to all personnel involved in the operation, monitoring, and cleaning of pass-through hatches and chambers between different cleanroom areas within the sterile manufacturing facility.

3. Responsibilities

• Production Assistant/Operator: Operates and monitors pass boxes during material transfer.
• Quality Assurance Officer: Verifies compliance during audits and routine inspection.
• Engineering Personnel: Maintains and services pass boxes as per maintenance schedule.
• Cleaning Staff: Responsible for cleaning and sanitization of the equipment as per schedule.

4. Accountability

The Production Head is accountable for ensuring that all operations of pass-through equipment comply with GMP and aseptic handling procedures.

5. Procedure

5.1 Types of Pass-Through Equipment

1. Static Pass Box: For non-biological material transfer between areas with same or lower classification.
2. Dynamic Pass Box: Equipped with HEPA filters, used between classified areas for sterile transfer.

5.2 Pre-Operational Checks

1. Check the cleaning status label on the pass box.
2. Verify air flow status in dynamic pass boxes (minimum 90 FPM, unidirectional).
3. Ensure interlocking mechanism between doors is functional.
4. Inspect UV lamp functionality if applicable and record in logbook (Annexure-1).

5.3 Material Transfer Procedure

1. Place material in the pass box from the originating area.
2. Close the outer door completely before opening the inner door.
3. Wait for the hold time (default: 2 minutes in dynamic pass boxes).
4. Receiver from cleanroom area opens the inside door and removes materials.
5. Disinfect the internal surfaces using 70% IPA after each transfer.

5.4 Cleaning and Sanitization

1. Static Pass Box:
   • Clean using lint-free wipes and IPA 70% after each shift.
   • UV lamp should be cleaned weekly with a dry wipe.
2. Dynamic Pass Box:
   • Clean filters and grills daily using approved methods.
   • Record cleaning activity in Annexure-2.

5.5 Preventive Maintenance

1. Engineering to perform monthly checks of:
   • Fan filters
   • Motor assembly
   • Door interlocks
2. HEPA filter integrity to be checked annually.

5.6 Precautions

• Never open both doors simultaneously.
• Do not overload the pass box; maintain laminar flow.
• Reject damaged or contaminated material before placing in pass-through equipment.

6. Abbreviations

• SOP: Standard Operating Procedure
• IPA: Isopropyl Alcohol
• HEPA: High-Efficiency Particulate Air
• FPM: Feet per Minute

7. Documents

1. Pass Box Usage Log – Annexure-1
2. Cleaning and Sanitization Log – Annexure-2
3. Preventive Maintenance Record – Annexure-3

8. References

• EU GMP Annex 1: Manufacture of Sterile Medicinal Products
• WHO GMP Guidelines for Cleanroom Classification
• ICH Q9: Quality Risk Management

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: Pass Box Usage Log

Date	Material Name	From	To	Time	Operator
18/06/2025	Sterile Vials	Prep Area	Filling Room	10:15	Rajesh Kumar

Annexure-2: Cleaning and Sanitization Log

Date	Type	Performed By	Verified By	Remarks
18/06/2025	Routine	Sunita Reddy	Ajay Verma	Clean

Annexure-3: Preventive Maintenance Record

Date	Component	Action Taken	Engineer	Remarks
10/06/2025	HEPA Filter	Integrity Test Passed	Rohit Deshmukh	OK

Revision History

Revision Date	Revision No.	Details	Reason	Approved By
01/03/2022	1.0	Initial Issue	New SOP	QA Head
18/06/2025	2.0	Revised for dynamic pass box protocol updates	Annual Review	QA Head