INSTALLATION QUALIFICATION PROTOCOL 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 Open Fronted Containment Facility, 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 Open Fronted Containment Facility 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 Klenzaids Bioclean Devices (P) Ltd., Open Fronted Containment Facility, 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 |
| 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 |
- 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-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 | General arrangement drawing |
- Verification of Technical Specification for In-House & sub-components / Bought out items
- Purpose
To verify that each major component of the Klenzaids Product, Open Fronted Containment Facility, 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, Open Fronted Containment Facility, 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 | Open Fronted Containment Facility Model: OFCF-32 | ||||
| Overall dimensions | 1870 mm (W) x 2800 mm (L) x 2480 mm (H) | ||||
| 2. HEPA Filter (Exhaust) | |||||
| Sr. No. | |||||
| 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. | |||||
| 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. | |||||
| 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. | |||||
| 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. | |||||
| 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. | |||||
| 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 | ||||
- 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 | |||
- Material of Construction Verification
- Rationale –
To verify that all assembly of Klenzaids Product, Open Fronted Containment Facility 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, Open Fronted Containment Facility, 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] |
Critical Instrument Calibration Verification
- Rationale-
To verify that all critical instrument for the Open Fronted Containment Facility 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 hall be in a state of calibration.
- Critical Instrument Calibration Verification
| Description | Manufacturer | Current Calibration | ||
| Yes/No | Sign / Date | |||
| Megnehelic Gauge | ||||
- 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 | ||
| Documents & Drawings Verification | |||||
| Verification of Technical Specification for In-House & Sub-contract / bought out items. | |||||
| Utility Verification | |||||
| Material of Construction Verification | |||||
| Critical Instrument Calibration Verification | |||||
- Data ANALYSIS, Summary of IQ & Recommendations
- AMENDMENT RECORD
| S. No. | Item Name | Remarks | Signature & Date |
Note : Any changes made in the system must be recorded in this sheet.
CONCLUSION
