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Qualification of Dry Heat Sterilizer or Tunnel.pptx
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. Dry Heat Sterilizer/ Tunnels
Principle of Dry Heat Sterilizer/ Tunnels
Construction of Dry Heat Sterilizer/ Tunnels
Working of Dry Heat Sterilizer/ Tunnels
Qualification
Installation Qualification
Operational Qualification
Performance Qualification
References
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3. Dry heat is the most commonly used method to sterilize & depyrogenate
pharmaceutical components, glassware & products.
Commonly used dry heat sterilizers in pharmaceutical industry are;
1. Hot air oven
2. Tunnel sterilizer
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Dry Heat Sterilizer/ Tunnels
5. Sterilization is achieved by means of conduction.
The heat in the chamber is absorbed by the item inside it & passes towards the
center of the item layer by layer.
For the item to be fully sterilized, it needs to reach the required temperature.
It inflicts damage by oxidizing molecules leading to the organism’s death.
Resistant spores are killed by exposing them at a higher temperature for a long
period of time.
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Principle of Dry Heat Sterilizer/ Tunnels
7. The DQ includes;
Facility layout
Decision of batch or continuous process
Utility requirements & specifications
Pressure differential requirements
Required capacity of the sterilizer
Type of materials to be sterilized
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Design Qualification
8. All utility connections such as electrical & HVAC should meet the design
specifications .
Materials of construction of both the sterilizer & the facility should meet the
design specifications
The following pieces of equipment should be calibrated in situ:
Temperature sensors & recording devices
Temperature Controllers like in situ Pressure gauges, Belt speed controller &
recorder
Velometers
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Installation Qualification
9. A. Temperature Monitors: The temperature controllers, recorders & sensors on
the process equipment must be calibrated before the unit can be operated
reliably.
B. Cycle Timer: The accuracy of the timer must be determined, so that assurance is
provided for cycle length.
C. Door Interlocks: If a unit is equipped with double doors, the interlocks must
operate such that the door leading to the aseptic area cannot be opened.
D. Heaters: All of the heating elements must be functional. It is preferable to have
them monitored continuously with ammeters in order that burned-out elements
can be immediately detected.
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Operational Qualification
10. E. Cooling Coils: To enable a faster cool-down cycle, the air is often circulated
across coolant coils.
F. Belts: The belt speed is a critical operating parameter in continuous hot-air
tunnels. Recorders for charting the belt speed are recommended for units with
adjustable speed settings
G. Particulate Counts: Particulate counts should be checked before & after
sterilization.
H. Chamber Leaks: The perimeter of the doors for batch sterilizers should be
checked for air leakage while operating.
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11. (1) Air balance determination: In an empty oven, data are obtained on the flow
rates of both intake & exhaust air. Air should be balanced so that positive pressure is
exerted to the nonsterile side when the door is opened.
(2) Heat distribution of an empty chamber: Thermocouples should be situated
according to a specific predetermined pattern.
(3) Heat-penetration studies: These studies should be designed to determine the
location of the slowest heating point within a commodity at various locations of a
test load in the sterilizer. Thermocouples are placed in the commodities located in
the areas likely to present the greatest resistance to reaching the desired temperature.
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Performance Qualification of Hot Air Oven
12. (4) Mechanical repeatability: During all these studies, mechanical repeatability in
terms of air velocity, temperature consistency, reliability & sensitivity of the oven &
instrumental controls must be verified.
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13. (1) Air Balance Determination:
In this study, items being sterilized are moving exposed to different air systems
(e.g., heating zone & cooling zone).
Air flow must be balanced in order to provide a gradual decrease in air
temperature as items move along the conveyor.
(2) Heat-Distribution Studies:
Thermocouples used in tunnel sterilizer validation must be sufficiently durable to
withstand the extremely high temperatures (23000 C) in the heating zone area of
the tunnel.
Heat-distribution studies should determine where the cold spots are located as a
function of the width of the belt & height of the tunnel chamber.
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Performance Qualification of Tunnel Sterilizer
14. (3) Heat-Penetration Studies:
Prior to microbial challenge testing of the tunnel sterilization, heat-penetration
studies must be completed in order to identify the cool spot in the entire load.
3 to 5 replicate runs for each commodity size & every loading configuration
should be done using 10 to 20 thermocouples distributed throughout the load.
Careful analysis of the temperature data after each run will be valuable in the
determination of the cool spot.
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15. (4) Mechanical Repeatability:
Tunnel sterilizers must demonstrate mechanical repeatability in the same manner
as batch ovens.
Air velocity, air particulates, temperature consistency & reliability of all the
tunnel controls (heat zone temperatures, belt speed) must be proved during the
physical validation studies.
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Sterilization- making something free from microorgnisms
Conduction= process by which heat is directly transmitted to the material
Batch process require more time
While continuous process takes less time
Utilities= it requires electricity & continuous air flow
Pressure differential = the place where equipment installed should be kept at positive pressure; so that the outer air cant enter inside
HVAC – Heat, Ventilation & Air Conditioning
In situ= at its original place
Velometer- used to measure speed of air
Ammeters= instrument which measure electric current
Charting – recording
Perimeter- continuous line which forms boundry