Some clients are doubts how to send the URS the supplier to check if the supplier’s packaging machine can arrive their requirements. Pls check the below URS which is a very high standard requirement about the cartoning machine. Which is specialized for pharmaceutical industry.
DESIGN CRITERIA
A.Basic Operation
Requirement |
1. The Vendor shall design, build and test a machine to automatically receive the specified product(s) from the Owner’s upstream conveyor, collate the product into a designed configuration, transfer and erect cartons from magazine, load the product(s) into the carton and close the carton securely. |
2. The equipment shall be designed to function and meet or exceed all performance requirements as a completely automatic unattended machine unless manual features are specified in the Data Sheet. |
3. The Vendor assumes total responsibility for any and all engineering and design requirements necessary to guarantee that the components provided will operate in concert with all mechanical, electrical, instrumentation and control components, and to ensure that overall system performance will be in accordance with the Owner’s intended use. |
4. The system shall not subject the carton or product to any conditions that may damage them during the process. |
5. Equipment Vendor shall provide recommendations and review any carton specifications and drawings so the Owner can order cartons from its normal suppliers that are compatible with this equipment. |
B.Equipment Included
Requirement |
1. All auxiliary equipment required for operation to meet the specific requirements detailed in the Data Sheet and shall be included with the machine by the Vendor. This may include, but not be limited to the following devices and services: |
a. Vacuum Source |
b. Product Infeed Conveyors, Accumulators and Collators |
c. Product Discharge Conveyors, Accumulators and Collators |
d. Leaflet Magazines, Folders and Feeders |
e. Reject Devices with Conveyors and Accumulators at each location where component rejects are sensed. |
f. Carton Magazine and Erection Equipment |
g. Carton Sealing Equipment |
h. Carton Coding and Code Reading Equipment |
i. Change Parts |
j. Software Programming, Testing, Debugging and Documentation |
k. All special programmers, software, keys, licenses, etc., to allow the Owner to access, edit and validate the control system. |
2. The only utilities to be provided by the Owner shall be a single 3 phase power source, a single 220V power source protected by a UPS for the PC only, and compressed air. Any other electrical requirements for power or control will be supplied from a transformer supplied by the Vendor and mounted in the main electrical cabinet. |
3. The machine shall be constructed with a single inlet to be connected to Owner’s compressed air supply. Any required filters, regulators or air lubricators and all branch lines to the pneumatic devices shall be supplied and installed within the machine. It is preferred that the air inlet be located near the electrical entrance so that two parallel inlet lines can be made during installation. |
C.Equipment Features
Requirement |
1. Continuous motion horizontal cartooning machine, with solid steel structure |
2. High-resistant operator protection covers |
3. Electrical installation complying with EN 60204 norm |
4. Voltage 400 V, 50 Hz, 3-phases, + Neutral + Earth |
5. Control logic by microprocessor with color TOUCH SCREEN For programming and visualization of the machine status |
6. In-line feeding conveyor, with continuous motion, equipped with toothed belts (absolutely no chains) and with changeable step buckets, with possibility of simultaneous adjustment |
7. Horizontal conveyor belt for cartons |
8. Blister quantity detection system inside the feeding conveyor; |
9. Minimum level detection in the carton magazine; |
10. Group for product insertion into the carton; |
11. Product insertion system by blade; |
12. Pusher disengagement, to allow the product rejection in case of missing cartons (or incomplete packages), without machine stop |
13. Carton rejection without machine stop |
14. 2 complete carton size included. |
15. Lamp for machine status visualization (3 colours). |
16. Blister automatic feeding unit, complete with vertical magazine, electronic counting device with relevant |
17. disengagement for direct release into the blister transfer conveyor belt (without blister feeding belt). |
18. 2 feeding magazines for manual feeding of blisters by 2 operators to the blister magazine |
19. Leaflet folding unit, for leaflets from magazine, complete with insertion group, check of minimum charge and detection of leaflets pick-up effected |
20. Further control of faulty carton rejection, with down-stream machine stop. |
21. Hardware and software for connexion to an external printer, for direct printing of production data (printer supplied by Customer). |
22. Fitting, wiring and testing of a modem, supplied by IMA, for tele-assistance service between our machine and IMA electrical dept. Customer to put telephone line at disposal. |
23. Power supply, with UPS system (supplied by the Customer). |
24. Design and construction shall facilitate size changeover and clean-up within one hour by a single qualified and experienced person. |
25. Unless otherwise specified, machine, frame, supports, non-transparent guards, trim panels, and electrical control enclosures shall be of stainless steel 304 OR Anodized aluminium. |
26. Steel Other than grade 304 shall be limited to motor and gear box housings, bearing housings, chains, sprockets and shafts, pneumatic and electric control components. |
27. Other non-stainless steel components shall be of aluminium or plastic to provide optimum performance for the application. |
28. Guards shall be in accordance with OSHA standards. Interlocks shall be provided where required to prevent the machine from operation when the guards are not in place. Guards that protect areas that require frequent access for adjustment, maintenance or changeover shall be easily opened for access without the need for hand tools. Guards for areas where a view of the equipment’s operation is beneficial shall be fabricated of plexi glass OR Equivalent. |
29. Machine shall be designed for ease of maintenance. Features such as individually replaceable solenoid valves and grouping of lubrication to outside of machine shall be employed. |
A.Other Design Factors
Requirement |
1. The machine shall be capable of operating on a continuous basis with no more than one 15 minute service period required for each 8 hour shift and one 2 hour preventive maintenance period for every 100 hours of operation |
2. Performance acceptance test shall compromise of a product run, either actual or simulated upon installation in the Owner’s plant of approximately 8 hours that demonstrates that the equipment performs reliably the requirements as specified herein. |
2.0.1 CONTROLS AND INSTRUMENTATION
Requirement |
A. An operator control station shall be provided on the side of the machine for ease of changeovers and adjustments and for convenience during normal operation. |
B. Sensor shall be provided for the following and any other function vital to the proper operation and reliable performance of the machine and line: |
1. Any function specified in the Data Sheet. |
2. Product Presence |
3. Carton Presence |
4. Leaflet (or any other specified object) Presence |
5. Low Carton Level in Magazine
6. Low Level for Leaflets (or any other specified object) |
7. Drive Overload Insertion Overload |
8. Monitor of Proper Carton Closure |
9. Jam Conditions |
10. Carton Counter |
11. Reject Counters |
12. Backup at Discharge |
C. Software Interlocks to include but are not limited to: |
FDA 21 CFR PART 11:
Hardware and software adjustment of the machine , to the minimum requirements of the FDA 21 CFR part 11. This activity consists on implementing and suppling the following:
* handling of electronic signature through ID and a -4-levels- cryptic password
* handling of Audit Trail (events recording, critical parameters and accesses to the system)
* handling launch of production batch
* handling closure of production batch
* handling of the data integrity
* Instruction manual of the system in English language
* validation documentation of the system in English language
Documentation package
For machine qualification and support for the validation activities of the customer, available in Italian/English languages. The documentation includes the
Following:
- list of the documents
- project plan
- project flow-chart
- functional specifications
- software design specifications
- technical electrical and software documentation
- quality control chart
- installation testing specifications and recording of the tests results
- functional testing specifications and recording of the tests results
- performance specifications
- Preliminary performance tests specifications and recording of the test results.
- operation and maintenance manual
- 1 spare parts manual
- 1 set of electrical and pneumatical documentation
- 1 lay-out of the machine
- 1 USB drive + 1 compact Flash Memory for complete PC system back up
Machine Details:
