Complete Pharma Solution
DESIGN QUALIFICATION OF AUTOMATIC VERTICAL ROUND BOTTLE STICKER LABELLING MACHINE
The Automatic Vertical Round Bottle Sticker Labeling Machine is one of the most users friendly. The machine is used for full/partial wrap around labeling on different size of round containers. It is capable of labeling up to 80 to 120 containers per minutes depending on products and label size. The automatic model is equipped with roller spacing device resulting in a simple operation with “No change parts required”
Contents
- Objective
- Scope
- Responsibilities
- Machine Description
- Technical Specification
- Consumption (Utility & Power)
- Material of Construction
- Product Contact Parts
- Test Certificates / Inspection Reports
- MOC Certificates
- FAT Procedure
- Change Control Procedure
- Reference Documents
- Summary
- Abbreviation
- Approval Sheet
- Customer Approval Sheet
OBJECTIVE:
- To design, engineer, and supply the Automatic Vertical Round Bottle Sticker Labeling Machine.
- To prove that each operation proceeds as per the design specification and the tolerances prescribed there in the document is the same at utmost transparency.
SCOPE:
- The scope of this qualification document is limited to the Design Qualification of Automatic Vertical Round Bottle Sticker Labeling Machine suitable for labeling on round surface of bottles. This qualification document is part of a validation activity for the Automatic Vertical Round Bottle Sticker Labeling Machine.
- Qualification of support utilities is not within the scope of this qualification documents.
- The equipment shall be used for sticker labeling round surface of bottle. The equipment shall operate under dust free environment & conditions as per the GMP requirement.
RESPONSIBILITIES:
Client:
- To provide the URS for the equipment.
- To perform the Factory Acceptance Test (FAT).
Manufacturer:
- To provide the complete technical details of the equipment pertaining to its design, comprising of the following:
- Machine Description
- Technical Specifications for bought-out items
- Product Contact Parts
- Brief Process Description
- To facilitate the client for the Factory acceptance test of the machine at their works/ site.
- If at any point in time, any change is desired in the mutually agreed design, Change control procedure shall be followed and documented
MACHINE DESCRIPTION:
The Automatic Vertical Round Bottle Sticker Labeling Machine is one of the most users friendly. The machine is used for full/partial wrap around labeling on different size of round containers. It is capable of labeling up to 80 to 120 containers per minutes depending on products and label size. The automatic model is equipped with roller spacing device resulting in a simple operation with “No change parts required”
Process:
The round containers positioned on conveyor are released at equal distance by creating space between two containers with the help of roller spacing device. At the labeling point, an electronics product sensor senses container & releases a label from Vertical Round label roll. If machine is equipped with batch printing device, batch printing device prints the batch no. & other matter on label while label is stationary between dispensing of two labels. The sensed round container moves on conveyor and picks the released label. Then the labeled container moves further through a rubber pressing belt & stationary rubber pad which ensures neat & perfect fixing of label on the container diameter.
TECHNICAL SPECIFICATION:
| Sr. No | Parameter | Specifications |
| 1. | MODEL | PSAL-120 |
| 2. | OUTPUT | 80 TO 100 BPM |
| 3. | MAIN MOTOR | MAKE : BONFIGLIOLI
0.5HP/0.37KW/1.75A/1397RPM/230V/1PHASE |
| 4. | CONVEYOR MOTOR | MAKE : BONFIGLIOLI
0.25HP/0.18KW/0.6A/1380RPM/230V/1PHASE |
| 5. | SERVO MOTOR | MAKE : DELTA
1HP/0.75KW/4.75A/3000RPM/230V/1PHASE |
| 6. | MAIN GEAR BOX | MAKE : BONFIGLIOLI
MODEL : VF44 F120 P71 B5B3 |
| 7. | CONVEYOR GEAR BOX | MAKE : BONFIGLIOLI
MODEL : VF44 F120 P63 B5B3 |
| 8. | MAIN A.C DRIVE | MAKE : ALLEN BRADLEY
MODEL : 22F-A4P2N103 |
| 9. | SERVO DRIVER | MAKE : DELTA
MODEL : ASD-B2L-0721-B |
| 10. | PRODUCT SENSOR | MAKE : BAUMER
MODEL : 0300Y.GR |
| 11. | LABEL SENSOR | MAKE : BAUMER
MODEL : OL05.I |
| 12. | PRINTER SENSOR | MAKE : LEUZE
MODEL : GS61/6 |
| 13. | PRINTER | MAKE : RYNAN TECHNOLOGIES
MODEL : B1040P |
| 14. | ENCODER
|
MAKE : AUTONICS
MODEL : E50S8-5000-3-Y-1 |
| 15. | HMI | MAKE : DELTA
MODEL : DOP-103BQ |
| 16. | PLC | MAKE : DELTA
MODEL : DVP12SA211T |
| 17. | MACHINE DIMENSION | 1820mm Length x 1140mm Width x 1245mm H |
CONSUMPTION (UTILITIES & POWER)
| Main Motor | Specification |
| Voltage
Hp Kw Hz Phase |
230
0.5 0.37 50 SINGLE |
| Conveyor Motor | Specification |
| Voltage
Hp Kw Hz Phase |
230
0.25 0.6 50 SINGLE |
| Servo Motor | Specification |
| Voltage
Hp Kw Hz Phase |
230
1 0.75 50 SINGLE |
MATERIAL OF CONSTRUCTION:
| r. No. | Component | MOC |
| 1. | Machine frame structure | SS 304 Square Pipe Structure |
| 2. | Door Set | SS 304, – Hair-lined pre-finished sheet |
| 3. | Conveyor Belt | Nylon Endless |
| 4. | All Shafts | MS & SS |
| 5. | Chain wheel for Conveyor | Nylocast |
| 6. | Chain wheel | Alloy Steel |
| 7. | Chain | Rollon Make, 3/8” Pitch |
| 8. | All Bearing (Make) | Imported |
| 9. | All Oil Seal | Pioneer Make |
PRODUCT CONTACTPARTS:
| Sr. No. | Name of the Part | MOC |
| Not Applicable | ||
TEST CERTIFICATES / INSPECTION REPORTS:
| Sr. No. | Component | Type |
| 1. | Motor | Test Certificate |
| 2. | Gear Box | Test Certificate |
| 3. | A.C. Drive | Test Certificates |
| 4. | Servo Motor | Test Certificate |
MOC CERTIFCATES:
| Sr. No. | Component |
|
|
SS |
FAT PROCEDURE:
Factory Acceptance Test Procedure shall be as follows:
- After the completion of erection work of the machine, client or authorized representative, on behalf of the client shall be informed to perform the factory acceptance test (FAT)
- Client or authorized representative, on behalf of the client, shall perform the FAT at the manufacturer site and record all the data in the prescribed FAT document as per the details given below:
- Test Criteria
- Design verification check list
- Deficiency and corrective action report
- Pre – installation requirements
- Final reports.
CHANGE CONTROL PROCEDURE:
Any modification arising in the design at a later stage, shall be incorporated only after due authentication of change control procedure. The client and the manufacturer should authenticate the change control procedure.
REFERENCE DOCUMENTS – ANNEXURE:
| Sr. No. | Documents |
| 1. | Equipment Brochure |
| 2. | Operational and Instructional Manual |
| 3. | General Arrangement Drawing |
| 4. | Electrical Circuit Diagram |
SUMMARY: (Should be handwritten)
ABBREVIATIONS:
| Abbreviated Form | Expanded Form |
| NA | Not Applicable |
| DQ | Design Qualification |
| GMP | Good Manufacturing Practice |
| URS | User Requirement Specification |
| HP | Horse Power |
| RPM | Revolution Per Minute |
| Hz | Hertz |
| MOC | Material Of Construction |
| SS | Stainless Steel |
| MS | Mild Steel |
APPROVAL SHEET:
Prepared by:
The signature below claims to have compiled the protocol with respect to the User Requirement Specification
Reviewed by:
The below signatory claims to have verified the specifications as laid in the defined qualification protocol.
Approved by:
The below signatory authenticates the protocol to have met with the specifications and that the machine is as per the defined protocol.
CUSTOMERS APPROVAL
Reviewed by:
The Reviewer’s signature claims to have verified the specifications as laid in the defined qualification protocol.
Approved by:
The Approver authenticates the protocol to have met with the specifications as laid in the User Requirement Specification and that the machine is as per the defined protocol.