| 1.0 |
OBJECTIVE (WHAT)
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This procedure describes the guideline for specifying the user requirement specification for Automatic Blister Packing Machine (Model: BQS) at ground floor manufacturing section. |
| 2.0 |
PURPOSE (WHY)
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written procedure shall be followed for user requirement specification for Automatic Blister Packing Machine (Model: BQS). |
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The User Requirements Specification (URS) is provided to aid the user through the important components and specification
necessary to procure Automatic Blister Packing Machine (Model: BQS) that meets the user’s needs in the most cost-effective method possible. |
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The URS is then provided to the Supplier to provide a price quote for Automatic Blister Packing Machine (Model: BQS) including the design of the equipment. |
| 3.0 |
SCOPE ( WHEN) |
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The purpose of this User Requirement Specifications (URS) is to define the minimum requirements for Automatic Blister Packing Machine (Model: BQS)
Supplier must ensure that the design, materials and component selection, connected mechanical and electrical services of the Automatic Blister Packing Machine (Model: BQS) will be consistent with good engineering practice.
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4.0 |
RESPONSIBILITY AND ACCOUNTABILITY
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| S. No. |
Designation |
Responsibility and Accountability |
| 01 |
Trainee, Assistant, Associate, Engineer, Chemist, Officer, Supervisor, Incharge |
To prepare, follow, document, distribute, control, and retrieve URS. |
| 02 |
Asst. Manager, Manager, Asst. Team Leader, Team Leader, Group Leader, Executive, Sr. Executive. |
To ensure implementation of URS and recommendation for change in URS. |
| 03 |
Head of respective Department, Head-Quality |
To ensure implementation of URS and Authorised for change in URS. |
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| 5.0 |
Introduction:
Name of Equipment : Blister Packing Machine BQS ( ACG)
Location of Machine : Primary Packing Machine
Overview: The purpose of the blister packing machine is to pack the tablets/ capsules in blister as unit dosage form with high output.
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| 5.1 |
REQUIREMENT
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| 5.1.1 |
This URS helps the user to define the technical specification of Automatic Blister Packing Machine (Model: BQS) for the packing of products such as different types of capsules and tablets using suitable change parts.
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| 5.2 |
OPERATIONAL REQUIREMENT
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| 5.2.1 |
Basic configuration |
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Automatic Blister Packing Machine (Model: BQS) that packed the various types of product such as different types of capsules and tablets using suitable change parts/ Format parts.
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| 5.2.2 |
Specification |
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| Machine Specifications: |
| Make |
ACG |
| Model no. |
BQS |
| No. of machine required |
01 nos. |
| Forming Area |
240 mm( Width) x 180 mm (Advance ) |
| Forming Depth |
Up to 12 mm For PVC foil (thermoforming) |
| Up to 09 mm For Alu foil (Cold forming) |
| Forming cycle |
Up to 45 Cycle per min. for Thermo-forming foil |
| Up to 35 Cycle per min. for Cold-forming foil |
| Forming Speed |
Up to 8.1 meter per minute |
| Noise level |
Up to 80 dB at 1 meter |
| Punching cycle |
Max. 180 stroke per minute |
| Percentage Rejection |
Up to 0.10 % for standard DS |
| No. of Tracks |
Single, Twin, Three Tracks (It can be vary as per pack size) and comb pack possible. |
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| Foils Specifications : |
| Forming Films |
| Materials
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PVC |
| PVC/ PVdC |
| ACLAR |
| Triplex ( PVC/PE/Pvdc) |
| Cold Form foil ( alu) |
| Range |
· PVC- 250 -350µ
· PVC/PVDC- 250 to 350μ PVC with 40 to 90 gsm PVDC coating
· PVC/PE/PVdC- 250 to 350μ PVC with 25 to 30μ PE with 40 to 90 gsm PVDC coating
· PVC / Aclar (Duplex) – 250 to 350μ PVC with 15 to 102μ Aclar
· ALU- 130 to 135μ – Amcor or equivalent (PA 25 micron/AL 48 micron/PVC 60 micron) |
| Thickness |
Max. 350 microns |
| Min. 250 microns |
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| Width |
Max. 252 mm |
| Roll Diameter Max. |
400 mm |
| Lidding Foil |
| Materials
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Push Through ( alu) |
| Peel able (Paper), |
| Child Resistant ( CR) |
| Thickness
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20 to 30 microns alu. Foil |
| Standard paper and CR foil |
| Width |
Max. 246 mm |
| Roll Diameter Max. |
Max.250 mm |
| Blister Quality : |
| 1.Variation in cavity depth 0.2 mm , cutting variation 0.5 mm |
| 2. Variation of cavity distance from edges shall be within ± 0.5 mm. |
| 3. Unsealed area up to 0.5 mm will be visible around cavities. |
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| Tablet Specifications : |
| Round Shape: Diameter 6.00 mm to 20.00 mm and Thickness 2.5 mm to 10 mm above shall be compatible. |
| Caplet shape/ Oval Shape/ Diamond Shape: Length 10.0 mm to 23.0 mm, Width 3.0 mm to 9.0 mm, thickness 2.5 mm to 10.00 mm and all types of tablets shall be compatible. |
| Capsules Specifications : |
| All Capsules size (00 to 4 ) shall be compatible |
| Material of Construction of product contact parts: |
| · SS 316 L
· Alloy Temper 63400 (HE9) WP
· Alloy Temper 64430 (B51S) WP (HE 30)
· Nylon
· Silicon Rubber
· Teflon |
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| Standard Features Required : |
| 1 |
Blister packing machine with dedicated feeding system consisting of hopper, linear vibrator and rotary vibrator with complete SS cladding & Acrylic guarding but with change part. |
| 2 |
Facility for receiving pvc/alu change part consisting of heating station & necessary controls. |
| 3 |
Facility for receiving alu/alu blister change parts consisting of pneumatic cylinder with valve. |
| 4 |
Inkjet printer for batch code printing with servo drive. |
| 5 |
arm suction wheel pick up of blister for change parts.(It can be vary as per pack size) |
| 6 |
Print registration control system. |
| 7 |
Motor driven wiper brush to remove excess tablets/ Capsules from the film. |
| 8 |
Embossing station consisting of guide pillars, moving plate, fixed plate, bush (4 nos), ball bushing and includes basic parts. |
| 9 |
Controller for brush box with motors |
| 10 |
Validation documents consisting of DQ, IQ, & OQ. |
| 11 |
High Low Level sensor along with robust mounting on the hopper. |
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| 12 |
Low Level Sensor for Lidding and Base Material. |
| 13 |
One set of standard embossing types of height 1.59 / 2mm, 112 letters. |
| 14 |
Required third pick up arm for handling blister ( Should be match as per pack size) |
| 15 |
Brush Box feeding system for curved coated tablets, made of Hard Anodized Aluminium Plates. With horizontal and vertical brushes. |
| 16 |
Lidding foil splice detection system. |
| 17 |
Inkjet printing for batch code printing and embossing unit for metallic embossing. |
| 18 |
Base foil splice detection system. |
| 19 |
Cover on PVC Roll, Hinge Cover on Forming station, Cover on wiper brush, cover on feeding area, Guide Plate Guarding. |
| 20 |
Stray tablet detection system. |
| 21 |
Water Chiller 3T of cooling capacity of 6000 kcal/hr. |
| 22 |
Plug assist forming provision |
| 23 |
Embossing / Perforation for Alu/PVC and alu /alu |
| 24 |
Blister conveyor to be integrated with cartonator machine. |
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| ACG Inspection: |
| 25 |
Upgraded Blister inspection system with mounting parts. Inspection system must be capable of detection of multicolour caps/ Tablets with multicolour pellets and light color capsules body and cap. |
| 26 |
Pin Hole Detector – Forming Film with auto rejection |
| 27 |
Pin Hole Detector – Lidding Foil |
| 28 |
Stray product detection system for ALU-PVC blister. |
| Format Parts ( Change parts): |
| 29 |
One set of standard PVC/Alu Change parts with embossing with/without perforation. |
| 30 |
One set of standard Alu/Alu Change parts with embossing with/without perforation. |
| Basic Machine Requirement: |
| Features |
Description |
| Forming film reel mount |
2 Rolls provision |
| Foil presence check sensor continuously monitors the forming film presence. |
| Clamping in forming & sealing station |
Hydraulic |
| Heating Station |
Individual heating Cartridges type thermal plates with V-coated plates |
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| Forming Station |
To form the blister cavity on the web |
| Feeding Station |
Hopper
Linear Vibrator
Rotary vibrator |
| Lidding foil roll mounting |
Foil presence check sensor continuously monitors the forming film presence. |
| Embossing (Embossing Letter Set is Optional Part) |
Hot embossing |
| Perforation (Included in Format Part). |
Hot perforation |
| Vacuum source |
Vacuum Generator |
| Sealing Station |
To seal the blister |
| Cooling station |
To cool the sealed blister |
| Pulling Station |
To pull the web |
| Indexing Station |
Index the foil before punching |
| Punching Station |
To cut the blister as per the format |
| Guarding |
Acrylic Guards |
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| 5.3 |
Standard Utilities Requirement |
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Parameters |
Specification |
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Supply Voltage |
3 Phase, 415 Volts AC ± 5% |
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Supply Frequency |
50 Hz |
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Connected Load |
19 kW Maximum |
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Full load Current |
16 amp per phase |
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Air Pressure |
5 to 6 Bar, Compressed air in accordance with ISO8573-1:2010 |
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Air Consumption |
30 CFM @ 6 Bars with air enture. |
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Cooling Water Temp. |
14 to 20°C for PVC |
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8 to 10°C for PVdC |
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Cooling Water Flow Rate |
15 to 20 liters/min |
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Cooling Capacity |
9000 Kcal/hour (3 USRT) |
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Ambient Temperature range |
18 to 30°C |
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Humidity Range |
40 to 60 % RH |
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Lighting |
Greater than 300 Lux |
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Vacuum Requirement |
26 to 28’’ of Hg |
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5.3.1 |
Standard Control System with HMI
The main function of a PLC is to translate the instructions into the digital codes needed to operate the device or machine and to collect data from field instrumentation & display the information on the operator station. The instruments are connected to the system equipment. The collected data will be utilized by the PLC for process control. The user interface, based in an industrial type MMI, will assist the operator to supervise and control the process. Based on the displayed information the operator, by means of the user interface, can provide commands to the PLC. The PLC then executes the operator instructions. |
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User Management |
Total 3 Level,
3 user group ( operator -5, supervisor -3 , admin -2) |
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User auto logout facility |
Auto logout after 10 minutes (fixed) |
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Hardware & Software details |
7” Touch Screen, Flash Memory – 128 MB.
USB 2.0 x 1, 10/100 Base-T x 1
COM1: RS-232
COM2: RS-485 2W/4W
COM3: RS-485 2W |
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Protection Structure |
NEMA4 / IP65 Compliant Front Panel |
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Software |
Easy Builder Pro |
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Labeling and Nomenclature for cables/components |
As per ACG Pam standard |
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5.3.2 |
Specification: |
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Control System |
Operating panel based Standard Control System |
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Control Cabinet |
M.S. Painted Control Cabinet + SS Doors (IP Protection – N/A) |
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Operator Console |
HMI with closed enclosure |
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Tower Lamp: |
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YELLOW Light |
Machine is in Ready Condition |
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RED Light |
Machine is in Fault Condition |
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GREEN Light |
Machine is in Running Condition |
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5.4 |
Start-up of safety components |
| 5.4.1 |
Start-up of safety components in general execution: by Supplier |
| 5.5 |
Training |
| 5.5.1 |
Advantages and prevention of the risk of a machine stop |
| 5.5.2 |
Safety and continuity |
| 5.5.3 |
The training will be done at the production unit for below mentioned points.
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| 5.5.3.1 |
Two Emergency stop switches provided, one at operating panel and another at punching station area |
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5.5.3.2 |
Non CE Machine – Mechanically operated switch for front side guards (Polycarbonate / Acrylic) with machine stop system. Common Guard alarm for front guard will display on HMI & Machine will Stop at Cycle End. |
| 5.5.3.3 |
Warning labels at appropriate places. |
| 5.5.3.4 |
Control components mounting in fully enclosed cabinet |
| 5.5.3.5 |
Operator accessible area, console and switches with 24 VDC |
| 5.5.3.6 |
MCBs to avoid over current situation. |
| 5.6 |
Maintenance |
| 5.6.1 |
The training will be done by an expert service technician. |
| 5.6.2 |
Training for the maintenance as well as trouble shooting during operation and cleaning. |
| 5.6.3 |
Instructions how to use the operating manual and Maintenance of the equipment. |
| 5.7 |
Handover of the equipment |
| 5.7.1 |
Handover of unit with signing the handover protocol.
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| 6.0 |
COMPATIBILITY AND SUPPORT
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| 6.1 |
The extent of the supply must include all necessary components, installation and wiring to ensure that the complete system will be able to deliver functionality suitable for the intended use. In addition the supply must include, but not be limited to the following: |
| 6.2 |
Transport of all components. |
| 6.3 |
Commissioning |
| 6.4 |
Installation Qualification (IQ) |
| 6.5 |
Operational Qualification (OQ) |
| 6.6 |
Performance Qualification (PQ) |
| 6.7 |
Documentation |
| 6.8 |
Spare parts and consumables, wherever applicable. |
| 6.9 |
The supplier of the equipment must be a proactive contributor in suggesting optimal solutions throughout the lifetime of the project. |
| 7.0 |
DOCUMENTATION REQUIRED
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| 7.1 |
COMPLIANCE WITH SPECIFICATIONS
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| 7.1.1 |
Supplier must confirm compliance with this URS. Supplier is required to respond by confirming that the equipment/system complies fully with the requirement and current/updated certificate of conformance or, if not in compliance, stating in what ways it differs from the requirements. |
| 7.1.2 |
In the event of conflicting requirements in this URS, Supplier has to make the buyer aware of the conflicting requirements, and Supplier has to solve these conflicts in co-operation with the buyer.
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| 7.2 |
QUALIFICATION |
| 7.2.1 |
The unit must be qualified in terms of IQ and OQ. Supplier is responsible for performing a site acceptance test (SAT) and for IQ & OQ. |
| 7.2.2 |
The Supplier must provide installation requirements upfront of the installation. IQ and OQ should be performed by the Supplier. |
| 7.2.3 |
Where buyer, regarding to the Specification and other referenced documents, identifies no deviations, it must be assumed that the Supplier is in full compliance with all listed documents. |
| 7.2.4 |
The qualification documents shall be generated in English. |
| 7.2.5 |
The format and level of detail of the documentation are according to supplier’s documents and can be reviewed by the production personnel On request. |
| 7.3 |
DOCUMENTATION |
| 7.3.1 |
Contents according to internal company regulations and normative standards |
| 7.3.2 |
Instructions and user manual in English |
| 7.3.3 |
Spare parts list in English |
| 7.3.4 |
Subcontractor’s documentation/updated certificates in English |
| 7.3.5.1 |
Test certificates for major bought out parts such as Gearboxes, motors, vacuum pump |
| 7.3.5.2 |
Calibration Certificates for Thermocouple |
| 7.3.5.3 |
Declaration for Sensor, Pneumatic & Electronics Components |
| 7.3.5.4 |
Calibration Certificates of all gauges. |
| 7.3.6 |
Drawings/diagrams in English
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| 7.4 |
PREPARATION OF THE DQ DOCUMENTS |
| 7.4.1 |
Quality and Project Plan (QPP) |
| 7.4.2 |
Functional Specification (FS) |
| 7.4.3 |
Hardware Design Specification for Process Equipment (HDSP) |
| 7.5 |
PREPARATION OF IQ/OQ DOCUMENTS |
| 7.5.1 |
Hardware acceptance test protocol for process equipment (HATP) |
| 7.5.2 |
Acceptance test protocol for inputs & outputs (ATP-IO) |
| 7.6 |
PREPARATION AND EXECUTION OF FAT PROTOCOL |
| 7.6.1 |
Customer and supplier will meet at supplier’s factory for Factory Acceptance Test. Supplier creates a qualification protocol for all items to be tested during FAT before execution. The tests are limited because the machine cannot be installed at Supplier with all equipment. Also, not all energies and media are available. The tests are executed as far as possible. A full functional test can be done on-site. |
| 8.0 |
OTHERS (GMP & SAFETY REQUIREMENTS)
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| 8.1 |
The equipment to be supplied under this specification must be suitable for use in a Pharmaceutical manufacturing plant. |
| 8.2 |
Specification for Material of Construction |
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Product contact surface – SS 316 and Non contact surface – SS 304. |
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Seals, gaskets etc – Silicon food grade. (Certificate required)
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| 8.3 |
Desired means for avoiding contamination and cross contamination for the product(s). |
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All measured critical action shall be taken to avoid cross contamination. |
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Accessibility for ease of clean. |
| 8.4 |
Desired Product / Process safety systems. |
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Motor should be properly covered with SS-304, earthling should be connected with motors. |
| 8.5 |
STANDARD SAFETY FEATURE : |
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Two Emergency stop switches provided, one at operating panel and another at punching station area |
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Non CE Machine – Mechanically operated switch for front side guards (Polycarbonate / Acrylic) with machine stop system. Common Guard alarm for front guard will display on HMI & Machine will Stop at Cycle End. |
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Warning labels at appropriate places |
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Control components mounting in fully enclosed cabinet |
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Operator accessible area, console and switches with 24 VDC |
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MCBs to avoid over current situation. |
| 9.0 |
PARAMETER |
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I. Design qualification (DQ)
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II. Installation Qualification (IQ)
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III. Operational Qualification (OQ)
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IV. Performance Qualification (PQ)
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10.0
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SUMMARY |
| 10.1 |
To procure dedicated Automatic blister packing machine (Model: BQS) as per all specification mentioned above. |
| 11.0 |
REMARKS |
| 11.1 |
Supplier must ensure that the equipment is thoroughly cleaned and properly packed before delivery. Any open ends must be sealed
to prevent ingress of dust or moisture. |
| 11.2 |
Any faults or deficiencies found during commissioning or installation must be notified to the buyer at shortest possible time and are to be corrected by supplier at shortest possible time without any additional cost. |
| 11.3 |
Supplier must be solely responsible for the supply of goods and services. Supplier must ensure that the equipment is suitable for what
they are intended, not-withstanding anything in the documents comprising this specification. |
| 11.4 |
Supplier must be responsible for the delivery of the units and assembly of the system. |
| 11.5 |
The supplier is responsible for the installation of the unit, and for the connection of utility points.
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| 11.6 |
The schedule for delivery of documents and components and for installation must be agreed and followed.
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| 11.7 |
The equipment must be provided with suitable and adequate packaging for protection against weather, freezing, pilferage and rough
handling.
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