OBJECTIVE for URS of Capsule Filling Machine:
The purpose of this document is to detail the basic guidelines to the vendor for the purpose of fabricating the Capsule Filling machine as per the defined specifications. This document is generating for the purpose of specifying the URS of Capsule Filling Machine. The (User Requirements Specification) URS of Capsule Filling Machine is provided to define the important components, variables and options necessary for the Supplier to provide a functional of Capsule Filling machine that meets the needs in the most cost-effective method possible. It is the foremost and the basic requirement of the process and system as envisaged by the project team and management.
TABLE OF CONTENTS
| TITLE |
| Objective |
| URS 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 equipment and its major components design specifications and also comprising of the following sub assemblies of the equipments:
Structure Assembly
Drive Assembly
Turret Assembly
Empty capsule Loader Assembly
Powder Filling Device
Pellet Filling Attachment (Pneumatic & Mechanical)
Tamping Station
Pin Plate Assembly
Electrical Control Assembly
Group Sampling
PLC Description
Contact Parts MOC
Non Contact Parts MOC
Safety Feature
Electrical Motor
Main Drive Motor
Vacuum Pump Motor
Electrical Control Panel
SCOPE OF SERVICES:
To design a Capsule Filling Machine should meet with WHO , cGMP guide lines.
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, equipment and piping ducting layout (with dimensions), 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 Capsule filling Machine should have fallowing features:
Capacity 80,000 to 90,000 Capsules/Hour.
Suitable for Powder and pellets both.
Suitable for Capsule size 0 to 5.
Capsule and pellet low level sensor.
Powder low level sensor.
Rejection mechanism of capsule should be available, if powder or pellets not filled in the capsule.
Automatic Sampling of the Capsules.
Safety Guard interlocking.
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 URS of Capsule Filling Machine:
Documentations:
Relevant catalogues and technical details in duplicate to be given with DQ.
Layout showing overall dimensions for each item of Capsule Filling Machine and dimensions of base to be submitted at the earliest for approval.
Power and services requirements for each item of Capsule filling 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 Capsule Filling Machine delivery in triplicate, as early as possible.
All Capsule Filling Machine drawings as built to be submitted for records in triplicate.
The service requirement Capsule Filling 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 Capsule Filling Machine at the earliest.
Construction certificate shall be provided with the Capsule Filling 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 Capsule Filling Machine shall be used for filling powder or pellet or tablets in capsules. 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.
Capsule Filling 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 filling of capsule size 0 to 5.
Machine should have capability to fill powder, pellets as well as tablets.
Machine should be on PLC based control with HMI control.
Magnehelic gauges for measuring Air pressure.
Capsule hopper and pellet hopper should be made up of SS316L having low level sensor.
Proximity sensor for powder low level sensor should be attached.
Capsule machine should be attached with a polishing unit for polishing the capsules.
Pneumatic cylinder should be attached below exit chute for auto sampling of the filled capsules for in-process checking purpose.
Air displacement unit with filter pad should be attached to extract the extra powder from the machine.
Shorter elevator should attach to short out the defected empty capsule and auto feed the empty. capsules to the hopper.
Empty capsule sorter should be attached at final stage to sort out the empty capsules if any remains unfilled or come incidently.
SAFETY FEATURES:
Capsule Filling Machine should have the following features:
Main motor trip facility should be available.
Vacuum pump motor trip facility should be available.
Powder 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 Capsule Filling Machine.
Proper earthing features should be available in the machine to overcome any electrical hazards.
The limit switch shall be provided in Capsule Filling Machine door which shall be interlocked with machine motor. As soon as door is opened Capsule Filling Machine motor should turn “OFF”.
TECHNICAL SPECIFICATION:
| EQUIPMENTS | Details |
| Output: Up to 90,000 capsules/Hour. | |
| Compatibility: Machine should be capable for Powder filling, pellets filling as well as tablet filling. | |
| Capsule Filling Machine | Contact Part MOC: Contact metallic part should be SS 316L and surface finish of contact parts should not be less than 0.5 RA. |
| NON Contact Part MOC: Non contact metallic part should be SS 304 surface finish of non contact parts should be mirror finished. | |
| General: Mounted on Anti vibration pad. | |
| Electrical Motors: Main Drive: 415 Volt, 50 Hz, 3 Phases. Powder Feeder: 415 Volt, 50 Hz, 3 Phases. Vacuum Pump Motor: 415 Volt, 50 Hz, 3 Phases. Air Displacement Unit Motor: 415 Volt, 50 Hz, 3 Phases. Sorter Elevator Motor: 415 Volt, 50 Hz, 3 Phases. De-dusting and Polishing: 415 Volt, 50 Hz, 3 Phases. Vacuum Cleaner for DP: 415 Volt, 50 Hz, 3 Phases. Mini capsule Sorter: 415 Volt, 50 Hz, 3 Phases. Empty Capsule Sorter: 415 Volt, 50 Hz, 3 Phases. | |
| Utility: Compressed Air Pressure: 4 CFM. Air Displacement Unit Flow: 2800 LPM. Vacuum Requirement: Yes. |