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 by	Checked by	Checked by	Checked by	Approved by
Signature
Date
Name
Department	Production	Quality Assurance	Production	Head -Maintenance	Head – 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 point	Acceptance Criteria (Specification)	Observations	Checked by Sign/Date
1	Visual inspection of the equipment.	Visually there should not be any abnormality.
2	Check the area of installation (Dryer area cubicle).	Area of installation should have sufficient space for operation and servicing of the equipment.
3	Check the levelling of the machine using level indicator.	Air bubble shall be at centre position of level indicator.
4	Check the major components and their electrical cables for housing and anchoring.	Major components and their electrical cables shall be securely housed and anchored.
5	Check the electrical ports.	All electrical ports shall be cleaned.
6	Check 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 point	Acceptance Criteria (Specification)	Observations	Checked by Sign/Date
1	Loading capacity	96 trays with approx 2 – 3 kg material in each trays
2	Dimension	Approximate 2750 (L) x 1900 x 2400 (H) mm
3	Heating shelfs	Heating 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.
4	Door bolts	Door bolts shall be provided to lock the vacuum chamber door.
5	Vacuum pump	Vacuum pump facility shall be provided to generate the vacuum in the chamber.
6	Condenser	Condenser facility shall be provided for condensing the vapors drawn from vacuum chamber.
7	Receiver	Receiver shall be provided to collect the condensate solvent and to draw vapour through vacuum pump.
8	Digital temperature indicator cum controller	Digital temperature indicator cum controller shall be provided to control the incoming hot water temperature.
9	Digital temperature indicator	Digital temperature indicator shall be provided to display the inlet temperature and product temperature of dryer.
10	Circulation pump	Circulation pump shall be provided to circulate the hot water through drying equipment and tank.
11	Vacuum break valve	Vacuum break valve shall be provided in front of equipment for easy access.
12	Nitrogen purging valve	Nitrogen purging valve shall be provided in front of equipment for easy access.
13	View glass	View glass shall be provided in front of equipment to view the indoor material.
14.0	Driving/electrical parts
14.1	Driving and electrical parts	Driving and electrical parts shall be covered with SS304 material. There shall be separate cabinet for electrical parts to avoid pollution from driving parts.
15.0	Operating panel
15.1	Operating panel	Operating panel shall be installed in front of equipment for easy access.
15.2	Emergency stop button	Emergency stop button shall be provided on operating panel to stop the equipment in emergency.

Sub Components Specification Verification Report

Sr. No.	Check point	Acceptance Criteria (Specification)	Observations	Checked by Sign/Date
1	Condenser	Qty.: 1 No.
2	Receiver	Qty.: 1 No.
3	Vacuum pump	Qty.: 1 Set.
4	Circulation pump	Qty.: 1 Set.
5	Motor	Qty.: 1 No.
6.0	Sensor details
	Incoming hot water temperature sensor	Qty.: 1 No.
	Inlet temperature sensor	Qty.: 1 No.
	Product temperature sensor	Qty.: 1 No.
7.0	Electrical parts
	Rupture disc/ Explosion vent	Qty.: 1 No.
8.0	Pneumatic parts
	Inlet control solenoid valve	Qty.: 1 Set
	Steam inlet control valve	Qty.: 1 Set
	Vacuum gauge	Qty.: 1 Set

• Measuring Device Calibration Verification Report

Sr. No.	Measuring Device	Acceptance Criteria	ID. No./ Sr. No.	Calibration  Done On & Calibration Due Date	Observation	Checked by Sign/Date
	Multimeter	It shall be within its calibration period.

• Utility Verification Report

Sr. No.	Utility parameter	Acceptance Criteria (Specification)	Observations	Checked by Sign/Date
	Electrical	Three phase 415 V AC ± 10% and 50 Hz ± 5%.
	Steam supply	NLT 6.0 kg/cm2

• Safety Features Verification Report

Sr. No.	Safety features	Acceptance Criteria (Specification)	Observations	Checked by Sign/Date
1	Edges	Edges of construction shall be rounded.
2	Electricity	The equipment shall be earthed.
3	Driving part	Driving part shall be covered.
4	Emergency stop button	Emergency stop switch shall be provided.
5	Sealing system	The equipment shall consist of inflatable gaskets.
6	Vacuum relief plate/explosion disk	Rupture disc provision shall be provided to opens at a pressure of 0.25 bar.
7	Control panel	Control panel shall be flameproof.

• Material of Construction (MOC) Verification Report

Sr. No.	Component	Acceptance Criteria (Specification) for MOC	Observations	Checked by Sign/Date
1	Chamber	SS 316
2	Tray	SS 316
3	Heating shelfs	SS 316
4	Condenser	SS 316
5	Receiver	SS 316
6	Support columns/legs	SS 304
7	Hot water distribution headers	SS 304
8	Tank	SS 304
9	Steam inlet control valve	SS 304
10	Silicone rubber gaskets	Food grade

• Test/Inspection Certificate Verification Report

Sr. No.	Check point	Acceptance Criteria (Specification)	Observations	Checked by Sign/Date
1	Motor	It shall be tested/inspected for its performance.
2	Vacuum pump	It shall be tested/inspected for its performance.
3	Circulation pump	It shall be tested/inspected for its performance.
4	Sensor	It shall be tested/inspected for its performance.
5	Vacuum gauge	It shall be tested/inspected for its performance.
6	Control panel flame proof	It shall be tested/inspected for its performance.
7	Rupture disc	It shall be tested/inspected for its performance.
8	Steam inlet control valve	It shall be tested/inspected for its performance.
9	Wall panel insulation material	It shall be tested/inspected for its performance.
10	Vacuum tray dryer	Guarantee/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.	Operation	Acceptance Criteria	Observations	Checked by Sign/Date
1	Turn the main switch panel (red) ON/OFF button to ON position.	Main panel shall turn ON.
2	Turn the main switch panel (red) ON/OFF button to OFF position.	Main panel shall turn OFF.
3	Press (green) ON button of hot water pump	Hot water pump shall turn ON.
4	Press (red) OFF button of hot water pump	Hot water pump shall turn OFF.
5	Press (green) ON button of vacuum pump	Vacuum pump shall turn ON.
6	Press (red) OFF button of hot water pump	Vacuum pump shall turn OFF.
7	By pressing temp set (green) button set the hot water temperature at 90°C.	Hot water temperature shall be entered successfully.
8	By pressing up (green) button increase the set hot water temperature.	Set hot water temperature shall increase successfully.
9	By pressing down (green) button decrease the set hot water temperature.	Set hot water temperature shall decrease successfully.

• Temperature Verification Report

Sr. No.	Operation	Acceptance Criteria	Observations	Checked by Sign/Date
1	Set 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
2	Set 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
3	Set 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
4	Set 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
5	Set 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
6	Set 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 Location	LOD Result at Initial	LOD Result at End	Checked by sign/date
1	Top Centre Tray
2	Middle Centre Tray
3	Bottom Centre Tray

• LOD Report:

Maximum capacity of VTD:

Product Name :

Batch No.:

Batch Size :

Sr. No.	Sample Location	LOD Result at Initial	LOD Result at End	Checked 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 criteria	Impact 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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