- PURPOSE
- To describe the Installation Qualification of Vertical Laminar Reverse Flow Containment
- Station and to define the Specification of the system in order to:
- Ensure that the equipment meets the specification as per Design Qualification.
- Aid verification of the installation as per equipment general arrangement drawing.
- Ensure that the system installation meets acceptance criteria.
- Ensure that the equipments will be installed in accordance with current Good manufacturing Practices.
- SCOPE
- The scope of this document applies to the installation qualification of Vertical Laminar Reverse Flow Powder Containment Station.
- RESPONSIBILITIES
- It is the responsibility of the Manufacturer to perform all the specifications verification checks and tests with respect to installation qualification and compiling data in co-ordination with client.
- It is the responsibility of the client to check and approve the installation qualification.
- PROCEDURE
- The following requirement / practices apply to Vertical Laminar Reverse Flow Powder Containment Station, Installation Qualification activities:
- Verify that systems are installed in accordance with approved engineering drawings and documents, which shall include the following
- General arrangement drawing.
- Installation specification; and
- Equipment manuals
- Verify that the equipment and instrumentation are clearly described as per vendor, model, capacity, materials of construction and any critical criteria.
- Verify that major components are tagged or labelled with a unique ID number.
- INSTALLATION QUALIFICATION TESTS
- The table below lists the tests to be performed as part of the Installation Qualification phase.
| TEST NUMBER | CRITICAL FEATURE |
| 5.1 | Documents & Drawings Verification |
| 5.2 | Verification of Technical Specification for
In-House & sub-components / bought out items |
| 5.3 | Utilities Verification |
| 5.4 | Material of Construction verification |
| 5.5 | Critical Instrument Calibration Verification |
- Documents & Drawings Verification
- Rationale – To verify that the documentation provides complete and correct technical references and permits servicing of the units.
- Test equipment – None Required.
- Procedure –
- Verify that the required documents and drawings listed in the table 5.1.5 are available.
- Review the documents and drawings for completeness and exactness with the installed units.
- Attach the copies of the drawings to this document or reference the location from where they can be easily retrieved.
- Any items in the installation, which are not conforming to the corresponding drawings, must be commented on in the appropriate space. List the non-conformances and the reasons for them in an attachment if necessary.
- Acceptance Criteria –
- The documents must be accurate and complete.
- The drawing information must correspond to the physical installation.
- Drawing Verification Results:
| Sr. No. | Description | Document No. | Verified By | Date |
| 1 | Installation, Operation and Maintenance Manual | |||
| 2 | General arrangement drawing |
- Conclusions / Comments:
- Verification of Technical Specification for In-House & sub-components / Bought out items
- Purpose – To verify that each major component of the Vertical Laminar Reverse Flow Powder Containment Station, are present and identified.
- Test Equipment – None Required
- Procedure- Confirm that identification nameplates have been applied to the units and that these indicate the following (where applicable).
- – Type
- – Identification (Tag) No.
- – Manufacturer
- – Model Number
- Confirm that the various components of Vertical Laminar Reverse Flow Powder Containment Station are present and tagged as per specifications and drawings, in the proper number and configuration.
- Note any deviations or discrepancies and recommend follow up action if required.
- Acceptance Criteria – All units and parts specified in design qualification and on latest revision of drawings must be present, documented and tagged.
- Major Components Results
| Description | Specification | Meets
Spec. (Yes/No) |
Verification Source | Sign. | Date |
| 1. Equipment Description | |||||
| Name | Vertical Laminar Reverse Flow Powder Containment Station Model: 2256-RF-SS-SP-4 | ||||
| Hepa Area | 1900 mm(L) X1900 mm (W) | ||||
| Overall dimensions | 2050 mm (W) X 2565 mm (D)X 2535 mm (H) | ||||
| 2. HEPA filter (Exhaust) | |||||
| Sr. No. | 318, 320 | ||||
| Micron Rating | 0.3µ | ||||
| Filter Efficiency | 99.997% of 0.3µ | ||||
| Size | 24” x 06” x 03” | ||||
| Filter media | Micro Fibre Glass | ||||
| Batch No. | 07/06 | ||||
| Type | T/E | ||||
| Grade | I | ||||
| Rated Capacity | 150 CFM | ||||
| Pressure Drop | 25 mm | ||||
| Performance Type | Vertical | ||||
| Make | |||||
| Qty. | 02 Nos. | ||||
| 3. HEPA filter | |||||
| Sr. No. | 324,321,323,326,325,322 | ||||
| Micron Rating | 0.3µ | ||||
| Filter Efficiency | 99.997 % of 0.3µ | ||||
| Size | 36” x 24” x 03” | ||||
| Filter media | Micro Fibre Glass | ||||
| Batch No. | 07/06 | ||||
| Type | T/E | ||||
| Grade | I | ||||
| Rated Capacity | 1080 CFM | ||||
| Pressure Drop | 25 mm | ||||
| Performance Type | Vertical | ||||
| Make | |||||
| Qty. | 06 Nos. | ||||
| 4. Intermediate Filter | |||||
| Sr. No. | 275, 276, 277 | ||||
| Micron Rating | 3µ | ||||
| Filter Efficiency | 70-65% on ASHRAE STD 52-76 equivalent to 99% on BS- 2831 Test Dust II for Particles down to
3 m |
||||
| Size | 24” x 18” x 06” | ||||
| Flow Rate | 750 cfm at 0.20” | ||||
| Filter media | Fibre Glass Media | ||||
| MOC of frame | S.S. | ||||
| Gasket | Neoprene | ||||
| Make | |||||
| Qty. | 03 Nos. | ||||
| 5. Prefilter | |||||
| Sr. No. | 281, 282, 283 | ||||
| Micron Rating | 5µ | ||||
| Filter Efficiency | 60-65 % on ASHRAE STD 52-76 equivalent to 98% on BS- 2831 Test Dust II for Particles down to
5 m |
||||
| Size | 30” x 24” x 03” | ||||
| Flow Rate | 625 cfm at 0.15” | ||||
| Filter media | Fibre Glass Media | ||||
| MOC of frame | S.S. | ||||
| Gasket | Neoprene | ||||
| Make | |||||
| Qty. | 03 Nos. | ||||
| 6. Blower Motor | |||||
| Sr. No. | 615, 619, 629, 116 | ||||
| Type | Single phase, Induction Motor | ||||
| Motor Construction | Non Flame Proof | ||||
| Power Rating | 0.37 KW / 0.5 HP / 230 V / 50 Hz / 1400 RPM | ||||
| Make | West End Electricals | ||||
| Qty. | 04 Nos. | ||||
| 7. Differential Pressure Gauge Across Prefilter | |||||
| Sr. No. | W21REB | ||||
| Range | 0-10 mm WC | ||||
| Least Count | 0.2 mm WC | ||||
| Model | 2000-10 MMC | ||||
| Max. Pressure | 15 PSIG | ||||
| Make | Dwyer | ||||
| 8. Differential Pressure Gauge Across Intermediate filter | |||||
| Sr. No. | RO60124WH48 | ||||
| Range | 0-25 mm WC | ||||
| Least Count | 0.5 mm WC | ||||
| Model | 2000-25MMC | ||||
| Max. Pressure | 15 PSIG | ||||
| Make | Dwyer | ||||
| 9. Differential Pressure Gauge Across HEPA Filter | |||||
| Sr. No. | R060405AV05 | ||||
| Range | 0-50 mm WC | ||||
| Least Count | 1 mm WC | ||||
| Model | 2000-50 MMC | ||||
| Max. Pressure | 15 PSIG | ||||
| Make | Dwyer | ||||
- Conclusions / Comments:
- Utilities Verification
- Rationale – To verify that all necessary utilities are correctly installed.
- Procedure:
- Confirm that utilities connections are configured as per specification and in compliance with local codes.
- Record the results in the table below. Note any deviations or discrepancies.
- Acceptance Criteria – All services and connections must be installed and documented.
- Utilities Specification Results
| Description | Specified | Observation | Initial / Date
mm/dd/yy |
|
| Electrical | To be provided | |||
- Conclusions / Comments:
- Material of Construction Verification
- Rationale – To verify that all assembly of Vertical Laminar Reverse Flow Powder Containment Station has been manufactured as per the specification provided by the customer.
- Test equipment – Moly testing unit (To identify SS 304 and SS 316 materials)
- Procedure:
- Put a drop of Molybdenum solution on the material to be tested.
- Take battery & keep anode at one end of the material and cathode at Moly drop.
- If the solution turns pink and stays for around one minute, then it is SS 316 & if the solution turns pink and immediately vanishes, then it is SS 304.
- Acceptance Criteria:
- All material of construction for the Vertical Laminar Reverse Flow Powder Containment Station, shall meet the MOC provided in Design Qualification.
- Material other than SS 316 and SS 304 are verified based on their material testing certificates provided by the Manufacturer.
- Material of Construction verification Results
| Description | Specification | Meets
Spec. (Yes/No) |
Verification Source | Initials | Date |
| Module of equipments | SS 304 [18 G] | ||||
| Side Panels | SS 304 [18 G] | ||||
| Table | SS 304 [18 G] |
- Conclusions / Comments:
- Critical Instrument Calibration Verification
- Rationale – To verify that all critical instrument for the Vertical Laminar Reverse Flow Powder Containment Station has been calibrated before starting the Operational Qualification.
- Procedure:
- Verify that all critical instruments are calibrated using an approved procedure, against a traceable standard.
- Note any deviations or discrepancies and recommend follow up actions if required.
- For all critical instruments, attach copies of calibration certificate to this protocol.
- Acceptance Criteria – All critical instrumentation for Vertical Laminar Reverse Flow Powder Containment Station shall be in a state of calibration.
- Critical Instrument Calibration Verification
| Description | Make | Sr. No. | Verification Source | Operating Range | Current
Calibration |
|
| Yes/No | Sign / Date | |||||
| Differential Pressure Gauge Across HEPA | Dwyer | R060405AV05 | ||||
| Differential Pressure Gauge Across Intermediate Filter | Dwyer | RO60124WH48 | ||||
| Differential Pressure Gauge Across Prefilter | Dwyer | W21REB | ||||
- Conclusions / Comments:
- The table below lists the tests performed and related results.
| Test Number
|
Critical Feature
|
Pass | Fail | Deviation Found | |
| Yes | No | ||||
| 5.1 | Documents & Drawings Verification | ||||
| 5.2 | Verification of Technical Specification for In-House & Sub-contract / bought out items. | ||||
| 5.3 | Utility Verification | ||||
| 5.4 | Material of Construction Verification | ||||
| 5.5 | Critical Instrument Calibration Verification | ||||
- Data ANALYSIS, Summary of IQ & Recommendations
- AMENDMENT RECORD
Sr. No. |
Item Name |
Remarks |
Signature & Date |
- Note: Any changes made in the system must be recorded in this sheet.
- CONCLUSION
-
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