SOP for Design Qualification of Capsule Printing machine
- OBJECTIVE
- To design, engineer, and supply the Capsule Printing Machine and to provide assurance that the machine is manufactured as per the URS and it comply with the Scope of Supply.
- To prove that each operation proceeds as per the design qualification and the tolerances prescribed there in the document, are the same at utmost transparency.
- SCOPE
- The scope of this qualification document is limited to the Design Qualification of Capsule Printing Machine. This qualification document is part of a validation activity for the Capsule Printing Machine.
- RESPONSIBILITIES
- CLIENT
- To Check and Approve the design qualification.
- MANUFACTURER
- To design, engineer and provide the complete technical details of the equipment pertaining to its design qualification viz.
- Machine overview,
- General arrangement drawing,
- Equipment orientation with layout,
- Specifications of the sub-components/ bought out items, and their make, model & quantity, and backup records/ brochures,
- Details of Utilities,
- Material of construction of all components
- To confirm the safe delivery of the equipment to the user site.
- To ensure that no un-authorized and or unrecorded design modifications shall take place. If at any point in time, any change is desired in the mutually agreed design, Change control procedure shall be followed and documented.
- To ensure the proper installation and commissioning of the equipment.
- MACHINE DESCRIPTION
- Capsule Printing Machine prints by offset gravure. Monograms or trademarks are etched on the surface of a gravure roll. The etched areas are filled with ink. A flexible thin blade wipes extra ink from the surface.The etched areas remain full.
- An offset roll rotates in contact with the gravure roll. Ink is transferred from the etched areas to the offset roll. When the offset roll contacts the object ink is again transferred to print the capsule.
- Control / Electrical Panel
- Operating Control Panel
- The Non Flame proof control panel is made of MS covered with SS cover.
It is located on the Machine.
- Control panel contains.
- START / STOP Switch
- Auto/Jog Rotary Switch
- Jog Push Button
- Emergency Stop
- Speed Adjustor Knob with Lock
- TECHNICAL SPECIFICATIONS OF COMPONENTS & SUB -COMPONENTS USED / BOUGHT OUTS
| Description | Specification |
| 1. Equipment Description | |
| Name | Capsule printing machine |
| Make | Parle Pharma Machineries |
| Model | Scorpio PPMPT -32-I |
| Sr.No. | 102 |
| Overall dimensions | 1820(H)X1210(W)X1180(L)[mm] |
| Inclined Control Hand wheel | 02 No’s |
| 2. Main Motor | |
| Type | 3 Phase induction motor |
| Model | BN80 B4 |
| RPM | 1400 |
| Power Rating | 0.75KW / 230V / 50Hz |
| Make | Bonfliglioli Riduttori |
| 3. Indexing Gear Box | |
| Type | AS25/P P90 |
| Mount Pos. | B3 |
| Ratio | 93 |
| Make | Bonfliglioli |
| 4 Main Gear Box | |
| Type | WSS/UF CI HS RS |
| Code | 132379 |
| Mount Pos. | B3 |
| Ratio | 10 |
| Make | Bonfliglioli |
| Description | Specification |
| 5 VFD | |
| Model | ATV11HU18M2A |
| Power Rating | 0.75KW,200/240V,
50/60Hz |
| Make | Telemecanique |
| 6 Air Switch | |
| Qty | 02No’s |
| Solenoid Valve | 01 each |
| 7 Pressure Gauge | |
| Range | 0-10 kg / cm2 |
| Least Count | 0.2 kg / cm2 |
| Make | Legris |
| Location | FRL Unit |
- DETAILS OF UTILITIES
| DESCRIPTION | SPECIFICATIONS |
| Electrical connection | To be provided |
| Compressed Air | To be provided |
- MATERIAL OF CONSTRUCTION
| Description | Specification |
| Hopper | |
| Ink reservoir | |
| Feed Disc | |
| Metal Disc | |
| Disc Nut | |
| Gravure Roll | |
| Lower Offset Roll | |
| Upper Offset Roll | |
| Air Nozzles | |
| Air Ejector Nozzle | |
| Exit Chute |
- ENCLOSURES
| Sr. No. | Description | Drawing No. |
| 1 | General arrangement drawing of Capsule Printing Machine |
|
- CHANGE CONTROL PROCEDURE
Change in the agreed design shall be addressed through the well-defined Change control procedure.
- DESIGN QUALIFICATION REPORT
- APPENDIX
| cGMP | current Good Manufacturing Practices |
| GEP | Good Engineering practices |
| MS | Mild steel |
| NFLP | Non Flame Proof |
| SS | Stainless Steel |
| KW | Kilo Watt |
| DQ | Design Qualification |
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