1. OBJECTIVE:
To lay down a standard operating procedure for Double cone Blender.
2. SCOPE:
This procedure provides a standard method to operate and handle the Double cone Blender.
3. RESPONSIBILITY:
Machine 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/048
4.2. Check and make sure that Double cone blender has been autoclaved.
4.3. Adjust the angle of the blender with the help of a moving wheel to a required position for convenience in loading the materials.
4.4. Load the materials from the container to the blender as per the sequence specified in the individual Batch Manufacture Record (BMR).
4.5. After loading the materials, close the lid of the blender.
4.6. Put the safety pin on the lid and fit it properly within its groove. Lock the blender lid by moving the wheel in clockwise direction.
4.7. Before starting the operation, ensure that the lid and the safety pin lock has been assembled properly.
4.8. Put the safety guard before commencement of the operation.
4.9. Switch on the equipment and note down the starting time.
4.10. Blend the material as per the time specified in the individual BMR.
4.11. To unload the material, Ensure that the equipment is put off.
4.12. Remove the safety guard.
4.13. Adjust the position of the blender at the required angle for convenience in unloading the materials.
4.14. Unlock the safety pin and remove the lid from the blender.
4.15. Unload the blended materials.
Note:
• Use latex gloves elbow size during loading and unloading of materials.
• Before loading of the materials, ensure that the inner and outer surface of the drum blender is cleaned & sterilized as per the standard procedure respectively.
• During blending operation attach status label to the drum blender specifying the name of the product, Batch no.,Mfg Date., and Expy Date along with signature of production manager.
Tuesday, July 21, 2009
Tuesday, July 14, 2009
SEMI-AUTOMATIC LIQUID VIAL FILLING AND RUBBER STOPPERING MACHINE
1. Objective:
To lay down a standard operating procedure for Semi-Automatic Liquid vial filling & Rubber stoppering Machine.
2. Scope:
This procedure provides a standard method of operation and handling of the Automatic Liquid vial filling & Rubber stoppering Machine.
3. Responsibility:
§ Machine operator.
§ Senior Chemist.
§ Head - Production.
4. Procedure:
4.1. Check and make sure that entire machine parts are cleaned as per SOP No: P/P/012.
4.2. Make sure that Line clearance is duly checked and signed by QA Personal as per SOP No:P/P/047
4.3. Fill the solution to be filled, in the pressurized tank.
4.4. Connect the piston bottom hose to pressurized tank and piston top hose with the filling needles.
4.5. Adjust the speed of the conveyor according to the movement of piston in such a way that both speeds should be equal to avoid the spillage of the filling solution & breakage of the vial.
4.6. Set the required volume to be filled by adjusting the volume adjustment screw in the piston. Switch on the machine.
4.7. Piston will suck the solution from the tank and fill it in vial through the filling needle.
4.8. The filled vials will be transferred to the sealing section through the conveyor.
4.9. In the sealing section, feed the seals into the sealing hopper and switch on the machine.
4.10. The filled vials to be sealed will come to the turret through the conveyor.
4.11. The seals will sit on the neck of the filled vials through the chute from the hopper. After that the sealing fingers will press the seals.
4.12. Collect the sealed vials and send it to labeling section after getting approval from QC for Leak Test.
DRY HEAT STERILIZATION (MONITA)
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 tight.
4.7. Switch on the main supply.
4.8. Set the temperature on the control panel depending upon the load to be sterilized.
For example: 2000C for Ampoules/Vials & 1100C for Wads.
4.9. Switch on the Heater 1, Heater 2, Heater 3, Damper and HEPA Filter.
4.10. The temperature will gradually rise and will be indicated by the temperature indicator.
4.11. Switch off the Damper and HEPA filter after the temperature reaches the 1500C, to remove water vapour from the chamber and filter the air which is coming from atmosphere to the chamber respectively.
4.12. Switch off anyone one of the heater after the temperature attains 2000C.
4.13. Maintain the same condition for validated time which is depending upon the load to be sterilized.
For example: 2 Hrs for Ampoules/Vials and 3 Hrs for Wads.
4.14. After the sterilization cycle is completed, Switch off the main supply.
AUTOMATIC LABELING MACHINE
1. Objective:
To lay down a Standard Operating Procedure for Labeling Machine
2. Scope:
This procedure provides a Standard method of operation and handling of the Labeling Machine.
3. Responsibility:
¯ Operator.
¯ Senior Chemist.
¯ Head - Production.
4. Procedure:
4.1. Check and make sure that Line clearance is duly checked and signed by QA Personal as per SOP No: P/P/043.
4.2. Clean the machine with soft cloth.
4.3. Wash the Gum pot with 0.5% (v/v) Teepol solution followed by raw water.
4.4. Stick the Stereo’s with appropriate details like Batch. No., Mfg. Date, Exp. Date, and MRP on the printing master by means of the Gum tape.
4.5. Feed Ampoules/Vials on the Feeding Hopper, labels on the label Box and Gum in the Gum pot.
4.6. Spread Printing ink in the Ink roller. Switch on the Machine.
4.7. Hopper Roller transfers the Ampoules/Vials to be labeled from the Feeding Hopper to the Guide.
4.8. At the same time label master picks up the gum from the Gum pot and label from the label box. After that stereo’s will print the details on the label from the label master and leave in the pin.
4.9. The transferred Ampoules/Vials from the Guide take the printed label from the pin and gets pasted to it and leave on the Unscrambler through conveyor belt.
4.10. After completion of the labeling, dismantle the Glue pot, Gum roller, Ink printing roller.
4.11. Soak the Glue pot in 0.5% (v/v) Teepol solution, wash the Gum roller with DM water. Clean the printing roller with Iso propyl alcohol / Thinner.
FILTERATION OF SOLUTION
1. Objective:
To lay down a standard procedure for Filtration of Solution
2. Scope:
This procedure provides a standard method of Filtration of Solution.
3. Responsibility:
¯ Senior Chemist.
¯ Head - Production.
4. Procedure:
4.1. Check and make sure that the area is clean & free from the previous product and any other materials related to previous products.
4.2.
4.3. Place the membrane followed by 2-20 m prefilter in the 293mm membrane holder.
4.4. Connect the Nitrogen tube to the pressure vessel.
4.5. Connect the inlet and outlet tube of the membrane holder with pressure vessel and collection vessel respectively which has been already autoclaved.
4.6. Fill the solution to be filtered in the pressure vessel and pass the Nitrogen at the pressure of
4.7. The solution will come out and enters into the membrane assembly and then get filtered through membrane.
4.8. The filtered solution gets collected in the collection vessel.
AUTOMATIC INJECTABLE POWDER VIAL FILLING AND RUBBER STOPPERING MACHINE
1. Objective:
To lay down a standard operating procedure for Automatic injectable powder vial filling & rubber stoppering Machine.
2. Scope:
This procedure provides a standard method of operation and handling of the Automatic injectable powder vial filling & Rubber stoppering Machine.
3. Responsibility:
§ Machine operator.
§ Senior Chemist.
§ Head - Production.
4. Procedure:
4.1. Check and make sure that Automatic Injectable Powder Vial and Rubber stoppering machine has been cleaned as per SOP No:P/P/011
4.2. Make sure that Line clearance is duly checked and signed by QA Personal as per SOP No:P/P/050
4.3. Make sure that the filling area has been cleaned properly.
4.4. Switch on the Laminar flow and make sure that it has been wiped with 70% IPA.
4.5. Receive the incoming sterilized, siliconised and dried containers on the unscrambler and suitably guided on to the moving woven conveyor belt at the required speed for the correct placement below the powder wheel.
4.6. Put the sterile powder in powder hopper, which will agitate powder by a pair of mechanical agitators for maintaining consistency and uniform bulk density.
4.7. The precise fill volume of powder is sucked into the port of the powder wheel by means of vacuum.
4.8. The excess powder is doctored off by a blade when powder wheel indexes further and remains in the port due to the vacuum till it reaches just vertically above the container.
4.9. The time dose of Nitrogen sequentially flushes out powder from the port of powder wheel into container one by one.
4.10. The filled containers are immediately separated on the conveyor by container separator and moves further for the stoppering operation.
4.11. Put sterilized, siliconised Rubber stoppers in the Rubber stopper hopper.
4.12. Rubber stoppers are made to pass through mechanical orientation system and stacked vertically in the rubber stopper chute from Rubber stopper hopper.
4.13. The moving container is held firmly between two cogged neoprene belts for correct pick up of rubber stopper from the outlet of Chute.
4.14. Further the container is passed beneath two pressing rollers for tight sealing of rubber stopper.
AUTOMATIC AMPOULE FILLING & SEALING MACHINE (3 STROKE)
1. Objective:
To lay down a standard operating procedure for Automatic Ampoule Filling & Sealing Machine
2. Scope:
This procedure provides a standard method of operation and handling of the Automatic Ampoule Filling & Sealing Machine.
3. Responsibility:
§ Machine Operator.
§ Senior Chemist.
§ Head - Production.
4. Procedure:
4.1. Check and make sure that Automatic Ampoule Filling and Sealing Machine has been cleaned as per SOP No: P/P/010
4.2. Make sure that Line clearance is duly checked and signed by QA Personal as per SOP No: P/P/044
4.3. Make sure that the filling area has been cleaned properly.
4.4. Switch on the Laminar flow and make sure that has been wiped with 70% IPA.
4.5. Feed the Ampoules to an inclined charging hopper from Sterilized S.S boxes.
4.6. The Ampoules are passed continuously through rotating feeding wheel, which in turn transfers the Ampoules positively to Ampoule conveyor by the Charging hopper.
4.7. The Ampoule conveyor carries the Ampoules vertically at an angle of 300.
4.8. Pass the nitrogen (Inert Gas) into the empty Ampoules.
4.9. The volume to be filled passes through the pumps, by positive displacement through the non-return valve, filling tubes and filling needles, finally into the Ampoules.
4.10. Pass the nitrogen (Inert Gas) into the Filled Ampoules.
4.11. The filled Ampoules are moved to sealing station.
4.12. In sealing station the Ampoules necks are pre-heated and the pre-heated necks are gripped by the draw-off tongs and sealed.
4.13. Make sure that the sealing has been done before the Inert gas can diffuse to the outside.
4.14. Collect the sealed Ampoules in the collection hopper with proper labelling.
MOIST HEAT STERILIZER
1. Objective:
To lay down a Standard Operating Procedure for Moist Heat Sterilizer with circular chart
2. Scope:
This procedure provides a Standard method to operate the Moist Heat Sterilizer with circular chart.
3. Responsibility:
v Operator.
v Senior Chemist.
v 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. Open the pressure lock door by turning the handle anti-clockwise, till the quick throw handle easily pushed down.
4.3. Load the materials to be sterilized into the chamber by keeping the materials in trolley with proper labeling.
4.4. Close the pressure lock door by pulling up the quick throw handle, after which the handle is to be turned clockwise till it is reasonably tight.
4.5. Open the bypass valve of the moisture separator for 5 minutes to remove all the condensed water which is already present, from the line and then close it.
4.6. Open the main line steam inlet valve.
4.7. Switch on the solenoid jacket steam valve, it will allow the steam inside of the jacket and due to this, pressure will gradually build up in the jacket.
4.8. Safety valve will open, if the inside pressure exceeds 15 lbs. So it will maintain the constant pressure in it.
4.9. Switch on the Inner solenoid steam valve, it will allow the steam inside of the chamber and due to this, pressure will gradually build up in it.
4.10. Open the outlet valve of the chamber and switch on the vacuum pump to suck out the air from the chamber to atmosphere to avoid the formation of air pocket.
4.11. After few minutes, close the outlet valve and switch off the Vacuum pump.
4.12. Drain the condensed steam for few minutes from the chamber by opening the bypass valve of the chamber.
4.13. Check thermograph for recording chart, ink and then put it on.
4.14. ‘Exposure Period & Temperature’ should be as per the validated time for various loads.
For Example:
§ 1210C/15 lbs for machinery parts, Latex gloves, tanks, sterile area dresses.
§ 1160C/10 lbs for Autoclaving (Non-aseptic) pharmaceutical products.
4.15. Switch off the solenoid jacket steam valve, Inner solenoid steam valve and close the Main steam valve.
4.16. Allow the steam to exhaust until both the pressure gauge indicates zero psi by opening the outlet steam valve of the chamber.
4.17. Prior to unloading the sterilized load on the sterile side, make sure that the sterilized load has been cooled to room temperature and the door of Non-sterile area side has been closed.
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