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.
Officer- Production for implementation of this SOP
Head – Production for overall compliance with this SOP
Master Copy: Quality Assurance Department
Control Copy: Production Department
Display Copy: Production Department
5.0 Procedure for Dry Heat Sterilization:
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.
5.2.1 Procedure for operating from a non-aseptic area:
188.8.131.52 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.
184.108.40.206 Open the door and clean the DHS as per the current version of the SOP titled “Cleaning of Dry Heat sterilizer.”
220.127.116.11 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.
18.104.22.168 Open the compressed air line valve located n the pendant manually.
22.214.171.124 Ensure that the emergency stop button is released. Switch On the mains switch. PLC and the printer.
126.96.36.199 Keep the selector switch in the ON position.
188.8.131.52 Keep the selector switch in the auto position.
184.108.40.206 Press login. A password will display.
220.127.116.11 Enter the correct password, and the system will display it.
18.104.22.168 Press the function key on the program mode, and the display will show the recipe.
22.214.171.124 Set the print interval at 5 min. Press the enter key.
126.96.36.199 Set heater zone 1- Temperature at 196°C and Press the enter key.
188.8.131.52 Set heater zone 2 – Temperature at 194°C and Press the enter key.
184.108.40.206 Set the heater zone 3- Temperature at 192°C and Press the enter key.
220.127.116.11 Set heater zone 4 – Temperature 180°C and Press the enter key.
18.104.22.168 Set the exhaust close – Temperature at 60°C and Press the enter key.
22.214.171.124 Set the sterilization temperature at 200°C and Press the enter key.
126.96.36.199 Set the high limit alarm at 231°C and Press the enter key.
188.8.131.52 Set the sterilization to abort temperature at 180°C.
184.108.40.206 Set sterilization time as 150 minutes and Press the enter key.
220.127.116.11 Set the cooling over temperature at 60°C and Press the enter key.
18.104.22.168 Set the stabilization time as 20 minutes and Press the enter key.
22.214.171.124 Set the sterilization time specified in the batch manufacturing record and Press the enter key.
126.96.36.199 After the setting completion, set the values. If required, press save—otherwise, press auto.
188.8.131.52 Press the Date & time key to check the real-time clock and calendar data such as (Date. Month. Year. Hour. Minute. Seconds) with actual and display shows.
184.108.40.206 If there is any difference, press the login button and enter the correct password.
220.127.116.11 Enter the time clock and calendar data with the help of the increment or decrement key. Press the enter key.
18.104.22.168 Press the AUTO mode.
22.214.171.124 Press RUN.
126.96.36.199 Start process and indicator will check the printing of program data on a printer with the entered date.
188.8.131.52 When the pressure comes to less than cooling over-temperature, switch off the printer PLC and the main switch.
184.108.40.206 Procedure for operating from a non-aseptic area:
220.127.116.11.1 Ensure that the non-sterile side door of Dry Heat Sterilization is closed by checking the yellow bulb indicator in OFF mode.
18.104.22.168.2 Open the door and unload the items from the DHS from the sterile area side.
22.214.171.124.3 Close the door.
126.96.36.199.4 Attach the printout to the batch manufacturing Record.
188.8.131.52.5 Make the necessary entries in the batch manufacturing record and the log sheet.
6.0 Acceptance Criteria:
6.1 Compliance with the above guidelines
SOP: Standard Operating Procedure
QA: Quality Assurance
DHS: Dry Heat Sterilization
PLC: Programmable logic controller