Compression Machine IQ (Installation Qualification)
Compression Machine IQ is a documented verification process that the instrument or piece of equipment has been properly delivered, installed, and configured according to standards set by the manufacturer or by an approved installation checklist. Installation qualification of Compression machine IQ requirements for equipment includes checking for proper location, proper energy supply, and acceptable environmental conditions. There is also checking of contents against the packing list, verifying software installation, documenting computer-controlled instrumentation, verifying connections with peripherals, and recording calibration and validation dates, among others.
Table of content Compression Machine IQ
- Purpose
- Scope
- Responsibilities
- Procedure
- Installation Qualification tests
- Documents & Drawings Verification
- Verification of Technical Specifications 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 of Compression Machine IQ:
To describe the Installation Qualification procedure to be used during qualification of Single Rotary Tableting Machine-16 Station, its accessories and to define the specification of the system in order to:
- ensure that the equipment meets the specification as Design Qualification.
- 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 of Compression Machine IQ:
This procedure applies to the installation qualification of Single Rotary Tableting Machine-16 Station and its accessories to be installed.
- RESPONSIBILITIES:
- It is the responsibility of the Manufacturer to prepare the installation qualification protocol as per Design Qualification
- It is the responsibility of the client to check and approve the installation qualification protocol.
- It is the responsibility of the Manufacturer to perform all the specifications verification checks and tests with respect to installation qualification and compiling data in co-ordination with client.
PERFORMANCE QUALIFICATION FOR TABLET COMPRESSION
- Procedure of Compression Machine IQ:
The following requirement / practices apply to Single Rotary Tableting Machine-16 Station Installation Qualification activities:
- Verify that systems are installed in accordance with approved engineering drawings and documents, which shall include the following
- General arrangement drawing.
- Installation specification
- Equipment manuals
- 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.
- Compression Machine IQ Test:
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 –
None Required.
- Procedure –
- Verify that the required documents and drawings listed in the below table are available.
- Review the documents and drawings for completeness and exactness with the installed units.
- Attach the copies of the drawings 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.
- Documentation Verification Results.
| Sr. No | Description | Document No | Verified By | Date |
| 1 | Installation, Maintenance and Operation Manual | |||
| 2 | General arrangement drawing |
- Verification of Technical Specifications for In-House & sub-components / Bought out items
- Purpose
To verify that each major component of the Single Rotary Tableting Machine-16 Station 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 Single Rotary Tableting Machine-16 Station 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 design qualification 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 | ||||||||||
| Equipment Name | Single Rotary Tableting Machine | |||||||||
| Equipment Code | EQ/PR/125 | |||||||||
| Model No. | CPMD3-16 | |||||||||
| Serial No | 251/118 | |||||||||
| Turret RPM | Min = 16
Max = 42 |
|||||||||
| Output (Tablet/ Hour) | Min = 15360
Max = 40320 |
|||||||||
| Hopper capacity | 21 Liter | |||||||||
| No of Hopper | 1 Nos. | |||||||||
| Tablet diameter | Max = 25.4 mm | |||||||||
| Depth of fill | 20 mm | |||||||||
| Max. Operating pressure | 10 Tons | |||||||||
| Overall dimensions (in mm, with guards open) | 900 (L) X 975 (W) X 2050 (H) | |||||||||
| 2. Electrical / Mechanical | ||||||||||
| 2.1. Main Motor | ||||||||||
| Type | 3 Phase Induction motor, foot mounted | |||||||||
| Sr. No. | K5608544 | |||||||||
| Make | Bharat Bijlee | |||||||||
| Capacity | 2.0HP, 935RPM, 415V, 50Hz ± 5 | |||||||||
| 2.2. VFD | ||||||||||
| Model | Powerflex-40 | |||||||||
| Sr. No. | BD010NOW5420082 | |||||||||
| Cat. No. | 22B-D010N104 | |||||||||
| Make | Allen Bradley | |||||||||
| 2.3. Hydraulic Gauge | ||||||||||
| Sr. No. | 06-03/212 | |||||||||
| Range | 0-10 Tons | |||||||||
| Least Count | 0.25 | |||||||||
| Make | Clit | |||||||||
| 2.4. Oil Pump | ||||||||||
| Model No. | AM | |||||||||
| Sr.No. | 1120 | |||||||||
| Make | CPMPL | |||||||||
| 2.5. Safety Guard Interlock Switch | ||||||||||
| Qty. | 04 Nos. | |||||||||
| Sr. Nos. | 5/18413, 6/00311,
5/10511, 6/00300 |
|||||||||
| Make | KATLAX | |||||||||
| 2.6. Upper Punch Sensor | ||||||||||
| Sr. No. | 7746-03/06 | |||||||||
| Power rating | 10-35 VDC | |||||||||
| Make | Osna Electronics | |||||||||
| 2.7. V-Belt | ||||||||||
| Size | C-85 | |||||||||
| Qty. | 01 Nos. | |||||||||
| 3. Control Panel | ||||||||||
| 3.1. Main Drive | ||||||||||
| Controls | Stop, Start Push buttons | |||||||||
| Qty.
|
02 Nos. | |||||||||
| 3.2. Electro Magnetic Clutch | ||||||||||
| Controller | Engage, Disengage push buttons. | |||||||||
| Qty. | 02 Nos. | |||||||||
| 3.3. Safety Guard Interlock / Bypass Switch | ||||||||||
| Qty. | 01 No. | |||||||||
| 3.4. Digital Counter | ||||||||||
| Type | 7 digit counter | |||||||||
| Model | MC-203 | |||||||||
| Sr. No. | 06041010 | |||||||||
| Options | RPM/ Count/ Pr. Rate | |||||||||
| 3.5. Ampere Meter | ||||||||||
| Make | Rishabh | |||||||||
| Location | Control Panel | |||||||||
| Range | 0-5 | |||||||||
| 3.6. Emergency Switch | ||||||||||
| Qty. | 01 No. | |||||||||
- 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 connection | To be provided | |||
- Material of Construction Verification for Compression Machine IQ
- Rationale –
To verify that all assembly of Single Rotary Tableting Machine-16 Station 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 SS316 & if the solution turns pink and immediately vanishes, then it is SS304
- Acceptance Criteria
- All material of construction for the Single Rotary Tableting Machine-16 Station shall meet the MOC provided in Design Qualification.
- 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 | Signature | Date |
| Turret | SGI | ||||
| Turret Diepot Ring | SS 316 | ||||
| Discharge Spout | SS316 | ||||
| Hopper | SS316 | ||||
| Hopper Lid | SS316 |
- Critical Instrument Calibration Verification for Compression Machine IQ
- Rationale –
To verity that all critical instruments for the Single Rotary Tableting Machine-16 Station 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 certificates to this document.
- Acceptance Criteria
- All critical instrumentation for the Single Rotary Tableting Machine-16 Station shall be in a state of calibration.
- Instrumentation List Results
| Description | Make | Least Count | Set point Operating Range | Current
Calibration |
|
| Yes/No | Sign / Date | ||||
| Hydraulic Gauge | Clit | 0.3 | 0-10 tons | ||
- Compression Machine IQ Tests Status
The table below lists the tests performed and related results.
| Test Number
|
Critical Feature
|
Pass / Fail | |
| Pass | Fail | ||
| 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 | ||
| 5.5 | Critical Instrument calibration verification | ||
- Data Analysis, Summary of IQ & Recommendations
- AMENDMENT RECORD
Sr. No. |
Item Name |
Remarks |
Signature & Date |
Note: Any changes made in the system must be recorded in this sheet.
- CONCLUSION
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