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. • Autoclave
• Principle of Autoclave
• Construction of Autoclave
• Working of Autoclave
• Qualification of Autoclave
• Installation Qualification
• Operational Qualification
• Performance Qualification
• References
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Autoclave
The autoclave works on the principle
of moist heat sterilization where
steam under pressure is used to
sterilize the material present inside
the chamber.

4. • When water is heated in a closed container, saturated steam is produced under
pressure.
• According to Boyle's Law, when volume of the steam, is kept constant, the
temperature is directly proportional to pressure. If the pressure is reduced, it boils
at a lower temperature. If pressure rises, It boils at a greater temperature.
• At 15 lbs pressure 121 ̊̊C temperature can be obtained. Moist heat coagulates cell
proteins of the microorganisms thus kills all the living entities (including spores)
in 15 minutes.
• Hot saturated steam is efficient means of destroying organisms, since it penetrates
rapidly and gives up its latent as it condenses on the cooler objects.
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Principle & Working of Autoclave

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Construction of Autoclave

6. • Design qualification includes:
Facility layout
Utility requirements & specifications
Required capacity of the sterilizer
Type of materials to be sterilized (Liquids, wrapped, hollow or porous materials).
Requirement for Pre-vacuum cycles
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Design Qualification

7. • The IQ process is intended to demonstrate autoclave;
 meet all specification
installed properly &
supporting program (SOP, Maintenance sheet) are in place.
• The IQ includes following checks:
• Supplier or manufacturer name & address shall be checked. Any deviation
observed should be informed to the supplier or manufacturer through purchase
department for corrective action.
• Equipment name, make & model no. shall be noted down.
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Installation Qualification

8. • In-house equipment Code No. shall be allocated to check the location of installed
Equipment
• Mechanical equipment specification (chamber, valve, filters & vacuum pump.)
• Site specification / utilities
• Construction material
• Change / spare parts
• Operating & maintenance manuals
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9. • The OQ process intended to demonstrate that components of autoclave operate
properly & ready for performance or load testing.
• OQ includes following checks:
Operational tests (Operator modes, emergency stop, doors, display checks,
switch, interlock checks & programmable parameter).
Saturated steam check
Filter sterilization
Leak / air removal test
Power loss recovery test
Several utilities need to be verified like clean steam generator, air filtration
system, power source & cooling water.
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Operational Qualification

10. Selection & Calibration of Thermocouples must be durable for repeated use as
temperature indicators in steam sterilization validation & monitoring.
Accuracy of thermocouples should be 0.5°C.
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11. Heat-Distribution Studies:
• Heat-distribution studies include two phases:
1. Heat distribution in an empty autoclave Chamber
2. Heat distribution in a loaded autoclave chamber.
• Heat-distribution studies may employ thermocouples at the cool spot in the
chamber.
• The principle is to found the cool spot & the effect of the load size &/or
configuration on the cool spot location.
• The difference in temperature between the coolest spot & the mean chamber
temperature should not greater than 2.5°C.
• Greater temperature differences may be indicative of equipment malfunction.
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Performance Qualification

12. References
1. http://www.slideshare.net/JadhavAnkushJadhav/qualification-of-
manufacturing-equipments?from_m_app=android
2. 7. Subrahmanyam CVS, Setty JT, Sarasija S & Devi VK in “ Pharmaceutical
Engineering- Principles & Practices”, Vallabh Prakashan, New Delhi, 2001,
390-391, 397-399.
3. Reddy, B. V., Reddy, B. R., & Navaneetha. K., “A Review on validation of
Autoclave, Membrane Filtration.’ International Journal of Chemistry and
Pharmaceutical Sciences, 2014, 2(2), 642-650.
4. Reddy, B. Venkateswara, et al. "A Review On Qualification Of Autoclave,
RMG, FBD, Cone Blender, Tablet Compression Machine." Journal of Global
Trends in Pharmaceutical Sciences,2014, 5(1), 1450-1459.
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13. Thank you
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