Qualification of Tray Dryer.pptx

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

1. Topic:- Qualification of Tray Dryer Subject Name :- Pharmaceutical Validation Subject Code:- MQA204T Department of Pharmaceutical Quality Assurance Smt. B. N. B. Swaminarayan Pharmacy College, Salvav – vapi Presented by:- Machhi Dhruvi A. 2 nd sem M.Pharm .

2. CONTENTS 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 22-05-2022 Dhruvi Anilkumar Machhi 2

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. 22-05-2022 Dhruvi Anilkumar Machhi 3

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. 22-05-2022 Dhruvi Anilkumar Machhi 4 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. 22-05-2022 Dhruvi Anilkumar Machhi 5 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. 22-05-2022 Dhruvi Anilkumar Machhi 6 Working of Tray Dryer

7. Tray Dryer Control Parameters: 22-05-2022 Dhruvi Anilkumar Machhi 7 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 22-05-2022 Dhruvi Anilkumar Machhi 8 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. 22-05-2022 Dhruvi Anilkumar Machhi 9 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 22-05-2022 Dhruvi Anilkumar Machhi 10

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. 22-05-2022 Dhruvi Anilkumar Machhi 11 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. 22-05-2022 Dhruvi Anilkumar Machhi 12

13. References 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. Subrahmanyam CVS, Setty JT, Sarasija S & Devi VK in “ Pharmaceutical Engineering- Principles & Practices”, Vallabh Prakashan , New Delhi, 2001, 390-391, 397-399. 22-05-2022 Dhruvi Anilkumar Machhi 13

14. Thank you 22-05-2022 Dhruvi Anilkumar Machhi 14