INSTALLATION QUALIFICATIONS OF DISPENSING BOOTH

INSTALLATION QUALIFICATIONS OF DISPENSING BOOTH

TABLE OF CONTENT

  • Purpose
  • Scope
  • Responsibilities
  • Procedure
  • Installation Qualification tests
    • Documents & Drawings Verification
    • Verification of Technical Specification for In-House & sub-components / Bought out items
    • Utilities Verification
    • Material of Construction Verification
    • Critical Instrument Calibration Verification
    • Installation Qualification Tests Status
  • Data Analysis, Summary of IQ & Recommendations
  • Amendment Record
  • Conclusion

 

  • PURPOSE

To describe the Installation Qualification of Dispensing Booth, its accessories and to define the Specification of the system in order to:

  • 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 Dispensing booth  and its accessories to be installed at Sano Cito Therapeutic Inc. (Unit-II).Vill. Loharan P.O. Ghatti, Solan -173211 (H.P)

 

  • RESPONSIBILITIES:
    • It is the responsibility of the Validation Team to prepare and check installation qualification protocol.
    • It is the responsibility of the Quality Assurance approve the installation qualification protocol.

 

  • PROCEDURE

The following requirement / practices apply to Klenzaids Bioclean Devices (P) Ltd., Dispensing Booth, Installation Qualification activities:

 

  • Verify that systems are installed in accordance
    • General arrangement drawing.
    • Installation specification; and
  • 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  NUMBERCRITICAL FEATURE
5.1Documents & Drawings Verification
5.2Verification of Technical Specification for

In-House & sub-components / bought out items

5.3Utilities Verification
5.4Material of construction verification
5.5Critical 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 –

Not Required.

 

  • Procedure –
    • Verify that the required documents and drawings listed in the table 5.1.5 is 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. NoDescriptionDocument NoVerified ByDate
1General arrangement drawing

 

 

 

 

 

 

Conclusions / Comments:

 

 

 

 

 

 

 

PASS                                      FAIL

Verified  By:     _______________________            Date:   ______________

 

Checked By:   ________________________            Date:     ______________

 

 

  • Verification of Technical Specification for In-House & sub-components / Bought out items
    • Purpose

To verify that each major component of the Klenzaids Product, Dispensing Booth, 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)

– Manufacturer

– Model Number

  • Confirm that the various components of Klenzaids Product, Dispensing Booth, 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 drawings must be present, documented and tagged.

 

 

  • Major Components Results

 

DescriptionSpecificationMeets

Spec. (Yes/No)

Verification SourceInitialsDate
1.              Equipment Description
NameDispensing Booth Model: OFCF-32
Overall dimensions1870 mm (W) x 2800 mm (L) x 2480 mm (H)
2.                HEPA Filter (Exhaust)
Sr. No.242/0902,243/0902
Micron Rating0.3µ
Filter Efficiency99.97% of 0.3µ
Size1205 mm x170mm x75mm
Filter mediaFiber Glass
MakeKlenzaids Bioclean Devices (P) Ltd.
Qty.02 Nos.
3.              HEPA Filter
Sr. No.238/0902,239/0902, 240/0902
Micron Rating0.3µ
Filter Efficiency99.97% of 0.3µ
Size1220 mm x 610mm x75mm
Filter mediaFiber Glass
MakeKlenzaids Bioclean Devices (P) Ltd.
Qty.03 Nos.
4.              HEPA Filter
Sr. No.241/0902
Micron Rating0.3µ
Filter Efficiency99.97% of 0.3µ
Size1220 mm x 640mm x75mm
Filter mediaFiber Glass
MakeKlenzaids Bioclean Devices (P) Ltd.
Qty.01 Nos.
5.              Intermediate Filter
Sr. No.BL, BR
Micron Rating
Size1140 mm x 420 mm x 45 mm
Flow Rate750 cfm at 0.20”
Filter mediaFiber Glass Media
MOC of frameS.S.
GasketNeoprene
Qty.02 Nos.
6.              Prefilter
Sr. No.B-1, B-2, B-3 & B-4
Micron Rating
Size910 mm x 600 mm x  45mm
Flow Rate625 cfm at 0.15”
Filter mediaFiber Glass Media
MOC of frameS.S.
GasketNeoprene
Qty.04 Nos.
7.              Motor Blower
Sr. No.199/0902, 200/0902
Motor ConstructionNon Flame Proof
Power Rating1.0 HP / 3 ph / 415 v / 1.8 amp
Motor RPM1440 rpm
MakeKlenzaids Bioclean Devices (P) Ltd.
Qty.02 Nos.
8.               Magnehelic Pressure Gauge
Range0-25 mm WC
Leas count0.5 mm WC
MakeDwyer

 

 

 

 

 

Conclusions / Comments:

 

 

 

 

 

PASS                                      FAIL

 

Verified By:                ________________________            Date:   ______________

 

Reviewed By:                         ________________________            Date:   ______________

 

  • 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

 

DescriptionSpecifiedObservationInitial / Date

mm/dd/yy

ElectricalTo be provided

 

 

 

 

 

 

 

Conclusions / Comments:

 

 

 

 

 

 

PASS                                      FAIL

 

Verified By:                ________________________            Date:   ______________

 

Reviewed By:                         ________________________            Date:   ______________

 

 

  • Material of Construction Verification

 

  • Rationale –

To verify that all assembly of Klenzaids Product, Dispensing Booth has been manufactured as per the specification provided by the customer.

 

  • Test equipment –

Moly testing unit (To identify 304 or 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 Klenzaids Product, Dispensing Booth, shall meet SS 304 std.
    • Material other than SS316 and SS304 are verified based on their material testing certificates provided by the Manufacturer.

 

 

 

  • Material of Construction verification Results

 

DescriptionSpecificationMeets

Spec. (Yes/No)

Verification SourceInitialsDate
Body of equipmentS.S. 304 [18 SWG]

 

Conclusions / Comments:

 

 

 

 

 

PASS                                      FAIL

Verified By:                ________________________            Date:   ______________

 

Reviewed By:                         ________________________            Date:   ______________

 

 

  • Critical Instrument Calibration Verification

 

  • Rationale-

To verify that all critical instrument for the Dispensing Booth 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 Open Fronted Containment Facilities shall be in a state of calibration.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

  • Critical Instrument Calibration Verification
DescriptionManufacturerCurrent

Calibration

Yes/NoSign / Date
Megnehelic Gauge

 

 

Conclusions / Comments:

 

 

 

 

 

 

PASS                                      FAIL

 

Verified By:                ________________________            Date:   ______________

 

Reviewed By:                           _______________________            Date:   ______________

 

 

  • Installation Qualification Tests Status

The table below lists the tests performed and related results.

Test Number

 

Critical Feature

 

Pass / FailDeviation Found
PassFailYesNo
5.1Documents & Drawings Verification
5.2Verification of Technical Specification for In-House & Sub-contract / bought out items.
5.3Utility Verification
5.4Material of Construction Verification
5.5Critical Instrument Calibration Verification

 

 

 

 

 

 

 

 

 

 

 

 

 

  • Data ANALYSIS, Summary of IQ & Recommendations

 

 

 

 

 

 

 

 

 

 

 

 

   7.0       AMENDMENT RECORD

 

S. No.

Item Name

Remarks

Signature & Date

 

    Note : Any changes made in the system must be recorded in this sheet.

 

 

8.0   CONCLUSION

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Prepared by                                                     Reviewed by                                       Approved by

 

Qualifications & Validations