Vacuum Tray Dryer Installation, Operational and Performance Qualification


Vacuum Tray Dryer is a static type of dryer used in various industries under vacuum atmosphere to dry temperature sensitive materials as well as pharmaceutical and allied products. It gives complete drying and vaporization of moisture of the product. We at Bhagwati Pharma are manufacturer of Vacuum Tray Dryer. The vacuum tray dryers are been customized according to the clients specification and the available capacities ranges from 6 to 96 trays per batch.

They are suitable for various purposes that includes pharmaceutical, Herbal, chemical & foodstuff.

Vacuum Tray Dryer works on the principle of conduction considering the vacuum conditions.  There are several shelves placed under which products are placed. Top shelves gives proper heating and helps to prevent dried powder from escaping into the solvent extraction system. Baffles are been placed between the shelves. It contains an inlet and outlet nozzle both are connected to its own header throughout its own nozzle.

  Equipment Name :Vacuum Tray Dryer
Equipment Model No.:MEVTD 96 G
Equipment Sr. No.:858
Equipment ID No.:XYZ
Equipment Area :Drying room
Equipment Manufacturer Name :Millennium Equipments Private Limited.
Equipment Application :For drying of wet granules and pellets
Report Date : 

REPORT APPROVAL:         

 Prepared byChecked byChecked byChecked byApproved by
Signature       
Date     
Name     
DepartmentProductionQuality AssuranceProductionHead -MaintenanceHead – Quality Assurance
  1. OBJECTIVE:
    1. To record the findings of installation, operational and performance qualification of vacuum tray dryer having ID. No. XYZ.
2.0        SCOPE:
  • The scope of this report is limited to vacuum tray dryer having ID. No. XYZ.
  • RESPONSIBILITIES:
    • Maintenance Officer/Executive:To prepare qualification report and co-ordinate the entire qualification activity.
    • Quality Assurance Officer/Executive: To witness the qualification study and ascertain that the study is conducted as per the protocol.
    • Production Officer/Executive: To execute qualification study in co-ordination with other departments.
    • Head Maintenance: To review the qualification documents.
    • Head Quality Assurance: To review and approve the qualification documents.
  • EQUIPMENT DESCRIPTION:
    • Refer installation qualification protocol.
  • PROCEDURE:

Qualification of the equipment should meet the acceptance criteria outlined in the following steps.

  • Installation Verification Report
Sr. No.Check pointAcceptance Criteria (Specification)ObservationsChecked by Sign/Date
 1Visual inspection of the equipment. Visually there should not be any abnormality.  
 2Check the area of installation (Dryer area cubicle).Area of installation should have sufficient space for operation and servicing of the equipment.  
 3Check the levelling of the machine using level indicator.Air bubble shall be at centre position of level indicator.  
 4Check the major components and their electrical cables for housing and anchoring.Major components and their electrical cables shall be securely housed and anchored.  
 5Check the electrical ports.     All electrical ports shall be cleaned.  
 6Check the electrical circuit diagram.                                                                   All electrical connections shall be found connected as per electrical circuit drawing (reference No. DW-CE010)  
  • Technical Specification Verification Report
Sr. No.Check pointAcceptance Criteria (Specification)ObservationsChecked by Sign/Date
 1Loading capacity96 trays with approx 2 – 3 kg material in each trays  
 2DimensionApproximate 2750 (L) x 1900 (W) x 2400 (H) mm  
 3Heating shelfsHeating shelf’s shall be provided for holding and heating the trays.Sufficient distance shall be provided between two trays after mounting the trays on the shelfs.  
 4Door boltsDoor bolts shall be provided to lock the vacuum chamber door.  
 5Vacuum pumpVacuum pump facility shall be provided to generate the vacuum in the chamber.  
 6CondenserCondenser facility shall be provided for condensing the vapors drawn from vacuum chamber.  
 7ReceiverReceiver shall be provided to collect the condensate solvent and to draw vapour through vacuum pump.  
 8Digital temperature indicator cum controllerDigital temperature indicator cum controller shall be provided to control the incoming hot water temperature.  
 9Digital temperature indicatorDigital temperature indicator shall be provided to display the inlet temperature and product temperature of dryer.  
 10Circulation pumpCirculation pump shall be provided to circulate the hot water through drying equipment and tank.  
 11Vacuum break valveVacuum break valve shall be provided in front of equipment for easy access.  
 12Nitrogen purging valveNitrogen purging valve shall be provided in front of equipment for easy access.  
 13View glassView glass shall be provided in front of equipment to view the indoor material.  
 14.0Driving/electrical parts
 14.1Driving and electrical partsDriving and electrical parts shall be covered with SS304 material.
There shall be separate cabinet for electrical parts to avoid pollution from driving parts.
  
 15.0Operating panel
 15.1Operating panelOperating panel shall be installed in front of equipment for easy access.  
 15.2Emergency stop buttonEmergency stop button shall be provided on operating panel to stop the equipment in emergency.  

Sub Components Specification Verification Report

Sr. No.Check pointAcceptance Criteria (Specification)ObservationsChecked by Sign/Date
 1CondenserQty.: 1 No.  
 2ReceiverQty.: 1 No.  
 3Vacuum pumpQty.: 1 Set.  
 4Circulation pumpQty.: 1 Set.  
 5MotorQty.: 1 No.  
 6.0Sensor details
 Incoming hot water temperature sensorQty.: 1 No.  
 Inlet temperature sensorQty.: 1 No.  
 Product temperature sensorQty.: 1 No.  
 7.0Electrical parts
 Rupture disc/ Explosion ventQty.: 1 No.  
 8.0Pneumatic parts
 Inlet control solenoid valveQty.: 1 Set  
 Steam inlet control valveQty.: 1 Set  
 Vacuum gaugeQty.: 1 Set  
  • Measuring Device Calibration Verification Report
Sr. No.Measuring DeviceAcceptance CriteriaID. No./ Sr. No.Calibration  Done On & Calibration Due DateObservationChecked by Sign/Date
 MultimeterIt shall be within its calibration period.    
  • Utility Verification Report
Sr. No.Utility parameterAcceptance Criteria (Specification)ObservationsChecked by Sign/Date
 ElectricalThree phase 415 V AC ± 10% and 50 Hz ± 5%.  
 Steam supplyNLT 6.0 kg/cm2  
  • Safety Features Verification Report
Sr. No.Safety featuresAcceptance Criteria (Specification)ObservationsChecked by Sign/Date
 1EdgesEdges of construction shall be rounded.     
 2ElectricityThe equipment shall be earthed.  
 3Driving partDriving part shall be covered.  
 4Emergency stop buttonEmergency stop switch shall be provided.  
 5Sealing systemThe equipment shall consist of inflatable gaskets.  
 6Vacuum relief plate/explosion diskRupture disc provision shall be provided to opens at a pressure of 0.25 bar.  
 7Control panelControl panel shall be flameproof.  
  • Material of Construction (MOC) Verification Report
Sr. No.ComponentAcceptance Criteria (Specification) for MOCObservationsChecked by Sign/Date
 1ChamberSS 316  
 2TraySS 316  
 3Heating shelfsSS 316  
 4CondenserSS 316  
 5ReceiverSS 316  
 6Support columns/legsSS 304  
 7Hot water distribution headersSS 304  
 8TankSS 304  
 9Steam inlet control valveSS 304  
 10Silicone rubber gasketsFood grade  
  • Test/Inspection Certificate Verification Report
Sr. No.Check pointAcceptance Criteria (Specification)ObservationsChecked by Sign/Date
 1MotorIt shall be tested/inspected for its performance.  
 2Vacuum pumpIt shall be tested/inspected for its performance.  
 3Circulation pumpIt shall be tested/inspected for its performance.  
 4SensorIt shall be tested/inspected for its performance.  
 5Vacuum gaugeIt shall be tested/inspected for its performance.  
 6Control panel flame proofIt shall be tested/inspected for its performance.  
 7Rupture discIt shall be tested/inspected for its performance.  
 8Steam inlet control valveIt shall be tested/inspected for its performance.  
 9Wall panel insulation materialIt shall be tested/inspected for its performance.  
 10Vacuum tray dryerGuarantee/Warrantee certificate shall be provided.  

Note: Whether component is tested /inspected of its performance shall be verified based on the test/inspection certificate provided by the manufacturer.

  • Operational Functionality Verification Report
Sr. No.OperationAcceptance CriteriaObservationsChecked by Sign/Date
 1Turn the main switch panel (red) ON/OFF button to ON position.Main panel shall turn ON.  
 2Turn the main switch panel (red) ON/OFF button to OFF position.Main panel shall turn OFF.  
 3Press (green) ON button of hot water pumpHot water pump shall turn ON.  
 4Press (red) OFF button of hot water pumpHot water pump shall turn OFF.  
 5Press (green) ON button of vacuum pumpVacuum pump shall turn ON.  
 6Press (red) OFF button of hot water pumpVacuum pump shall turn OFF.  
 7By pressing temp set (green) button set the hot water temperature at 90°C.Hot water temperature shall be entered successfully.  
 8By pressing up (green) button increase the set hot water temperature.Set hot water temperature shall increase successfully.  
 9By pressing down (green) button decrease the set hot water temperature.Set hot water temperature shall decrease successfully.  
  • Temperature Verification Report
Sr. No.OperationAcceptance CriteriaObservationsChecked by Sign/Date
 1Set the hot water system temperature at 40°C and record the hot water inlet temperature and product temperature from temperature controller panel.For information only  
 2Set the hot water system temperature at 50°C and record the hot water inlet temperature and product temperature from temperature controller panel.For information only  
 3Set the hot water system temperature at 60°C and record the hot water inlet temperature and product temperature from temperature controller panel.For information only  
 4Set the hot water system temperature at 70°C and record the hot water inlet temperature and product temperature from temperature controller panel.For information only  
 5Set the hot water system temperature at 80°C and record the hot water inlet temperature and product temperature from temperature controller panel.For information only  
 6Set the hot water system temperature at 90°C and record the hot water inlet temperature and product temperature from temperature controller panel.For information only  
  • Performance Verification Report LOD Report:

Minimum capacity of VTD:

Product Name :
Batch No.:
Batch Size :
  Sr. No.Sample LocationLOD Result at InitialLOD Result at EndChecked by sign/date
 1Top Centre Tray   
 2Middle Centre Tray   
 3Bottom Centre Tray   
  • LOD Report:

Maximum capacity of VTD:


Product Name :
Batch No.:
Batch Size :
  Sr. No.Sample LocationLOD Result at InitialLOD Result at EndChecked by sign/date
 Top Centre Tray   
 Middle Centre Tray   
 Bottom Centre Tray   

Temperature mapping study report:

Temperature mapping study is carried out with maximum batch size (i.e. by loading 96 trays with approximately 2 to 3 kg material in each tray) with data recording interval of 15 min.


Product Name :
Batch No.:
Batch Size :
  • Minimum temperature location:
  • Highest fluctuation location:
  • Maximum temperature location:
  • DEVIATION REPORT:
Sr. No.Deviation (s)Justification for acceptance criteriaImpact on installation, operation and performance
            
            
            
  • CHANGE CONTROL:
  • LIST OF ANNEX:


  • SUMMARY AND CONCLUSION OF QUALIFICATION:
  • CERTIFICATION OF QUALIFICATION:

Qualification is satisfactory.                                       Yes/No

Hence equipment can be used for routine use.           Yes/No 

                                                                               Head – QA

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