Objectives of Dynamic Pass Box OQ Operational Qualification
The primary objective of Dynamic Pass Box OQ Operational Qualification is to verify that the equipment operates consistently, safely, and according to its intended design under normal operating conditions. During Operational Qualification, the Dynamic Pass Box is tested repeatedly to ensure that all critical functions perform reliably and consistently while meeting predefined acceptance criteria.
The specific objectives of Dynamic Pass Box OQ include:
- To verify the operational performance of the Dynamic Pass Box by confirming that it functions as intended during routine operation and consistently delivers reliable results.
- To ensure compliance with design specifications and user requirements by demonstrating that the equipment meets the approved User Requirement Specification (URS), manufacturer’s recommendations, and predefined acceptance criteria.
- To confirm compliance with current Good Manufacturing Practices (cGMP) by verifying that the equipment operates in accordance with applicable pharmaceutical quality and regulatory requirements.
- To evaluate all critical operational features such as the HEPA filtration system, motor blower, UV light, LED lighting, door interlocking system, OLED display, alarm functions, and control switches to ensure they perform correctly.
- To verify startup, shutdown, and cleaning procedures so that the equipment can be operated safely, efficiently, and consistently by production personnel following approved Standard Operating Procedures (SOPs).
- To assess built-in safety features including door interlocking, alarm systems, electrical safety, and other protective functions that help prevent contamination, cross-contamination, and operational errors.
- To provide documented evidence that the Dynamic Pass Box is qualified for routine pharmaceutical operations and is ready to proceed to the Performance Qualification (PQ) stage.
Scope of Dynamic Pass Box OQ
This Operational Qualification (OQ) Protocol applies to the Dynamic Pass Box installed between the Material Receiving Area and the Sampling Area of the Hormone Section. It defines the qualification methodology, testing procedures, documentation requirements, and acceptance criteria used to verify the equipment’s operational performance.
Successful completion of the Operational Qualification confirms that the Dynamic Pass Box operates as intended and is suitable to proceed to Performance Qualification (PQ).
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Pre Approval Of Documents
Prepared by
| Designation | Name | Date | Signature |
| Executive/Officer QA |
Reviewed By
| Designation | Name | Date | Signature |
| Head Engineering | |||
| Head Production |
Approved by
| Designation | Name | Date | Signature |
| Head QA |
Supply needs before performing OQ:
| Description | Specification |
| Make | |
| Model | |
| Serial no | |
| Control system | 220 volts, Single phase power supply |
Brief Process Description for Dynamic Pass Box OQ
A Dynamic Pass Box (DPB) is used to safely transfer materials between cleanrooms of different cleanliness grades or between a cleanroom and a non-clean area without compromising the controlled environment. It is equipped with a HEPA filtration system, UV light, and an electromagnetic door interlocking system to minimize the risk of contamination and cross-contamination during material transfer.
The Dynamic Pass Box operates on the principle of continuous clean airflow. A centrifugal blower draws air through a HEPA filter, which removes airborne particles before supplying clean air into the pass box chamber. This filtered airflow creates a clean environment inside the chamber, helping to maintain product quality and cleanroom integrity.
For safe operation, the pass box is designed with an interlocking mechanism that allows only one door to open at a time. When one door is open, the opposite door remains locked, preventing direct air exchange between the two connected areas.
After the material is placed inside the chamber and the door is closed, the UV light is activated to reduce the microbial load on the material surface. Once the UV exposure cycle is complete, the material can be safely removed from the opposite side of the pass box.
| Parameter | Specification |
| Make | As per approved manufacturer |
| Model | As per GMP-approved model |
| Cleanliness Class | ISO Class 5 (ISO 14644-1:1999(E)) / Class 100 (U.S. FED STD. 209E) |
| Overall Dimensions | 1040 (W) × 1020 (D) × 1200 (H) mm |
| Working Chamber Dimensions | 800 (W) × 800 (D) × 800 (H) mm |
| Pass Box Type | Three-way opening Dynamic Pass Box |
| Construction | Stainless Steel (SS 304) |
| Power Supply | 230 V AC, Single Phase, 50/60 Hz |
Main Components
The Dynamic Pass Box is equipped with the following key components:
- Main cabinet
- HEPA filter
- Pre-filter
- Fresh air filter
- Motor blower
- Magnehelic gauge
- Atmospheric nozzle
- PAO test port
- Electromagnetic interlocking controller with OLED display
- LED light with protective grill
- UV light with protective grill
- Power supply plug
- Permanent magnetic door locking system
These components work together to provide efficient air filtration, controlled airflow, reliable door interlocking, and effective contamination control during material transfer.
| Component | Specification |
| Pre Filter | Quantity: 1 No.; Size: 810 × 260 × 50 mm; Rating: EU-4; Efficiency: 90% down to 5 µm; Aluminum frame; Flange type |
| HEPA Filter | Quantity: 1 No.; Size: 610 × 610 × 69 mm; Rating: EU-14; Efficiency: 99.997% at 0.3 µm; Aluminum extrusion frame; Mini Pleat Box Type |
| Fresh Air Filter | Quantity: 1 No.; Size: 200 × 200 × 50 mm; Rating: EU-4; Efficiency: 90% down to 5 µm; Aluminum frame; Box type |
| Motor Blower | Quantity: 1 No.; Rated Power: 300 W; Rated Speed: 2050 RPM; Single Phase |
| Magnehelic Gauge | Quantity: 1 No.; Make: Omicron; Range: 0–50 mm WC |
| UV Light | Quantity: 1 No.; Size: 1.5 ft.; Power: 15 W |
| LED Light | Quantity: 2 Nos.; Size: 2 ft.; Power: 10 W each |
| On/Off Switches | Used to operate the blower, UV light, and LED light |
| PAO Upstream Port | Used for upstream aerosol introduction during HEPA filter integrity testing |
Utility Required for Pass Box Operational Qualification
| Utility Parameter | Specification |
| Voltage | 230 V AC ± 5% |
| Frequency | 50 Hz ± 2% |
| Electrical Connection | 3-Wire |
| Power Supply | Single Phase (1 Phase, 1 Neutral, 1 Earthing) |
Note: Verify that the electrical supply complies with these requirements before initiating the Operational Qualification to ensure accurate test results and reliable equipment performance.
Functional Description: –
| Description | Function |
| Switch | To Switch On/Off UV Light, LED Light & Motor Blower |
| OLED Display | OLED Display with Door Release Switches to open the door. OLED Display showing “DOOR CLOSE” when all the doors are locked &“WAIT” when any of the doors is open. OLED Display with Hour Meter Monitoring. |
| Electromagnetic Lock with Interlocking Systems | In normal condition all the doors are in close condition. If one side door is open, another side door should not be opened. If Door continually opens for preset time, then beep/ alarm starts. |
| Setting Switch | To set or reset UV Light Hour Meters & Door Lock time. |
| UV Light | To Remove Bacterial Contamination. |
| LEDLight | To provide required LUX Level in the Working Area. |
| Magnehelic Gauge | Magnehelic Gauge to Monitor Differential Pressure across HEPA Filter. |
| Permanent Magnet | To Keep the Door Lock during Power Failure. |
| Function of Motor Blower | To supply designed Air Flow for supply. |
| Function of Atmosphere Nozzle | To connect low pressure probe of Pressure Gauge to ambient. |
| Function of PAO Port | For charging aerosol at up stream of HEPA Filter for Filter Integrity Test. |
Acceptance Criteria:
All switches shall be working properly as per their operation as defined in functional description
System/ Equipment/ Instruments shall be operate as defined in the standard operating procedure, if differ then record deviation.
Operation shall be smooth and there should not be any abnormal sound/ noise.
Dynamic Pass Box OQ procedure: –
General Prequisite
- The Operational Qualification status of the Dynamic pass box shall be checked and the execution shall be started only after completion of Installation Qualification report.
- Availability of calibration certificates of all the attached instruments shall be checked.
- The power supply and connected utility shall be checked before starting Operational Qualification.
- The operating functions of control panel switches and buttons shall be checked.
- No Deviation observed during Operation Qualification.
Ensure electrical supply to Dynamic Pass Box is proper.
When both the doors are locked UV Light is ON.UV, LED light & Motor Blower can also be switched on/Off manually when the Doors are locked.
Press “GO”Switch for door opening & place the material inside the pass box and close the door. When any of the doors is open Motor Blower & LED Light gets on automatically.
In case the door is in opened form or more than10 seconds, audio alarm gets activated.
After closing the door UV Light will get “ON”& LED Light & Motor Blower gets OFF”.
After placing the material inside the Pass Box, user can take material from other side for use.
Results:
Record the results in below table.
| Component Description | Acceptance Criteria | Observations (Ok/Not Ok) | Observed By (Sign & date) | Remarks (If any) |
| OLED Display | OLED Display showing Door Close/Open Status | |||
| AF Switch | Motor Blower shall be Switched On/Off by pressing key | |||
| LEDLight Switch | LED Light shall be switched On/Off by pressing key | |||
| UV Light Switch | UV Light shall be switched On/Off by pressing key | |||
| SettingSwitch | UV Hours Meter & Door Lock time shall be Set/Reset by Pressing the Setting switch | |||
| Permanent Magnet | Door shall be Locked When Closed during Power Failure |
Safety Feature & Alarm in Dynamic Pass Box Operational Qualification
| Safety feature | Function | Identified by/Date |
| Electrical Insulation | Safety | |
| Earthing | To avoid the shock |
Post Approval of Documents
Prepared by
| Designation | Name | Date | Signature |
| Executive/Officer QA |
Reviewed By
| Designation | Name | Date | Signature |
| Head Engineering | |||
| Head Production |
Approved by
| Designation | Name | Date | Signature |
| Head QA |
Acronym Used
| OQ | Operational Qualification |
| DPB | Dynamic Pass box |
| WH | Warehouse |
| QA | Quality Assurance |
| URS | User Required Specification |
| UV | Ultra Violet |
| HEPA | High Efficiency Particulate Air |
| SS | Stainless Steel |
| MCB | Miniature Circuit Board |
| ISO | Indian Standardized Organisation |
| cGMP | Current Manufacturing practices |
| MM | Millimetre |
| PAO | Poly Alpha Olefin |
| OLED | Organic Light Emitting Diode |
| V | Voltage |
| AC | Alternate Current |
| MOC | Material of construction |
| µ | Micron |
| RPM | Revolution per minute |
| WC | Water Column |
| W | Watt |
| Amp. | Ampere |
Frequently Asked Questions (FAQs) for Dynamic Pass Box OQ
Q-1. What is Dynamic Pass Box Operational Qualification (OQ)?
Answer: Dynamic Pass Box Operational Qualification (OQ) is the documented process of verifying that a dynamic pass box operates correctly under normal working conditions.
Q-2. Why is Operational Qualification (OQ) important for a Dynamic Pass Box?
Answer: OQ is important because it proves that the pass box functions correctly before it is used in routine pharmaceutical operations.
Q-3. Can OQ be performed before Installation Qualification (IQ)?
Answer: No. Operational Qualification should only begin after Installation Qualification has been completed successfully.
Q-4. How often should a Dynamic Pass Box be requalified?
Answer: There is no single fixed interval. Requalification is commonly performed at scheduled intervals defined or whenever major repairs, modifications, relocation.