INSTALLATION QUALIFICATION PROTOCOL DISPENSING BOOTH
The Dispensing Booth is a reverse laminar airflow unit designed for safe and controlled handling of powders during dispensing operations. The system operates on the principle of negative pressure containment, ensuring that airborne particles generated during dispensing are effectively confined within the working area.
The booth functions by drawing approximately 20% of fresh air from the surrounding environment through pre-filters, while about 20% of the air is exhausted through an exhaust HEPA filter (with approximately 90% efficiency). The remaining 80% of the air is recirculated within the system, thereby maintaining a consistent negative pressure inside the work zone.
This controlled airflow pattern prevents the escape of dust or powder particles into the external environment, thereby minimizing the risk of cross-contamination and ensuring operator protection. The enclosed and controlled area within the booth is referred to as the “safe working zone.”
The effectiveness of the reverse laminar airflow is verified through a smoke study, typically performed using titanium tetrachloride. This test, known as the Air Direction Flow Test, visually demonstrates the airflow pattern and confirms proper containment within the booth.
TABLE OF CONTENTS
1.0 Approval
2.0 Objective
3.0 Responsibility
4.0 Equipment Identification
5.0 Equipment Location
6.0 Documentation
7.0 Pre-requisites for Installation Qualification
8.0 Installation Qualification Procedure
9.0 System Description
10.0 Procedure
10.1 Installation Checklist [Form – A]
10.2 Inspection Checklist [Form – B]
10.3 Leveling and Alignment [Form – C]
10.4 Material of Construction [Form – D]
10.5 Guarantee/Warranty Certificates [Form – E]
10.6 Drawing Verification [Form – F]
10.7 SOP Identification [Form – G]
10.8 Supporting Utilities Check [Form – H]
10.9 Critical Instruments Calibration [Form – I]
11.0 Deviation and Corrective Action [Form – J]
12.0 Change Control Proposal [Form – K]
13.0 Revalidation Criteria
14.0 Acceptance Criteria
15.0 Summary
16.0 Conclusion
1.0 APPROVAL
2.0 OBJECTIVE
The objective of this protocol is to verify and document that the Dispensing Booth is installed in accordance with:
- Approved design specifications
- Manufacturer’s recommendations
- Current Good Manufacturing Practices (cGMP)
This includes verification of:
- Proper installation and assembly
- Availability and connection of utilities
- Identification and calibration of critical components
- Compliance with approved documentation
- Readiness for Operational Qualification (OQ)
3.0 RESPONSIBILITY
- Engineering Department: Installation and verification of equipment
- Production Department: Operational verification and support
- Quality Assurance: Review, approval, and compliance verification
- Plant Head: Provision of installation area
QA shall ensure compliance with acceptance criteria and authorize qualification completion.
4.0 EQUIPMENT IDENTIFICATION
- Equipment Name: Dispensing Booth
- Model No.:
- Serial No.: 060502121
- Tag No.:
- Manufacturer: CLEAN ROOM PRESENTATION
- Purchase Order No.:
- Date:
5.0 EQUIPMENT LOCATION
- Facility: Oral Cephalosporin Facility
- Floor: Ground Floor
- Area: Process Area
- Room Name: Dispensing Booth – II
- Room ID:
6.0 DOCUMENTATION
| S. No. | Document | Annexure |
|---|---|---|
| 6.1 | URS / Data Sheet | Annexure 1 |
| 6.2 | Purchase Order Copy | Annexure 2 |
| 6.3 | Design Qualification | Annexure 3 |
7.0 PRE-REQUISITES
- Equipment unpacked and available for inspection
- Area cleaned and ready
- Layout verification completed
- Electrical and utility connections available
- Installation as per manufacturer’s recommendation
8.0 INSTALLATION QUALIFICATION PROCEDURE
- Verify installation location as per layout
- Check assembly against drawings
- Verify leveling and alignment
- Identify and verify critical components
- Confirm Material of Construction (MOC)
- Verify utilities compliance
- Review calibration status of instruments
- Verify availability of drawings
- Identify SOPs
- Record deviations, if any
9.0 SYSTEM DESCRIPTION
The Dispensing Booth operates on the principle of Reverse Laminar Airflow (RLAF) maintaining negative pressure in the working zone.
- ~20% fresh air intake through pre-filters
- ~20% air exhausted through HEPA filters
- ~80% air recirculated
This ensures:
- Containment of powder
- Prevention of cross-contamination
- Operator safety
Airflow pattern is verified through smoke study (airflow visualization test).
10.0 INSTALLATION QUALIFICATION PROCEDURE
Check the installation of equipment :
- To verify the location of installation as per the equipment layout.
- To verify the proper assembly of the components as per the equipment drawings and record the installation location and verification of assembly in Form [A]
- To check the leveling and alignment as per the procedure and record the observation in Form [C].
- Identify the critical components of equipment and verify that the components are complying as per desired specifications and record the observations in Form [A & B].
- Check the MOC of the component and record the observation of the MOC in Form [D].
- Identify the utility supplies required for equipment operation and verify that utilities are as per the specification and record the observation in Form [H].
- Identify the critical instruments supplied with the equipment or installed on the utility supply line. Verify that instruments are as per the desired specifications. Review the calibration status of the instruments & record the status in Form [I].
- List the available drawing and record the Ref. No. for their location / availability in Form [F].
- Identify the SOPs and assign SOP Numbers, record the SOP Title and Number in Form [G].
- Record the deviation (if any) in Form [J] and report the details of action taken.
10.1 Installation Checklist [Form – A]
| S. No. | Description | Y/N/NA | Checked By | Verified By |
|---|---|---|---|---|
| 10.1.1 | Equipment installed as per layout | |||
| 10.1.2 | Electrical connections verified | |||
| 10.1.3 | Control panel positioning correct | |||
| 10.1.4 | Proper coving provided |
10.2 Inspection Checklist [Form – B]
The following inspection checklist shall be used to verify that all components of the Dispensing Booth comply with the specified design and technical requirements. Observations shall be recorded against each parameter during execution of Installation Qualification.
A. General Specifications
| Description | Specification |
|---|---|
| Overall Dimensions (W × D × H) | 1990 × 1450 × 2900 mm |
| Work Area Dimensions (W1 × D1 × H1) | 1800 × 1050 × 2000 mm |
| Level of Main Body | Perfectly Level |
| Machine Guards | SS 316 |
B. Filter System
| Description | Specification |
|---|---|
| Pre-Filter | 800 × 750/2 × 50 mm, Flange Type, Efficiency: 95% @ 10µ, MOC: SS 304, Make: CRP, Qty: 02 Nos. |
| Fine Filter | 750 × 700/2 × 75 mm, Flange Type, Efficiency: 95% @ 5µ, MOC: SS 304, Make: CRP, Qty: 02 Nos. |
| Pre-Filter Grill | 890 × 845 × 18 mm, Perforated Type, MOC: SS 304, Make: CRP, Qty: 02 Nos. |
| HEPA Filter | 1065 × 610 × 100 mm, Box Type, Efficiency: 99.99% @ 0.3µ, MOC: Aluminium Powder Coated, Make: CRP, Qty: 03 Nos. |
| HEPA Filter Grill | 1080 × 625 mm, Perforated Type, MOC: SS 304, Make: CRP, Qty: 03 Nos. |
| Exhaust Filter | 915 × 150 × 150 mm, Box Type, Efficiency: 90% @ 0.3µ, Make: CRP, Qty: 01 No. |
| Exhaust Filter Grill | 875 × 110 mm, Louver Type, MOC: SS 304, Make: CRP, Qty: 01 No. |
C. Structural Components
| Description | Specification |
|---|---|
| Side Frames | Right: 2000 × 1100 × 70 mm, Left: 2000 × 1100 × 35 mm, Double Skin, MOC: SS 304, Make: CRP, Qty: 01 each |
| Tube Light Diffuser | 1625 × 175 × 2 mm, MOC: Polycarbonate, Make: CRP, Qty: 01 No. |
| Work Table | 540 × 540 × 750 mm, Self-standing with M12 leveling jack, MOC: SS 304 perforated, Qty: 01 No. |
D. Mechanical & Electrical Components
| Description | Specification |
|---|---|
| Blower | Make: Dynamic Motor, Model: DB 24 S4, Rating: 3A, 660W, 230V, Speed: 1400 RPM, Airflow: 2570 CMH, Qty: 02 Nos. |
| CFL Light | Make: Philips, Rating: 36W, 230V, Type: 4 Pin, Qty: 03 Nos. |
| Chokes | Make: Philips, Rating: 40W, 230V, Qty: 03 Nos. |
| Tube Light Starter Base | Make: Anchor, Range: 2A, 240V, Qty: 03 Nos. |
| Starter | Make: Philips, Rating: 20–80W, 230V, Qty: 03 Nos. |
E. Instruments & Control System
| Description | Specification |
|---|---|
| Magnehelic Gauge | Make: Dwyer, Range: 0–25 mm WC, Qty: 02 Nos. |
| Magnehelic Gauge | Make: Dwyer, Range: 0–50 mm WC, Qty: 01 No. |
| MCB | Make: Indo Kupp, Rating: 4A, 230V, Qty: 02 Nos. |
| Keypad with Feather Touch Switch | Make: CRP, Type: CKP–UF–01, Qty: 01 No. |
| Module with Socket & Switch | Make: M.K., Rating: 6/16A, 250V, 4 Module, Qty: 02 Nos. |
(All specifications to be recorded against observations)
10.3 Leveling and Alignment [Form – C]
Method for Checking Leveling of Equipment
B.1 Using Spirit Level Indicator
- Place the spirit level indicator at various locations on the equipment frame.
- Observe the position of the air bubble.
Acceptance Criteria:
The air bubble of the spirit level indicator shall remain centrally aligned, indicating proper leveling of the equipment.
B.2 Using Water Level Indicator
- Use a transparent tube filled with water of suitable length.
- Place the tube at different corners of the equipment.
- Compare the water levels at both ends and adjust the equipment accordingly.
Acceptance Criteria:
The water level at both ends shall match with the reference edges, confirming that the equipment is level. This procedure shall be repeated for all sides on the same plane.
C. Method for Checking Alignment
C.1 Dial Indicator Method
- Mount the dial indicator on the coupling.
- Slowly rotate the shaft manually.
- Record the readings during rotation.
Acceptance Criteria:
The Total Indicator Reading (TIR) shall not exceed 0.305 mm.
C.2 Straight Edge Method
- Place a straight edge along the circumference of both driver and driven pulleys.
- Adjust the motor base to minimize any gap.
- Measure the gap using a filler gauge.
Acceptance Criteria:
The gap between the straight edge and pulleys shall be not more than 1.0 mm.
10.4 Material of Construction [Form – D]
A. Verification Table
The Material of Construction of critical components of the Dispensing Booth shall be verified as per specified requirements and recorded below:
| Name of Component | MOC Specification | Mode of Verification |
|---|---|---|
| Cabinet | SS 304 | Lab Test Report / Molybdenum Test |
| Work Table | SS 304 | Lab Test Report / Molybdenum Test |
| Side Panel | SS 304 | Lab Test Report / Molybdenum Test |
| Pre-Filter Housing | SS 304 | Lab Test Report / Molybdenum Test |
B. Method for Verification of Material of Construction (MOC)
(Molybdenum Test for Stainless Steel Identification)
The Molybdenum Test shall be performed to confirm the grade of stainless steel used in the equipment components.
Procedure:
Ensure that the metal surface to be tested is clean and free from contaminants.
Place one drop of electrolyte solution from the Molybdenum test kit onto the test surface.
Switch ON the detector.
Touch the metal probe of the detector to the test surface and the carbon electrode into the electrolyte solution.
Allow current to pass for not more than 3–4 seconds.
Observe the color change of the solution.
Acceptance Criteria:
| Observation | Interpretation |
|---|---|
| Red color appears and remains stable for more than 2 seconds | Material is SS 316 |
| No color change or green color appears | Material is SS 304 |
| Black color appears and remains stable for more than 2 seconds | Material is SS 302 |
10.5 Guarantee/Warranty [Form – E]
Blower warranty documentation
10.6 Drawings Verification [Form – F]
Wiring diagram
Equipment drawings
10.7 SOP Identification [Form – G]
| Type | SOP No. | Title |
|---|---|---|
| Operation | Operation of Dispensing Booth | |
| Cleaning | Cleaning Procedure | |
| Maintenance | Preventive Maintenance |
10.8 Utilities Check [Form – H]
Voltage: 230V
Power: ~1500W
Current: 15 Amps
10.9 Critical Instruments [Form – I]
Magnehelic Gauges for filter pressure monitoring
Calibration verification required
11.0 DEVIATION AND CORRECTIVE ACTION
All deviations shall be documented
Root cause analysis and CAPA required
QA approval mandatory
12.0 CHANGE CONTROL
All changes must be documented and approved through change control procedures.
13.0 REVALIDATION CRITERIA
Requalification required in case of:
Major component replacement
Equipment modification
Relocation of equipment
14.0 ACCEPTANCE CRITERIA
All checklist items (Forms A–K) must comply
No critical deviations
All utilities and instruments verified
15.0 SUMMARY
| Check | Observation | Remark |
|---|---|---|
| IQ Compliance | Yes/No |
16.0 CONCLUSION
The Dispensing Booth does / does not comply with the Installation Qualification requirements as per Protocol.
The equipment is recommended / not recommended for Operational Qualification (OQ).