Name of the Equipment |
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Name of the Department |
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Equipment Identification No. |
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Protocol No. |
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Issue Date |
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Supersedes |
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Reason for Change |
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Number of Pages |
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PREPARED BY DETAILS:
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Signature |
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Date |
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Designation | Production Manager | Engineering Manager | QA Manager |
TABLE OF CONTENTS:
Sr. No | Title |
1.0 | Table of contents |
2.0 | Objective |
3.0 | Scope |
4.0 | Qualification Team |
5.0 | Responsibilities |
6.0 | Installation procedure |
7.0 | Acceptance criteria |
8.0 | Re-qualification criteria |
9.0 | FORMS: |
FORM A: Details of equipment | |
FORM B: Details of main components | |
FORM C: Utility requirement | |
FORM D: MOC of the component | |
FORM E: Details of change parts if any | |
FORM F: Lubrication | |
FORM G: List of manuals | |
FORM H: List of drawing | |
FORM I: Deviation Report | |
10.0 | Summary & Approval of Installation Qualification |
11.0 | Checklist for Installation Qualification |
OBJECTIVE:
- To define the Installation Qualification (IQ) requirements for the Capsule Polishing Machine.
- Ensure that the equipment installed conforms to the purchase specifications & the manufacturer's recommendations.
- To document the information that the equipment meets the acceptance criteria.
QUALIFICATION TEAM:
Responsible staff from:
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RESPONSIBILITIES:
Responsibilities | Details |
Vendor | Ø Supplying drawings, manuals and necessary documents for the generation and implementation of this protocol. |
Engineering | Ø Initial receipt and inspection of incoming equipment, drawings & certificates. Ø Preparation of description reports of equipment and its various components. Ø Preparation of written procedures for preventive maintenance of the equipment and its components. Ø Engineering Head will check the protocol and report. |
QA | Ø Preparation of this protocol in assistance with the Engineering department. Ø Audit & review the data documented during equipment qualification & ensure that it meets the acceptance criteria. Ø Final approval of Protocol & report. |
INSTALLATION PROCEDURE:
- Check the installation site for the fulfillment of the manufacturer’s recommendations (utilities such as electricity, etc.) and room dimensions.
- In-house identification No: for the equipment shall be allocated.
- Information and general layout of the equipment.
- The location for the installation of equipment shall be made ready.
- Compare equipment, as received, with the purchase order and write the equipment details in FORM-A. Attach a copy of the purchase order as an annexure.
- Check the equipment & its main components (accessories) for any damage. Write the details of the main components in FORM-B.
- Check the utilities provided are according to the manufacturer’s recommendation. Refer FORM-C.
- The material of construction of the components. Refer FORM-D.
- Check the change parts if any with the machine supplied. Refer FORM-E.
- Details of the lubricants, which should be used in the operation of the machine and its specifications. Refer FORM-F.
- Check the manuals received for completeness. Mention the equipment manuals in FORM-G.
- Check the drawings received for completeness. FORM-H.
- Any deviation observed during the qualification study shall be recorded in FORM-I & the manufacturer shall be informed. If the deviation is minor & is not going to affect the routine performance of the equipment, IQ study may be completed with proper justification.
- Prepare an IQ report comprising of Observations made, problems encountered, a summary of deviation report, results of any tests & any other relevant information.
- The installation of the Capsule Polishing Machine fulfills the selection criteria and purpose of the application, in accordance with the protocol.
- The Capsule Polishing Machine is installed and verified as per the procedure given in the protocol.
- Modification or change in the main component.
- Equipment is sent for major repair.
- Equipment is transferred from one location to another.
Name of the equipment |
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Identification No. |
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Manufacturer’s name & Address |
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Make/Model |
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Overall Dimension in mm (W x L x H) |
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Material of Construction |
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Weight of the Machine |
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Location for Installation |
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Purpose |
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Main components of the equipment |
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DESCRIPTION OF EQUIPMENT:
- The Automatic single brush capsule polishing machine is designed basically to polish the capsules after inspection of capsules prior to final packing. Various sizes of capsules can be polished very well. The rotary spiral principle of polishing ensures a high gloss finish.
- Inspected capsules are entering to the inlet funnel of the capsule polishing chamber which is provided with the top cover of the polishing chamber.
- Capsules travel from the polishing chamber in a spiral motion with a taper direction and get thoroughly polished by nylon bristles spiral brush. All capsules are coming out from the outlet chute of the capsule chamber. The loose powder which is deposited in the polishing chambers is sucked by the vacuum blower.
Sr. No. | Description | Qty. | Checked By |
1 | Trolley |
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2 | Bracket |
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3 | Nylon net |
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4 | Compression spring |
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5 | Flange |
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6 | Polishing brush |
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7 | Ball bearing |
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8 | Bearing housing |
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9 | Timer belt |
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10 | Base frame |
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11 | Timer pulley |
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12 | Motor |
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13 | Top cover |
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14 | Top cover-perforated |
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15 | Bottom cover-perforated |
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16 | Bottom cover |
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17 | Suction tray |
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Empty capsule ejection unit | |||
18 | Stand |
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19 | Empty capsule collection box |
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20 | Outlet chute |
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21 | Rectification box |
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22 | Rectification hopper |
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23 | Hopper |
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24 | Acrylic top cover |
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Air Displacement Unit | |||
25 | Structure |
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26 | Blower |
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27 | Extension piper for blower |
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28 | Two-way flange for hose pipe. |
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29 | Gasket for flange |
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30 | Filter tank |
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31 | Filter bag |
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32 | C-section rubber ring |
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33 | Ring for filter bag |
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34 | Tie rod for compression spring |
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35 | Compression spring |
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36 | Conical ring for filter bag |
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37 | Lock nut for shaking rod |
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38 | Compression spring |
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39 | Bed shaking rod |
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40 | Lock nut for guide bush |
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41 | Lid for filter tank |
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42 | Hex bolt for tie rod |
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43 | Rubber washer for guide bush |
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44 | Guide bush for shaking rod |
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45 | Knob for bag shaking rod |
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46 | Hose pipe for filter tank |
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Sr. No. | Utility | Specified | Observed | Engg. Sign & Date |
1. | Electric supply | |||
Load |
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Voltage |
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Phase |
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Frequency |
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2. | Compressed Air |
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3. | Max. Consumption of Air |
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4. | Earthing |
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Sr. No | Component | MOC | Contact part Yes/No | Identification No./ Sr. No. | Date/Sign (Engg.) |
1 | Impeller of ECE unit |
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2 | Fan assembly of ECE unit |
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3 | Empty capsule ejection body |
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4 | Impeller of ADU |
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5 | Fan assembly of ADU |
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6 | ADU Body |
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7 | Filter bag |
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List down the Change Part Details
Sr. No. | Description | Location | Contact part Yes/No | Type of lubricant |
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2. |
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3. |
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4. |
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5. |
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FORM G: LIST OF MANUALS
Sr. No. | Manual | Manual Recd./ Not Recd. | Date & Signature (Engg.) |
1. | Instruction |
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2. | Installation |
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3. | Operation |
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4. | Maintenance |
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No. | Drawing Title | Recd./Not Recd. | File Location | Date & Signature (Engg.) |
1. | Electrical drawing |
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2. | Schematic diagram |
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FORM I: DEVIATION REPORT
Deviation / OOS:
________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________
Justification & Impact:
____________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________
Name |
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Signature |
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Date |
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Department | Engineering | Head Q.A. |
| Prepared By | Verified By |
SUMMARY & APPROVAL OF INSTALLATION QUALIFICATION:
SUMMARY:
____________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________
APPROVAL:
Installation Qualification (IQ) is satisfactory 
Hence can proceed to Operation Qualification (OQ)
Name |
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Signature |
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Date |
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Department | Engineering | Head Q.A. |
| Prepared By | Verified By |
CHECKLIST FOR INSTALLATION QUALIFICATION:
No. | List | Enclosed/Not Closed | Sign/Date Engg. |
1. | FORM A: Details of equipment |
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2. | FORM B: Details of main components |
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3. | FORM C: Utility requirement |
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4. | FORM D: Material of construction |
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5. | FORM E: Change parts |
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6. | FORM F: Lubrication chart |
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7. | FORM G: Details of manuals |
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8. | FORM H: Drawings |
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9. | FORM I: Deviation report |
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10. | Summary & Approval of Installation Qualification |
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