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
- Installation Qualification Tests Status
- Data Analysis, Summary of IQ & Recommendations
- Amendment Record
- Conclusion
- PURPOSE
To describe the Installation Qualification of Coating Machine and to define the Specification of the system in order to:
- ensure that the equipment meets the intended specification.
- aid verification of the installation as per equipment general arrangement
- 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 Coating Machine to be installed at Pharmaceutical company.
- RESPONSIBILITIES:
- It is the responsibility of the Validation Team to prepare and check the installation qualifications protocol.
- It is the responsibility of the Quality Assurance to approve the installation qualification protocol.
- It is the responsibility of the Validation Team to perform and check all the specifications verification checks with respect to installation qualifications protocol and compiling data.
- It is the responsibility of the Quality Assurance to approve the installation qualification.
- PROCEDURE
- The following requirement/practices apply to Coating Machine installation
qualifications activities:
Verify that system is installed in accordance with approved engineering drawings and documents which shall include the following.
- Equipment manuals.
- Installation specification; and.
- General arrangement drawing.
- 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 | |
| Installation Qualification Tests Status |
- 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 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.
- Documentation Verification Results.
| Sr. No. | Description | Document No | Verified By | Date |
| 1 | Installation, Operation and Maintenance Manual | |||
| 2 | General arrangement drawing |
- Verification of Technical Specification for In-House & sub-components /
Bought out items
- Purpose
To verify that each major component of the Coating Machine 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 Coating Machine 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 and on latest revision of drawings must be present, documented and tagged.
- Major Components Results
| Description | Specification | Meets
Spec. (Yes/No) |
Verification Source | Signature | Date | ||||
| 1. Equipment Description | |||||||||
| Name | Coating Machine | ||||||||
| Make | Chamunda Pharma | ||||||||
| Machine No. | 51/7 | ||||||||
| Model | CPM C36 GMP | ||||||||
| Capacity | 32 Kg | ||||||||
| Specification | Non Flame proof construction | ||||||||
| Overall dimensions | 1680 mm(L) X 920 mm(W) X 1500 mm(H) | ||||||||
| 2. Main Motor | |||||||||
| Sr. No. | 69028396 | ||||||||
| Model | Flange Mounted | ||||||||
| Power Rating | 3Ph / 50 Hz / 415 V / 1.5 HP | ||||||||
| Make | NGEF | ||||||||
| RPM | 1440 | ||||||||
| 3. Worm Reduction Gear Box | |||||||||
| Sr. No. | 4R 56185 | ||||||||
| Type | A337 | ||||||||
| Ratio | 70/1 | ||||||||
| Make | Greaes Gears | ||||||||
| 4. V – Belt | |||||||||
| Belt No. | B62/1575 | ||||||||
| Make | Rilton Roulunds | ||||||||
| Qty. | 01 | ||||||||
| 5. Blower Motor | |||||||||
| Sr. No. | 69028274 | ||||||||
| Model | Flange Mounted | ||||||||
| Power Rating | 3Ph / 50 Hz / 415 V / 0.5 HP | ||||||||
| Make | NGEF | ||||||||
| RPM | 1365 | ||||||||
| 6. Electric Heater | |||||||||
| Power Rating | 3 kw | ||||||||
| Location | Blower Assembly | ||||||||
| 7. Temp. Adjustment Dial | |||||||||
| Location | Above Main Motor Covering | ||||||||
| Range | 0-110 0 C | ||||||||
| Least Count | 50C | ||||||||
| 8. Control Panel | |||||||||
| Main Motor START / STOP Switch | 01 No. Each | ||||||||
| Blower Motor START / STOP Switch | 01 No. Each | ||||||||
| Machine ON Indicator | 01 No. | ||||||||
- Equipment Number Identification
| Equipment Name | Sr. No. | Equipment no.
(If applicable) |
Checked By | Date |
| Main Motor | _______ | |||
| Blower Motor | _______ | |||
| Worm Reduction Gear Box | _______ |
5.3.1 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. Note any deviations or discrepancies.
- Acceptance Criteria
- All services and connections must be installed and documented.
- Utilities Specification Results
| Description | Specified | Observation | Initial / Date |
| Electrical connection | To be provided |
- Material of Construction Verification
- Rationale –
To verify that all assembly of Coating Machine has been manufactured as per the specification provided by the customer.
- Test equipment –
Moly testing unit (To identify SS 304 or 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 Coating Machine shall meet the MOC mentioned in Specification Column.
- 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 | Signature | Date |
| Coating Pan | SS 316 | ||||
| Hot Air SS braided hose | SS 316 |
- 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 | Utilities Verification | ||||
| 5.4 | Material of Construction Verification | ||||
- Data Analysis, Summary of IQ & Recommendations
- AMENDMENT RECORD
| Sr. No. | Item Name | Remarks | Signature and Date |
Note: Any changes made in the system must be recorded in this sheet.
CONCLUSION