Objective URS of Sifter:
This document is for the purpose of specifying the user requirement for sifter. The URS of Sifter is provided to define the important components, variables and options necessary for the Supplier to provide a functional of sifter that meets the needs in the most cost-effective method possible.
The URS of Sifter is also provided to the Supplier to provide a price quote for the supply for sifter including the design, Performance and manufacture of the equipment. The sifter 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.
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 |
| 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 sifter 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 for URS of Sifter:
| Name of the equipment | Sifter |
| Screen diameter | As per requirement |
| Model/Type | As per cGMP model (sifter 2HP) |
| Capacity | As per requirement |
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 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 limbs 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 55 %Zoning: Class D GradePressure:15 Pa |
| Features | Design conforming to cGMP standards Contact 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.AC Frequency drive or starter for motor |
| Document & Certificate | Manuals and Maintenance Instructions Operator manual Installation 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 diagrams Cable list. Equipment location drawing for electrical equipment and instruments. |
| Qualification Protocols | DQ Protocols and reports. FAT protocol and report. SAT protocol and report IQ protocol and report OQ Protocol and report Vendor shall organize for Execution of IQ/OQ and support for PQ |
| Training | Vendor shall 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 Documents MOC Certificate will be providing during FAT with FAT documents Calibration certificate provide for gauge during FAT. |
Brief system description:
Sifter is designed in an effort to exceed the highest cGMP requirement and to ensure the most economical and efficient tablet production.
The Vibro Sifter machine works on the principle of gyratory vibrations. The material is separated based on its particle size. Once the motor gets energized, vibration is caused in the screen/sieve making the material travel across the sieves according to its particle size The material to be sifted is fed into the sifter from the top and is then distributed evenly on the cylindrical screen
In three different planes, the development of vibration along the vertical axis utilizing a specially designed vibratory motor that meets various output requirements. It causes 100% rotary motion and causes dispersion stirring & amp; stratification of material to sift. Feed material flows in Horizontal movement along with a loop pattern on Vibro screen.
The basic construction of the machine consists of :
- Standard stainless steel 316 L straight profile machine housing & T/C connector for the mounting to machine drive and frame
- Non contact parts SS304 with matt finish
- Non metallic contact parts, any material with food grade quality having no potential impact on the products
Dust cover
The dust cover is attached to the top of the vibratory sifter in this configuration. In most cases, it is crafted from stainless steel or another type of metal.
Filter screen:
A filter screen is one of the most important parts of vibro sifter. It plays a big part in the sifting process. The filter screen is made with a wire mesh that has a very fine, smooth surface. This ensures that the ingredients can be sieved in the most effective manner also, the filter screen can help stop any leaks while processing materials. Depending on the configuration of your vibro sifter, the screen might come in a number of different sizes.
Wire mesh screen ring
This component comes in a circular shape. It’s hemmed around the outer edge of the wire mesh screen. The screen ring is attached to the mesh using adhesive, allowing for enhancing the longevity of the mesh. Also, the strong bonding ensures the wire mesh stays in place during material processing, even if the unit vibrates vigorously.
Clamp ring
As the name implies, a clamp ring also comes in a circular shape. This component is used to hold and secure the sieve decks and filter screens. Today, most vibro sifters feature quick- release clamp rings, allowing operators to assemble and disassemble the vibrating sieving machine without tools. The clamp ring functions as a seal to protect the ingredients from falling out of the sieves. It also allows the vibro sifter to be dust-tight, keeping dust or contamination at bay, regardless of how intensely the unit is being shaken.
Material outlet
The material outlet is a discharge chute where all graded and screened particles leave the machine. This component, welded together with the sieve deck, is placed at the bottom of a screen. For materials containing more than two ingredients, the material outlets from top to bottom discharge the sieved particles from coarse to fine products.
Springs
When it comes to the major parts of vibro sifter, the springs should never be overlooked. They also play a big role in the process of sieving. A vibratory sifter is often fabricated with multiple springs. These springs are used to hold the sieves up in the air. They enable the vibro sifter machine to move easily and freely when it vibrates. The springs also act as a damper, reducing vibrations so that the floor doesn’t get damage
Electric motor
As one of the most important vibro sifter parts, this component functions as the powder source, letting the whole device do all its jobs without stopping. The motor is in charge of turning electrical power into energy that runs the unit. The vibrating motion created by the electric motor allows ingredient particles to travel through the screens more quickly. By the way, the motor size of a vibro sifter can vary based on the design and size of the machine, as well as its output capacity.
Technical Specification for URS of Sifter:
| Particulars | Specification |
| Tablet size | As per requirement |
| Machine weight | As per requirement |
| Capacity | As per requirement |
| Output | As per requirement |
| Model/Type | As per cGMP model (sifter 2HP) |
| Speed Available | As per output |
| Particle Sizing range | As per requirement |
| Overall dimension (mm) | As per requirement |
| VFD/Starter | As per motor rating |
| Castor wheel | Revolving brake type -4 Nos. –P.U. Fix Type -4Nos. P.U. |
| Spare Parts | Gasket For Discharge Hopper Gasket For Chute Gasket For Charging Hopper |
| Electric panel | Electrical panel with push button and indicator.Emergency Switch.On/ off switch |
| Identification | Details of Make, Name, Serial. No., Capacity, Model and Year of manufacture should be available |
Safety Features of URS of Sifter:
| 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 Question’s) for URS of Sifter:-
Q-1 What is URS for Vibratory Sifter ?
Answer:- URS for sifter is User requirement specification in which all the technical specification has been defined about the Vibratory sifter which has to be given to manufacturer.
Q-2 Vibratory sifter is used for ?
Answer:- Vibratory sifter is used for uniform granulation.
Q-3 What are the technical specifications for Vibratory Sifter?
Answer:- Technical Specifications including Machine Weight, Capacity, Speed Available, VFD etc.