OBJECTIVE for URS of Rapid Mixer Granulator:
The purpose of this document is to detail the basic guidelines to the vendor for the purpose of fabricating Rapid Mixer Granulators as per the defined specifications. This document is generating for the purpose of specifying the URS of Rapid Mixer Granulator. 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 Rapid Mixer Granulator 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 It is the foremost and the basic requirement of the process and system as envisaged by the project team and management.
CONTENTS
| TITLE |
| Objective |
| Protocol Approval |
| Scope |
| Scope of Services |
| Compatibility & Support |
| Technical Requirements |
| Finishing And Line Balancing |
| Electrical |
| Salient Features |
| Safety Features |
| Technical Specification |
PROTOCOL APPROVAL:
PREPARED BY:
| Department | Name | Signature | Date |
| Quality Assurance (Officer/ Executive) |
REVIEWED BY:
| Department | Name | Signature | Date |
| Production (Executive/ Manager) | |||
| Engineering (Executive/ Manager) |
APPROVED BY:
| Department | Name | Signature | Date |
| Quality Assurance (Head QA) |
SCOPE:
Scope of URS cover finalization of Rapid Mixer Granulator and its major components design specifications and also comprising of the following sub assemblies of the equipments:
- Pneumatically Actuated Lid.
- Motors should be NFLP.
- Three Blade Impeller and four blade chopper.
- WIP system should be provide.
- Wet Mill at discharge point should be avialable.
- Impeller with lifting arrangement.
- Trolley mounted WIP system should be available.
Note: Scope of URS cover finalization of equipment and its major components and design specifications and also comprising after finalization the URS.
SCOPE OF SERVICES:
To design the Rapid Mixer Granulator should meet with WHO, cGMP guidelines.
The system should have unique features & high tech, with simplicity in operation and reliable. The system design should facilitate minimum time with easy accessibility for servicing and maintenance.
Commissioning include supervision and erection of system and their alignments. Trial run of system is to be taken with and without dummy materials as per specified capacities at shop and after installation.
Our offer shall be complete with literature and catalogue of all the items offered, process flow diagrams, GA drawing the information required on the equipment specs such as dimensions, electrical details, utility requirement, utility hook- up details, installation drawings, P & Ids, etc.
The installation shall meet with the highest standards of cGMP and international standards of construction.
Exclusion from Scope of Supply.
All Civil Work
Utility
Electric supply, wherever required.
COMPATIBILITY & SUPPORT:
Training of following is required from supplier side, but not limited to
- Equipment operation
- Maintenance
- Cleaning and changeover process
- Trouble shooting
- Installation of equipment
- Installation of Inlet Handling unit
- Installation of Exhaust air Handling unit
TECHNICAL REQUIREMENTS for URS of Rapid Mixer Granulator:
Documentations:
Relevant catalogues and technical details in duplicate to be given with DQ.
Layout showing overall dimensions for each item of Rapid Mixer Granulator and dimensions of base to be submitted at the earliest for approval.
Power and services requirements for each item of Rapid Mixer Granulator including utility characteristics required.
Certification for MOC of contact parts, servo motors, main motors, sensors etc.
Shipping weight and crate dimensions.
Safety features.
Change parts requirement, if any.
Complete technical specifications.
All instruments/ gauges/controls including electronic controls should be calibrated and calibration certificates along with calibration procedure followed to be provided (traceability to National Standards to be informed by vendor). Vendor should recommend frequency for calibration of instrument/ gauges/controls.
Certificates for the following should be provided wherever applicable. MOC, Pressure Test, Performance Test. Design Qualification (DQ) and General assembly Drawings shall be submitted to company within two weeks after issuance of Purchase Order. Operation and maintenance manuals shall be submitted prior to Rapid Mixer Granulator delivery in triplicate, as early as possible.
All Rapid Mixer Granulator drawings as built to be submitted for records in triplicate.
The service requirement Rapid Mixer Granulator shall be clearly indicated. The service hook-up details to be provided.
Commissioning methods and commissioning tests/Qualification/Acceptance criteria shall be specified either in operational manual or in commissioning document to be submitted prior to delivery of Rapid Mixer Granulator at the earliest.
Construction certificate shall be provided with the Rapid Mixer Granulator.
Training to operators to be carried out and documented evidence to be submitted.
Details and frequency of Preventive maintenance is to be provided.
Draft SOP for the operation is to be provided before any Qualification activity is under taken.
Recommended cleaning procedure is to be given in the manual. A declaration of hard to clean area is to be given in the manual.
Finishing And Line Balancing:
The system comprises of Rapid Mixer Granulator shall be used to produce the granules from bulk powder. The equipment shall operate under dust free environment and conditions as per the GMP requirements.
The contact surface of the machine should be mirror finished and non contact part of the machine should be Mat finished.
Machine Anti vibrating adjustable pad should be attached at the base of the machine.
Stair Case with Railing should be availed with machine (MOC SS304).
Electrical:
All drive motors to be flameproof suitable for 415 V ± 10%, 3 Phase, 50 ±5% Hz.
Rapid Mixer Granulator offered should be guaranteed for workmanship and quality of materials for a minimum period of one year from the date of commissioning.
All system to be provided with overhead relay for protection against single phasing and low voltage.
All bought out items / Motors /Sub Module should be of reputed make meeting International Standards.
All system accessories offered should be guaranteed for workmanship and quality of materials for a minimum period of one year from the date of commissioning.
SALIENT FEATURES:
High Shear Mixer Granulator should be as per cGMP Guidelines.
Working Capacity 400 Liter Approx.
Equipment should consist of mixing bowl, impeller and chopper.
The bowl should be special shape for fluidizing effect.
The impeller has a suitable blade configuration and the blades are having such an angle so as to fluidize the powder effectively.
Suitable discharge port is provided so as to discharge the material without human contact directly into a container. The discharge port is operated pneumatically through a cylinder arrangement.
The entire operation is operated and controlled through a Programmable Logic Controller.
Auto lubrication of Machine Parts.
Safety Guard interlocking.
SAFETY FEATURES:
Tablet Rapid Mixer Granulator should have the following features:
The air-purged seals should be provided at both the impeller & the chopper drive. These seals help prevent any powder from entering the drive elements or any foreign materials entering the process area.
If for any reason, any of the machine guards are opened, then the equipment should detect the condition & stop both the drives. This will help ensure operator safety.
If for any reason, any of the motor is overload, then the equipment should detect the condition & stop both the drives. This will help ensure motor safety.
If for any reason, compressed air pressure is below set point, then the equipment should detect the condition & stop both the drives. This will help ensure process safety.
Emergency stop switch should be attached at easily accessible place.
Proper earthing features should be available in the machine to overcome any electrical hazards.
The limit switch shall be provided in Rapid Mixer Granulator should door which shall be interlocked with machine motor. As soon as door is opened Rapid Mixer Granulator motor should turn “OFF”.
TECHNICAL SPECIFICATION:
| Description | Specification | ||
| PGT/RMG-001 | PGT/RMG-002 | PGT/RMG-003 | |
| Capacity | Up to 600 Liter. | Up to 400 Liter. | Up to 150 Liter. |
| Equipment | Basic machine should be complete with product bowl, Mild Steel structure covered with Stainless Steel 304. All contact parts in SS 316LPneumatically actuated LidMotors should be NFLP3 blade impeller + 4 blade chopperWIP system should be ProvidedWIP spray ball arrangement should be providedFunnel with ball valveWet Mill at discharge providedLid with connection & programming with Vac-U-Max SystemImpeller With Lifting Arrangement (External Lifting)Trolley mounted WIP System with pump provided and it is common between RMG & FBD | ||
| Material of construction | For RMG – Product bowl, impeller, chopper & lid should be made up of SS 316L and all other non-contact components are of SS 304.Exterior easy to clean & non-corrosive.Material test certificates to be provided. | ||
| Calibration | All components that require calibration shall be identified and calibrated. Calibration certificates to be provided at the time of Installation qualification.Reference of Master Calibration Certificate will be mentioned in the calibration certificate.Test Certificates/ calibration charts of sensors & control instruments to be provided. | ||
| Qualifications/ Documentation | The manufacturer shall complete and provide the documents pertaining to Design, Installation & Operation Qualification. Alarms & Interlocks.Information on purchased/ bought-out parts Circuits & interlocks details. | ||
| Safety features | Adequate safety features for men and material shall be provided along with the equipment. | ||
| Control | The equipment shall be controlled through PLC based System. | ||
| System | Operating Panel is HMI. | ||
| Electrical System | The electrical system of the equipment shall be housed as per the cGMP and guidelines with adequate safety.Electrical panel is to be installed in service area. | ||
| Printer | Only Printer port to be provided for printing. | ||