applies to all AMD personnel involved in microbiological testing procedures such as sterility testing, microbial limit testing, environmental monitoring, and preservative efficacy studies conducted under aseptic conditions.

3. Responsibilities

• Microbiologist: Implements aseptic technique in all sample handling and testing steps, ensures regular sanitization of the LAF, and maintains logs.
• Analytical Scientist: Ensures compliance during transfers of materials and samples into aseptic areas.
• QA Officer: Conducts periodic audits to verify adherence to aseptic practices and evaluates training records.
• Head – AMD: Approves aseptic protocols and ensures training, qualification, and documentation.

4. Accountability

The Head of Analytical Method Development is accountable for ensuring aseptic technique implementation, periodic retraining, and maintenance of a contamination-free testing environment.

5. Procedure

5.1 Personal Hygiene and Gowning

1. Personnel must be free from contagious illness or skin infections.
2. Perform hand washing with antimicrobial soap followed by drying with sterile towels.
3. Wear sterile gown, gloves, face mask, cap, and shoe covers in the designated gowning area.
4. Disinfect gloves using 70% IPA before entering the LAF.

5.2 Area Preparation

1. Switch on the LAF 30 minutes prior to use and verify airflow with an anemometer if required.
2. Wipe all interior surfaces with sterile 70% IPA or appropriate disinfectant.
3. Place UV lamp ‘ON’ for 15–30 minutes if applicable, and turn off before work begins.
4. Ensure that all required materials (media, pipettes, tubes) are sterilized and placed aseptically in the LAF.
5. Record cleaning activities in Annexure-1: Aseptic Area Preparation Log.

5.3 Handling of Samples and Materials

1. Minimize movement within and around the LAF during operation to avoid air turbulence.
2. Disinfect external surfaces of containers and materials with 70% IPA before placing inside LAF.
3. Work at least 6 inches inside the LAF to avoid external air disturbance.
4. Use sterile forceps and avoid touching critical parts of sterile equipment (e.g., pipette tips, tube openings).

5.4 Aseptic Techniques During Testing

1. Do not talk, cough, or sneeze inside the LAF. Avoid rapid hand movements.
2. Flame sterilize tools like inoculating loops using spirit lamps or Bunsen burners.
3. Cap and uncap sample containers one at a time. Do not leave containers open unnecessarily.
4. Perform all microbial transfers using sterile pipettes or micropipettors with barrier tips.
5. Document each aseptic test activity in Annexure-2: Test Execution Log.

5.5 Post-Testing Activities

1. Dispose of all used material in designated autoclave or biohazard bags.
2. Disinfect LAF interior with 70% IPA and allow it to run for 15 minutes post-use.
3. Update LAF usage log with date, time, analyst name, and activity performed.

5.6 Qualification and Training

1. Personnel must undergo initial aseptic technique training and annual retraining.
2. Evaluate practical skills using media fill simulation or growth media handling challenge tests.
3. Maintain training records in Annexure-3: Personnel Qualification Log.

6. Abbreviations

• LAF: Laminar Airflow
• IPA: Isopropyl Alcohol
• GMP: Good Manufacturing Practice
• GLP: Good Laboratory Practice
• SOP: Standard Operating Procedure

7. Documents

1. Aseptic Area Preparation Log – Annexure-1
2. Test Execution Log – Annexure-2
3. Personnel Qualification Log – Annexure-3

8. References

• USP <797> – Pharmaceutical Compounding—Sterile Preparations
• EU GMP Annex 1 – Manufacture of Sterile Medicinal Products
• WHO Guidelines on Good Manufacturing Practices

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Aseptic Area Preparation Log

Date	LAF ID	Disinfectant Used	Sanitized By	Remarks
18/05/2025	LAF-002	IPA 70%	Rajesh Kumar	Cleaned & Ready

Annexure-2: Test Execution Log

Date	Sample ID	Test Performed	Analyst	Remarks
19/05/2025	MLT/25/101	Microbial Limit Test	Sunita Reddy	Completed

Annexure-3: Personnel Qualification Log

Name	Date Trained	Trainer	Evaluation Method	Status
Ajay Verma	10/04/2025	QA Trainer	Media Fill	Qualified

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
04/05/2025	2.0	Expanded aseptic gowning and LAF validation protocol	Annual GMP Review