- Objective
- Instrument Description & Identification
- Installation Check List
- Major Components
- Utilities
- Standard Operating Procedure / Calibration Procedure
- Installation Verification
- Summary of Installation Qualification
- Qualification of the unit installation and examination of all background information is performed to assure conformance to Rene Industries Limited and the manufacturer's specifications.
- The Instrument meets the current regulatory requirements.
- No unauthorized or unrecorded modifications have taken place.
- Standard Operating Procedures (SOP), Calibration Procedures, and Checklist have been identified and listed.
- All critical instrumentation has been identified.
- All utilities are properly connected.
- All test reports, drawings, and manuals, are available and maintained
- Special cam drive ensures jerks-free movement
- The instrument would stroke for 30 strokes/minute and with a stroke height of 55mm.
- Instruments have an easy-loading system of baskets with swivel-free movement through a simple nap
- The instrument works in two different mode
- Timer mode: In this mode, the basket stroke for the programmed time and park itself on the opposition at the end of the test to give an alarm. Programmable timers can be set from seconds to minutes and minutes to hours.
- Manual Mode: In this mode, the display shows ---------. No time is displayed in this mode. The elapsed time can be viewed by pressing the Timer Key. The display will display the elapsed time for about 5 Sec. When the test is over & instrument is stopped, the total integration time can be seen by pressing the Timer key
- Instrument works in the temperature range of 20°C to 39.9°C with an accuracy of ± 0.5°C
Manufacturer | Electrolab |
Instrument name | Disintegration Apparatus |
Instrument ID | |
Model Number | ED 2L |
Serial No |
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3. INSTALLATION CHECKLIST
Sr. No. | Item |
3.1 | Instrument appearance check |
3.2 | Parts Check |
3.3 | Installation site check |
Sr. No. | Item | Observation | Checked by |
3.1 | Instrument appearance check |
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3.2 | Part Check | ||
3.2.1 | Basic Machine |
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3.2.2 | Bath |
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3.2.3 | Beaker 2Nos. |
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3.2.4 | Basket Assembly 02 Nos. |
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3.2.5 | Guided disk clear 12 Nos. |
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3.2.6 | Manual |
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3.2.7 | Main cord 1No |
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3.2.8 | Temperature probe |
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3.3 | Installation site Check | ||
3.3.1 | Room temperature (15°C to 30°C) |
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3.3.2 | Humidity |
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3.3.3 | Corrosive Gases |
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3.3.4 | Free from excess dust and moisture |
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3.3.5 | Vibration Free |
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3.3.6 | Away from direct sunlight |
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3.4 | Equipment Connection Check | ||
3.4.1 | Power cable and control cable connection of Instrument |
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- Basic unit
- Water bath
- Basket assembly
- Beakers
- Tube holder
- Tubes
- Mesh
- Disk
- Motor
- Control panel
Description | Specified | Checked By | |
Make | Electrolab |
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Model No. | ED 2L |
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Serial No. | NA |
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Overall Dimensions | 350 x 350 x 510 mm |
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Base Plate | Size | 350 x 350 mm |
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Installation Consideration | Yes/No |
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Properly mounted, supported & connected | Yes/No |
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Properly labeled / Identified | Yes/No |
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Description | Specified | Checked By |
Beakers | ||
Beaker-1 | ||
Capacity | 1000ml |
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Height | 142mm - 148mm |
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Outside Diameter | 103mm - 108mm |
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Beaker-2 | ||
Capacity | 1000ml |
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Height | 142mm - 148mm |
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Outside diameter | 103mm - 108mm |
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Installation Consideration | Yes/No |
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Properly mounted, supported & connected | Yes/No |
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Properly labeled / Identified | Yes/No |
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Point of electric connection | 1 No. of 230 V AC 50Hz, 5 Amp Socket |
Power supply | 230 VAC, 50Hz ± 10% should be free from electric noise |
Frequency | 50 Hz |
Power Capacity | 700 VA |
Title | Number | Checked By |
Operation Procedure of Disintegration Tester |
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Calibration Procedure of Disintegration Tester |
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7. INSTALLATION VERIFICATION
Sr. No | Consideration | Yes/No | Checked By |
1. | Major components are securely anchored and protected from shock |
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2. | There is no observable physical damage |
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3. | Sufficient room for servicing provided |
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4. | Required electrical connections are tight, proofed, and grounded |
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5. | Instrument identification nameplate is visible |
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6. | Unit installed and secured in place as per manufacturer recommendations |
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7. SUMMARY OF THE INSTALLATION QUALIFICATION
Sr. No. | Description | Yes/No | Checked By |
1. | All acceptance criteria outlined in the Installation Qualification were met |
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2. | All specifications verified |
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3. | Deviations if any |
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8. CERTIFICATION STATEMENT
| Signatories | Signature | Date |
Executed by | Quality assurance |
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Reviewed by | Production |
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Reviewed by | Quality Control |
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Approved by | QA Manager |
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Authorized by | Plant Manager |
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