SOP for Bowie Dick Test

Objective

To lay down a procedure for a bowie dick test

Scope

This SOP applies to the Bowie Dick test in a pharmaceutical plant.

Responsibility

Production Officers / Executives shall be responsible for following the procedure mentioned in this SOP.

Accountability

The production Head shall be accountable for the compliance of SOP.

Procedure

• Switch ON the machine with the key.
• Ensure that the autoclave chamber is dry and the temperature is ambient.
• Check the cleaning of the chamber and all around the machine.
• Check the availability of soft water, pure steam, plant steam, and compressed air.

• Check the pressure of compressed air should not be less than 6.0 kg/cm².
• Open the valve of the plant steam supply line and ensure that the pressure of plant steam supplied to the autoclave in the pressure gauge is not less than 2 kg/cm².

ALSO READ: SOP for Bacterial Endotoxin Test

• Open the valve on the pure steam supply line and ensure that the pressure of pure steam supplied to the autoclave in the pressure gauge is Not Less Than 2 kg/cm².
• Load the bowie dick test kit in the Bung processor cum Steam Sterilizer (Keep the kit at 200mm from the bottom of the chamber) as per the validated loading pattern.
• Press the “door close switch” to close the door.
• Check the pressure of the following mentioned below on the front of the panel:

1. Jacket Pressure: 0.0 Kg/cm²
2. Sterile side gasket: 3.0 Kg/cm²
3. Non-sterile gasket: 3.0 Kg/cm²
4. Chamber pressure: 0.0 Kg/ cm²

• Select the Cycle No. on the MMI of the Bung processor cum Steam Sterilizer. Check and verify the standard parameter of the bowie dick test on a man-machine interface (MMI) as per mentioned below:
• Set Parameter:

Sr. No	Parameters	Set value of cycle
1	Pre-Vacuum	-0.500 Bar
2	Pre pressure	0.500 Bar
3	No of pre pulses	3 Nos
4	Heat up 1	110.0 °C
5	Heat up Hold 1	5 min
6	Heat up 2	115.0 °C
7	Heat up Hold 2	3 min
8	Heat up 3	118.0 °C
9	Heat up Hold 3	2 min
10	Heat up control Band	0.4 °C
11	Sterilization Hold temperature	122.0°C
12	Sterilization Hold time	1020 seconds
13	Temperature control Band	0.2 °C
14	Overshoot temperature	124.0 °C
15	Sterilization stop temperature	120.9 °C
16	Sterilization Reset temperature	120.8 °C
17	Process End pressure	-0.050 Bar
18	Exhaust ON	5 sec
19	Exhaust OFF	55 sec

• On completion of the sterilization according to the set parameter, an indicator of “process end” will glow on the sterile side door and the process will stop, displaying the message ‘Process End’ on MMI.
• Check the cycle graph for the Bowie Dick test load for temperature and time during the sterilization hold.
• Check the uniform color of Bowie dick paper is dark brown after the cycle.
• If the graph does not match the cycle will be considered invalid. Repeat the Bowie Dick test. Inform the deviation to the Quality Assurance Department. Carry out further processing as per the suggestions from the quality assurance.
• Record the cycle details of Operation in the Equipment Logbook as per SOP and get it checked by the Concerned Supervisor / Officer

Annexures

Nil

Abbreviations

SOP: Standard Operating Procedure

MMI: Man-Machine Interface

PLC: Programmable Logic Controller

Revision History

Nil

ALSO READ: Bowie Dick Test for Validation Autoclave