ORAL DOSAGE FORM SOPs

1.0 PURPOSE:

To provide procedure for Operation and Cleaning of Paste kettle.

2.0 SCOPE:

This procedure is applicable to cleaning of area, equipment and accessories in manufacturing at Production Department.

5.0 PROCEDURE:

5.1  General condition & Precaution:

5.1.1 Ensure that temperature sensor is fixed correctly, before operation.

5.1.2 Ensure that electrical supply is disconnected before start of cleaning activity.

5.1.3 Ensure that stirrer is fixed inside the paste kettle at correct position.

5.1.4 Wear protective gears like hand gloves and nose masks while handling the material.

5.1.5 Emergency knob is provided on the operating panel to stop the equipment in case of emergency.

5.2   Prestartup:

5.2.1    Check ´Cleaned` label affixed on paste kettle and ensure that cleaning operation has been recorded.

5.2.2    Visually inspect paste kettle and surrounding area for cleanliness.

5.2.3    Ensure that temperature, relative humidity and differential pressure of area are within the specified limits (if applicable).

5.2.4    If the environmental conditions are out of specified limits, inform to Engineering Officer / Executive for corrective action as per current version of respective SOP and start operation only after attaining conditions as per specified limits (if applicable).

5.2.5    In case of Type-B cleaning, ensure that swab/rinse water sample is approved by QC (Quality control) department (if applicable).

5.2.6    Get approval from IPQA Officer / Executive on ´Cleaned` label of equipment as per respective current version of SOP.

5.2.7    Get line clearance from IPQA Officer / Executive in BMR.

5.2.8    Write the details on “STATUS” label affixed on equipment.

5.3       Setup:

5.3.1    Fix the stirrer blade assembly to rotating stirrer shaft.

5.3.2    Connect the main electric supply and switch ´ON` the mains for heating the water in jacket.

5.3.3    Digital temperature indicator is provided to indicate the temperature on the operating panel.

5.4       Operation of paste kettle:

5.4.1    Start the electrical connection and on main switch on the control panel and start heater button on set the desired required temperature as specified in Batch Manufacturing Record (BMR).

5.4.2    Four green knobs are provided for setting temperature parameters. Press the top right green knob to increase the temperature, press second top green knob to decrease the temperature, press the third knob to reset the temperature & press fourth green knob for saving the entered data.

5.4.3    Record the operation start details in equipment logbook.

5.4.4    Take specified amount of purified water required for product to be processed into paste kettle or follow procedure as specified in BMR.

5.4.5    Start stirrer using 'ON' push button provided on operating panel.

5.4.6    As temperature of purified water reaches to the set value as specified in BMR, add binding agent into the water gradually with continuous stirring or follow procedure as per BMR.

5.4.7    Continue stirring until binder solution is formed and temperature of solution reaches to specified value as per BMR.

5.4.8    After preparation of binder solution/paste, stop the stirrer using 'OFF' push button provided on operating panel.

5.4.9    Cut off the heater button on the control panel.

5.4.10  Remove the stirrer by rotating the wing nut in anticlockwise direction.

5.4.11  To unload binder material, tilt kettle by rotating hand wheel in anticlockwise direction and collect binder solution/paste in SS container.

5.4.12  Transfer container containing binder solution/paste from paste preparation area to granulation area.

5.4.13  Record the operation end details in equipment logbook.

5.4.14  Also record operation start and end details in Batch Manufacturing Record (BMR)

5.4.15  After completion of the activity, switch “OFF” the power supply to paste kettle.

5.4.16  In case of day end cleaning, transfer any semi-finished product in a container after affixing duly filled “STATUS” label.

5.4.17  Affix “TO BE CLEANED” label to the paste kettle.

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1.0 PURPOSE:

To provide procedure for operation and cleaning of Rapid Mixer Granulator.

2.0 SCOPE:

This procedure is applicable to operation and cleaning of Rapid Mixer Granulator at Production Department.  

5.0 PROCEDURE:

5.1       General condition & precaution:

5.1.1    Visually check the intactness of gaskets before fitting.

5.1.2    Ensure that mixer (impeller) and granulator (chopper) are moving freely without any abnormal sound before operation.

5.1.3    Ensure that discharge port is closed before charging material in RMG bowl.

5.1.4    Ensure that all moving parts are fixed correctly.

5.1.5    Ensure that all limit switches are working properly.

5.1.6    Ensure that electrical supply is disconnected before start of cleaning activity.

5.1.7    Use gloves, nose mask and safety goggles (if required) while handling the machine

5.1.8    Emergency knob is provided on operating panel to stop the equipment in case of emergency

5.2       Prestart up:

5.2.1    Check “CLEANED” label affixed on RMG and ensure that cleaning operation has been recorded with proper identification of type of cleaning i.e. Type- A cleaning/Type -B cleaning.

5.2.2    In case of Type-B cleaning, ensure that swab/rinse water sample is approved by QC department (if applicable).

5.2.3    Visually inspect RMG and surrounding area for cleanliness.

5.2.4    Ensure that temperature, relative humidity and differential pressure of area are within specified limits.

5.2.5    If the environmental conditions are out of specified limits, inform to Engineering Officer / Executive for corrective action as per current version of respective SOP and start operation only after attaining conditions as per specified limits.

5.2.6    Get line clearance from IPQA Officer / Executive in BMR.

5.2.7    Affixed the “STATUS” label on RMG.

5.3       Set up:

5.3.1    Transfer cleaned and dried parts to cleaned granulation area.

5.3.2    Open the lid of RMG and fix the impeller in its position by placing gasket and rotating conical screw cap in clockwise direction for tightening.

5.3.3    Assemble the chopper blades with the shaft and tighten it by turning the bolt nut in anticlockwise direction.

5.3.4    Visually check the intactness of lid gasket and fix it in channel of lid properly.

5.3.5    Visually check the intactness of charging port gasket and fix it.

5.3.6    Visually check the integrity of vent filter bag.

5.3.7    Fix the dedicated vent filter bag with its cover/housing using gasket and clamp.

5.3.8    Close the lid of RMG by locking clamps.

5.3.9    Visually check the intactness of gaskets of discharge port and fix it. Close the discharge port cover using wing nuts.

5.3.10  Affix the ‘Cleaned’ label on equipment.

5.4       Operation of RMG:

5.4.1    Switch on the RMG by turning the selector switch to “ON” and the releasing the emergency stop button.

5.4.2    Press “IMPELLER SLOW” functional key to start the Impeller in manual mode at SLOW speed. The “IMPELLER SLOW” function key is in toggle mode i.e. when “IMPELLER SLOW” is pressed Impeller is started at slow speed & “IMPELLER SLOW” key glows and when the same key is pressed again, the Impeller is made OFF.

5.4.3    Press “IMPELLER FAST” key to start the Impeller in manual mode at FAST speed. The “IMPELLER FAST” function key is in toggle mode i.e. when “IMPELLER FAST” is pressed Impeller is started at fast speed & “IMPELLER FAST” glows green and when the same key is pressed again, the Impeller is made OFF.

5.4.4    Press “CHOPPER SLOW” key to start the chopper in manual mode at SLOW speed. The “CHOPPER SLOW” function key is in toggle mode i.e. when “CHOPPER SLOW” is pressed chopper is started at slow speed & “CHOPPER SLOW” glows green and when the same key is pressed again, the chopper is made OFF.

5.4.5    Press “CHOPPER FAST” key to start the chopper in manual mode at FAST speed. The “CHOPPER FAST” function key is in toggle mode i.e. when “CHOPPER FAST” is pressed chopper is started at fast speed & “CHOPPER FAST” glows green and when the same key is pressed again, the chopper is made OFF.

5.4.6    “DISCHARGE PORT” key is pressed, Discharge Action Screen will open then feed the RPM required of Impeller / Chopper / Cone Mill motor during the discharge also select the direction of cone mill forward/Reverse and finally press discharge port open function key, discharge port will get opened, “DISCHARGE PORT” key glows and When the same key is pressed again the discharge port is gets closed and “DISCHARGE PORT” key stops glowing.

5.4.7    The machine running time is displayed on the screen.

5.4.8    To reset the machine running time, press “RESET” key is pressed for at least 3 sec.

5.4.9    Perform the Dry mixing activity as per the mixing time and mixer / chopper speeds as mentioned in the BMR.

5.4.10  Add the granulation fluid / binder through the charging port manually / peristaltic pump and granulate the material as per the procedure mentioned in the BMR.

5.4.11  After the completion of granulation process open the discharge valve by pressing the “Discharge Port” key on the screen and unload the granules by keeping the speed as mentioned in the BMR into the FBD bowl / suitable container.

5.4.12  Switch off the main supply by pressing the ‘Emergency’ button. Open the lid and scrap the sides and the bottom surface of the bowl to remove the adhering material using Teflon scrapper and ensure the complete wet mass is unloaded from the RMG.

5.4.13  After completion of operation affix “TO BE CLEANED” label on equipment.         

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1.0 PURPOSE:

To provide procedure for operation and cleaning of Fluid Bed Drier.

2.0 SCOPE:

This procedure is applicable to operation and cleaning of Fluid Bed Drier at Production Department.   

5.0 PROCEDURE:

5.1   PRECAUTION:

5.1.1  Ensure that required compressed air pressure 1.5 to 3 kg/cm² is attained before start of activity.

5.1.2    Whenever there is drop in air pressure, the FBD stop automatically, indicating message on PLC air pressure low.

5.1.3    Ensure that the earthing is connected properly to the FBD bowl before start of operation.

5.1.4    Wear protective gears like hand gloves, nose masks and safety goggles (if required) while handling the material.

5.1.5    Emergency knob is provided on the operating panel to stop the equipment in case of emergency.

5.1.6    Visually check the intactness of gaskets before fitting.

5.1.7    Visually check the integrity of Dutch weave sieve fitted on FBD bowl.

5.1.8    Ensure that all clamps are tightened before operation.

5.1.9    Ensure that all moving parts are fixed properly.

5.1.10  Ensure that all limit switches are working properly, before operation.

5.2       PRESTART UP:

5.2.1    Check ´Cleaned` label affixed on fluid bed dryer and ensure that cleaning operation has been recorded with proper identification of type of cleaning i.e. Type- A cleaning/Type -B cleaning.

5.2.2    In case of Type-B cleaning, ensure that swab/rinse water sample is approved by QC department (if applicable).

5.2.3    Visually inspect fluid bed dryer and surrounding area for cleanliness.

5.2.4    Ensure that temperature, relative humidity and differential pressure of area are within specified limits.

5.2.5    If the environmental conditions are out of specified limits, inform to Engineering Officer / Executive for corrective action as per current version of respective SOP and start operation only after attaining conditions as per specified limits.

5.2.6    Get approval from IPQA Officer / Executive on ´Cleaned` label of equipment as per respective current version of SOP.

5.2.7    Get line clearance from IPQA Officer / Executive in BMR.

5.2.8    Write the details on “STATUS LABEL” affixed on equipment

5.3       SET UP:

5.3.1    Set up of filter bag assembly:

5.3.1.1 Switch ‘ON’ the PLC and wait till start up screen appears.

5.3.1.2 Ensure that filter bag holding ring of shaking shaft is at lower position.

5.3.1.3 Fix the filter bag holding ring in the shaking shaft by locking the clamps.

5.3.1.4 Visually check the integrity of the product dedicated filter bag.

5.3.1.5 Visually check the intactness of the filter bag tube gasket.

5.3.1.6 Fit the filter bag fingers in finger holding hooks of filter bag holding ring one by one.

5.3.1.7 Tie the filter bag tube surrounded by the filter bag with rope properly.

5.3.1.8 Attach the rope between the filter frames and filter suspension ring to prevent the filter from getting damaged during shaking process.

5.3.1.9   Fix compressed air supply tube inside the retarding chamber to filter bag tube gasket.

5.3.1.10  Lift up the filter unit by pressing the filter Up key on Screen.

5.3.1.11  Release the filter Up key when filter reached the topmost position.

5.3.1.12  Go to manual mode. Inflate the filter bag tube after lifting the filter bag to its normal position by  pneumatic cylinder, using push button on HMI in manual mode.

5.3.2    Set up of FBD bowl:

5.3.2.1 Visually check the integrity of perforated bottom plate.

5.3.2.2 Visually check integrity of Dutch weave sieve.

5.3.2.3 Fix the Dutch weave sieve to the bowl by lowering the all toggle clamps and fixing the hooks of holding plate. Lift the toggle clamps to lock the sieve holding plate properly.

5.3.2.4 Ensure that Dutch weave sieve is fitted properly to the bottom of bowl using toggle clamps.

5.3.2.5 Remove the dummy plug and fix the temperature sensor at its respective position into the bowl properly.

5.3.2.6 Visually check the intactness of the view glass and fix it with Allen screws at respective position properly.

5.3.2.7 Assemble the sample collection port and fix it at respective position properly.

5.3.3    Set up of lower plenum:

5.3.3.1 Visually check the intactness of product container sealing gasket of lower plenum.

5.3.3.2 Fix the product container sealing gasket in the circular groove of lower plenum at its respective position properly.

5.3.3.3 Connect the compressed air supply tubes to the product container sealing gasket.

5.3.3.4 Close the opening of drain pipe by using closure and clamps.

5.3.3.5 Tighten the clamp by rotating screw in clockwise direction.

5.3.4    Set up of retarding chamber:

5.3.4.1 Visually check the intactness of the view window glass and fix it at respective position properly.

5.3.4.2 Visually check intactness of product container sealing gasket of retarding chamber.

5.3.4.3 Fix the product container sealing gasket in the circular groove of retarding chamber at its respective position properly.

5.3.4.4 Connect the compressed air supply tubes to the product container sealing gasket.

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1.0 PURPOSE:

To provide procedure for operation and cleaning of Multimill.

2.0 SCOPE:

This procedure is applicable to operation and cleaning of Multimill in Production department

5.0 PROCEDURE:

5.1        General condition and precaution:

5.1.1    Visually check the integrity of screen before and after each activity.

5.1.2    Ensure that electric supply is disconnected before start of cleaning activity.

5.1.3    Before operation apply brakes (if any) to the Polyurethane (PU) wheels of the multimill.

5.1.4    Wear protective gears like hand gloves, nose mask and safety goggles (if required) during milling.

5.1.5    Ensure that while operating the multimill all the parts are fixed and tightened properly.

5.1.6    Ensure that all limit switches are working properly before operation.

5.1.7    Avoid overfeeding of material through hopper.

5.2       Prestart up:

5.2.1    Check ‘CLEANED’ label affixed on Multimill and ensure that the cleaning operation has been recorded with proper identification of type of cleaning i.e. Type- A cleaning or Type -B cleaning.

5.2.2    In case of Type-B cleaning, ensure QC department (if applicable) approves that swab/rinse water sample.

5.2.3    Visually inspect the equipment and the surrounding area for cleanliness.

5.2.4    Ensure that temperature, relative humidity and differential pressure of area are within specified limits.

5.2.5    If the environmental conditions are out of specified limits, inform to Engineering Officer / Executive for corrective action and start operation only after attaining conditions as per specified limits

5.2.6    Get approval from IPQA officer / Executive on the "CLEANED” label of equipment as per SOP.

5.2.7    Get line clearance from IPQA officer / Executive in the Batch Manufacturing Record.

5.2.8    Write the details on ´STATUS `label affixed on multimill.

5.3       Set up:

5.3.1    Fix swinging blades with knife-edge in forward direction in rotor assembly.

5.3.2    Fix the retaining pins in rotor assembly to secure swinging blades.

5.3.3    Fix the rotor assembly with swinging blades to the drive shaft and tighten it by using washer and bolts.

5.3.4    Visually check the integrity of screen and record in BMR.

5.3.5    Align screen on the base plate having circular groove to fix screen.

5.3.6    Fix the screen base plate along with the screen with two studs at respective position. Tighten it by using wing nuts.

5.3.7    Fix the gasket in the circular groove on the mounting plate of discharge port assembly.

5.3.8    Fix the discharge port with mounting plate and tighten wing nuts.

5.3.9    Fix the charging hopper with gasket on the mounting plate and tighten oval nuts.

5.3.10  Keep clean, labelled IPCs or HDPE containers lined with poly bags below the discharge chute of multimill for collecting the milled material.

5.4       Operation of multimill:

5.4.1    Connect electric supply to multimill and switch ´ON` the mains.

5.4.2    Ensure that blades are moving freely without any abnormal sound.

5.4.3    Set the direction of swinging blades in forward and reverse direction by using green push button on the operating panel as per Batch Manufacturing Record.

5.4.4    Adjust the speed of rotor assembly with swinging blades by using speed adjustment knob on the operating panel as per requirement or as per Batch Manufacturing Record.

5.4.5    Transfer and Load the material to be milled through charging hopper with scoop.

5.4.6    Perform the milling operation as specified in Batch Manufacturing Record.

5.4.7    Remove the IPCs or HDPE container containing milled material and transfer it to respective area with ´In process status` label on it (if required).

5.4.8    After completion of milling, switch “OFF” multimill by using selector switch on operating panel.

5.4.9    Record the operation start and end details in equipment usage and cleaning logbook as per SOP.

5.4.10  Also record the operation start and end details in Batch Manufacturing Record (BMR).

5.4.11  In case of Type –B cleaning, transfer any container containing semi-finished product to the respective area after affixing a duly filled “STATUS” label.

5.4.12  Affix “TO BE CLEANED” label .

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1.0 PURPOSE:

To provide procedure for operation and cleaning of Octagonal Blenders.

2.0 SCOPE:

This procedure is applicable to operation and cleaning of Octagonal Blender at Production department.

5.0 PROCEDURE:

5.1 Precaution:

5.1.1 Ensure that the safety railing is closed properly before start of operation of octagonal blender.

5.1.2 Ensure that all the interlocks are working properly and maintain safe distance during operation of octagonal blender.

5.1.3 Wear protective gears like hand gloves, nose masks and goggles (if required) while handling the material.

5.2  Pre start up:

5.2.1    Check “Cleaned” label affixed on blender and ensure that cleaning operation has been recorded with proper identification of type of cleaning i.e. Type- A cleaning/Type -B cleaning

5.2.2    In case of Type-B cleaning, ensure that swab/rinse water sample is approved by QC department (if applicable).

5.2.3    Visually inspect the equipment and the surrounding area for cleanliness.

5.2.4    Ensure that temperature, relative humidity and differential pressure of area are within specified limits.

5.2.5    If the environmental conditions are out of specified limits, inform to Engineering Officer / Executive for corrective action as per current version of respective SOP and start operation only after attaining conditions as per specified limits

5.2.6    Get approval from IPQA Officer/Executive on the "CLEANED” label of equipment as per SOP.

5.2.7    Get the line clearance from IPQA Officer/Executive in the Batch Manufacturing Record.

5.2.8    Affix the "MACHINE STATUS” label on the equipment.

5.3       SET UP:

5.3.1    Ensure that baffle shafts assembled inside the blender at respective position properly.

5.3.2    Fix the gasket in the slot of the rectangular charging port.

5.3.3    Transfer the cover of rectangular charging port & fix it on the slot at respective position.

5.3.4    Tighten the wing nuts of rectangular charging port cover by rotating it in clockwise direction.

5.3.5    Close and tighten the discharge port by using manually operated hand wheels provided on the blender.

5.3.6    Ensure that discharge port is closed properly.

5.3.7    Ensure the vent bag of PTS system is fixed properly to the blender.

5.3.8    Set the blender in “AUTO MODE” by using auto function key on CONTROL PANEL.

5.3.9    Operate the blender by using green push button and stop the blender by using red push button on the operating panel.

5.4       OPERATION

5.4.1    Bring the Blender in the upright position by operating the motor start & motor stop push button on control panel or by inching push button on control panel.

5.4.2    Ensure that the lid of the butterfly valve at the bottom of the blender is properly closed.

5.4.3    Connect the charging port of the Blender with Powder transfer unit.

5.4.4    Charge the materials to be blended in octagonal blender.

5.4.5    After completion of charging, remove the Powder transfer unit from the blender and close the charging unit properly.

5.4.6    Close the safety railing properly.

5.4.7    Set the required blending RPM & time for blending on control panel as per Batch Manufacturing Record.

5.4.8    Set the required blending time by using “TIME SET”, “INCREASE”, “DECREASE” and “RESET” push button on the operating panel.

5.4.9    Then press the Green Start push button on the control panel.

5.4.10  Then blender will start rotating and will stop after the completion of the blending time cycle.

5.4.11  After completion of blending time, open the safety railing.

5.4.12  After completion of blending operation, align the Blender in upright position, so that the discharge end should be at the bottom

5.4.13  To run the Blender in inch mode, push inch button on the control panel. The motor will be ON till the INCH key is pressed and will stop as soon as the key is released.

5.4.14  Place the IPCs / HDPE container lined with polybag below the discharge port of octagonal blender.

5.4.15  Open the butterfly valve at the bottom end and collect the blended material into the collecting IPCs / HDPE containers.

5.4.16  Follow the above procedure to unload all the material in IPCs / HDPE container lined with polybag.

5.4.17  Affix duly filled ‘IN-PROCESS STAGE’ label on IPCs/ HDPE container and transfer it to respective area.              

5.4.18  Record the operation start and end details in Equipment Usage and Cleaning Log as per SOP.

5.4.19  Also record the operation details in Batch Manufacturing Record.

5.4.20  After completion of the activity switch “OFF” the main electric switch on operating panel.

5.4.21  In case of day end cleaning, transfer any semi-finished product in a container after affixing duly filled “STATUS” label.

5.4.22  Affix “TO BE CLEANED” label to the equipment.

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1.0 PURPOSE:

To provide procedure for operation and cleaning of Metal detector.

2.0 SCOPE:

This procedure is applicable to operation and cleaning of Metal detector at Production department.

5.0 PROCEDURE

5.1 PRECAUTIONS:

5.1.1    Ensure that indicator lights are working properly.

5.1.2    Wear protective gears like hand gloves, nose masks and safety goggles (if required) while handling the material.

5.2  PRE START UP:

5.2.1    Check the “CLEANED LABEL” affixed on Equipment and ensure that the equipment cleaning operation has been recorded with proper identification of type of cleaning i.e. Type- A cleaning or Type -B cleaning.

5.2.2    In case of Type-B cleaning, ensure that swab/rinse water sample is approved by QC department.

5.2.3    Visually inspect the equipment and the surrounding area for cleanliness.

5.2.4    Ensure that temperature, relative humidity and differential pressure of the area are within the specified limits and record it as per SOP.

5.2.5    If the environmental conditions are out of specified limits inform to Engineering Officer /Executive for corrective action. Start operation only after attaining the conditions as per specified limits and record the same in the BMR.

5.2.6    Get approval from IPQA Officer/Executive on the "CLEANED LABEL” of equipment as per SOP.

5.2.7    Get the line clearance from IPQA Officer/Executive in the Batch Manufacturing Record (BMR).

5.3       SET UP:

5.3.1    Transfer clean and dried parts to respective cubicle.

5.3.2    Fix the acrylic channel, rejected product collection box at respective position properly.

5.3.3    Connect the main electric supply and switch "ON” the Metal Detector.

5.3.4    Display on LCD shows “INITIALISING…01”.

5.3.5    Wait for 05 Seconds, after 05 Seconds the display shows as below

            PRODUCT CODE: 00

            BATCH CODE : 0054

            SENSITIVITY : 150

            COUNT :0000/0000.

5.3.6    Press RESET key For 4 –5 Sec to enter supervisor settings.

5.3.7    Enter the password by using INC or DEC key

5.3.8    Entering the correct Password press ENT and the display shows PRODUCT CODE.

5.3.9    Set the required Product code (0 to 99 Product codes) Eg. Product Code is settled at 00.

5.3.10  Entering the correct Product Code Press SET Then the display shows. PRODUCT NAME

5.3.11  Press SET key Then the display shows BATCH CODE enter the batch code and press SET key.

5.3.12  SENSITIVITY will appear on the LCD Display. Set the required Sensitivity level by pressing the INC or DEC keys.

5.3.13  The sensitivity can be settled form 000 to 255 settings

5.3.14  Entering the Sensitivity press SET key Then the display shows…PHASE.

5.3.15  Set the required Phase level by pressing the INC or DEC keys.

5.3.16  The Phase can be selected from 000 to 064 settings.

5.3.17  Enter any Phase setting within the range and press ENT for Eg. PHASE is selected at 0024.

5.3.18  After Entering the PHASE press ENT, Then the display shows…SELF TEST DISABLE.

5.3.19  SELF TEST can be enabled by pressing INC or DEC keys Set the required delay by pressing the INC or DEC keys.

5.3.20  The Delay time can be selected from 00.0 seconds to 99.9 seconds.

5.3.21  Press SET key then the display shows RECORD STORAGE ENABLE Please note that RECORD STORAGE should be enabled to get the printout of required data of a particular date. 

5.3.22  Press SET key then the display shows… DELAY OFF.

5.3.23  Enter any Delay OFF setting within the range and press ENT Eg. DELAY OFF is setted at 0.00

5.3.24  After Entering the DELAY OFF press SET key Then the display shows… DELAY ON Set the required delay by pressing the INC or DEC keys.

5.3.25  The Delay On time can be selected from 0.00 seconds to 9.99 seconds.

5.3.26  Enter any Delay On setting within the range and press SET key, then the Display shows OPERATOR CODE Select the required operator code by pressing the INC or DEC keys, press SET key, then the Display shows OPERATOR NAME Eg. DELAY (OFF) is setted at 0.30 seconds.

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1.0 PURPOSE:

To provide procedure to follow for all personnel involved in handling of dies & punches

2.0 SCOPE:

This procedure is applicable for handling of dies & punches in Tablet manufacturing at Production Department.

5.0 PROCEDURE:

5.1 ORDERING OF DIES AND PUNCHES:

5.1.1 For ordering the set of dies and punches for new product, get approved drawing from Formulation Development in case of exhibit / new products or from Technology Transfer department in case of site transfer products.

5.1.2 For ordering the new set of dies and punches for products already manufactured at other locations, get approved drawings, in case of non-availability of drawings send tablet samples to tool manufacturer and get the drawings to take for further approval process by FDD / TAG.

5.1.3 For ordering the set of dies and punches for existing product to be compressed on another machine/tooling, send the drawing reference number and order the new punch set from the tooling supplier.

5.1.4 For ordering additional new set of dies and punches for existing products and the machine, send the indent to purchase department along with the copy of approved drawing.

5.1.5 Get the drawing approved by formulation development for the new product and by production department for the existing product.

5.1.6 After approval of drawing, raise an indent along with approved drawing to purchase department with details of embossing, break line, special instructions if any, tooling preference, if any specific compression machine preference, tooling standards etc., Indent should also request the manufacturer to supply calibration report, Tooling drawing, Material of construction certificate, complete set of inspection and relevant tooling report along with the consignment.

5.1.7 Indent more than the number of stations required to run as applicable.

5.1.8 In case of new product with special shaped punches and dies, inspect the sample punch set sent by the manufacturer and take compression trial if required. Check all the physical parameters of tablet and machine suitability.

5.1.9    If all the parameters are satisfactory, approve the challan.

5.1.10  In case the punches and dies are not approved, reject the tooling / send for rectification as per the decision taken as appropriate case by case basis.

5.1.11  Follow the similar approval procedure for the tooling resupplied from the manufacturer after rectification or replacement supply/new supply.

5.2   INSPECTION ON RECEIPT:

5.2.1 Receive the punch sets from stores and check the number of sets received as per the Delivery challan/ MRV.

5.2.2 Check each set for details like manufacturing date, suppliers identification, serial number, size, embossing etc. against the drawing where ever applicable, physical appearance of the punches and verify calibration report, material of construction certificate, tooling drawing and completed set of inspection report along with the consignment. In case, any discrepancy the same to be recorded punches & Dies register and communicated to purchase / supplier for action as required.

5.2.3 Clean each punch and die using dry cloth. Wipe with 70% v/v Isopropyl alcohol and check for physical damage like burs on punch tip, scoring on tip diameter, scoring mark on punch bodies, corrosion of punch tip and body, wear on punch tip and head if any for punches and for dies check the surface of die and die bore for its finish by using 10X magnifying glass (if required). In case of any observation/ physical damage record the same in the punch calibration record and report to Department Head for further action as required.

5.3   CALIBRATION OF PUNCHES AND DIES:

5.3.1 Fix the calibrated dial gauge on to the bench comparator.

5.3.2 Place the upper and lower punch on the “V” block such that the punch is horizontal and dial gauge Plunger is vertical.

5.3.3 Lift the plunger of the dial and position the “V” block with plunger below it.

5.3.4 Set the dial gauge reading to zero by rotating the outer ring of dial gauge and rotate the punch.

5.3.5 Observe for any deflection in dial gauge needle for one complete rotation of punch.

5.3.6 Note down the readings in the punch calibration record.

5.3.7 Repeat the above steps for concentricity of punch tip and barrel.

5.3.8 Measure the overall and actual length of every punch using calibrated Vernier caliper.

5.3.9 Note down the readings in the punch calibration record.

5.3.10  Measure the punch tip diameter and barrel diameter using calibrated Vernier caliper.

5.3.11  Note down the readings in the punch calibration record.

5.3.12  Measure the outer diameter and height of die using Vernier caliper and record.

5.3.13  If the readings are not within the prescribed limit in the above measurement, do the corrective action as explained below.

5.3.13.1 FOR PUNCH HEAD;

5.3.13.1.1 Load punch on motorized chuck without damaging the punch tip and keeping the head outside.

5.3.13.1.2 Switch on the motorized chuck.

5.3.13.1.3 Apply 80 grid emery cloth over the punch head with firm pressure until all the marks are removed.

5.3.13.1.4 Apply 180 grid emery cloth for fine polishing.

5.3.13.1.5 Clean with cotton wool followed by cleaning of procedure of punches.

5.3.13.1.6 Subject the punches for inspection and record in the inspection format. Any punches falling out of specification need to be taken for destruction after approval.

5.3.13.2 FOR PUNCH TIP:

5.3.13.2.1  Load punch on motorized chuck keeping tip outside chuck.

5.3.13.2.2  Switch on motorized chuck. 

5.3.13.2.3    Put 600 grid emery paper on lapping stick,

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1.0 PURPOSE:

To provide procedure for operation and cleaning of Tablet compression machine.

2.0 SCOPE:

This procedure is applicable to operation and cleaning of Tablet compression machine at Production Department.

5.0 PROCEDURE:

5.1  General condition & precaution:

5.1.1    Avoid machine operation in jog or running mode while fixing of punches.

5.1.2    Ensure that lubrication system is functioning properly before operation.

5.1.3    Ensure that safety guards are closed properly before start of operation.

5.1.4    Wear protective gears like hand gloves, nose masks and safety goggles (if required) while handling the material.

5.1.5    Emergency knob is provided on the operating panel to stop the equipment in case of emergency.

5.1.6    Ensure that Vernier caliper, hardness tester, weighing balances and other in-process instruments are calibrated before use.

5.1.7    Use Vernier caliper for checking the thickness, diameter/length and width of compressed tablets.

5.1.8    Use hardness tester for checking the hardness of compressed tablets.

5.1.9    Use weighing balance for checking the weight of compressed tablets as per current version of SOP.

5.1.10  Check the friability and DT of compressed tablets using DT and friability apparatus as per current version of respective SOP.

5.1.11  Avoid touching to the moving parts of the machine during operation.

5.2       Prestart up:

5.2.1    Check “CLEANED” label affixed on compression machine, metal detector and de-duster and ensure that cleaning operation has been recorded with proper identification of type of cleaning i.e. Type- A cleaning/Type -B cleaning.

5.2.2    In case of Type-B cleaning, ensure that swab/rinse water sample is approved by QC (Quality Control) department (if applicable).

5.2.3    Visually inspect compression machine, metal detector and de-duster and surrounding area for cleanliness.

5.2.4    Ensure that temperature, relative humidity and differential pressure of area are within specified limits.

5.2.5    If the environmental conditions are out of specified limits, inform to Engineering Officer / Executive for corrective action as per current version of respective SOP and start operation only after attaining conditions as per specified limits.

5.2.6    Get approval from IPQA Officer / Executive on “CLEANED” label of compression machine, metal detector and de-duster as per respective current version of SOP.

5.2.7    Get line clearance from IPQA Officer / Executive in BMR.

5.2.8    Affixed the “STATUS ” label on equipment.

5.3       Set up:

5.3.1    Transfer required clean punch set as per BMR from die punch room to respective compression cubicle using s.s trolly.

5.3.2    Transfer clean parts of compression machine to respective clean compression cubicle.

5.3.3    Before fitting the punches on machine, ensure that both tablet thickness controls are set to maximum i.e. lower roll carrier is at its lowest position.

5.3.4    Adjust the fill weight to minimum and thickness to maximum by using dials on compression machine.

5.3.5    Open the acrylic guards of compression machine and set punches, dies and other accessories on machine.

5.3.6    Setting of round shape dies and punches:

5.3.6.1 Arrange issued dies, punches in sequential order and clean it with 70% v/v IPA and dry with lint free cloth.

5.3.6.2 Apply food grade oil on the periphery of dies.

5.3.6.3 Keep die on die pocket and press gently to fit into die pocket.

5.3.6.4 Keep die rod over the die through upper punch guide hole and gently apply pressure by tapping.

5.3.6.5 Ensure that surface of all the dies perfectly flushes with surface of the turret.

5.3.6.6 Apply food grade oil on the thread of die locking screw and fix it into the die screw hole with the dowel located in the key of die screw hole.

5.3.6.7 After fixing of all the dies, tighten the die-locking screws by rotating in clockwise direction with suitable Allen key. Hand wheel is provided to rotate the turret manually.

5.3.6.8 Repeat the steps from 5.3.6.2 to 5.3.6.7 for fixing of all the dies of punch set by rotating turret with hand wheel.

5.3.6.9 Remove the lower weight cam assembly of the machine and check the lower punch guide holes for its cleanliness.

5.3.6.10Rotate turret slowly with the help of hand wheel so that a punch guide hole is exactly aligned above the punch loading port/station.

5.3.6.11 Apply thin layer of food grade oil on the punch head, barrel and insert into the lower punch guide hole.

5.3.6.12 Ensure that punch tips is moving freely inside the die bore.

5.3.6.13 Fix antiturning plugs into slots and tighten screws of antiturning strips.

5.3.6.14 Rotate the turret by using hand-wheel until the punch is clear of the punch loading station.

5.3.6.15 Repeat the steps from 5.3.6.10 to 5.3.6.14 to fit the remaining lower punches by rotating turret with hand wheel.

5.3.6.16 Avoid protruding of punch tip above die table at ejection point, if so adjust the ejection cam using screw handle till the level is achieved.

5.3.6.17 After fitting of all lower punches, fit the lower weight cam assembly of the compression machine.

5.3.6.18   Fit the lower cam track guards using screws.

5.3.6.19   Check that all lower punches are moving freely through cam track.

5.3.6.20   Remove upper punch guide plate and check upper punch guide holes for its cleanliness.

5.3.6.21 Apply a thin layer of food grade oil on the punch head, barrel and insert into upper punch guide hole.

5.3.6.22  Push the punch to its highest position and ensure that it drops freely on its own weight.

5.3.6.23  Rotate the turret by using hand wheel until the punch is clear of the loading station.

5.3.6.24  Repeat the steps from 5.3.6.21 to 5.3.6.23 for fitting of remaining upper punches and ensure that punch moves freely through cam track.

5.3.6.25 Fit the upper punch guide plate and tighten it by rotating screw in clockwise direction.

5.3.6.26  After setting of total set of punch on machine, check for free movement by rotating turret with hand wheel for two full rotations.

5.3.6.27 Check that upper punches are moving freely through cam track without damaging feeder by rotating hand wheel.

5.3.7    Setting of capsule shape and other shape dies and punches:

5.3.7.1 In case of shaped punches other than round, dies are always fixed along with upper punches.

5.3.7.2 Arrange issued dies and punches in sequential order and clean it with 70% v/v IPA and with dry lint free cloth.

5.3.7.3 All upper punches are provided with a key in the center of barrel.

5.3.7.4 Apply a thin layer of food grade oil on the periphery of die, punch head and punch barrel.

5.3.7.5 Remove the upper punch guide plate by rotating Allen screw in anticlockwise direction.

5.3.7.6 Check upper punch guide holes for its cleanliness.

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1.0 PURPOSE:

To provide procedure for operation and cleaning of Semi Automatic Capsule filling machine.

2.0 SCOPE:

This procedure is applicable to operation and cleaning of Semi Automatic Capsule filling machine at Production Department.

5.0 PROCEDURE:

5.1 General condition & precaution:

5.1.1    Ensure that safety guards are closed properly before start of operation.

5.1.2    Wear protective gears like hand gloves, nose masks and safety goggles (if required) while handling the material.

5.1.3    Emergency knob is provided on the operating panel to stop the equipment in case of emergency.

5.1.4    Ensure that Vernier caliper, weighing balances and other in-process instruments are calibrated before use.

5.1.5    Use Vernier caliper for checking the locking length of filled capsules.

5.1.6    Use weighing balance for checking the weight of empty/filled capsule.

5.1.7    Avoid touching to the moving parts of the machine during operation.

5.2       Prestart up:

5.2.1    Check “CLEANED” label affixed on automatic capsule filling machine.

5.2.2    In case of Type-B cleaning, ensure that swab/rinse water sample is approved by QC (Quality Control) department (if applicable).

5.2.3    Visually inspect automatic capsule filling machine, metal detector, aligned instrument and surrounding area for cleanliness.

5.2.4    Ensure that temperature, relative humidity and differential pressure of area are within specified limits.

5.2.5    If the environmental conditions are out of specified limits, inform to Engineering Officer / Executive for corrective action and start operation only after attaining conditions as per specified limits.

5.2.6    Get approval from IPQA Officer / Executive on “CLEANED” label of automatic capsule filling machine, metal detector and aligned instrument.

5.2.7    Get line clearance from IPQA Officer / Executive in BMR.

5.2.8    Affixed the “STATUS” label on equipment.

5.3       Set up:

5.3.1    Reassembly of Loader assembly:

5.3.1.1 Take shaft to the upper most position by turning the head wheel.

5.3.1.2 Fix the rectifier block from front of the vertical shaft.

5.3.1.3 The rectifier block rest on the two dowels provided on the base plate.

5.3.1.4 Take shaft to the lowermost position by turning the hand wheel. Place the horizontal blade assembly from the back side of vertical shaft carefully so that the blade are not damaged.

5.3.1.5 The centre blade of blade assembly should pass through the slot of the vertical shaft.

5.3.1.6 The horizontal blade assembly should be put inside by tilting the assembly on left side, otherwise it cannot be assembled. Ensure that the horizontal blade pass through rectifier block smoothly without damaging the same and tighten the horizontal blade assembly to the link.

5.3.1.7 Tighten the two Allen key screw of rectifier block for fixing it in the base plate.

5.3.1.8 Place the magazine assembly on the vertical shaft carefully such that vertical blade are going in the slots of the rectifier block.

5.3.1.9 Check the centre of the vertical blades in the centre of the slots of rectifier with the help of gauge. Ensure s gap between rectifier block and magazine as 1.0 mm by means of filter gauge.

5.3.1.10 Tighten the Allen screw of the magazine assembly on vertical shaft firmly.

5.3.1.11Place the capsule reservoir number on the dowels of base plate and tighten the two knobs of the reservoir. Repeat the procedure for other station reservoir.

5.3.1.12 Fix the hopper mounting plate above the reservoir.

5.3.1.13 Fix the capsule hopper on the mounting plate by tightening two knobs below the mounting plate.

5.3.1.14 Place the sensor into the capsule hopper.

5.3.2    Reassembly of Tamping unit.

5.3.2.1 Place the support pad back into its position.

5.3.2.2 Assemble the dossing disc in its position by tightening the mounting bolts. Do not tighten the mounting bolts fully until setting is completed.

5.3.2.3 Place the SS cover plate with the help of locating dowels in its position.

5.3.2.4 Now tighten the four Allen cap screw on the both sides (the SS cover is fitted with punch grid plate and scrapper plate.

5.3.2.5 Rotate the hand wheel and bring the shaft to topmost position. Place the tamping guide plate in its position.

5.3.2.6 Tighten the hexagonal bolts of the tamping pin guide plate using spanner.

5.3.2.7 Rotate now hand wheel such that tamping pin guide plate is at its lower most position.

5.3.2.8 Align the tamping pin guide plate with the dosing disc with the help of 4 gauge pins. The gauge pins should move freely up and down. If the gauge pins do not enter freely, shift the dosing disc radially until the gauge pins fall freely from the holes of the dosing discs when released.

5.3.2.9 Now fully tighten the 3 hexagonal bolts of the dosing disc with box spanner extension rod and ratchet with handle. Ensure the gap between dosing disc and wiper block to 0.1 mm by using filler gauge.

5.3.3    Assembly of tamping pins with tamping pin holding block:

5.3.3.1 Insert the four tamping pins in the tamping pin guide plate.

5.3.3.2 Keep the tamping pin holding block on the guide plate.

5.3.3.3 Tighten the clamping knob of tamping pins holding block till the pointer on block shows 25 scale reading.

5.3.3.4 Place the tamping pin removing / fixing block below the tamping pins on the dosing disc.

5.3.3.5 Now bring down the tamping pin guide plate by rotating the hand wheel.

5.3.3.6 The tamping pins will be pressed in the tamping pin holder.

5.3.3.7 Pull the lever inside the block and clamp it by Allen screw.

5.3.3.8 Repeat the procedure, for assembling pins with tamping pin holder block for blocks 1 to 5. Do not forget to remove the tamping pin removing / fixing block from the dosing disc after the assembly procedure is completed.

5.3.3.9 For block number 6, simply place the tamping pins in their seating area and lock the locking plate in position. Do not use tamping pin removing / fixing blocks for block number 6.

5.3.3.10Take the tamping guide plate up by rotating had wheel and fit the cover by locating slot/ pins provided on the S.S cover.

5.3.3.11Place the powder hopper with stirrer from top of the machine on powder stirrer unit and fix it with the clamping knobs.

5.3.3.12 Fix the stirrer by locking pin.

5.3.3.13 Place the sensor in to the powder hopper.

5.3.3.14 Adjust the lower end of the S.S tube along with rubber enclosure into the dosing disc and fix the upper part to the powder hopper with S.S nut.

5.3.3.15At machine station number 5, fix the empty capsule collection box and its cover. Ensure the gap between cap clamp plate and air jet block is approximately 2 mm (this is factory setting).

5.3.4    Assembly of closing unit (Machine station No. 6):

5.3.4.1 At machine station no 6 fix all closing pins using spanner 10/11.

5.3.4.2 Check the alignment of closing pins.

5.3.4.3 Place the gauge pin on the closing pins.

5.3.4.4 The gauge sleeve should move up and down freely on the closing pins. If the gauge pin not entering freely, straighten the closing pins accordingly using hollow pipe or a ring spanner.

5.3.4.5 Fix the suction block using ‘T’ Allen key.

5.3.4.6 Place the closing plate form the top and tighten the hexagonal bolt.

5.3.4.7 At machine station number 4 fix the exit chute guide plate and fix the top cover of the exit chute assembly ( Note- Do not tighten the screw excessively of cap and body bush clamping plate of the turret assembly. Place the magazine assembly on a flat surface with vertical blade assembly facing upwards during storage).

5.3.5    Alignments and settings of Dosing disc with respect to tamping pin guide plate at machine station number 4.

5.3.5.1 Insert the gauge pin from the top of tamping pin guide plate.

5.3.5.2 The guide pin should enter freely in the dosing disc through the tamping pin guide plate.

5.3.5.3 Shift the dosing disc radially until the gauge pins fall freely from the holes of the dosing disc when replaced if gauge pins do not enter freely

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1.0 PURPOSE:

To provide procedure for operation and cleaning of Colloidal Mill.

2.0 SCOPE:

This procedure is applicable to operation and cleaning of Colloidal Mill at Production Department.

5.0 PROCEDURE:

5.1  PRECAUTIONS:

5.1.1    Ensure that clearance between the stator and rotor assembly is properly adjusted.

5.1.2    Wear protective gears like hand gloves, nose masks and safety goggles (if required) while handling the material.

5.1.3    Avoid holding of the material / solution in charging hopper of machine for overnight.

5.2  PRE START UP:

5.2.1    Check the Equipment Usage and Cleaning Log and ensure that the equipment cleaning operation has been recorded with proper identification of type of cleaning i.e. Type- A cleaning or Type -B cleaning.

5.2.2    In case of Type-B cleaning, ensure that swab/rinse water sample (if required) is approved by QC department.

5.2.3    Visually inspect the equipment and the surrounding area for cleanliness.

5.2.4    Get approval from IPQA Officer/Executive on the "CLEANED” label of equipment as per SOP.

5.2.5    Ensure that temperature, relative humidity and differential pressure of the area are within the specified limits and record it as per SOP.

5.2.6    If the environmental conditions are out of specified limits inform to Engineering Officer /Executive for corrective action and start operation only after attaining the conditions as per specified limits and record the same in the Batch Manufacturing Record.

5.2.7    Get the line clearance from IPQA Officer/Executive in the Batch Manufacturing Record.

5.2.8  Affix the “MACHINE STATUS” label on the equipment.

5.3   SET UP

5.3.1    Fix the hosepipes at its respective position to circulate the hot water through the steam jacket (if applicable).

5.4  OPERATION:

5.4.1    Adjust the clearance between the stator and rotor by rotating the adjustment lever provided below the hopper resting platform.

5.4.2    Transfer labelled SS container below the solution outlet of Colloid Mill.

5.4.3    Close the outlet of Colloid Mill by rotating the three way cock handle.

5.4.4    Switch “ON” the main electric supply.

5.4.5    Ensure that the direction of rotation of rotor is clockwise if seen through the top of the charging hopper.

5.4.6    Transfer the material to be milled into the charging hopper of the Colloid Mill.

5.4.7    If the recirculation of material required then rotate the three-way cock handle to recirculating position.

5.4.8    Perform the milling of the material for the specified time as per Batch Manufacturing Record.

5.4.9    After completion of milling, rotate the three-way cock handle to outlet position to collect the milled material.

5.4.10  Collect the milled material in a pre-labelled SS container below the discharge chute of Colloid Mill.

5.4.11  Switch ‘OFF’ the main electric supply.

5.4.12  Record the operation start and end details in Equipment Usage and Cleaning Log as per SOP.

5.4.13  Also record the operation start and end details in Batch Manufacturing Record (BMR).

5.4.14  Affix “TO BE CLEANED” label to the equipment.

5.5.   Cleaning procedure:

5.5.1    Serial cleaning procedure (Type-A cleaning):

5.5.1.1 Type-A cleaning: Cleaning during batch changeover of same product, ascending strength (provided that color is same), before resuming activity after maintenance of non-product contact parts and day end cleaning.

5.5.1.2 Connect the silicone pipe to purified water supply line, open the purified water supply valve and allow the purified water to drain for NLT 30 seconds.

5.5.1.3 Collect the potable water in the charging hopper of colloid mill up to approximately 2/3rd of its capacity.

5.5.1.4 Switch ‘ON’ the electric supply of colloid mill by using green push button and run it for approximately 5 minutes.

5.5.1.5 Recirculate the water to clean the circulating assembly from inside.

5.5.1.6 Drain the waste water through the outlet end and collect the waste water in a container.

5.5.1.7 Switch ‘OFF’ the electric supply and disconnect the electric supply.

5.5.1.8 Destroy the waste water by pouring it through drain of the area.

5.5.1.9 Clean the internal and external surface of colloid mill with lint free cloth dipped in purified water followed by dry lint free cloth.

5.5.1.10   Clean the electric cable, operating panel and PU wheels with dry lint free cloth.

5.5.1.11  Check for visual cleanliness of the cleaned parts; if the visual cleanliness is unsatisfactory repeat the steps from the 5.5.1.4 to 5.5.1.12.

5.5.1.12   If the cleanliness found satisfactory after visual inspection affix “CLEANED” label on the equipment.

5.5.1.13           Record the cleaning start and end time in Equipment Usage and Cleaning Log .

5.5.2    Non serial cleaning procedure (Type-B cleaning):

5.5.2.1 Type-B cleaning: Cleaning during changeover of different products with different active ingredients, colour, descending potency, post maintenance of product contact parts and when the next product is not known and campaign batches manufacturing activity after every five batches.

5.5.2.2 Follow the procedure mentioned in steps 5.5.1.4 to 5.5.1.13 as mentioned in Type-A cleaning.

5.5.2.3 Add 2% v/v S.L.S solution to the purified water and circulate and start milling for 10 min and drain the water containing S.L.S .

5.5.2.4 Let the milling continue and rinse with purified water until the detergent S.L.S solution foam is totally finished.

5.5.2.5 Wipe the outer body with wet lint free cloth , after with dry lint free cloth.

5.5.2.6 If cleanliness found satisfactory after visual inspection affix “CLEANED” label on the equipment.

5.5.2.7 Intimate to Quality Assurance (QA) for inspection of the equipment and taking swab/rinse water sample (if required).

5.5.2.8 Record the cleaning end time in Equipment Usage and Cleaning Log.

5.5.2.9 If clean equipment is not in use then perform Type-B cleaning after seven days.

5.5.2.10  After Type B cleaning, before using equipment within seven days, perform Type-A cleaning.

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