Design Qualification For Glatt Autocoater (GCS-500)
Design Qualification For Glatt Autocoater (GCS-500)
- PURPOSE :
The purpose of Design qualification of the equipment is to ensure that all the critical aspects including, Safety, effective cleaning, maintenance, process requirements, utilities requirement (pipe work), product requirement, working space, assembling & dismantling of accessories have been considered in designing the equipment and is properly documented as per cGMP.
- SCOPE :
Design qualification is to be performed at the time when planning and choosing for
new equipment.
- RESPONSIBILITY :
| User Dept
(Pharma Coating) |
To evaluate the design parameters with respect to URS, functional requirements, cGMP and record the information. |
| Engineering
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To verify the equipment parameters and utility requirements. |
| Safety
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To verify the safety aspects of equipment. |
| Quality control | To verify the aspects on which the quality of the product is dependent. |
| Quality assurance | To review and approve the protocol. |
| Unit Head | To authorize the protocol. |
- PROJECT REQUIREMENTS: –
To design machine for Tablet coating which is to be installed in Coating area.
4.1. SYSTEM DESCRIPTION : –
- WORKING PRINCIPLE :
Coating is performed on tablets by achieving state of equilibrium among parameters like quantity of tablets, rate of tumbling (Pan RPM), spray rate and rate of drying.
4.1.2 DESCRIPTION OF EQUIPMENT UNITS :
- Hot Air Unit :
The unit provides filtered hot air for drying of tablets while coating at the derived temperature and CFM. Interlocks and sensors / provision for calibration / verification of subunits to be provided for process safety.
- Processing Unit (Coating Pan) :
Processing unit consists pan, baffles for proper mixing of tablets during spraying process, pan cabinet and suspension delivery unit. Interlocks like Pan RPM with Spray ON/OFF and sensors / provision for calibration / verification of pan speed to be considered during designing.
- Exhaust Unit :
This unit create suction & negative pressure inside the pan with respect to cubicle to improve drying efficiency. Interlocks like exhaust blower with inlet blower and sensors / provision for calibration / verification of subunits to be provided for process safety.
- Scrubber :
The exhausted air should pass through a scrubber unit to remove the solid / solvent particles from the air before it allows to escape in atmosphere. The system of scrubber consist water sump, scrubber pump and mechanism to trap the solid / solvent particle. It allows clean air to exhaust in atmosphere.
- Control system (Electric, Pneumatic and Electronic circuit) :
System consist of operating mode, ON/OFF switches, parameters controller, digital indicator and controller to operate whole system as a single unit.
Interlocks like Exhaust lower with Scrubber ON/OFF, Inlet blower with Exhaust, Spray ON/OFF with Inlet temperature, spray ON/OFF to atomisation and Spray ON/OFF with Pan RPM to be provided.
- Suspension delivery system (Feed vessel, Peristaltic pump, Spray Guns etc.) :
System controls dosing of suspension depending upon tube size, spray gun nozzle size and speed of roller assembly of the pump. Arrangement for assembling and dismantling of spray gun or replacement of nozzle to be considered during designing.
- CRITICAL VARIABLES TO BE MET:
Critical variables to be met |
User requirement |
FunctionalSpecification |
Remark |
5.1 Location suitability : |
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| 5.1.1 Location :
Coating Area |
Should accommodate in Coating area and should have sufficient area for easy operation | As per user requirements |
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| 5.2 Equipment design / Control / Process / Product parameters : | |||
| 5.2.1 Capacity | Maximum 350 Kg | Maximum 350 Kg |
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| 5.2.2 Diameter of Pan | 1570 mm | 1570 mm |
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| 5.2.3 Dimensions | —- | L– 2294 mm, W– 2030 mm,
H– 2530 mm |
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| 5.2.4 Weight | Weight of the machine should be less than 1000 Kg/cm2 | Weight will be 2200 Kg.
i.e. 0.05 Kg/cm2 |
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| 5.2.5 Pan | Pan should be perforated (3.0 mm perforations) and Hemispherical shape with solid fischer type baffles | Pan will be perforated (3.0 mm perforations) and Hemispherical shape with solid fischer type baffles
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| 5.2.6 Pan Speed | Pan should be provided with speed range of 0.5 to 15 RPM (using AC drive unit for Pan drive motor) | Pan will be provided with speed range of 0.5 to 15 RPM (using AC drive unit for Pan drive motor)
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| 5.2.7 Direction of Pan rotation | Direction of rotation of Pan should be ‘Clockwise’ | Direction of rotation of Pan will be ‘Clockwise’
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| 5.2.8 Baffles | 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 | Shape and size of all the baffles will be uniform, without any gap OR trap in between any Baffle and Pan surface
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| 5.2.9 Pan Light | Pan light should be provided of better illumination level on top of the Pan | The drum is internally illuminated with a flameproof lamp, mounted on a bull eye flange | |
| 5.2.10 Spray Gun Arm | Spray gun arm should be retractable type | The complete spray arm with the nozzles can be retracted out of the drum and pivoted (auto-lock) to the right hand side of the machine | |
| 5.2.11 Spray Guns | Spray guns should be provided with 1.0 mm SS nozzle and individual gun should have spray rate adjustment facility | Spray guns will be provided with 1.0 mm SS nozzle and individual gun will have spray rate adjustment facility
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| 5.2.12 Peristaltic Pump | Multi-head Peristaltic Pump should be provided | Multi-head Peristaltic Pump will be provided
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| 5.2.13 Height of Pan mouth from floor | Height of the center of the Pan mouth should be approximately at 1350 mm from floor
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Height of the center of the Pan mouth will be at 1350 mm from floor | |
| 5.2.14 View window | View window should be provided on pan door | The front fascia of the housing is provided with a large blanking flange with transparent door
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| 5.2.15 Pan Cabinet | Top surface of Pan cabinet should be easily cleanable | Top surface of Pan cabinet will be easily cleanable
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| 5.2.16 Bottom turf | Bottom turf of pan should be accessible for cleaning, Drain of the bottom turf should be provided with solenoid valve and bypass drain line
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Bottom turf of pan will be accessible for cleaning, Drain of the bottom turf will be provided with solenoid valve and bypass drain line | |
| 5.2.17 Pan Cabinet Doors | For easy opening of Pan Cabinet doors hinges should be provided and all the cabinet doors should be provided with gaskets to ensure leak proof operation | For easy opening of Pan Cabinet doors hinges will be provided and all the cabinet doors will be provided with gaskets to ensure leak proof operation
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| 5.2.18 Suspension Feed Vessel | Capacity should be approx. 125 Ltr., Feed vessel should be provided with pneumatic stirrer | 125 litres capacity jacketed solution-feeding vessel, non-pressurised in SS316L with lid and agitator, with pneumatic motor and PU wheels with brakes
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| 5.2.19 Unloading system | Automatic unloading system should be provided | Discharging pipe is used to empty the pan. It is mounted in the drum opening using a quick mounting bracket. Rotating the drum causes the product to be discharged from the coater into a waiting container
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| 5.2.20 Hot Air Unit | Hot air unit should be provided of 3500 CFM with dehumidification unit.
It should consist of 10m filter, chilled water coil, silica desiccant bed for dehumi-dification, Blower, Steam coil, 3m filter, HEPA filter Hot air should achieve max. 80° C temperature |
Hot air unit will be provided of 3500 CFM with dehumidification unit.
It will consist of 10m filter, chilled water coil, silica desiccant bed for dehumi-dification, Blower, Steam coil, 3m filter, HEPA filter Hot air will achieve max. 80° C temperature
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| 5.2.21 Exhaust Unit | Exhaust unit should be provided of 3500 CFM | Exhaust unit will be provided of 3500 CFM
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| 5.2.22 Scrubber Unit | Should be provided for exhausted air with water sump, pump etc.
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Scrubber will be provided with water tank, pump etc. | |
| 5.2.23 Scrubber : Air Sampling port | Air sampling ports should be provided to scrubber unit at before scrubbing and after scrubbing positions | Air sampling ports will be provided to scrubber unit at before scrubbing and after scrubbing positions
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| 5.2.24 Location of Hot air unit, Exhaust unit and Scrubber | Should installed on service floor and should have sufficient area for easy operation | The inlet and outlet air handling units will be mounted in separate case which can be mounted upstream
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| 5.2.25 Filter Cleaning | Doors to be provided for dismantling and assembling of filters for cleaning | Doors will be provided for dismantling and assembling of filters for cleaning
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| 5.2.26 Duct cleaning port | Cleaning port (man hole) should be provided on Exhaust ducting | Opening arrangement on exhaust ducting (upstream near housing) is provided for duct cleaning, also drain with TC provided at bottom
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| 5.2.27 Parameters to be controlled | – Inlet air temperature ±2°C
– Pan Speed – CFM of Inlet and Exhaust blower – Peristaltic Pump RPM – Atomisation air pressure |
Following Parameters will be controlled :
– Inlet air temperature ±2°C – Pan Speed – CFM of Inlet and Exhaust blower – Peristaltic Pump RPM – Atomisation air pressure |
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| 5.3 Equipment design / Control / Process / Product parameters : | |||
| 5.3.1 Material of Construction | |||
| 5.3.1.1 All contact parts | Should be SS 316 L | AISI 316 L | |
| 5.3.1.2 Non-contact parts | Should be SS 304 | AISI 304 | |
| 5.3.1.3 Tubings for Air and Suspension | Should be food grade | Silicone, EPDM, PTFE | |
| 5.3.1.4 Gaskets / O’rings | Should be food grade silicon | Food grade silicon
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| 5.3.1.5 All wheels | Should be PU with SS brackets | PU with SS brackets
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| 5.3.2 Feasibility | Equipment should have easy dismantling and assembling system. Equipment should be easy to clean and maintain | Equipment will have easy dismantling and assembling system. Equipment will be easy to clean and maintain
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| 5.4 Safety : | |||
| 5.4.1 Guards | Guards should be provided to all moving parts | Guards will be provided to all moving parts
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| 5.4.2 All Motors | All the Motors (Scrubber pump, Exhaust blower, Pan motor, Inlet blower, peristaltic pump) and Pan light should be Flameproof | All the Motors (Scrubber pump, Exhaust blower, Pan motor, Inlet blower, peristaltic pump) and Pan light will be Flameproof
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| 5.4.3 Earthing | Double earthing should be provided to the machine and all motors | Double earthing will be provided to the machine and all motors
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| 5.4.4 Noise Level | Noise level of the machine should not be more than 90dB | Noise level during machine running will not more than 90dB
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| 5.4.5 Vibrations | Abnormal vibrations should not be observed | No Abnormal vibrations during operation
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| 5.4.6 Surface | All the surfaces should be free from sharp edges | All the surfaces will be free from sharp edges
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| 5.4.7 Emergency Off | Emergency Off push button on Pan cabinet and ON/OFF switch with lock & key arrangement on operating panel should be provided | Emergency Off push button on Pan cabinet and ON/OFF switch with lock & key arrangement on operating panel will be provided | |
| 5.4.8 Limit Switches | Limit switches should be provided on spray arm and pan drive (pan cabinet) door | Interlocks will be provided for spray arm and pan drive (pan cabinet) door | |
| 5.5 Control System of the machine : | |||
| 5.5.1 Control | The control system of the machine should be user friendly and easy to operate | The control system of the machine will be user friendly and easy to operate, with following :
Mitsubishi PLC, Hardware from all reputed make like Siemens, Festo, SMC etc. All parameters on screen With first intelligently designed HMI from Beijer Electronics called Exter series MMI with tough Industrial designed 64000 Colors with touch screen Data Acquisition system to capture data from SMART Controls and display the same on a PC using SCADA interface Flow diagram, real time and historic trends, trend analysis, detailed reports including graphs and alarm lists can be viewed and printed |
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| 5.5.2 Operation Modes | – Fully Auto operation
– Manual Individual operation through PLC |
Fully automatic mode OR manual mode operation through PLC options provided
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| 5.5.3 Temperature control | Inlet air temperature should be controlled within ± 2° C | Inlet air temperature will be controlled within ± 2° C
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| 5.5.4 Temperature sensors | Sensors of Inlet & Exhaust air temperature should be at the nearest point of the Pan | Sensors of Inlet & Exhaust air temperature will be at the nearest point of the Pan
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| 5.5.5 Spray Rate & Inlet CFM | Online Spray rate and CFM of inlet air should be displayed on operating panel
Spray gun choking indication on operating panel should be provided to identify the choked spray gun during operation
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Online Spray rate and CFM of inlet air displayed on operating panel
Spray gun choking indication on operating panel provided to identify the choked spray gun during operation |
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| 5.5.6 Recipe Mode | Recipe mode should be provided with 100 products data storing and managing facility | Recipe mode will be provided with 100 products data storing and managing facility
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| 5.5.7 Data Storage | System should store data of at least 100 batches at a time
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System can store data of 100 batches at a time | |
| 5.5.8 Reports generation | Print Parameter should be updated after every 1 sec | Print Parameter update time is settable (minimum – every 1 sec)
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| 5.5.9 Digital Indicators | Compressed air pressure and Differential pressure indication across HEPA and Pan cabinet should be provided on the operating panel
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Compressed air pressure and Differential pressure indication across HEPA and Pan cabinet will be provided on the operating panel
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| 5.5.10 Interlocks | – Spraying with blowers
– Spraying with Pan speed – Spraying with Inlet & Exhaust temperature – Spraying with atomisation air pressure – Spraying with spray arm in / out position – Spraying with Pan cabinet doors – Inlet & Outlet dampers with blowers ON / OFF – Scrubber Pump with water level – Compressed air supply to pneumatic panel with operating panel ON / OFF
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Interlocks Provided :
– Spraying with blowers – Spraying with Pan speed – Spraying with Inlet & Exhaust temperature – Spraying with atomisation air pressure – Spraying with spray arm in / out position – Spraying with Pan cabinet doors – Inlet & Outlet dampers with blowers ON / OFF – Scrubber Pump with water level – Compressed air supply to pneumatic panel with operating panel ON / OFF
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- REFERENCES :
- URS
- Functional specification
- DOCUMENTS TO BE ATTACHED :
Following documents to be attached, if available
- Proposal for new equipment
- CER copy
- ABBREVIATIONS :
| cGMP | : | Current Good Manufacturing Process | SS | : | Stainless Steel |
| URS | : | User Requirement Specifications | Ltr | : | Litre |
| RPM | : | Revolutions Per Minute | m | : | Micron |
| CFM | : | Cubic Feet per Minute | HEPA | : | High Efficiency Particulate Air |
| Kg | : | Kilogram | max. | : | Maximum |
| mm | : | Millimeter | °C | : | Degree Centigrade |
| EPDM | : | Ethylene Propylene Diene Monomer | PTFE | : | Poly Tetra Fluoro Ethylene |
| L | : | Length | PU | : | Poly Urethane |
| W | : | Width | dB | : | Decibel |
| H | : | Height | PLC | : | Programmable Logical Control |
| Kg/cm2 | : | Kilogram per square centimeter | sec | : | Seconds |
| AC | : | Alternative Current | CER | : | Capital Expenditure Requisition |
| SCADA | : | Supervisory Control And Data Acquisition | PC | : | Personal Computer |
- ANY CHANGES MADE AGAINST THE FORMALLY AGREED PARAMETERS :
- REVIEW (INCLUSIVE OF FOLLOW UP ACTION, IF ANY) :
- RECOMMENDATIONS / CONCLUSION :
Equipment supplier should give the following documents :
- Food Grade Certificate of the Hose
- MOC test reports, Contact parts, Non-contact parts
- Filter Integration Test certificates
- Equipment manual
- Schedule for maintenance
- List of spare parts….. etc.
