OBJECTIVE of OQ for Dynamic Pass Box
To determine that the OQ for Dynamic Pass Box perform as intended by repeatedly running the system on its intended schedules and recording all relevant information and data. Results must demonstrate that installation consistently meets per-determined specifications under normal condition, and where appropriate the worst case situations.
To verify that the equipment operates in accordance with the design and user requirements as defined by set Acceptance Criteria and complies with relevant cGMP Requirements.
To verify the Operational features of Dynamic pass box and to ensure that it produces desired Quality & rated output according to manufactures specifications.
To verify all the Operational features from user point of view of the Equipment, Cleaning Procedure, Start up & Shut down Procedure and Safety Features.
TABLE OF CONTENT
| PARTICULARS | PAGE NO. |
| TITLE PAGE | |
| TABLE OF CONTENT | |
| OBJECTIVE | |
| SCOPE | |
| PRE APPROVAL OF DOCUMENTS | |
| SCOPE OF SUPPLY | |
| BRIEF PROCESS DESCRIPTION | |
| TECHNICAL SPECIFICATION | |
| TECHNICAL SPECIFICATION OF BOUGHT OUT COMPONENTS | |
| REQUIRED UTILITIES | |
| OPERATION QUALIFICATION PROCEDURE | |
| SAFETY FEATURES & ALARM | |
| POST APPROVAL OF DOCUMENTS | |
| LIST OF ABBREVIATIONS |
SCOPE
The scope of this operational qualification protocol cum report is limited to qualification of Dynamic pass box installed in between material receiving area & sampling area of Hormone Section.
This Protocol will define the methods and documentation used to perform OQ activity the Dynamic pass box for OQ. Successful completion of this Protocol will verify that Dynamic pass box meets all acceptance criteria and ready for Performance Qualification.
This document is applicable for Dynamic pass boxlocated at Accent Pharmaceuticals & Diagnostics Vill – Bhalon(Seri), Forest Road, Solan, Himachal Pradesh (INDIA)
PRE APPROVAL OF DOCUMENTS
Prepared by
| Designation | Name | Date | Signature |
| Executive/Officer Engineering |
Reviewed By
| Designation | Name | Date | Signature |
| Head Engineering | |||
| Head Warehouse | |||
| Head Quality Control | |||
| Head Production |
Approved by
| Designation | Name | Date | Signature |
| Head QA |
SCOPE OF SUPPLY:
| Description | Specification |
| Make | |
| Model | cGMP |
| Serial no | |
| Control system | 220 volts, Single phase power supply |
BRIEF PROCESS DESCRIPTION:
- Dynamic pass box is normally used to transfer materials and goods between clean rooms of different levels or between clean room and non-clean room. Besides UV light and an interlock system, dynamic pass box is equipped with a suction HEPA filter. A dynamic pass box works like an airlock or laminar it has an interlocking system on both sides to protect from contamination and cross-contamination. Dynamic pass box door can open one side at once, and the other side door remains closed.
- Dynamic pass box is a self-cleaning pass box. The air sucked by a centrifugal blower than passed through HEPA filter. After the pressure is equalized, the filtered air enters the working zone at a uniform air velocity, forming a clean working environment
- When the material is put inside pass box & the door is closed, UV light will turn on and material is placed under UV for some time to kill bacteria. Then the material can be taken out
TECHNICAL SPECIFICATION:
| Particulars | Specification | Identified by / Sign. & date | Remarks |
| Make | |||
| Model | As per cGMP model | ||
| Capacity | ISO Class5 (ISO 14644-1:1999(E))/Class 100(U.S FED STD. 209E) | ||
| Overall dimension (mm) | |||
| Workingdimension (mm) | |||
| Pass box type | 3-way opening | ||
| General components | Main Cabinet HEPA Filter Pre Filter Fresh Air Filter Motor Blower Magnehelic Gauge Atmospheric Nozzle PAO Port Electromagnetic Interlocking Controller with OLED Display LED Light with Protective Grill UV Light with Protective Grill Power Supply Plug Permanent Magnet | ||
| Identification | Details of Make, Name, Serial No., Capacity, Model and Year of manufacture should be available | ||
| Utility Requirement | ac, 1 Ph. 50/60Hz. |
TECHNICAL SPECIFICATION OF THE BOUGHT-OUT COMPONENT
| Particulars | Specification | Identified by / Sign. & date | Remarks |
| Make | |||
| Unit Serial No. | |||
| Pre Filter | Qty – 1 nos. Size – 810 x 260 x 50 mm Make – M/s True air Rating – EU-4 Efficiency – 90% down to 5 µ MOC of frame – Aluminum Type (Flange/Box) – Flange type Grill Provision – No | ||
| HEPA filter | Qty – 1 nos. Size – 610 x 610 x 69 mm Make – M/s True air Rating – EU-14 Efficiency – 99.997% down to 0.3 µ MOC of frame – Aluminum Extrusion Type (Flange/Box) – Mini Pleat HEPA filter Box type Grill Provision – No | ||
| Fresh Filter | Qty – 1 nos. Size – 200 x 200 x 50 mm Make – M/s True air Rating – EU-4 Efficiency – 90% down to 5 µ MOC of frame – Aluminum Type (Flange/Box) – Box type | ||
| Motor Blower | Qty – 1 nos. Make – EBM PAPST Rated power – 300 W Rated RPM – 2050 Phase (1φ/3φ) – Single phase (1φ) | ||
| Magnehelic gauge | Qty – 1 nos. Type – Magnehelic gauge Make – Omicron Range – 0 to 50 mm of WC | ||
| UV light | Qty – 01 nos. Size – 1.5 ft. Watt – 15 W | ||
| LED Light | Qty – 02 nos. Size – 2 ft. Watt – 10 W | ||
| On/Off Switches | Qty – 02 nos. Use – For Blower, UV Light & LED Light | ||
| Upstream Port | Qty – 01 nos. Use – For PAO Testing Upstream of HEPA filter | ||
| Other details | Electromagnetic Card 3 Door DPB – Harrison Power Adaptor(12VDC) – 1 Nos. Buzzer – 1 Nos. MCB DP(6 AMP) – 1 Nos. Contactor (9 AMP) – 1 Nos. Regulator(450W) – 1 Nos. Connector – Phoenix Atmospheric Nozzle – 1 Nos. Material of Construction – SS 304 PVC Tube for Magnehelic Gauge – 2 Mtr. Supply Cable – 3 Mtr. As Built Drawing No. – MSPL/ACC/DPB/199 Electrical Circuit Diagram. – MSPL/ACC/ELEC/199 |
REQUIRED UTILITES:
| Utility/ Parameter | Features |
| Electrical Utility | Voltage: 230 V AC ± 5% |
| Frequency: 50 Hz ± 2% | |
| Connection: 3 Wire | |
| Phase: 1 Phase, 1 Neutral,1Earthing |
PROCEDURE of OQ for Dynamic Pass Box:
- 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.
Functional Description: –
| Description | Function |
| Switch | To Switch On/Off UV Light, LED Light & Motor Blower |
| OLEDDisplay | 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. |
| SettingSwitch | 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. |
| Functionof 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 IntegrityTest. |
Acceptance Criteria:
All switches shall be working properly as per their operation as defined in functional description
Standard Operating Parameters Verification
Objective:
Objective of this verification is to provide documented evidence that system/ equipment/ instrument operate satisfactory as per its standard operating procedure.
Test Method:
Acceptance Criteria:
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.
Operation Procedure: –
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 | AcceptanceCriteria | Observations (Ok/Not Ok) | ObservedBy (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
| 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 Engineering |
Reviewed By
| Designation | Name | Date | Signature |
| Head Engineering | |||
| Head Warehouse | |||
| Head Quality Control | |||
| Head Production |
Approved by
| Designation | Name | Date | Signature |
| Head QA |
LIST OF ABBREVIATIONS
| 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 |