Performance Qualification Protocol of Autoclave

STERILIZATION CYCLE

The standard sterilization cycle has three distinct stages:

1. Heat up.
2. Sterilization holds.
3. Cool and exhaust.

• During the heat-up phase, the steam enters into the chamber and jacket and fills the same till the temperature inside the same is 121°C or 134°C at 15 PSI or 30 PSI
• During the heat-up phase, the chamber and jacket temperature is maintained at 121°C or 134°C at 15 PSI or 30 PSI for the specified amount of time in minutes which is adjustable by a timer.
• During the cool and exhaust phase, the steam supply is cut off and the steam inside the chamber is allowed to exhaust and all the condensate is drained and the door is opened when the pressure drops down to about 0 PSI. The load now can be taken out for further processing.

Performance qualification is done in the following stages.

1. Empty chamber studies
2. Fully loaded chamber with container mapping, if required

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• All the above studies will reveal the actual heat distribution for a pre-defined loading configuration and also the penetration of steam inside the container particularly in the case of big-size glassware as well as in other locations. This will give the idea regarding. the hot spot and cold spot. 
• The biological indicators will be affixed at suitable locations and will be tested by the microbiology lab for sterility studies. All the attached recording instruments will record the parameters and the same will be affixed. The sensor placement for recording and controlling instruments will be as per the attached diagram.

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1. DESCRIPTION OF VALIDATOR:

• The validator used is a microprocessor-based full functional device with 16PT 100, class types A probes. The probes have the smallest possible diameter so as to reduce the thermal time delay to a minimum. 
• The validator has sufficient internal non–volatile memory to store 10000 readings at a stretch and the same can be downloaded onto a personal computer. 
• The validator is supplied with client software that analyses all the temperature data for all 16 channels both in the graphical format as well as tabular one. The printouts for all the channels can be taken along with time and also readings. 
• The validator also has a printer port that enables the real-time printing of all the channels on a dot matrix printer.

2. DATE OF MANUFACTURING:

Calibrated on :

Next calibration due on:

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3. THE DETAILS OF THE SENSOR:

Make : Radix Sensors Private. Limited.

Type : RTD PT 100, Simplex, ungrounded

Accuracy : +/- 0.3% of FSD

Size : diameter 3mm x 100mm long in SS 304 sheet

Class : A

4. PERFORMANCE QUALIFICATION

A. Empty Chamber

• The placement of all the sensors on the validator is shown in the attached drawing
• The readings and the associated graphs are attached herewith.

B. Loaded Chamber

• The placement of all the sensors on the validator is shown in the attached drawing.
• The readings and the associated graphs are attached herewith.

The following microbiology tests have been performed on the biological indicators:

1. Sterility strips (biological indicator)
2. The detailed test report has been attached.

5. CONCLUSION:

The validation study for the above autoclave has been done on ____________ And the results of the same have been attached. Based on all the results the above study has Been successful / failed.

The reasons for failure are as under:

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Comments/remarks if any:

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