst
FTM	B. subtilis	100 CFU	Growth	16/06/2025	Sagar Patil

Annexure-3: Sterility Test Report

Product	Batch	Test Date	Result	Reviewed By
Inj. Pantoprazole	IVPNT045	15/06/2025	Complies	Dr. Sheetal Nair

Revision History

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial release	New SOP	QA Head
18/06/2025	2.0	Updated with detailed filtration and inoculation steps	Annual Review	QA Head