INSTALLATION QUALIFICATIONS OF DISPENSING BOOTH

December 9, 2020February 11, 2023 ABHA

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	3µ
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	5µ
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
Test Number	Critical Feature	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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S. No.

Item Name

Remarks

Signature & Date

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

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