User Requirement Specification for Coating Machine
This article Contains the User Requirement Specification for Coating Machine. This machine is used for coating of tablets where we can do the functional coating i.e. Film Coating, enteric Coating etc.
User Requirement Specification for Coating Machine
| CONTENTS | |||
| 1.0 | Introduction section | ||
| 2.0 | Overview | ||
| 2.1 | Use | ||
| 2.2 | Capacity | ||
| 3.0 | Operational Requirement | ||
| 3.1 | Capacity | ||
| 3.2 | Process Requirement | ||
| 3.2.1 | Quality Standards | ||
| 3.2.2 | Limitations | ||
| 3.2.3 | Brief Description | ||
| 3.3 | Functions expected | ||
| 3.3.1 | Operation Cycle | ||
| 3.3.2 | Recipe Mode | ||
| 3.3.3 | Report Generation | ||
| 3.3.4 | Operator involvement | ||
| 3.4 | Power failure | ||
| 3.4.1 | Action in case of power failure | ||
| 3.4.2 | Interlocking of ancillaries | ||
| 3.4.3 | Utilities | ||
| 3.4.4 | Action in case of power resume | ||
| 3.4.5 | Operator involvement after resume | ||
| 3.4.6 | Action in case of PLC system failure | ||
| 3.5 | Alarm & Warning (hooter) | ||
| 3.5.1 | List of Alarm | ||
| 3.5.2 | Alarm management | ||
| 3.5.3 | Logging of alarm events | ||
| 3.5.4 | Protection for Alarm | ||
| 4.0 | Main Function and Interface | ||
| 4.1 | Main Function | ||
| 4.1.1 | Parameters to be controlled | ||
| 4.1.2 | Interlocks | ||
| 4.1.3 | Fine Control | ||
| 4.2 | Interface | ||
| 5.0 | Data and Security | ||
| 5.1 | Parameters to be entered | ||
| 5.2 | Security levels | ||
| 6.0 | Environment | ||
| 6.1 | Layout | ||
| 6.1.1 | Room Size | ||
| 6.2 | Physical conditions | ||
| 6.2.1 | Class of Area | ||
| 6.2.2 | Temperature and RH | ||
| 6.3 | Utility | ||
| 7.0 | Compatibility and Support | ||
| 7.1 | Operation | ||
| 7.2 | Cleaning facility | ||
| 7.3 | Maintenance | ||
| 7.4 | Support | ||
| 7.5 | Responsibility of supplier | ||
| 7.6 | Capability of system | ||
| 8.0 | Documentation | ||
| 8.1 | With Quotation | ||
| 8.2 | After Purchase Order | ||
| 8.3 | At Inspection | ||
| 8.4 | At Delivery | ||
| 8.5 | Calibration Certificates | ||
| 8.6 | MOC Certificates | ||
| 9.0 | Life Cycle | ||
| 9.1 | Delivery Period | ||
| 9.2 | Drawing Approval | ||
| 9.3 | Intermediate Inspection | ||
| 9.4 | Factory Acceptance Test | ||
| 9.5 | Site Testing | ||
| 9.6 | Startup Procedure | ||
| 9.7 | Qualification Documents | ||
| 10.0 | Safety Aspects | ||
| 10.1 | Emergency Off | ||
| 10.2 | Surface finish | ||
| 10.3 | Earthing & Bonding | ||
| 10.4 | Noise level | ||
| 10.5 | Guards | ||
| 11.0 | Acceptance and approval | ||
User Requirement Specification for Coating Machine
| 1.0 |
Introduction :This document is generated by user. This is the basic document to identify the user requirements of Function, Capacity, Features and Control System required for new Tablet Coating Machine to be installed in Coating area. The specifications and features specified in this document will be discussed and given to equipment manufacturer to generate an offer for new tablet Coating Machine. The User Requirements specified in this document will be verified during Equipment Qualification. |
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| 2.0 |
Overview :A new Tablet Coating Machine required for film coating of tablets. The machine should consist – Main Pan Cabinet, Suspension Delivery System & Operating Panel (in production cubicle) and Hot Air Unit with Dehumidifier, Exhaust Unit, Scrubber / Dedusting Unit, Power Panel & Pneumatic Panel (on service floor). |
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| 2.1 | Use : The Hemispherical shaped Perforated Coating Pan will be used for coating of tablets. Tablets to be coated will be loaded in the pan and allowed to mix by rotating the Pan in clockwise direction, the coating suspension will be sprayed over these rotating tablet bed under continues supply of hot air and exhaust. | ||
| 2.2 | Capacity : The capacity of the Coating Pan should be maximum 350 Kg. Diameter of the Pan should be 1570 mm. | ||
| 3.0 |
Operational Requirements :The equipment should be able to coat the tablets uniformly with minimum rejects and maximum weight gain. The operation process of the system should be simple and non dusty with all possible safety & operational interlocks. |
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| 3.1 | Capacity : The maximum capacity of the Coating Pan should be about 350 Kg. Capacity of Solution tank should be approx. 125 Ltr. | ||
| 3.2 | Process Requirement : Equipment should be able to coat the Tablets uniformly with minimal loss and rejects.
Pan should be Perforated (3.0 mm perforations) & Hemispherical shape with solid fischer type baffles. Pan should be provided with speed range of 0.5 to 15 RPM (using AC Drive unit for pan drive motor). Direction of rotation of Pan should be ‘Clockwise’. Shape and Size of all the Baffles should be uniform and there should not be any gap or trap in between any Baffle and Pan surface. Pan Light should be provided of better illumination level on top of the Pan. Height of the center of the Pan mouth should be approximately at 1350 mm from floor. View window should be provided on pan door. Spray gun arm should be retractable type. Spray guns should be provided with 1.0 mm SS nozzle size. Individual Spray gun should have spray rate adjustment facility. Spray gun choking indication on operating panel should be provided to identify the choked spray gun during operation. All the suspension and compressed air hoses should be pressure resistant, food grade quality and easily cleanable. Suspension tank should be provided with Pneumatic stirrer. Multi-head Peristaltic pump should be provided. Automatic Unloading system should be provided. Hot air unit should be provided with 10 micron – 3 micron – 0.3 micron (absolute HEPA) filtration and online Dehumidification system. Dehumidifier should be provided with silicon bed having online regeneration facility, chilled water coil, blower and steam coil. CFM at the terminal end of the Inlet duct should be- 3500. Steam coils should be provided for air heating system. Variation in Inlet air temperature should not be more than ± 2° C. The Hot air should achieve maximum 80° C temperature. Exhaust unit should be provided of 3500 CFM capacity. Differential pressure indicators should be provided across HEPA filter of Hot air unit. Doors to be provided for dismantling & assembling of filters for cleaning. There should be Handle on one end of the doors and other end fixed with hinges. Suitable Wet Scrubber should be provided for exhausted air with water sump, pump etc. |
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| 3.2.1 | Quality standards to be met : All contact parts should be SS 316 L and Non-contact parts should be SS 304. MOC of suspension and compressed air tubings should be food-grade. MOC of all the gaskets and o’rings should be food-grade silicon & White in color. MOC of all wheels should be ‘PU’ with SS brackets. | ||
| 3.2.2 | Product / Area / Site limitations : Hot air unit, Exhaust unit, Scrubber unit, Power panel and Pneumatic panel will be installed on service floor (above production floor) and slab height of production floor is 4.7 meter. | ||
| 3.2.3 | Brief description of Process : Tablets will be loaded in the Pan and pan will be rotated to predetermined speed. These tablets will be heated with the help of the hot air and after achieving certain exhaust temperature, coating suspension will be sprayed on them, dust & fumes generated during spraying process will be exhausted by exhaust unit. After completion of coating process Coated Tablets will be unloaded using auto unloading system.
Inlet blower & Pan drive should be provided with Variable frequency drive. All the pneumatic pipes and suspension tubings should be of food grade quality. Inlet and Exhaust air temperature sensors should be at the nearest point of the pan. Spray gun retractable arm should be swivel type with auto locking system. Online Spray rate and CFM of Inlet should be displayed on operating panel. Differential pressure indicators (across HEPA and Pan cabinet) and Air pressure indicators should be on operating panel. For easy opening of Pan Cabinet Doors, hinges should be provided. All the pan cabinet doors should be provided with gaskets to ensure leak proof operation. Top surface of Pan cabinet should be easily cleanable. Bottom Turf of pan should be accessible for cleaning. Drain of the bottom turf should be provided with solenoid valve and bypass drain line. Steam condensate (hot air unit) drain system should be provided and it should be operational from operating panel. Cleaning Ports (man hole) should be provided in Outlet Ducting. A port should be provided on hot air unit for DOP test of HEPA filter. Air Sampling ports should be provided to scrubber unit at before scrubbing and after scrubbing position. |
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| 3.3 | Functions expected : Control system should accept the physical data signals from field devices process the collected data & converts them into the system data. All the necessary calculations, control algorithms should be controlled by Control system to operate the system outputs properly. System should store data of at least 100 batches at a time. At least 10 users including User / Supervisor / Administrator level. | ||
| 3.3.1 | Operation cycle required : Scrubber pump ON – Exhaust blower ON – Inlet blower ON – Heater ON – Pan ON – Spraying ON (after achieving predefined exhaust temperature) – Spraying OFF (after completion of coating process) – Heater OFF – Inlet blower OFF – Exhaust blower OFF – Pan OFF – Scrubber Pump OFF. | ||
| 3.3.2 | Recipe mode : Recipe of 100 products should be stored and managed by the system.
Following parameters should be saved under each product : Ø Inlet Temperature (in ° C) Ø Exhaust Temperature (in ° C) Ø Pan Speed (in RPM) Ø Peristaltic Pump Speed (in RPM) Ø Atomisation Pressure (in Kg/cm2) Ø Differential Pressure across Pan cabinet (mm of wc) Ø Inlet Air Velocity (CFM) Ø Process Time (min) |
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| 3.3.3 | Report generation & Printing : Reports should be generated batch wise and date wise. Parameter update time should be 1 second maximum. | ||
| 3.3.4 | Operator involvement and Control : Operating panel having PLC panel with Colour Touch screen (machine MIMIC) and other controllers, indicators, displays etc.
The system should be provided with mainly 2 operation modes – Ø Fully Auto PLC operation Ø Manual individual operation through PLC (with all interlocks). |
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| 3.4 | Power failure and recovery : | ||
| 3.4.1 | Machine should stop safely in case of power failure and should not start automatically without operator interference after the power resume.
Enough care should be taken, so that system will not execute any command on its own after restart. Power resumed indications should be provided on control panel. And option should be provided to resume / abort the process after power resume. Operation should be restarted only after confirmation of working of all interlocks. |
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| 3.4.2 | Spraying should be stopped immediately in case of power failure. Dripping of suspension should be avoided by providing delay timer for atomisation pressure solenoid valve. | ||
| 3.4.3 | Steam supply to the coils should be stopped in case of power failure. | ||
| 3.4.4 | Machine parameters should retain values after power failure event. It should log all the events of power failure. On resume of power it should recollect the data. | ||
| 3.4.5 | In case of PLC communication failure appropriate message should appear to intimate the operator and also the machine set parameters should retain their values during communication failure event. | ||
| 3.4.6 | In case of PLC system failure all its output should turn off and thus no any abnormal operation should take place. Also, the operator should be warned about the failure by the system. | ||
| 3.5 | Alarms and Warnings (Hooter) : | ||
| 3.5.1 | Alarm should be given for following conditions :
Ø Scrubber Pump trip Ø Exhaust Blower trip Ø Pan motor trip Ø Inlet blower trip Ø Inlet compressed air pressure high / low Ø Atomisation pressure high / low Ø Inlet temperature high / low Ø Exhaust temperature high / low Ø Pan speed high / low Ø Differential pressure across HEPA (Low OR High) Ø Cabinet door open Ø Spray arm out |
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| 3.5.2 | System should have alarm management. It should be possible to give the priority to alarm condition. | ||
| 3.5.3 | System should log the alarm events with date and time stamp (Alarm history). It should be possible to retrieve the pre & post alarm condition data. | ||
| 3.5.4 | Alarm data should be integral part of database. It should not be possible to delete or edit the alarm. | ||
| 4.0 |
Main function and Interface : |
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| 4.1 | Main Function : Following should be the functions of the control system of the tablet coating machine –
Ø Machine should be operated locally through operating panel (in ‘PLC auto’ / ‘PLC Manual’ mode) near machine in production cubicle Ø Machine should run with all necessary process and safety interlocks Ø Machine should follow desired sequence of operation Ø System should display necessary parameters Ø System should allow setting of machine set parameters Ø System should allow setting of batch related parameters Ø System should create and save Recipe with given parameters Ø System should run as per loaded Recipe Ø System should display warning & give alarm on hooter for set parameters Ø System should allow to acknowledge the alarms & warnings Ø System should not allow operations without correct password Ø System should not allow set data modifications without correct security level Ø System should generate online batch reports as per preset time of interval Ø System should save history of alarms & warnings (Hooter). Ø Printer interface |
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| 4.1.1 | Parameters to be controlled :
Ø Inlet air temperature Ø Pan Speed Ø CFM of Inlet blower and Exhaust blower Ø Peristaltic Pump RPM Ø Atomisation air pressure |
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| 4.1.2 | Interlocks : Following interlocks should be provided –
Ø Scrubber Pump with water level in the tank Ø Inlet & Exhaust blowers with Scrubber Pump Ø Spraying with Blowers Ø Spraying with Pan speed Ø Spraying with Inlet & Exhaust temperature Ø Spraying with Atomisation air pressure Ø Spraying with Retractable arm In/Out position Ø Spraying with Pan Cabinet doors Open/Close Ø Inlet & Outlet Dampers shutting off with operating panel off Ø Compressed air supply to pneumatic panel with operating panel |
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| 4.1.3 | Fine Control : Inlet air Temperature should be controlled within ± 2° C of set inlet temperature. | ||
| 4.2 | Interface : Control system should be interfaced with operator interface (operating panel) and Remote operating terminal provision should also be provided.
The system should interface with following machine parts – Ø Scrubber Pump :- ON/OFF operation, Overload / Run feed back Ø Exhaust Blower :- ON/OFF operation, Overload / Run feed back Ø Inlet Blower :- ON/OFF operation, Overload / Run feed back, Dehumidifier feed back Ø Steam control valve :- Maintaining preset inlet air temperature Ø Pan Motor :- ON/OFF operation, Overload / Run feed back Ø Spraying :- ON/OFF operation, OFF / Run feed back Ø Pressure switch :- For Main compressed air supply & Atomisation air Ø Variable Frequency Drive :- For Pan motor & Inlet blower Ø Inlet & Outlet Damper Control :- For opening & shutting off Ø Spray Rate :- Maintaining preset spray rate
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| 5.0 |
Data and Security : |
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| 5.1 | Data : System should allow entry of following parameters :-
Ø Process Time (0 to 999 min) Ø Product Name (maximum 60 characters) Ø Batch Number (maximum 10 characters) Ø Lot Number (maximum 3 characters) Ø Inlet Temperature – Target, High limit & Low limit (0 to 200° C) Ø Exhaust Temperature – Target, High limit & Low limit (0 to 200° C) Ø Pan Speed – Target, High limit & Low limit (0 to 15 RPM) Ø Atomization Pressure – Target, High limit & Low limit (0 to 8 Kg/cm2) Ø Main Compressed air supply – High limit & Low limit (0 to 8 Kg/cm2) Ø Inlet CFM (0 to 5000 CFM – variation should NMT 5% to the set point)
The system should display following data : Ø Date (in DD.MM.YYYY format) Ø Time (in hh:mm Hrs. format) Ø Product Name Ø Batch Number Ø Lot Number Ø Process Time – Set & Remaining process time (Hrs. in hh:mm) Ø Inlet air temperature – Target & Actual value (in °C) Ø Exhaust air temperature – Target & Actual value (in °C) Ø Pan Speed – Target & Actual value (in RPM) Ø Spray Rate – Actual value (in gm/min) Ø Atomisation pressure (digital display in Kg/cm2) Ø Main Compressed Air supply pressure (digital display in Kg/cm2) Ø Inlet & Outlet CFM – Target & Actual value (in CFM)
The system should display ON / OFF status (by Red & Green color on MIMIC) of following items : Ø Scrubber Pump Ø Inlet Blower and Exhaust Blower Ø Pan Drive Ø Spraying |
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| 5.2 | Security : The system should have minimum 3 security levels :-
Operator – Access with own password only, Machine operations, Monitoring machine parameters & Alarm acknowledgement Supervisor – Access with own password & all operator passwords, Machine operations, Monitoring machine parameters, PID settings, Recipe loading & Alarm acknowledgement Administrator – Access with all passwords, Machine operations, Monitoring machine parameters, PID settings, Recipe loading, Alarm acknowledgement & Creating / Saving Recipe Data base of the system should be tamperproof. It should have backup system. It should be possible to take the backup without affecting the normal working of the system. Database should not be opened without password. Data in database should not be in direct form. To change the set point, if procedure calls, there should be facility for double authentication. There should be facility in the system so that it will force to change the password periodically. It should not be possible, even to administrator, to read the password from database. System should logout automatically to lowest security level after not detection of any activity for predetermined time. System should have audit trails for all events including login & logout. It should not be possible to delete or edit the database. System should not allow disabling the audit trail. Audit trails should include users name, old value, new value date & time along with comment, if any. The system must have a method for assigning user access rights with their need of access.
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| 6.0 |
Environment : |
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| 6.1 | Layout : | ||
| 6.1.1 | Room size details : 6700 mm (L) X 5800 mm (W) X 3000 (H) mm (Slab at 4700 mm)
Weight of the basic machine should be less than 1000 Kg/cm2. |
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| 6.2 | Physical conditions : | ||
| 6.2.1 | Class of Air of the area : 1,00,000 | ||
| 6.2.2 | Area temperature / RH : 22 ± 3° C / Not More Than 50 % RH. | ||
| 6.3 | Utility services available on the site : | ||
| Compressed Air (at 8 Kg/cm2) | |||
| Electrical Power (415 V ± 10%) | |||
| Steam (at 3 to 4 Kg/cm2) | |||
| Chilled Water (at 7 to 9° C) | |||
| 7.0 |
Compatibility and support : |
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| 7.1 | The Control system of the machine should be user friendly and easy to operate. | ||
| 7.2 | The equipment should have easy dismantling and assembling system. The equipment should be easy to clean and maintain. | ||
| 7.3 | Maintenance frequency for the machine should be defined. All the required spares for routine maintenance should be provided. Also a list of spares requiring regular replacement should be provided. | ||
| 7.4 | Manufacturer should provide support in case of problems, which may not be able to be rectified at the user end. | ||
| 7.5 | The supplier should install and commission the machine at the user site and provide the necessary training to the user for operation, cleaning & maintenance. Training to be provided for critical steps involved in operation, cleaning & maintenance of the machine. | ||
| 7.6 | System should have capability for future expansion with – spare hardware slots, configuration allocation facility for hooking up (remote / centralize monitoring system) and spare memory to incorporate other features required if any.
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8.0 |
Documentation : |
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| 8.1 | Along with quotation : Functional Specifications and Literature. | ||
| 8.2 | After receiving PO : Delivery schedule, Cabling schedule, Machine drawing for user approval prior to start manufacturing of the equipment. | ||
| 8.3 | At the time of Inspection : FAT protocol (if applicable). | ||
| 8.4 | At the time of delivery : Packing List, Installation & Operational Manual, Spray gun manual, PLC manual, Printer manual, Electrical circuit diagram, Pneumatic connection diagram.
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| 8.5 | Calibration certificates : Calibration of all Pressure Indicators, Digital Indicators & Controllers, Certificates of Motors, DOP test of HEPA, Validation of PLC, Validation of Scrubber, Integrity certificate of all Filters etc. | ||
| 8.6 | MOC certificates with material composition : Contact parts, Non-contact parts, Food grade Certificates of all Gaskets & O’ rings. MOC of machine should be item wise for each part (e.g. Baffles, Coating pan, Pan cabinet etc.) along with your test certificate reference number.
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9.0 |
Life Cycle : |
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| 9.1 | Delivery Period : 4 months. | ||
| 9.2 | Drawing approval authority and time span : ……………. / 7 days. | ||
| 9.3 | Intermediate Inspection : Not required. | ||
| 9.4 | Factory Acceptance Test : Not required | ||
| 9.5 | Site Testing : At the time of Receipt. | ||
| 9.6 | Startup Procedure : During Installation as per specified in Installation Manual. | ||
| 9.7 | Qualification documents expected from supplier : Test certificates and Manual. | ||
10.0 |
Safety Aspects |
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| 10.1 | Emergency Off push button on Pan cabinet and ON/OFF switch with lock & key arrangement on operating panel should be provided. | ||
| 10.2 | All the surfaces should be free from sharp edges. | ||
| 10.3 | All the motors (Scrubber pump, Exhaust blower, Pan motor, Inlet blower, Peristaltic pump) and Pan light should be Flameproof. Double earthing should be provided to the machine and all motors. Limit switches should be provided on spray arm and pan drive (pan cabinet) door. | ||
| 10.4 | Noise level of the equipment should not be more than 90 dB. And Vibrations should be normal. | ||
| 10.5 | Guards should be provided to all moving parts. | ||
| 11.0 |
Acceptance and approval :Acceptance & Approval of the document shall be joint responsibility of the persons undersigned. |
| DOCUMENT COMPILED BY |
DOCUMENT APPROVED BY |
DOCUMENT AUTHORISED BY |
