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SOP For Bowie Dick Test

Objective
To lay down a procedure for bowie dick test

Scope
This SOP is applicable for Bowie Dick test in pharmaceutical plant.

Responsibility
Production Officers / Executive shall be responsible for follow the procedure mentioned in this SOP.

Accountability:
Production Head shall be accountable for the compliance of SOP.


Procedure
  • Switch ON the machine with the key.
  • Ensure that autoclave chamber is dry and temperature is ambient.
  • Check the cleaning of 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 then 6.0 kg/cm².
  • Open the valve of 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.
  • Open the valve on 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 chamber) as per validated loading pattern.
  • Press the “door close switch” to close the door.
  • Check the pressure of following mentioned below on 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 bowie dick test on 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

Over shoot 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, indicator of “process end” will glow on sterile side door and the process will stop, displaying the message ‘Process End’ on MMI.
  • Check the cycle graph for 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 the 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

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