USER REQUIREMENT SPECIFICATION FOR ALU/ALU /PVC BLISTER MACHINE
TABLE OF CONTENT
| Sr. No. | Description | Page No. |
| Title page | ||
| Table of contents | ||
| Approval of Documents | ||
| Objective | ||
| Scope | ||
| Location of equipment | ||
| Material of Construction | ||
| System/equipment/instruments details | ||
| Brief system description | ||
| Technical specification | ||
| Alarms and Warnings | ||
| Spare and Change Parts | ||
| Documentation & Qualification | ||
| Safety features | ||
| References | ||
| List of Abbreviations | ||
| FAQ (Frequently Asked Questions) |
1. Approval of Documents:
Prepared by:-
| Name | Designation/Department | Signature | Date |
| Executive/Quality Assurance |
Reviewed by:-
| Name | Designation/Department | Signature | Date |
| Manager/Production | |||
| Manager/Engineering |
Approved by:-
| Name | Designation/Department | Signature | Date |
| Manager/Quality Assurance |
2. Objective for URS for Blister Packing Machine
This document is generated under the responsibility for the purpose of specifying the user requirement for ALU-ALU Cum PVC Blister Packing machine.
The User Requirements Specification (URS) is provided to define the important components and options necessary for the Supplier to provide a functional ALU-ALU/PVC Blister machine that meets the needs in the most cost-effective method possible. The URS is also provided to the Supplier to provide a price quote for the supply for ALU-ALU/PVC Blister packing machine including the design and functional specification and manufacture of the equipment.
The ALU-ALU/PVC Blister packing machine will be interfaced to the output and will be located in a designated operating area within a Occupational exposure Bands/ Occupational exposure limits (4 /5 ) and cGMP packaging operation.
3. Scope:
The scope of this document is to define the requirements of the ALU-ALU/PVC/PVDC Blister packing machine to be procured and to install in the facility.
4. Location of Equipment:
Machine will be installed in the Primary Packing area with Class D area of cleanliness.
5. Material of Construction
- Product Contact – Non-reactive, non-corrosive, non-absorptive and non-additive. Preferably SS 316 L. Smooth /Electro polished 240 grit/<0.5 RA Buff / mirror polished
- Non Product Contact – All non-product contact parts should be of SS 304 or suitable material.
- Gaskets – All gaskets should be of Food grade (USP Class VI) silicon rubber
- Lubricant – Food Grade
6. System/equipment/Instruments details:
| Name of the equipment | ALU/ALU Cum PVC Blister Packing Machine |
| Category | cGMP Pharmaceutical packing machine with 3-4 Occupational exposure limits. |
7. Brief system description:
- Design should be cGMP, flaw less, Occupational exposure Bands/Occupational exposure limits (3-4 ) and should permit effective operation, cleaning and maintenance in order to avoid cross contamination, build-up of residue, dirt and dust.
- The Basic machine comprises of mild steel chassis with SS 316 frames welded and bolted from a rigid frame device structure on which various modular stations are mounted in balcony design.
- All the drive component and extensive cabling are located behind and inside the machine. The various stations of the machine are controlled by the centrally mounted spline shaft driven by main motor. Having two servo motors for operating the indexing and the feeding system of the machine. The feeding is done by Product Transfer roller (PTR) for ALU/ALU Cum PVC Blister accurately.
- The entire machine is mounted on the six height adjustable studs so that the entire area below the machine is easily sanitized. The machine will be properly guarded to ensure operator safety. The cantilevered modular stations adjustments are accessed from the front side of the machine.
- The format parts are very easy to mount and dismount and are achieved using minimum tools and tackles. A complete set can be achieved in less than 15 minutes with minimum operator fatigue.
- To accommodate different shapes and sizes of the tablet and capsules
- Easy Operation using touch screen, to handle the different width of foil with different microns.
- Consistent to produce Blisters without any defect
- Continuous working for 8-10 hrs. in a shift of 8 hrs.
- Easy Changeover with effective cleaning
- Easy preventive maintenance
- Minimum / no breakdown maintenance.
- The basic machine will comprise of the following statistics/functions:
- Hopper and Chute
- Base film- loading station
- Cold forming station for forming the cavity in the base film.
- Feeding system
- Web transport station.
- Sealing Station for sealing of the base film to the lidding film.
- Film indexing station.
- Punching station
- Trim winding assembly
- Pin Hole Detection
- Camera probably with Jackson or any other as per requirement
- Splice sensor
- Fully hinged doors for easy maintenance, cleaning, product & format change over
- Doors should be of safety glass, scratch resistant & suitable for all types of cleaning agents
- No exposed painted parts
- External surface especially railing platform should be smooth for foil movement.
- Stainless steel interior for easy cleaning
- Provision for 1 / 2 Line embossing to be made on each blister using Metal/ Rubber stereos
- Counter for collation pack count and discharged pack counting.
8. Technical Specification:
| Sr. No. | Particulars | Specification |
| 1 | Max machine Speed | As per requirement |
| 2 | Max Forming Area | As per requirement |
| 3 | Min Pack size | As per requirement |
| 4 | Optimum Forming depth | As per requirement |
| 5 | Max Reel Diameter | As per requirement |
| 6 | Max Lidding Foil | As per requirement |
| 7 | Max Core Diameter | As per requirement |
| 8 | No fill detection | As per requirement |
| 9 | Eye mark sensor | As per requirement |
| 10 | Cooling Water Consumption | As per requirement |
| 11 | Compressed Air | As per requirement |
9. Alarms and Warnings –
Low Forming temperature
High Forming temperature
Low Sealing Temperature
High Sealing Temperature
Machine Door Guard open
Vacuum pump overloads safety or not maintained
Low air pressure
10. Spare & Change parts
List of recommended critical spare parts considering 2 years of satisfactory working of machine. After Sale Service/ AMC (if any) 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.
11. Documentation & Qualification
Vendor shall provide equipment manual, Quality certificates and MOC certificates.
Related SOPs and if any testing procedures.
Hard and soft copy of DQ / IQ/OQ protocol and report.
The Supplier should provide the required documentation (compliance to cGMP) at the desired stage of manufacturing for preliminary review. After approval, the final documents should be provided.
The Supplier shall provide documentation reflecting “as-built” condition with final delivery (Not limited to).
PLC Program
Stepwise inspection / FAT will be carried out by client or person approved. The supplier should provide all required material & facility during such inspection at no extra cost.
Vendor shall organize for Execution of IQ/OQ and support for PQ
12. Safety Features:
- Emergency Stop function.
- Whenever possible warning symbols should be provided as like door not locking properly.
- Closer of all parts.
- Machine should be sturdy enough to take care of vibrations and should be mounted on anti vibration pads.
- Noise level should be within acceptable limit. NMT 60 decibels within 1 meter from machine (Ref: OSHAS)
- Compressed air inlet airflow through pre filtration and finally through 0.2 micron filter.
13. Reference
References shall be taken from existing equipment and from the internet.
14. List of Abbreviations.
| URS | User Requirement Specification |
| ENG | Engineering |
| QA | Quality Assurance |
| SOP | Standard Operating Procedure |
| FAT | Factory Acceptance Test |
| DQ | Design Qualification |
| IQ | Installation Qualification |
| OQ | Operational Qualification |
| PQ | Performance Qualification |
| PLC | Programmable Logic Circuit |
| MOC | Material of Construction |
15. FAQ (Frequently Asked Question)
Q1. What does URS Mean?
Answer:- URS is defined as the User Requirement Specification. It is required document by the user to the vendor that what kind of specification user needs for the equipment/instruments that he wants to buy.
Q2. What does ALU-ALU/PVC/PVDC stands for?
Answer:- Alu-Alu stands for the Aluminium-Aluminium packing and PVC stands for Polyvinyl chloride and PVDC stands for Poly-vinyl Di-chloride.
Q3. What should be include in URS ?
Answer:- URS should be include as
Objective of the URS
Functional requirement
Regulatory Requirement as per FDA & cGMP
Design and Technical Specification
Safety Requirement
Q4. What Happens after Completion of URS?
Answer:- After finalization of URS, Design Qualification shall be initiated. Then Factory Acceptance Test shall be carried out followed by Site Acceptance Test. Then Design Qualification at site shall be carried out followed by Installation Qualification => Operational Qualification => Performance Qualification.