Objective of URS for Coating Machine:
This document is generated under the authority for the purpose of specifying the URS FOR COATING MACHINE
URS for Coating Machine is provided to define the important components, variables and options necessary for the Supplier to provide a functional Coating 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 Auto coater machine including the design and functional specification and manufacture of the equipment.
Table of Content for URS FOR COATING MACHINE
| Sr. No. | Description |
| Title page | |
| Table of contents for URS FOR COATING MACHINE | |
| Approval of Documents | |
| Objective of URS FOR COATING MACHINE | |
| Scope | |
| Location of equipment | |
| Material of Construction | |
| System/equipment/instruments details | |
| Scope of Supply | |
| Brief system description | |
| Technical specification | |
| Safety features | |
| List of Abbreviations | |
| FAQ (Frequently Asked Questions) |
Approval of Documents URS FOR COATING MACHINE :
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 |
Scope:
The scope of this document is to define the requirements of the Auto Coater machine in the facility.
Material Of construction
Product Contact – Non-reactive, non-corrosive, non-absorptive and non-additive with SS 316 L.
Baffles shall be non-corrosive, non-absorptive.
Non Product Contact – All non-product contact parts should be of SS 304 or suitable material.
Gaskets – All gaskets should be of Food grade with silicon rubber
References for URS FOR COATING MACHINE
Reference shall be taken from the internet and from equipment manual.
System/equipment/Instruments details:
| Name of the equipment | Auto Coater (As per Requirement) |
| Category | Pharmaceutical Tablet coating |
| Technology | Automatic |
Scope of Supply:
| Type of Device | Auto Coater |
| Type of Coating | Aqueous/Non Aqueous/Sugar coating |
| Machine Standard | The current state of the art ,compatible for products with Occupational Exposure Bands(OEB) and GMP Compliance.European medicine agency (EMA) and WHO, USFDA Regulations compliance. |
| Machine design standard for safety | The European machinery Directive 2006/42/EC.The European low voltage Directive 2014/35/EUEmergency stop principle of design.ISO 13852:1996 safety of machinery -safety distance to prevent danger zones being reached by upper limbs.ISO 13853:1996 safety of machinery safety distance to prevent danger zones being reached by lower limbsISO 13854:1996 safety of machinery- minimum gaps to avoid crushing of parts of the human body.ISO 14110:1998 safety of machinery- interlocking device associated with guards- principles for design & selection.EU-GMP-Guideline Part 1, Annexes 11 & 15.Code of Federal Regulations 21CFR , Part 210: cGMP in Manufacturing, Processing, Packing and Holding of Drugs: General. |
| Room Condition | Room Temperature:- 250 CRelative humidity:- NMT 65%Zoning: Class D GradePressure:10 Pa |
| Material and surface finish of parts in contact with the product | Non-reactive, non-corrosive, non-absorptive and non-additive Preferably SS 316 LAll contact parts other than stainless steel should be food grade material.All gaskets should be of Food grade (USP Class VI) silicon rubber or any FDA approved material. |
| Non Product contact | All non-product contact parts should be of SS 304 or suitable material. |
| Operating Mode/Temperature | PLC controls with 8” color touch screen- Automatic & manual modeControllable temperature between atmosphere20 to 100 degree Celsius |
| Electric controls panel with PLC system & HMI Touch Screen | PLC Controls with 8” HMI touch Screen.Operating Panel fitted on the machine.Automatic Control by PLC & manual mode Control for ON-OFF and manual shaking.Manual Mode ScreenAuto Mode Screen. |
| Document & Certificate | Manuals and Maintenance Instructions Operator manualInstallation and assembly instructions for all devices.User’s manuals for all components.Trouble shooting guide.Maintenance Manual.Safety instruction.Training documentation.Electrical and Control diagramsCircuit diagramsEquipment location drawing for electrical equipment and instruments. |
| Qualification Protocols | DQ Protocols and reports.IQ protocol and reportOQ Protocol and reportVendor shall organize for Execution of IQ/OQ and support for PQ |
| Training | Vendor shall impart necessary Operational training to user department and maintenance training to maintenance department. |
| Test ,Calibration, MOC Certification | All test certificates for brought items will be provides MOC Certificate will be providing during FAT with FAT documents |
Brief system description:
This equipment will be used primarily for coating of the tablets of different size and shapes with aqueous/non-aqueous/Sugar coating solutions.
Chamber construction
Constructed entirely from SS304 with SS 304 doors with complete leak proof enclosure in compliance to Occupational Exposure Bands (OEB) and cGMP guidelines full opening of flush type front door for ease of removal pan and plenums.
Coating zone Construction
Constructed entirely from SS316/ SS316L and complying with cGMP guidelines The coating zone consists of coating pan and Baffles. The coating pan is enclosed within the cubicle shaped leak proof enclosure provided with food grade rubber seals resulting in perfectly insulated doors. The doors provide easy access to all the parts requiring observation, inspection and maintenance.
Coating Pan
It should be horizontally placed, cylindrical pan of required size, diameter having conical shape welded on both sides of the cylindrical perforated pan. The sheet body is perforated with triangular pitch to ensure optimum hot air entry and subsequent circulation. The pan mouth faces the operator for easy loading and unloading of tablets. Perforated pan with smooth surface, uniform perforations and with horizontal airflow for drying. Pan should be of suitable diameter, height and mouth diameter with baffles to ensure efficient mixing without damaging tablet.
Pan Drive
The pan should be driven by flame proof motor through suitable reduction gearbox. The different operating speeds are obtained using a Variable Frequency Drive (VFD) capable of achieving speeds from 2- 12 RPM (As per requirement).
Baffles
Baffles should be designed with a unique contour inside the coating pan generate a highly smooth tumbling rotation of the product being coated, thus resulting in excellent and smooth coating SS316.
Lights
A Flameproof electric light should be fitted on the top of the enclosure to give sufficient light for observation of the working zone.
Coating Solution assembly
This consists of solution Peristaltic dosing pump and spray guns.
Solution storage vessel
There should be vertically placed storage tank of required capacity is cylindrical in shape for easy cleaning. It has a detachable type flat top cover with entry point at the top for refilling of coating solution. It also house a pneumatic motor driven agitator for maintaining the uniform consistency of the solution throughout the operation Agitator should be driven by motor with VFD.
Peristaltic pump
The Peristaltic pump should have 3/4 heads for precise and rapid priming facility and accurate dosing of solution through solution transfer tubes.
Spray Gun
The spraying unit should have consists of 5-6 Nos. highly efficient non-chocking spraying Guns mounted on stainless steel retractable header. These guns spray controlled quantity of uniform droplets in the coating zone. The spraying cone can be adjusted by changing the angle and distance between the guns and the bed of the coating pan. The guns are mounted on SS retractable header with adjustable angle arrangement gun and tablet bed. After operation, the retractable header can be pulled out and even rotated by 90 degree for easy cleaning /washing. The gun mounting assembly also houses temperature probe RTD 100 to measure bed temperature.
Automation & control
The following parameters are controlled:-
- Automatically controlled process parameters with indication and display such as:
Inlet/Outlet Air temperature
BED/cabinet temperature
Pan RPM
Spray on Time and Spray rate
Product wise parameter/programming memory
Atomizing Pressure
- Automatic stoppage of spray in case of:In the event of equipment malfunction or loss of utilities, the unit must contain all necessary protection devices to ensure that the equipment and the product remain in a safe condition.
Pan rotation stops
Exhaust blower stops
Hot air blower stops
Air pressure falls below set point.
WIP System
The auto Coater is equipped with completely automated WIP system. After the coating process is completed the washing can be switched on. The system provides highly effective water spray nozzles that spray water under pressure on the rotating pan. The used water drained from bottom plenum and or air can be circulated for quick drying of the pan.
Technical Specification URS for Coating Machine:
| Sr. No. | Particulars | Specification |
| Auto Coating Pan | ||
| Pan Diameter | As per Requirement | |
| Pan Mouth Diameter | As per Requirement | |
| Pan Brim Volume | As per Requirement | |
| Total working capacity | As per Requirement | |
| Pan Speed | As per Requirement | |
| Main drive Motor | As per design (FLP) | |
| ELECTRICAL HEATER | ||
| Total KW | As per design | |
| Heater Bank | As per design | |
| Header | Extended area, fixed SS Tube with Aluminum fins. | |
| Heating capacity | From Ambient to 80 degree Celsius | |
| BLOWERS | ||
| Hot air Blower capacity | As per design | |
| Exhaust Air Blower Capacity | As per design | |
| Blower type | Centrifugal, backward Curved Blades ( As per Requirement) | |
| Hot Air Inlet Blower Motor | As per Requirement | |
| Exhaust Air Blower Motor | As per Requirement | |
| PRE- FILTERS | ||
| Type | As per Requirement | |
| Size | As per design | |
| Efficiency | As per Requirement | |
| Filter Frame | As per Requirement | |
| HEPA FILTERS | ||
| Type | Glass impregnated paper with SS 304 case | |
| Size | As per design | |
| Efficiency | 99.99% down to 0.3 micron | |
| Filter Frame | 16 G SS 304 sheets or As per Requirement | |
| EXHAUST Filter | ||
| Type | HDPE 5 ply washable with Aluminium flanged case | |
| Size | As per design | |
| Efficiency | 90% down to 10micron | |
| Filter Frame | 16 G Aluminium sheets | |
| CONTROL SYSTEM | ||
| Equipment Control Via | PLC or As per Requirement | |
| PLC Make | As per Requirement | |
| Frequency drive | As per Requirement | |
Safety Features:
Blower Motor thermal overload.
All temperature sensor are equipped with independent safety system
Positive earthing is interlocked with system and safety.
Pressure switch for Air System.
Emergency stop on HMI: An emergency-stop switch should be supplied, which, when activated, should shut the system down immediately in accordance with the requirements.
All drive mechanism should have proper cover
Appropriate closure of all the rotating parts.
Alarms
For set parameters when out of set limit audio- visual alarm.
Nozzle blockage and less flow rate
Audio-visual alarm when the pressure drop is more than the desired level for wet scrubber.
Audio-visual alarm when pressure drop across the HEPA Filter exceeds set point.
Batch Halt
Batch Complete
Batch Halt
Batch Complete
Abbreviations.
| URS | User Requirement Specification |
| ENG | Engineering |
| QA | Quality Assurance |
| CFM | Cubic feet per minute |
| mm | Milli Meter |
| Ltr | Litre |
| Hr | Hour |
| MOC | Material of Construction |
| HMI | Human Machine Interface |
| mmWG | Milli meter of water gauge |
| FLP | Flame Proof |
FAQ’s (Frequently Asked Questions) regarding URS FOR COATING MACHINE
Q-1 What is the purpose of creating a User Requirement Specification (URS) for a coating machine?
Answer: The URS outlines the user’s needs and expectations for coating machine. It ensures that the machine meets regulatory requirements, operates efficiently, and adheres to Good Manufacturing Practices (GMP) for coating pharmaceutical products like tablet.
Q-2 What key information should be included in URS?
Answer: URS should includes, Process requirement, Regulatory compliance, Cleaning and sanitation, Safety requirement, Maintenance and utility requirements.
Q-3What are the essential safety features to be consider while preparing the URS?
Answer: Emergency Stop Buttons
Safety interlock and guards
Explosion proof design
Operators protection
Q-4 What utility requirements should be considered in URS?
Answer: Electrical requirement, Compressed air, Water, HVAC and air filtration.