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Installation Qualification of Vertical Laminar Reverse Flow Containment Station

  • 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
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
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.

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