Objective URS of Multimill :
The multi-mill machine will be interfaced to the output and will be located in a designated operating area should be compatible with occupational Exposure Limits (OELS) (4/5) and a cGMP operation. This document is generating for the purpose of specifying the URS of Multimill. The User Requirements Specification (URS) 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 of Multimill 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 Multimill
| 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 URS of Multimill:
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 multi-mill machine in factory.
Location of equipment:
- Machine will be installed in the granulation area with Class D area classification
References
- Reference has been taken from the existing equipment and from the internet or vendor brochure.
System/equipment/Instruments details:
| Name of the equipment | Multi-mill |
| Screen diameter | As per requirement |
| Model/Type | As per cGMP model (Multi Mill 2HP) |
Scope of Supply:
| Type of Device | Multi-mill |
| 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.ISO 15534:2000 Ergonomic design for the safety of machineISO 13849-1:1999 Safety machinery- safety related parts of control system.ISO 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 |
| 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:
- Multi-mill machine is designed in an effort to exceed the highest cGMP requirement and to ensure the most economical and efficient tablet production.
- Milling is an important step in pharmaceutical manufacturing process. This equipment is a self contained & portable unit for the process of size reduction. It uses the principle of impact of air. The product is dropped axially from the hopper in a communication chamber where it comes in contact with blades (either the knife edge or the impact edge) rotating at high speed. Multi Mill is basically an acceleration type miller where the powders milled are subjected to acceleration force created by centrifugal force and gravity. Multi Mill is used for rapid milling of dry and semi – dry products. The central portion of the Multi Mill is provided with unique designed blades. Top portion of the machine is provided with feeder for material feeding. The milling is accomplished quickly and with most products within few minute
- The basic construction of the machine consists of :
- Standard stainless steel 316 L straight profile machine
- Non contact parts SS304 with matt finish
- Non metallic contact parts, any material with food grade quality having no potential impact on the products
The Drive:
The machine is equipped with frequency controlled drive. A large torque can be achieved even at low speed and because of its high regulating speed. The is centrally driven by an electric motor
Hopper inlet:
The hopper is where goods are fed into the mill.
Milling Chamber:
The milling chamber has a screen to minimize particle size, as well as twelve milling and cutting edge blades, as well as two scraper blades.
Discharge Point:
The milled items are collected using these components.
Electrical chamber and mechanical chamber:
All mechanical components such as gears, motors, and moving belts, as well as electrical components such as wiring, switches, and MCBs, are installed in this segment.
Technical Specification URS of Multimill :
| Particulars | Specification |
| Machine weight | As per requirement |
| Capacity | As per requirement |
| Output | As per requirement |
| Model/Type | As per cGMP model (Multi Mill 3HP) |
| Speed Available | As per requirement |
| Particle Sizing range | As per requirement |
| Blade | Impact/ Knife Edges (no. of blades as per vendor) |
| Overall dimension (mm) | As per requirement |
| VFD | As per motor rating |
| Castor wheel | Revolving brake type -2 Nos. –P.U. Fix Type -2Nos. P.U. |
| Spare Parts | Bearing Gasket For Discharge Hopper Gasket For Chute Gasket For Charging Hopper |
| 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 switchHMI Electric panel with MCB, contactor, overload relay, controls relay, VFD, SMPS. |
| Identification | Details of Make, Name, Serial. No., Capacity, Model and Year of manufacture should be available |
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 | 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 |
| SMPS | Switched Mode Power Supply |
| MCB | Miniature circuit breaker |
| Kg/Hr | Kilo gram per hour |
| DB | Decibel |
| HP | Horse power |
| VFD | Variable frequency drive |
| PU | Polyurethane |
| AC | Alternate Current |
| NMT | Not more than |
| MOC | Material of Construction |
FAQ’s (Frequently Asked Questions) for URS of Multimill
1. What is a Multimill?
A Multimill is a machine used for high-speed chopping of dry or wet materials. It is widely used in pharmaceutical industries.
2. Why do we need a URS for the Multimill?
A URS ensures that the equipment meets operational, safety, and regulatory requirements. It provides clarity for vendors and acts as a baseline for validation.
3. What are the technical specifications of multimill?
Answer: Key technical aspects include:
Machine weight, capacity, blade types, screen used, particle sizing range and output.
4. What types of materials should the Multimill handle?
Specify the nature of materials (e.g., powders, wet granules) and any special considerations like corrosiveness, flammability, or sensitivity to heat.
5. What safety features should be included?
The URS should specify interlocks, emergency stop buttons, overload protection, and operator safety shields.