The purpose of this document is to detail the basic guidelines to the vendor for the purpose of fabricating the blister packing machine (BQS) as per the defined specifications. This document is generating for the purpose of specifying the URS of BQS.
OBJECTIVE for URS of BQS
The User Requirements Specification URS of BQSis provided to define the important components, variables and options necessary for the Supplier to provide a functional of URS of BQS that meets the needs in the most cost-effective method possible. It is the foremost and the basic requirement of a facility, equipment, process and system as envisaged by the project team and management.
CONTENTS
| Title |
| Objective |
| Protocol Approval |
| Scope |
| Scope of Services |
| Technical Requirements |
| Documentations |
| Finishing and Line Balancing |
| Electrical |
| Salient Features |
| Safety Features |
| Technical Specification for Blister Packing Machine |
| Scope of Work |
| Material of Construction |
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
The scope of URS is applicable for blister packing machine (BQS). URS will be required for a variety of purposes which include, but are not limited to:
- Construction of new facilities.
- Refurbishment of existing facilities.
- Introduction of new systems.
- Changes to existing systems.
SCOPE OF SERVICES
Design of blister packing machine (BQS) shall meet with regulatory Guide Lines.
Commissioning include supervision and erection of system and their alignments. Trial run of system is to be taken with and without load 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 and equipment the information required on the equipment specs such as dimensions, electrical details, utility requirement, utility hook-up details, installation drawings, P & IDs (Process and Instrumentation Diagrams), 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 like compressed air, chilled water supply wherever required.
- Electric supply, wherever required.
TECHNICAL REQUIREMENTS for URS of BQS
Documentations:
Relevant catalogues and technical details in duplicate to be given with DQ.
Layout showing overall dimensions for each item of system and dimensions of base to be submitted at the earliest for approval.
Power and services requirements for each item of the system.
Safety features
Change parts requirement, if any.
Complete technical specifications.
Type of finishes in terms of Ra/grits.
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, Dynamic Balancing, Performance Test.
Operation and maintenance manuals shall be submitted prior to equipment delivery, as early as possible.
All equipment drawings as built to be submitted for records in triplicate.
The service requirement equipment 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 equipment at the earliest.
Construction certificate shall be provided with the system.
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 & Changeover is to be provided before any Qualification activity is under taken.
Finishing and Line Balancing
The system should be comprises of Blister packing Machine (BQS) which is a fully automatic machine. Suitable for PVC blister and ALU-ALU packing capable of producing thermo formed blisters.
The blister packing machine (BQS) should be a high output blister packing machine for the packaging of Pharmaceuticals Products like tablets and capsules. In operation, the base-film is intermittently drawn from either of the two reel stocks and feed to the blister forming station.
Electrical
- All drive motors to be flameproof suitable for 415 V ± 5%, 3 Phase, 50 ±5% Hz.
- Blister packing machine (BQS) 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 on PLC based control with HMI control.
- Temperature indicator – digital or analogue display.
- Magnehelic gauges for measuring Air pressure.
- Hopper should be made up of SS316L having product sensor.
- Pinhole detector should be installed to detect the pin hole in the PVC and Alu – Alu.
- Sealing and forming temperature should be control on PLC.
- Auto feeder with brush box must be installed to feed the product on guide track.
- Online cutting and scoring of blister facility should be installed in the machine.
SAFETY FEATURES 2
Blister Packing Machine (BQS) should have the following features:
- Emergency Stops.
- Door interlock should be provided in the Blister Packing Machine (BQS).
- The limit switch should be provided in packing machine door which shall be interlocked with machine motor. As soon as door is opened packing machine motor shall turn “OFF”.
- Warning Labels at appropriate places.
TECHNICAL SPECIFICATIONS FOR URS of BQS
| DESCRIPTION | SPECIFICATION |
| Machine Type | Flat Forming, Flat Sealing, Blister Packing Machine |
| Basic Machine | Forming Film reel mounting station.Splicing Table.Forming Film joint Detection System.Heating Station.Forming Station- ThermoformingAlu – Alu Forming Feeding SystemStandard feeding systemLidding Film Reel Mounting StationLidding Foil End Detection SystemLidding Foil Joint Detection SystemSealing StationCooling stationPulling stationWeb Loop Detection systemIndexing Before Punching StationPunching StationBlister Pick-up System |
| Accessories | Polycarbonate GuardingWiper brush assemblyOver printing stationPrint Registration systemEmbossing / Perforation StationEmbossing letter set – 1.59mmController for brush box Third arm pick upDrum Feeding systemLoop sensor |
| Control Cabinet | MS Cabinet + SS Door |
Scope Of Work
The blister packing machine (BQS) distribution package should include design, engineering, manufacture, testing at works, packaging and forwarding, transportation, unloading at site, storage, erection, start up, installation and commissioning.
It should also include all accessories and control instrumentation such as but not restricted to the following:
- Start up and commissioning spares required shall be specified clearly in your offer.
- Inspection shall be as per specification.
- Documentation shall be as per specification.
In case of any deviation of scope of supplies and services as specified in the offer, contractor to clearly highlight the same.
Contractor to follow legend GA drawing and adhere to the equipment for maintaining consistency.
Material of Construction
- The product contact parts should be made of buffed S.S. 316 and aluminum (Teflon-coated).
- Main frame made out of M.S. Aluminum plate mounted on the frame. S.S. cladding on the aluminum plate.
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