OBJECTIVE for URS of Compression Machine :
The URS of Compression Machine (CADMACH) is provided to define the important components, variables and options necessary for the Supplier to provide a functional of compression machine that meets the needs in the most cost-effective method possible. The URS of Compression Machine (CADMACH) is also provided to the Supplier to provide a price quote for the supply for compression machine including the design, Performance and manufacture of the equipment. The purpose of this document is to detail the basic guidelines to the vendor for the purpose of fabricating the Compression machine as per the defined specifications. It is the foremost and the basic requirement of the process and system as envisaged by the project team and management.
CONTENTS
| TITLE |
| URS Approval |
| Objective |
| Scope |
| Scope of Services |
| Compatibility & Support |
| Technical Requirements |
| Finishing And Line Balancing |
| Electrical |
| Salient Features |
| Safety Features |
| Technical Specification |
| Deviation |
| Delivery |
PROTOCOL APPROVAL for URS of Compression Machine:
PROTOCOL PREPARED BY:
| Department | Name | Signature | Date |
| Quality Assurance (Officer/ Executive) |
PROTOCOL REVIEWED BY:
| Department | Name | Signature | Date |
| Quality Assurance (Executive/ Manager) | |||
| Production (Executive/ Manager) | |||
| Engineering (Executive/ Manager) |
PROTOCOL APPROVED BY:
| Department | Name | Signature | Date |
| Quality Assurance (Head QA) |
SCOPE:
Scope of URS cover finalization of compression machine and its major components design specifications and also comprising of the following sub assemblies of the equipments:
- Drive unit, Turret and Compression Unit
- Powder Feeding Unit (LHS & RHS)
- Powder Transfer Unit (LHS/RHS)
- Weight Adjustment Unit (LHS/RHS)
- Tablet Ejection Unit (LHS/RHS)
- Tablet Discharge Unit (LHS & RHS)
- Auto Intermittent Lubrication Unit
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 a Compression machine should meet with WHO, cGMP guidelines. Machine should have additional features such as Ejection force mechanism and Bi-Layer provision.
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 diagram and equipment, 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.
The Compression machine should have fallowing features:
Monolayer Capacity 80,000 to 700,000 Tablets/Hour.
Bi-layer Capacity 100000 Tablets/Hour.
Fully computerized dial less operation.
Auto Weight control system.
Compaction force by PLC.
Hopper with Agitator assembly with ACVFD.
Powder low level sensor.
Ejection Force Mechanism.
Automatic Sampling of the Tablets.
Auto lubrication of Machine Parts.
Safety Guard interlocking.
Powder Transfer Unit.
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
TECHNICAL REQUIREMENTS for URS of Compression Machine:
Documentations:
Relevant catalogues and technical details in duplicate to be given with DQ.
Layout showing overall dimensions for each item of Tablet Compression Machine and dimensions of base to be submitted at the earliest for approval.
Power and services requirements for each item of Tablet Compression Machine 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.
Operation and maintenance manuals shall be submitted prior to Tablet Compression Machine delivery in triplicate, as early as possible.
All Tablet Compression Machine drawings as built to be submitted for records in triplicate.
The service requirement Tablet Compression Machine 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 Tablet Compression Machine at the earliest.
Construction certificate shall be provided with the Tablet Compression Machine.
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 Tablet Compression Machine shall be used for filling 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.
Electrical:
All drive motors to be flameproof suitable for 415 V ± 10%, 3 Phase, 50 ±5% Hz.
Tablet Compression Machine 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:
Machine should be fully automatic capable for compress the powder at tablet thickness 0.25 mm to 8.5 mm.
Machine should have capability to compress the Bi-Layer Tablet.
Machine should be on PLC based control with HMI control.
Magnehelic gauges for measuring Air pressure.
Hoppers should be made up of SS316L having low level sensor.
Proximity sensor for powder low level sensor should be attached.
Pneumatic cylinder should be attached below exit chute for auto sampling of the tablets for in-process checking purpose.
Ejection assembly should be attached for sampling of Bi- layer tablet.
Dust Extractor unit with filter pad should be attached to extract the extra powder from the machine.
SAFETY FEATURES for URS of Compression Machine:
Tablet compression Machine should have the following features:
Main motor trip facility should be available.
Compressed air pressure motor trip facility should be available.
Emergency stop switch should be attached at easily accessible place.
Door interlock shall be provided in the Tablet compression Machine.
Proper earthing features should be available in the machine to overcome any electrical hazards.
The limit switch shall be provided in Tablet compression Machine door which shall be interlocked with machine motor. As soon as door is opened Tablet compression Machine motor should turn “OFF”.
TECHNICAL SPECIFICATION:
| Description | Specification |
| Station | 73 Station |
| Output | 70,0000 Tablet/Hour |
| Contact Parts | SS316 L (Inclusive of the Die pot table) |
| Non contact parts | SS 304 |
| Hopper capacity | 16.5 Liters |
| Tablet thickness | Min= 0.25mm Max = 8.5 mm |
| Max. Tablet Dia. | 13.00 mm |
| Max. Depth Of Fill | 18.00 mm |
| Type of Feeding | Force Feeding system |
| PLC | To control the machine |
| Industrial PC | To control the operating parameter |
| Lubrication Pump | For auto lubrication of machine parts |
DEVIATION:
Any Deviation or Modification to the User requirement specification shall be highlighted.
| Specification | Deviation | Checked by | Verified by |