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sop dry heat sterilization in injection section

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

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

2.0 SCOPE: This SOP is applicable for the Injection Section of the production department at the plant.

3.0 RESPONSIBILITIES:

      Head – Production for overall compliance of this SOP

     Officer- Production for implementation of 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:

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 fixed on the printer before starting Dry Heat Sterilization. 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 Dry Heat Sterilization is appropriately closed before opening the door from the non-sterile side by confirming with the sterile side operator.

5.2.1.2 Open the door and clean the DHS as per the current version of 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.

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 and display show as below.

5.2.1.8 Press login. Password will display.

5.2.1.9 Enter the correct password, and the system will display it below.

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. Press the enter key.

5.2.1.13 Set heater zone 2 – the temperature at 194°C. Press the enter key.

5.2.1.14 Set the heater zone 3 temperature at 192°C. Press the enter key.

5.2.1.15 Set heater zone 4 – temperature 180°C. Press the enter key.

5.2.1.16 Set the exhaust close – the temperature at 60°C. Press the enter key.

5.2.1.17 Set the sterilization temperature at 200°C. Press the enter key.

5.2.1.18 Set the high limit alarm at 231°C. 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. Press the enter key.

5.2.1.21 Set the cooling over temperature at 60°C. Press the enter key.

5.2.1.22 Set the stabilization time as 20 minutes. Press the enter key.

5.2.1.23 Set the sterilization time specified in the batch manufacturing record. 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 will show as below.

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, and the display will show as below.

5.2.1.29 Press RUN and the display will show below.

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 cord.

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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