cGMP and Regulatory Updates

1.0 PURPOSE : To provide a procedure for cleaning and maintenance of Air curtain. 2.0 SCOPE: Applicable to all the Air curtains installed in the unit. 3.0 RESPONSIBILITY: Technicians/Engineers/Executives/Asst. Manager. 4.0 ACCOUNTABILITY: Head of Engineering. 5.0 DEFINITION(S): Nil. PROCEDURE: 6.0 6.1.0 Monthly maintenance activities : 6.1.1 Disconnect the power supply and put under maintenance board on air curtain. 6.1.2 CLEANING PROCEDURE 6.1.2.1 Open the grills. 6.1.2.2 Clean the impeller with Vacuum followed by moist duster. 6.1.2.3 Lubricate the bush impeller. 6.1.2.4 Fix the grills. 6.1.3 Check the motor connections, earthing connections and dress the wires if required. 6.1.4 Take trial run, Check for any abnormal noise or vibrations, rectify if any. 6.1.5 Remove the under maintenance board. 6.1.6 Record the observation in the format for preventive maintenance of air curtain. SOP : ENGN : 003 : F1 6.2 Six monthly maintenance activities : 6.2.1 Check the Air velocity at four plac...

1. Objective: To lay down standard operating procedure for Dry heat sterilizer 2. Scope: This procedure provides a detailed method of operation and handling of the Dry heat sterilizer. 3. Responsibility: ¯ Operator. ¯ Senior Chemist. ¯ Head - Production. 4. Procedure: 4.1. Make sure that Line clearance is duly checked and signed by QA Personal as per SOP No:P/P/051 4.2. Wash the SS Box and clean the chamber of the dry heat sterilizer with DM water. 4.3. Run the sterilizer for half an hour by keeping the damper open after the first cleaning, to takeout all settled dust from its. 4.4. Turn off the sterilizer to clean the chamber by DM water with Non-fiber releasing cloth. 4.5. Place the load to be sterilized into the SS Box and put the SS Box back into the chamber of the dry heat sterilizer. 4.6. Close the pressure lock door, by pulling up the quick throw handle and turn the handle clockwise till the door is tig...