Objective URS of Paste Kettle:
Paste kettle will be interfaced to the output and located in a designated operating area should be compatible with Occupational Exposure Bands and a cGMP operation. This document is generating for the purpose of specifying the URS of Paste Kettle. The URS of Paste Kettle is provided to define the important components, variables and options necessary for the Supplier to provide a functional of multi-mill machine that meets the needs in the most cost-effective method possible.
The URS is also provided to the Supplier to provide a price quote for the supply for multi-mill machine including the design, Performance and manufacture of the equipment.
Table of Content for URS of Paste Kettle
| Description |
| Title page |
| Table of contents |
| Approval of Documents |
| Objective |
| Scope |
| Location of equipment |
| Communication |
| 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 |
| Executive/ QA |
Reviewed by:-
| Name | Designation/Department | Signature | Date |
| Manager/Production | |||
| Manager/Engineering |
Approved by:-
| Name | Designation/Department | Signature | Date |
| Manager/QA |
Scope:
- The scope of this document is to define the requirements of the paste kettle in company.
Location of equipment:
- Machine installed in the granulation area with Class D area classification.
References
- Reference has taken from the existing equipment and from the internet or vendor brochure.
System/equipment/Instruments details:
| Name of the equipment | Paste Kettle |
| Capacity | As per requirement |
| Model/Type | As per cGMP model |
Scope of Supply:
| Type of Device | Paste Kettle |
| Machine Standard | The current state of the art GMP Compliance. European medicine agency (EMA). |
| Machine design standard for safety | The European machinery Directive 2006/42/EC.The European low voltage Directive 2014/35/EU.ISO 13850:1996 safety of machinery- Emergency stops principle of design.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 oC.Relative humidity: – NMT 65 %Zoning: Class D GradePressure:15 Pa |
| Features | Design conforming to cGMP standardsContact part SS 316 and noncontact parts SS 304.Simple and Convenient operation, Changeover, Cleanliness, Operator protection and Ease to maintenance.Easy cleaning designed with easy removal weight adjustment sector. |
| 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 about URS of Paste Kettle :
- Paste Kettle uses for preparation of starch-based paste. Hemispherical shape container ensures that the heating of the starch paste is uniform and cover more surface area.
- The tilting type arrangement ensures ease in unloading the paste in another container or vessel. The starch is put in the kettle and adding water till desired thickness of paste is achieved. The kettle is jacketed and is heated till the starch melts and a thick paste is achieved. This paste can be mixed either manually or with the help of an anchor type agitator which will constantly agitate the paste so that there will be no lumps formation.
- Temperature can be set to desired degree by adjusting the thermostat provided and the temperature can be seen in the dial thermometer provided.
- The basic construction of the machine consists of :
- Standard stainless steel 316 L hemispherical shape pan with
- Pan shall be provided with SS 304 jacket of suitable thickness and insulated with glass wool
- Non metallic contact parts, any material with food grade quality having no potential impact on the products
The Drive:
The machine consisted with frequency controlled drive. A large torque can be achieved even at low speed. This is centrally driven by an electric motor.
Tilter
Mechanical tilting with worm / worm wheel arrangement. Tilting arrangement for kettle is provided for discharge for starch paste
Agitator
Detachable Agitator with Anchor blades and Teflon scrappers
Hydraulic system
Hydraulic lifting and lowering arrangement as an option
Pan
Hemispherical design for proper mixing paste
Jacket & insulation
Jacket provided with steam/thermic/fluid heating arrangement heating insulation provided to avoid heat loss
Impeller
Anchor type impeller design for proper mixing of paste
Technical Specification for URS of Paste Kettle:
| Particulars | Specification |
| Machine weight | As per requirement |
| Capacity | As per requirement |
| Motor | As per requirement |
| Power Voltage | 15 V, 3 Ph., 50 Hz. |
| Model/Type | As per cGMP model |
| Heating media | Electric, water heating |
| Stand | As per requirement |
| Agitator design | As per requirement |
| Overall dimension (mm) | As per requirement |
| VFD | As per motor rating |
| Jacket | SS 304 jacket for electric heating |
| Gearbox | Noiseless W 86 |
| 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 |
| Identification | Details of Make, Name, Serial. No., Capacity, Model and Year of manufacture should be available |
Safety Features for URS of Paste Kettle:
| 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 | All the Installation must be in accordance with the cGMP. | 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 |
| HP | Horse power |
| VFD | Variable frequency drive |
| Kw | Kilo watt |
| AC | Alternate Current |
| NMT | Not more than |
| MOC | Material of Construction |
FAQ’s (Frequently Asked Questions) for URS of Paste Kettle:
1. What is a paste kettle?
A paste kettle is a jacketed vessel used for the preparation of wet granulation binders by mixing and heating.
2. What are the key requirements of URS?
The URS typically includes:
- Capacity requirements
- Material of construction (e.g., SS 316 for product contact parts)
- Heating method (Steam, Electrical, or Oil)
- Temperature control range and accuracy
- Safety features
- GMP-compliant design
3. What materials are used for construction?
Paste kettles are made from stainless steel:
- SS 316 for product contact parts
- SS 304 for non-contact parts
5. How is temperature controlled in the paste kettle?
Temperature is controlled via:
- A digital PID temperature controller
- Jacketed heating with insulation