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SOP for Dry Heat Sterilization in injection section

1.0 OBJECTIVE: To lay down a procedure for operation Dry Heat Sterilization (DHS) in the injection section. 

2.0 SCOPE: This SOP on Dry Heat Sterilization is applicable to the Injection Section of the production department at the plant.

3.0 RESPONSIBILITIES:

Officer- Production for implementation of this SOP
Head – Production for overall compliance with- this SOP

4.0 DISTRIBUTION:

Master Copy: Quality Assurance Department
Control Copy: Production Department
Display Copy: Production Department

5.0 Procedure for Dry Heat Sterilization:

SOP for Dry Heat Sterilization in injection section

5.1 PRECAUTIONS:

5.1.1 Ensure that the area and the equipment are clean and free from the traces of the previous batch of products.
5.1.2 Ensure that the material loading to the dry heat sterilizer is as per the validated load pattern. 
5.1.3 Ensure that the plain paper is fixed on the printer before starting Dry Heat Sterilization process. Do not open both doors simultaneously.

5.2 OPERATION :

5.2.1 Procedure for operating from a non-aseptic area:

5.2.1.1 Ensure that the sterile side door of the Dry Heat Sterilizer is appropriately closed before opening the door from the non-sterile side by confirming with the sterile side person.
5.2.1.2 Open the door and clean the DHS as per the current version of the SOP titled “cleaning of Dry Heat sterilizer.”
5.2.1.3 Load the washed vials trolley in the DHS and close the door. Affix the status label on the DHS as per the “status labeling” SOP.
5.2.1.4 Open the compressed air line valve located n the pendant manually.
5.2.1.5 Ensure that the emergency stop button is released. Switch On the mains switch. PLC and the printer.

5.2.1.6 Keep the selector switch in the ON position.
5.2.1.7 Keep the selector switch in the auto position.
5.2.1.8 Press login. Password will display.
5.2.1.9 Enter the correct password, and the system will display it.
5.2.1.10 Press the function key on the program mode, and the display will show the recipe.
5.2.1.11 Set the print interval at 5 min. Press the enter key.

5.2.1.12 Set heater zone 1- the temperature at 196°C and Press the enter key.
5.2.1.13 Set heater zone 2 – the temperature at 194°C and Press the enter key.
5.2.1.14 Set the heater zone 3 temperature at 192°C and Press the enter key.
5.2.1.15 Set heater zone 4 – temperature 180°C and Press the enter key.
5.2.1.16 Set the exhaust close – the temperature at 60°C and Press the enter key.

5.2.1.17 Set the sterilization temperature at 200°C and Press the enter key.
5.2.1.18 Set the high limit alarm at 231°C and Press the enter key.
5.2.1.19 Set the sterilization abort temperature at 180°C.
5.2.1.20 Set sterilization time as 150 minutes and Press the enter key.
5.2.1.21 Set the cooling over temperature at 60°C and Press the enter key.

5.2.1.22 Set the stabilization time as 20 minutes and Press the enter key.
5.2.1.23 Set the sterilization time specified in the batch manufacturing record and Press the enter key. 
5.2.1.24 After the setting completion, set the values. If required, press save—otherwise, press auto.
5.2.1.25 Press the Date & time key to check real-time clock and calendar data such as date. Moth. Year. Hour. Minute. Seconds with actual and display shows.
5.2.1.26 If there is any difference, press the login button and enter the correct password.
5.2.1.27 Enter the time clock and calendar data with the help of the increment or decrement key. Press the enter key.
5.2.1.28 Press the AUTO mode.

5.2.1.29 Press RUN.
5.2.1.30 Start process and indicator will check the printing of program data on a printer with the entered date.
5.2.1.31 When the pressure comes to less than cooling over-temperature, switch off the printer PLC and the main switch.

5.2.1.32 Procedure for operating from a non-aseptic area:

5.2.1.32.1 Ensure that the non-sterile side door of Dry Heat Sterilization is closed by checking the yellow bulb indicator in OFF mode.
5.2.1.32.2 Open the door and unload the items from the DHS from the sterile area side.
5.2.1.32.3 Close the door.
5.2.1.32.4 Attach the printout to the batch manufacturing Record.
5.2.1.32.5 Make the necessary entries in the batch manufacturing record and the log sheet. 

6.0 ACCEPTANCE CRITERIA

6.1 Compliance with the above guidelines

7.0 ABBREVIATIONS/DEFINITIONS:

SOP: Standard Operating Procedure
QA: Quality Assurance
DHS: Dry Heat Sterilization
PLC: Programmable logic controller

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