the handling of sterilized items such as rubber stoppers, seals, sterile filters, vials, ampoules, and syringes used during aseptic filling in the Sterile Injectable Manufacturing area.

3. Responsibilities

• Production Operator: Transfers, loads, and handles sterile components as per procedure.
• Production Supervisor: Ensures compliance and documents all activities in BMR.
• QA Officer: Verifies sterility assurance practices and performs line clearance.
• Warehouse Personnel: Ensures delivery of sterilized components as per plan.

4. Accountability

The Head – Production and Head – Quality Assurance are accountable for maintaining the sterility of all components used in manufacturing.

5. Procedure

5.1 Pre-Checks

1. Verify cleaning and sterilization status of components based on Sterilization Load Report.
2. Ensure availability of approved BMR and materials issuance voucher.
3. Check integrity of sterile bags and labels on each pack before aseptic transfer.

5.2 Transfer to Aseptic Area

1. Transfer sterile components from the sterilizer using validated pass-through mechanisms (e.g., double-door autoclaves, dry heat depyrogenators).
2. Use designated trolleys, fully sanitized and dedicated for aseptic processing.
3. Perform QA line clearance before opening outer sterile bag.

5.3 Handling under Laminar Air Flow

1. Open sterile bags inside the LAF under Grade A conditions.
2. Inspect each component visually for any particulate or discoloration.
3. Transfer items directly to filling machines or load into sterile bins/trays as per batch requirements.

5.4 Component Usage and Controls

1. Use components on FIFO basis, ensuring within approved shelf-life of sterilization.
2. Document usage against the batch number in Annexure-1: Sterile Component Usage Log.
3. Ensure batch-specific reconciliation at the end of use.

5.5 Post-Use Disposal

1. Segregate unused components and return them to quarantine if applicable or discard as per SOP/SIM/075/2025 (Waste Disposal).
2. Deface labels of discarded materials and document disposal details in Annexure-2.

6. Abbreviations

• SOP: Standard Operating Procedure
• BMR: Batch Manufacturing Record
• LAF: Laminar Air Flow
• QA: Quality Assurance
• FIFO: First In First Out

7. Documents

1. Sterile Component Usage Log – Annexure-1
2. Component Disposal Record – Annexure-2
3. Line Clearance Checklist – Annexure-3

8. References

• WHO TRS 961 Annex 6 – GMP for Sterile Pharmaceutical Products
• ICH Q9 – Quality Risk Management
• EU GMP Annex 1 – Manufacture of Sterile Medicinal Products

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation	Manufacturing Executive	QA Executive	Head QA
Department	Production	Quality Assurance	Quality Assurance

11. Annexures

Annexure-1: Sterile Component Usage Log

Date	Component	Qty Issued	Qty Used	Batch No.	Operator
18/06/2025	Rubber Stopper	30,000	29,980	IV/275/25	Ajay Sharma

Annexure-2: Component Disposal Record

Date	Component	Qty Discarded	Reason	Disposed By	Verified By
18/06/2025	Flip-off Seal	20	Damaged seal	Sunil Reddy	QA Officer

Annexure-3: Line Clearance Checklist

Parameter	Status	Remarks	Checked By
Sterile Pack Integrity	OK	Sealed	Priya Desai
Label Verification	OK	Correct batch	Priya Desai

Revision History

Revision Date	Revision No.	Details	Reason	Approved By
01/02/2022	1.0	Initial SOP released	New Document	QA Head
18/06/2025	2.0	Inclusion of disposal log and updated QA role	Periodic Review	QA Head