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 Pharmaceutical Company.

  • 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 ________________, 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  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 –

Not Required.

  • Procedure –
    • Verify that the required documents and drawings listed in the table 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-conformance 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 General 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 ____________, Dispensing Booth, are present and identified.

  • Test Equipment

Not 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 ___________, 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

Description Specification Meets

Spec. (Yes/No)

Verification Source Initials Date
1.              Equipment Description
Name Dispensing Booth Model: OFCF-32
Overall dimensions 1870 mm (W) x 2800 mm (L) x 2480 mm (H)
2.                HEPA Filter (Exhaust)
Sr. No. 242/0902,243/0902
Micron Rating 0.3µ
Filter Efficiency 99.97% of 0.3µ
Size 1205 mm x170mm x75mm
Filter media Fiber Glass
Make Klenzaids Bioclean Devices (P) Ltd.
Qty. 02 Nos.
3.              HEPA Filter
Sr. No. 238/0902,239/0902, 240/0902
Micron Rating 0.3µ
Filter Efficiency 99.97% of 0.3µ
Size 1220 mm x 610mm x75mm
Filter media Fiber Glass
Make Klenzaids Bioclean Devices (P) Ltd.
Qty. 03 Nos.
4.              HEPA Filter
Sr. No. 241/0902
Micron Rating 0.3µ
Filter Efficiency 99.97% of 0.3µ
Size 1220 mm x 640mm x75mm
Filter media Fiber Glass
Make Klenzaids Bioclean Devices (P) Ltd.
Qty. 01 Nos.
5.              Intermediate Filter
Sr. No. BL, BR
Micron Rating
Size 1140 mm x 420 mm x 45 mm
Flow Rate 750 cfm at 0.20”
Filter media Fiber Glass Media
MOC of frame S.S.
Gasket Neoprene
Qty. 02 Nos.
6.              Prefilter
Sr. No. B-1, B-2, B-3 & B-4
Micron Rating
Size 910 mm x 600 mm x  45mm
Flow Rate 625 cfm at 0.15”
Filter media Fiber Glass Media
MOC of frame S.S.
Gasket Neoprene
Qty. 04 Nos.
7.              Motor Blower
Sr. No. 199/0902, 200/0902
Motor Construction Non Flame Proof
Power Rating 1.0 HP / 3 ph / 415 v / 1.8 amp
Motor RPM 1440 rpm
Make Klenzaids Bioclean Devices (P) Ltd.
Qty. 02 Nos.
8.               Magnehelic Pressure Gauge
Range 0-25 mm WC
Leas count 0.5 mm WC
Make Dwyer

 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
Description Specified Observation Initial / Date

mm/dd/yy

Electrical To be provided

Conclusions / Comments:

PASS                                      FAIL

Verified By:                ________________________            Date:   ______________

Reviewed By:             ________________________            Date:   ______________ 

  • Material of Construction Verification 
  • Rationale –

To verify that all assembly of ______________, 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 ____________, 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
Description Specification Meets

Spec. (Yes/No)

Verification Source Initials Date
Body of equipment S.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
Description Manufacturer Current

Calibration

Yes/No Sign / 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 / Fail Deviation Found
Pass Fail 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

   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

Preparation, Approval, Issue and Control of Art works for labeling of drug products

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