Objective for URS of Strip Packing Machine:
This document is generating for the purpose of specifying the user requirement for Strip packing machine. The URS of Strip Packing Machine is provided to define the important components, variables and options necessary for the Supplier to provide a functional of Strip packing machine that meets the needs in the most cost-effective method possible. The URS of Strip Packing Machine is also provided to the Supplier to provide a price quote for the supply for Strip packing machine including the design, Performance and manufacture of the equipment.
The Strip packing machine will be interfaced to the output and will be located in a designated operating area & will comply as per GMP operations
Table of Content
| Description |
| Objective |
| Table of contents |
| Approval of Documents |
| Scope |
| Location of equipment |
| Reference |
| Applicable codes and standard |
| System/equipment/Instruments details |
| Scope of supply |
| Brief system description |
| Technical specification |
| Safety features |
| List of Abbreviations |
Approval of Documents:
Prepared by:-
| Name | Designation/Department | Signature | Date |
Reviewed by:-
| Name | Designation/Department | Signature | Date |
Approved by:-
| Name | Designation/Department | Signature | Date |
Scope for URS of Strip Packing Machine:
Location of equipment:
Machine will be installed in the Strip packing area with Class D background.
References
The supplier shall use the following references in all communications: –
Applicable Codes and Standards: –
The entire Supplier’s work shall comply with all relevant Indian and International Standards and Codes of Practice.
The Supplier shall confirm all the Standards which have been used for the design and manufacture of the equipment.
System/equipment/Instruments details for URS of Strip Packing Machine:
| Name of the equipment | Strip packing machine |
| Capacity | 10/12 track, maximum sealing width 300 to 310 mm. |
| Model/Type | AsperGMPmodel |
Scope of Supply:
| Type of Device | Strip packing machine |
| Machine Standard | The current state of the art GMP Compliance. European medicine agency (EMA) and WHO, Regulations compliance. |
| Machine design standard for safety | The European machinery Directive 2006/42/EC.ISO 13850:1996 safety of machinery- Emergency stops principle of design.ISO 13852:1996 safety of machinery -safety distance to prevent danger zones being reached by upper limbs.ISO 13853:1996 safety of machinery safety distance to prevent danger zones being reached by lower limbsISO 13854:1996 safety of machinery- minimum gaps to avoid crushing of parts of the human body.ISO 14110:1998 safety of machinery- interlocking device associated with guards- principles for design & selection. |
| Room Condition | Room Temperature: – NMT 25 degree Celsius.Relative humidity: – NMT 55 %Zoning: Class D GradePressure:15 Pa |
| Features | Design conforming to cGMP standardsContact part SS 316 and noncontact parts SS 304.Easy cleaning designed with easy removal weight adjustment sector.AC Frequency drive for motor |
| Document & Certificate | Manuals and Maintenance Instructions Operator manualInstallation and assembly instructions for all devices.User’s manuals for all components.Trouble shooting guide.Maintenance Manual.Safety instruction.Training documentation. Electrical and Control diagrams Single line drawing for electrical distribution.Circuit diagramsCable list.Equipment location drawing for electrical equipment and instruments. |
| Qualification Protocols | DQ Protocols and reports.FAT protocol and report.SAT protocol and reportIQ protocol and reportOQ Protocol and reportVendor should organize for Execution of IQ, OQ and support for PQ |
| Training | Vendor should impart necessary Operational training to user department and maintenance training to maintenance department. |
| Test, Calibration, MOC Certification | All test certificate for brought items will be provides during FAT with FAT DocumentsMOC Certificate will be providing during FAT with FAT documentsCalibration certificate provide for gauge during FAT. |
Brief System Description for URS of Strip Packing Machine:
A strip packing machine is an automated packaging device used to enclose individual items, like tablets or capsules, between two strips of material, such as aluminum foil or plastic film, and then seal them together.
Function:
The machine takes a continuous roll of packaging material, forms pockets or cavities, places the products within, and then seals the strips together.
Materials:
Common packaging materials include aluminum foil and plastic film, chosen for their ability to provide air-tight and secure sealing.
Process:
Products, like tablets or capsules, are fed from a hopper into the machine. They then pass through a feeding system and into the sealing roller cavities, where the foil or film is drawn from rollers and seals them into a continuous strip.
Speed and Efficiency:
These machines are designed for high-speed packaging, capable of processing thousands of units per hour, reducing labor costs and enhancing production.
Variations:
Different strip packing machines cater to various product types, including tablets, capsules, lozenges, and other items. Some machines are specifically designed for pharmaceuticals, while others handle food or consumer goods.
Types:
Options include automatic and manual strip packing machines, PVC strip packing machines, and specialized machines like alu-alu strip packing machines (used for pharmaceutical packaging).
Industries:
Strip packing machines are used in diverse industries like pharmaceuticals, food and beverage, cosmetics, and consumer goods, offering versatile packaging solutions.
The basic construction of the machine consists of:
- Standard stainless steel 316 L straight profile machine housing
- NoncontactpartsSS304with matt finish
- Nonmetallic contact parts, any material with food grade quality having no potential impact on the products
Electrical chamber and mechanical chamber:
All mechanical components such as gears, motors, and moving parts as well as electrical components such as wiring, switches, and MCBs, are installed in this segment.
Technical Specification:
| Particulars | Specification |
| Machine weight | 1000 kg (approx.) |
| Capacity | 10/12 track, maximum sealing width 300 to 310 mm. |
| Output | 1500 to 4500 Tab/Cap. per min. (Output depends on Shape and Size of Tablet.) |
| Model/Type | As per GMP model |
| Speed Available | As per requirement |
| VFD | As per motor rating |
| Spare Parts | As per requirement |
| Machine Mounting | It should be 04 nos Anti vibration pad with 100 mm distance piece. |
| Electric panel | Electrical panel with push button and digital indicator.Emergency Switch.On/ off switchElectric panel with MCB, contactor, overload relay, controls relay, VFD, temperature controller & digital counter. |
| Process requirement | Feeding SystemSealing SystemBatch Coding UnitCutting SystemPrint Registration Control (PRC) |
| Utility Requirement | 3 Phase440 v50 Hz |
| Identification | DetailsofMake,Name,Serial.No.,Capacity,ModelandYearofmanufactureshouldbeavailable. |
Safety Features:
| Critical Variables | Acceptance Criteria | Reference |
| MCB | MCB is provided so that when there is an overload in current or any short circuit then the MCB trips. | Safety Requirement |
| Mechanical Guard | Mechanical guard for all rotating parts. | Safety Requirement |
| Joints | Welding of joints without any welding burrs. | Safety Requirement |
| Metal Parts | All the metal parts should be properly grounded without any sharp Edges. | Safety Requirement |
| Leveling and Balancing | Equipment should be properly balanced & leveled. | Safety Requirement |
| Installation | Allthe InstallationmustbeinaccordancewiththeGMP. | Safety Requirement |
| Electrical Wiring And Earthing | Electrical wiring should be as per approved drawings. Double external Earthing to control machine (panel and motors) and operator should be provided. | Safety Requirement |
| Noise Level | Below 80 db. | Safety Requirement |
| Emergency/Safety Switch | Provided easy access position | Safety Requirement |
Spare parts / Change parts
Vendor should provide Preventive Maintenance SOP, List of recommended critical spare parts with code no. considering 2 years of satisfactory working of machine. After Sale Service/ AMC for the machine should be provided after warranty period. Vendor should provide all spares required for 2 years of use at the time of shipment.
List of Abbreviations.
| URS | User Requirement Specification |
| ENG | Engineering |
| QA | Quality Assurance |
| cGMP | Current Good manufacturing |
| mm | Milli Meter |
| Ltr | Litre |
| Hr | Hour |
| SS | Stainless steel |
| DQ | Drawing Qualification |
| FAT | Factory acceptance test |
| SAT | Site acceptance test |
| IQ | Installation Qualification |
| OQ | Operational Qualification |
| PQ | Performance Qualification |
| AMC | Annual maintenance Charge |
| HMI | Human machine interface |
| MCB | Miniature circuit breaker |
| DB | Decibel |
| VFD | Variable frequency drive |
| AC | Alternate Current |
| MOC | Material of Construction |
| PVC | Poly vinyl chloride |