STANDARD OPERATING PROCEDURES

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STANDARD OPERATING PROCEDURES (SOPs) Cleaning Filling Drying Compression Sterilization membrane filtration coating “Do as written & Write as done” T.VANI JNTU-H

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What is SOP? A Standard Operating Procedure is a written step-by-step procedure for an activity carried out in a particular organization. Or SOPs can be defined as written documents specifying the procedures that must be followed to carry out operation. Preparation of SOP Written Review Approve

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Standard Operating Procedure for CLEANING Removal of residues/ contaminants from the equipment and facilities in the pharmaceutical industry .

Documentation of cleaning methods:

Documentation of cleaning methods Facilities Equipment Facilities include different areas & each requires different cleaning level. E.g.: Floors, corridors, Office, storage areas, packaging areas, Processing areas (sterile & non-sterile operations), Water supplies, pipelines.

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Standard Operating Procedure for Facility Cleaning Daily (or as needed) Mop floor in the morning and end of day with an approved detergent Sanitize floor atleast once daily. Empty waste containers. Wash with isopropanol . Inspect bulk drums and tanks and exterior walls and wipe with a solvent. All spills are wiped immediately. All waste should be properly disposed. Weekly Wash plastic curtains with approved detergent. Sanitize sink with approved disinfectant.

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Disconnect the machine/equipment from the main electric supply. Close any other hazardous utilities being fed to the machine e.g. steam. Dismantle the machine parts which come in direct contact with the product. Wash all parts with 0.5% v/v Teepol solution (or any other validated cleaning agent) and rinse with potable water and then be swabbed with 70% I.P.A. (Isopropyl Alcohol) solution in water Wash all rubber gaskets with 0.5% v/v Teepol solution or any other designated cleaning agent SOP for cleaning of Equipment

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Wipe all the clean dismantled parts of the equipment with clean lint free cloth . Assemble the parts of the machine. Take a trial run to check if the machine is working properly. Put the status label as “CLEANED” Cover the machine with a machine cover stitched from lint free synthetic fiber so as to prevent it from getting re-contaminated with powder or dust. Complete all the related documentation records and equipment log sheets.

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Standard Operating Procedure for FILLING

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Make sure that the filling area has been cleaned properly. Switch on the Laminar flow and make sure that, it has been wiped with 70% IPA. Feed the Ampoules to an inclined charging hopper. The Ampoules are passed continuously through rotating feeding wheel to the conveyor. The Ampoule conveyor carries the Ampoules vertically at an angle of 300. Pass the nitrogen (Inert Gas) into the empty Ampoules. SOP for FILLING

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7. The volume to be filled passes through the pumps into the Ampoules. 8. Again pass the nitrogen (Inert Gas) into the filled Ampoules. 9. The filled Ampoules are moved to sealing station for sealing. 10. Make sure that the sealing has been done before the Inert gas can diffuse to the outside. 11. Collect the sealed Ampoules through the collection hopper and sent for labelling .

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Standard Operating Procedure for DRYING Removal of small amount of water or other liquid from a material by the application of heat. Switch ON the dryer. Load the dryer with wet solid. Set temperature gauge. Set timer. Press start button. When drying has been completed open vent lever completely for 5 minutes. Unload the dried material.

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Standard Operating Procedure for COMPRESSION Compression is the process of forming a stable, intact compact mass when pressure is applied. Compression is done by using tablet Compression machines.

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Check the compressed air supply which should be not less than 6kg/cm 2 Switch on the main power supply and turn on the key. Touch the log icon, enter user ID and password. Touch the disk speed set up icon & adjust disk rpm. Set the feeder speed and filling depth icon . Adjust the prethickness by adjusting lower punch position.

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7. Set the main penetration and the main thickness by adjusting the upper punch position. 8. Touch the target quantity set up, enter the batch size quantity by ↑/↓ keys. 9. Touch the oil lubrication icon, set the interval time and supply time by ↑/↓ keys. 10. Switch on machine. 11. After the process of punching, the lower dye is lifted up and the tablets are ejected from the dye cavity by the swipe off blade.

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Standard Operating Procedure for STERILIZATION Sterilization is the process of killing or removing bacteria and all other forms of living microorganisms and their spores Sterilization Mechanical Chemical Physical Dry heat Moist heat Radiation Gaseous Disinfectants Filtration

Dry heat sterilization:

Dry heat sterilization Exposing materials to dry heat in hot air ovens 160 ˚ C for one hour

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Decontaminate, clean, and thoroughly dry all instruments and other items to be sterilized. Arrange the material to be sterilized in the Oven. Do not pack the load tightly since air is a poor conductor of heat. Switch on the power supply and control the temperature of the oven by adjusting the thermostat. Note the time when the desired temperature is reached (heating-up time). Hold the load in the oven at this temperature for a definite period of time. This is usually 60 minutes at 160˚C. After sterilization, remove items and use or store immediately. SOP for Dry heat Sterilization

Moist heat sterilization :

Moist heat sterilization Achieved by autoclaving 121⁰C for 15min.

SOP for Moist heat sterilization :

Decontaminate, clean, and thoroughly dry all instruments and other items to be sterilized. Ensure that there is sufficient water inside the chamber. Load the autoclave and fasten the lid keeping the discharge tap open. Adjust the safety valve to the required temperature and turn the heat on. Allow the mixture of air and steam to pass out freely till all air has been discharged. Close the air discharge tap and let the steam pressure rise within the chamber till it attains a temperature of 121˚C (1.5 kg/cm2). Hold on the pressure for 15 minutes. Turn off the heat and let the autoclave cool. Slowly open the air and steam discharge taps after the pressure gauge has reached zero. Allow the material to cool before these are handled. SOP for Moist heat sterilization

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Remove all glass pieces if any. Clean every thing with distilled water. Use hot distilled water to remove the strains, if present. Use disinfectants. Dry for half an hour. Wipe with decontaminating solution. SOP for Sterilization with Disinfectants

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7. Decontaminating solution contains: Liquid phenol 5% w/v Formaldehyde 8% v/v IPA 75% v/v Distilled water QS 8.Spray the hydrogen peroxide solution 20% w/v after cleaning and wiping. 9. Finally, fumigate by using Formaldehyde and Potassium permanganate.

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SOP for Membrane filtration of solution Check and make sure that the area is clean. Wash and Autoclave the Membrane holder. Place the membrane followed by 2-20µ prefilter in the 293mm membrane holder. Connect the Nitrogen tube to the pressure vessel. Connect the inlet and outlet tube of the membrane holder with pressure vessel and collection vessel respectively .

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6. Fill the solution to be filtered in the pressure vessel and pass the Nitrogen at the pressure of 3 to 4 kgs /cm 2 in the pressure vessel which will pump the solution to the membrane holder. 7. The solution will come out and enters into the membrane assembly and then get filtered through membrane. 8. The filtered solution gets collected in the collection vessel.

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Standard Operating Procedure for Coating Check the cleanliness of the machine visually. Check the compressed air supply should be not less than 6kg/cm 2. Ensure that the coating solution tank containing coating solution is connected by silicon tube to coating machine. Reset alarm and wait for sometime to stabilize the system. Touch mode setup icon from main menu and enter product name, batch number, lot number.

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6. Set the limit values for coating speed, exhaust temperature and supply temperature. 7. Set exhaust fan, supply fan of coating machine to build negative pressure in coating pan. 8. Select PUMP-1 for film coating. 9. Select PUMP-2 for sugar coating. 10. Select interval and running time for shaking. 11. Load the sample (tablets) & Switch on the machine.

REFERENCES:

REFERENCES C.V.S.Subramanyam, Pharmaceutical Engineering, 1st edition, Vallabh prakashan publishers. http://Tablet compression\Direct_compression.html http://gmponblog.vinvarun.biz/ http://pharmaceutical_drying/052.html http://www.maexamhelp.com/index.html