The document presents an overview of tray dryers used in pharmaceutical quality assurance, detailing their principles, construction, working mechanisms, qualifications, and performance testing. It explains how tray dryers operate through forced convection heating and the systematic qualification procedures to ensure efficient functioning. The text concludes with references for further reading on equipment qualification and pharmaceutical engineering practices.

1. Department of Pharmaceutical Quality Assurance
Smt. B. N. B. Swaminarayan Pharmacy College, Salvav–vapi
Presented by:-
Machhi Dhruvi A.
2nd sem M.Pharm.

2. • Tray Dryer
• Principle of Tray Dryer
• Construction of Tray Dryer
• Working of Tray Dryer
• Qualification of Tray Dryer
• Installation Qualification
• Operational Qualification
• Performance Qualification
• References
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3. Tray Dryer
• Tray dryer is the most commonly
used dryer.
• Tray dryer is the device used for
drying of wet products of the
crude drugs, chemicals, powders
or the granules, etc.
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4. • In tray dryer, hot air is continuously circulated.
• Forced convection heating takes place to remove moisture from the
solids placed in trays.
• Simultaneously, the moist air is removed partially.
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Principle of Tray Dryer

5. • It consists of a rectangular
chamber whose walls are
insulated.
• Trays are placed inside the
heating chamber.
• The number of trays may vary
with the size of the dryer.
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Construction of Tray Dryer
• Dryer is fitted with a fan for circulating air over the trays.
• Heaters are there inside to heat the air.
• The distance between the
bottom of upper tray & upper
surface of the substance
loaded in the subsequent tray
must be 40 mm.

6. Wet solid is loaded into trays & they are placed in the chamber.
Fresh air is introduced through inlet, which passes through the heaters & get
heated up.
Hot air is circulated by means of fans at 2 to 5 metre per second.
The water is picked up by air. As water evaporates, the water diffuses from
interior of solid by capillary action & drying takes place.
Moist air is removed through outlet.
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Working of Tray Dryer

7. Tray Dryer Control Parameters:
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Qualification of Tray Dryer
Fixed Variable (Monitor) Response (Test)
 Trays  Inlet/exhaust air
temperature
 Product temperature
 Drying time
 Air volume
 Humidity of
incoming air
 Humidity of exhaust
air
 Particle size
distribution
 Densities
 Loss on drying
 Assay

8. Procedure:
• Selection criteria shall be defined based on specific function to be
carried out by the machine & its efficiency.
• Requirement of accessories shall be decided & listed out.
Details of the Equipment:
• Equipment name, make & model number shall be noted down.
• In-house identification number shall be allocated
• Location for installation shall be decided
• Utilities required shall be listed down
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Installation Qualification

9. Procedure:
• Initiate the actual operation of the TD to ensure that machine is
operating within specification.
• Check the OQ parameters against their specifications.
• Observe the functioning of all controls available on control panel.
• Record the observation.
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Operational Qualification

10. Acceptance criteria:
• Operating inputs provided on the equipment when tested shall-
successfully comply with tolerance limit.
• The equipment should successfully perform when operated as per
SOP.
• Critical gauges/indicators provided on the equipment should be
calibrated.
• The equipment when operated shall not
produce abnormal sound
 show any discrepancy in its smooth operation
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11. • To check Heat Distribution by placing 10 thermocouples in geometric pattern
with the Tray Dryer shell & empty product container without any load to
ensure heat distribution in the drying chamber.
• Heat distribution study will be performed at +45 ̊ C & +105 ̊ C for one hour
after achieving the temperature on the controlling sensors to ensure proper
heat distribution.
Procedure:
• After completion of OQ, initiate the PQ of Tray Dryer.
• The effectiveness of drying will be qualified by determining reduction of
%moisture content in drying process.
• 3 batches of any product will be taken for PQ of Tray Dryer.
• At least 2 gm of sample is sampled for % moisture content, check from the
top, middle & bottom trays and it will be reported.
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Performance Qualification

12. Acceptance criteria:
• Temperature difference between all thermocouples & set temperature
should not differ by more than ± 5 ̊C.
• The reduction in moisture content after drying should be as per the
specification in the BMR.
• % RSD of LOD should not be more than 6 %.
• The equipment should produce intended outputs with respect to
quality & quantity consistently.
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13. References
1. Patil, B. N., Tippavajhala, V. K., & Pai, K. G., “Equipment
Qualification of a New Laboratory Tray Dryer.” Research
Journal of Pharmacy and Technology, 2019, 12(2), 805-
811.
2. Subrahmanyam CVS, Setty JT, Sarasija S & Devi VK in “
Pharmaceutical Engineering- Principles & Practices”,
Vallabh Prakashan, New Delhi, 2001, 390-391, 397-399.
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14. Thank you
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