1.         OBJECTIVE             

             1.1      To lay down a procedure for handling of Expired Raw materials       

2.         RESPONSIBILITY   

• Technical Assistant / Executive – Stores responsible to identify and segregate the  expired material

• QA – Executive shall be responsible to verify and labeling of the on-line rejected/expired material, to verify the non-conformance(s) if any and communicate to the Purchase Department for necessary action if required and to monitor the destruction activity

• Executive-Safety shall responsible to perform the destruction activity

• In-Charge-Stores shall responsible to ensure the compliance as per SOP

3.         PROCEDURE                       

•      The Executive stores shall verify all approved stocks on monthly basis for expired

             materials.

•      Materials which are non-moving in nature got expired over a period of time in the stores

             shall be identified and transferred to the expired area.

•      Strike out the existing approved label with a cross mark and affix the “EXPIRED

             MATERIAL” label in red colour (Anexxure-1).

•     All expired materials shall be segregated by MRR / Lot Number wise and stored separately in

            rejected material storage area.

•      The quantities shall be checked and enter material details in the Expired Materials Stock

             Register (Annexure-2).

•  Expired materials details shall be informed to Planning department for disposal instructions

•  On receiving the disposal instructions from planning department In-Charge stores shall initiate MNC as per SOP .

• QA personnel shall be forwarded the ‘Issue Details Report’ after approval of the initiated MNC by In-Charge QA and/or Head QA to the Stores Department for disposal of the material

      Destruction Procedure:

• After getting the ‘Issue Details Report’ from QA, Stores personnel shall be initiated destruction process of the material as per Annexure – 3. 

• The duly filled destruction format (Annexure – 3) and a copy of ‘Issue Details Report’ shall be forwarded to safety department along with expired raw material for destruction.

• After getting approval from Head-Q.A. remove the expired raw material from expired material room.

• Safety personnel shall destroy the material by dissolving in a bucket of water and finally discard the same into Effluent Treatment Plant. The same process shall be repeated for the entire rejected/expired quantity

• The Stores In-Charge and Quality Assurance personnel shall supervise the entire destruction process.

• Entries shall be made in the expired materials stock register after disposal.

.

4.         ABBREVIATIONS   

4.1       Q.A      –  Quality Assurance

4.2       MNC    –  Material Non Conformance

5.         REFERENCES          

5.1 Procedure for reporting and monitoring of Material Non-Conformance

6.         ANNEXURES            

6.1       Annexure – 1     – “Expired Material” label..

6.2       Annexure – 2     –   Expired Material Stock Register

6.3.       Annexure—3     –    Destruction Record.

Annexure—3      

DESTRUCTION RECORD

We have received approval from purchase for destruction of ___________________________________

as per the enclosed list vide document numbers from ____________ to ___________ date.  We

seek your clearance to destroy the same.

Thanks

(Warehouse – In charge)                                                                      (Quality Assurance)

Approved by : _________________

                         (Head RA & QA)

Destruction of Rejected goods

Date of destruction                              :

Destroyed by                                       :

Mode of destruction                            :

Remarks (if any)                                  :

Destruction supervised by                   : ______________________  __________________________

                                                              (Warehouse – In charge)               (Quality Assurance)

Encl. : Details of products /  materials, Batch No. & quantitiy.

_____________________________________________________________________________________

1. OBJECTIVE                                     

     1.1    To lay down a procedure for Operation of steam Boiler  6–Ton.

2.         RESPONSIBILITY   

• Assistant    Engineering – To Follow the SOP

• Executive   Engineering – To comply the SOP

3.         PROCEDURE                                               

   3.1       PRECAUTIONS

  3.1.1    Do not by pass any safety interlock.

3.1.2    Check the mobrey air break switch for low-level indication giving blow down at every 8 hours of operation.

 3.2       PRE START UP

 3.2.1    Check the water level in boiler.

 3.2.2    Check the water level in day tank.

3.2.3    Check the water hardness and PH once in a shift, the hardness should be below10 ppm and pH should be 8.5 to 9.5

 3.2.4    Check the fuel oil level in day tank

 3.2.5    Switch on the feed water pump.                                                         

3.2.6    Ensure proper temperature of Furnace Oil in Oil pre heater.

3.2.7    Open the fuel circulation valves

3.2.8    Start the fuel pump for oil re circulation

3.2.9 Close the boiler stop valves.

3.3       SET UP           

3.3.1    Steam pressure switch setting  -10.2 kg/cm²  (High), – 9.0 kg/cm² (Low).                                                     

3.3.2    Modular pressure switch setting  – Main scale at 8.5 kg/cm².

 3.3.3    Safety valve on oil pre heating header – 3.0 kg/cm².

  3.3.4    Fuel oil pressure at low flame – 13 to 14 kg/cm² & High flame – 19 to 20 kg/cm².

   3.3.5    Fuel oil backpressure at low flame  – 13. to 14 kg/cm² & high flame – 19 to 20 kg/cm².

   3.3.6   Fuel oil pre heating header pressure switch  – 3.0 kg/cm².

   3.3.7    Fuel oil temperature   Min  – 90⁰C.

                                                  Max   – 124⁰C.

  3.3.8    Stack temperature    Max – 300⁰C.

3.3.9 Pressure Reduction Valve Setting on fuel & Oil pre heating line – 3.0 kg/cm²

3.3.10  Feed water hardness – below 10 PPM.

   3.4       OPERATION

    3.4.1    Switch ON the fuel pump

    3.4.2    Check the oil  temperature and pressure

    3.4.3    Check the water level in Boiler

    3.4.4    open the Air vent Valve

    3.4.5    Switch ON the AUTO  button on MMI

    3.4.6    Check the flame Condition

   3.4.7    Close air vent valve after shell pressure has reached to 1 kg/cm²

3.4.8    Put  the modulator & firing control switch in ON position after shell pressure has reached to 3 kg/cm²

3.4.9    Check the modulating system working or not.

3.4.10  Check the smoke condition.

3.4.11  Open the stop valve after shell pressure has reached to 5.o Kg/cm².

3.4.12  Give the blow down according to salts concentration in Boiler.

3.4.13  Blow down the water from mobrey in regular intervals                      

3.4.14  Check the flame condition through view glass

3.4.15 Check the steam leakage and rectify if any.

3.4.16 Check and record the operating parameters in daily log sheet every one hour.

3.5       SHUT DOWN

      3.5.1      Put the modulating switch in ‘OFF’ position.

      3.5.2      Put the firing control switch ‘OFF’ position.  .

      3.5.3      Switch in ‘OFF’  the ‘AUTO’ button on MMI.

      3.5.4      Switch ‘OFF’ the blower.

3.5.5  Close the steam valve of oil heating header.

       3.5.6    Switch off the fuel pump.

       3.5.7    Close the fuel pump valves.

       3.5.8    Close the main steam valve.

3.5.9 Open the Air vent valve.

3.5.10`   Switch off the boiler panel

       3.5.11    Check all valves and switches once again.

      3.5.12     De-Pressurize the boiler.

4.         ABBREVIATIONS

4.1         PPM     Parts per million

4.2         MMI    Man Machine interface

5.         REFERENCES

Nil

6.         ANNEXURES

  6.1       Annexure – 1   –           Daily log sheet of steam boiler

1. OBJECTIVE

       To lay down a operation procedure of Air compressor and Dryer.

2.     RESPONSIBILITY

• Assistant  – Engineering  –  To Follow the SOP

• Executive – Engineering – To Comply the SOP

3.    PROCEDURE

       3.1   PRECAUTIONS

• Ensure that air outlet valves of Air compressor and air inlet valve of drier are in open condition.

• Keep ready air compressor and dryer.

• Do not open the by pass valve when the dryer is in operation.

• Do not adjust or tamper the safety devices.

      3.2 PRE START UP

• Drain Condensed water from heat exchangers

• Check for proper valve position of after cooler, air receiver and air drier

• Keep discharge valve open condition before starting the compressor

3.3   OPERATION

• Start the Air compressor by following the instructions displayed on MMI  of the PLC  
• Drain all low points in compressor suction and discharge lines.

• Drain condensate water from air receiver, pulsation bottles and moisture separators.

• Switch on the dryer towers

• Drain the water from pre, after and oil removing filters

• Check and ensure there should not be any abnormal noise from the compressor

• Record the operating parameters in Annexure-1 for every one hour

NOTE : OPERATING PARAMETER LIMITS

• Lubrication Oil Pressure :        1.1 to 2.8 kg/cm
• Interstage Air Pressure    :        2.0 to 3.5 kg/cm
• Discharge Air Pressure    :        8.5 to 10 kg/cm
• Load in Amps                  :       50

  3.4  SHUT DOWN

• Switch off the power supply to the motor through the on-off switch on the starter cum control panel. The air compressor automatically unloads before stopping.

• Switch off the supply for dryer towers

• Drain the water from pre, after and oil removing filters

• Close the outlet valve

4.         ABBREVIATIONS

MMI :   Main Machine Interface

PLC :    Programmable Logic Controller

5.         REFERENCES

Nil      

6.         ANNEXURES

6.1       Annexure- 1 -Daily log sheet of Air Compressor & Drier.

1. OBJECTIVE             

1.1       To lay down a procedure for Preventive Maintenance of Air compressor & Dryer  

2.     RESPONSIBILITY                                                  

• Assistant    Engineering  – To Follow the SOP

• Executive   Engineering – To comply the SOP

3.     PROCEDURE                       

• 3.1 WEEKLY MAINTENANCE

•  Clean the air intake filter with compressed air

• Check and ensure the air compressor load is below 20 Amps during unloading and below 50 Amps during loading.

• Check and ensure no air leakages in the system.

• Check the condition of belts.

• Check and ensure the automatic drain valve function

• Check and ensure the by-pass valve of dryer  in closed condition

• Check and ensure the function of the Dryer

• 3.2 MONTHLY MAINTENANCE

• Check and tighten the motor Bed Bolts.

• Clean the contactor kits with carbon tetra chloride.

• Open the motor terminal covers and tighten the terminals, replace terminal strip if terminals are broken.

• Clean the control panel with air blower and ensure no control wires should hang, tag the wires with cable tag if it is hanging.

• Check the oil level in air compressor, fill with oil if it is below the level.

• Check for any leakages in the pipe lines connected to dryer and receiver.

• Clean the automotive drain valve strainer

• 3.3 QUARTERLY MAINTENANCE

• Check  the alignment of the motor pulley and compressor pulley.

• Regrease the motor Bearings.

• Clean the inlet  discharge valves and replace if worn out or damaged.

• Open and clean the main, exhaust, non return, automatic drain  and solenoid valves.

• Check the Air suction and Discharge valves for worn-out  Parts, replace if required.

• Replace the Compressor  cartridge oil filter.

• Clean the oil strainer and oil cooler.

• Clean the heat exchanger tube bundle assembly.

•  Replaced  the suction filter element

 3.4  HALF YEARLY MAINTENANCE

• Check and clean the contactors, replace the contactor kits if it is damaged.

• Air inlet filter element to be replaced.

• Clean all the filter elements of dryer

• Replace the oil in the air compressor

• 3.5 YEARLY MAINTENANCE

• Check and ensure cylinder and cylinder heads are ok.
• Check and ensure no vibration of driven pulley.
• Check and ensure piston and packing rings are ok
• Replace all elements of dryer once in a year
• Check the physical condition of alumina, replace if required.
• After cooler (Water Cooled)De-Scaling shall be done once in  year

4.  ABBREVIATIONS

Nil

5.         REFERENCES

Nil      

6.         ANNEXURES

6.1       Annexure – 1               List of Air Compressor.

6.2       Annexure – 2               Weekly Preventive Maintenance Check list

6.3       Annexure – 3               Monthly Preventive Maintenance Check list

6.4       Annexure – 4               Quarterly Preventive Maintenance Check list.

6.5       Annexure – 5               Half yearly Preventive Maintenance Check list.

6.6       Annexure – 6               Yearly Preventive Maintenance Check list.

1. OBJECTIVE             

1.  To lay down a procedure for Preventive Maintenance of Tablet Compression Machine

2. RESPONSIBILITY                                                  

• Assistant – Engineering    – To follow the SOP

• Executive – Engineering    – To Comply the SOP

3. PROCEDURE           

• Weekly maintenance

• Check the machine rotation with hand wheel, it should rotate freely.

• Check the hydraulic oil, gearbox oil levels, should be 3/4^th of the oil chamber.

• Check the punch lubrication oil level, maintain up to the mark.

• Check the powder conveying system for proper functioning.

• Check all the PU pipes and PU connectors for leakages.

• Lubricate all moving parts with specified lubricant.

• Monthly maintenance

• Check all the movable parts for proper lubrication, if required lubricate them.

• Check the gearbox oil level, Punch lubrication oil level and hydraulic oil levels, if required top up them with specifies lubrication oil up to the mark.
• Check the PMM and feeder motors are moving freely, if required replace the bearings.

• Check the condition of PLC terminals, contactors and relays, if required clean them with CTC.

• Check all the inter locks working and limit switches condition, if required tighten the line connections.

• Check the powder conveying system vacuum unit, if required clean the cylinder and the vacuum assembly.

• Yearly maintenance

• Check the oil seals of the gearbox, if required replace with new seals.

• Drain the gearbox oil and refill with fresh oil up to the mark.

• Check the bearings of all moving parts, brackets and motor, if found any abnormality replace the worn out bearings.

• Check the hydraulic pump oil seals condition, if required replace the seals.

• Check the timing belts condition, if required replace the damaged belt.

• Check all the pneumatic and solenoid valves condition, if required replace the worn out items.

4. ABBREVIATIONS

• PU    :  POLY URETHANE

• PMM:   PRESSURE MAIN MOTOR

• PLC  :  PROGRAMMABLE LOGIC CONTROL

• CTC  :  CARBON TETRA CHLORIDE   

5. REFERENCES

Nil      

6. ANNEXURES

• Annexure-1      Weekly preventive maintenance checklist
• Annexure-2      Monthly preventive maintenance checklist.
• Annexure-3      Yearly preventive maintenance checklist

1. OBJECTIVE             

1. To lay down a procedure for Preventive Maintenance of Blister packing machine 230 XT, TR-100L.

• 2. RESPONSIBILITY                                                  

• Assistant – Engineering &Production  – To follow the SOP

• Executive – Engineering &Production  – To Comply the SOP

• 3. PROCEDURE           

• Weekly Maintenance

• Check all the movable parts for proper lubrication.

• Lubricate the Punching tool ball case, Embossing unit, platen heater assembly and sucker arm unit for friction free movement.  

• Check the platen heaters and sealing roller heaters for proper working.

• Check the oil level in the gearboxes with level scale.

• Check the FRL unit oil level and air leakages.

• Quarterly Maintenance

• Check the Vibrating coil for proper functioning, if required adjust the leaf springs for proper vibration.

• Check the clutch for engaging and disengaging in running condition.

• Lubricate all the movable parts including the guide rollers of the PVC or PVDC and Printed foil.

• Check all the inter locks are working properly, if required tighten the line connections.

• Check the stepped motor for proper working, if required adjust the line sensor for better sensing.

• Check the objective-sensing camera for proper function, if required verify the data loaded.

• Check the sealing roller and forming station heaters, if found any one failed replace the heater immediately.

• Yearly Maintenance

• Check all the Pneumatic cylinder seal kits, if found any damage replace the damaged kit.

• Check the bearings of the sealing roller, indexing roller, inching roller, PVC or PVDC draw rollers and printed foil guide rollers, if found any damaged replace worn-out bearings.

• Check the solenoid valves, coils and pneumatic valves condition, if required replace the damaged item.

• Check the timer belt and pulley condition, if required replace the timer belt with new one.

• Check the motor belts condition, if required replace with new belts.

• Drain the gearbox oil and refill with new oil.

• Check the platen heater plates and sealing roller for silicon synthetic polymer coating, if required recoat the silicon synthetic polymer for better performance.  

4. ABBREVIATIONS

• PVC : POLY VINILE CHLORIDE

• FRL : FILTER REGULATOR LUBRICATOR

• PVDC : POLY VINILE DIECHLORIDE

5. REFERENCES

         Nil     

6. ANNEXURES

• Annexure-1           Weekly Preventive maintenance checklist.
• Annexure-2           Quarterly Preventive maintenance checklist.
• Annexure-3           Yearly preventive maintenance checklist.

1. OBJECTIVE             

1.1       To lay down a procedure for Preventive Maintenance of Fluid Bed Drier-20Kgs, 120Kgs.

2. RESPONSIBILITY                                                  

• Assistant – Engineering       – To follow the SOP

• Executive – Engineering       – To Comply the SOP

3. PROCEDURE           

• Weekly Maintenance

• Check the pneumatic cylinders and solenoid valves for proper working condition.

• Check earthing bracket plungers for proper working, if required lubricate the plungers.

• Check the product bowl trolley castor wheels for free movement, if required lubricate the wheel bearings.

• Check the scrubber unit solenoid valves for proper working.

• Monthly Maintenance

• Check steam control valves and actuators for proper working ensure that no steam leak will be there in the lines and at actuators.

• Check the filter bag-shaking cylinder, if required adjust the cylinder for proper function.

• Check the pneumatic lines and cylinders for leakages, if found arrest the leaks.

• Check the air pressure of the upper seal, if required adjust the pressure regulator and switch.

• Clean the scrubber unit filter bags with water and dry with air, clean the collection container.

• Check for the damper actuating pneumatic cylinder ‘O’ ring and replace if necessary.

• Clean the inlet & outlet air handling unit pre-filters.

• Check the inter locks are working properly.

• Check the pneumatic valves and pressure switches for proper working condition.

• Yearly Maintenance

• Check the steam coil for leakages if found any arrest them or replace the steam coil.

• Check the blower motor and impeller housing bearings for abnormality, if found replace the bearings, and check the impeller balancing.

• Check the system filters and pre-filters, if required replace with new filters.

• Check the exhaust module HEPA filter, if found any damage repair it or replace with new filter.

• Check the upper seal and lower seals condition, if required replace with new seals.

• Check the castor wheels condition, if required replace with new wheels.

4. ABBREVIATIONS

• HEPA : HIGH EFFICIENCY PERTICULATE AIR

5. REFERENCES

         Nil      

6. ANNEXURES

• Annexure-1     Weekly preventive maintenance checklist
• Annexure-2     Monthly preventive maintenance checklist.
• Annexure-3     Yearly preventive maintenance checklist.

1. OBJECTIVE                    

1. To lay down a procedure for Preventive Maintenance of Automatic capsule filling line AF-40T, AF-90T, And AF-150T.

• 2. RESPONSIBILITY                                                  

• Assistant – Engineering       – To follow the SOP

• Executive – Engineering      – To Comply the SOP

• 3. PROCEDURE           

• Weekly Maintenance

• Check the oil level in the vacuum pump through view glass and refill the oil if required.

• Clean the vacuum pump filter and filter chamber.

• Check the powder mixing motor gearbox oil level with level scale and refill the oil if    required.

• Switch-off all electrical lines and clean the panel with vacuum.

• Check the Pneumatic cylinder of powder conveying system for proper functioning.

• Monthly Maintenance

• Clean and apply new grease to chain and cam assemblies in side the machine.

• Check all movable parts and tighten all fittings of basic machine and line machines.

• Check solenoid valve and clean the valve, ensure the coil is in working condition.
• Check that all the sensors and inter locks of the machine are working properly.

• Check all solenoid valves and coils of pneumatic controls are working properly.

• Check the metal detector electrical lines and clean the detector head.

• Check and clean the rejection cut out area and spring action of flap.

• Drain the vacuum pump oil and top up with new oil.

• Half -Yearly Maintenance

• Check all the link mechanisms, if found any damage replace the link with bush assembly.

• Check the tamping block springs, if found any damage replace the springs with new one.

• Check the motor bearings of vacuum and dust collection system, if required replace with new bearings.

• Clean the grease of sliding blocks rollers of turret and reapply the new grease to the rollers.

• Check the Metal detector controller circuit; clean the circuit board and contactors with vacuum.

• Check the pneumatic cylinder operation and tight the fastenings of the cylinder.

• Yearly Maintenance

• Check the seals of all shafts, if required replace the seals with new one.

• Check the vanes of the vacuum pump, if required replace with new vanes.

• Check the vacuum pump filter condition, if required replace with new one.
• Check all the cams for proper wetness, if required re grease all the cam tracks.

• Clean all moving segments with kerosene and apply new grease to the segments including bearings.

• Check the condition of the main motor and line motor timer belts, if required replace the timer belts with new one.

• Check all the machine alignments, if require realign the settings using Gauge pins with respective size.

• 4. ABBREVIATIONS

Nil

• 5. REFERENCES

Nil    

• 6. ANNEXURES

• Annexure – 1        Weekly preventive maintenance check list
• Annexure – 2        Monthly preventive maintenance check list
• Annexure – 3        Half- yearly preventive maintenance check list
• Annexure – 4        Yearly preventive maintenance check list

1. OBJECTIVE            

1. To lay down a procedure for Preventive Maintenance of Rapid Mixer Granulator-25, 250, 300Ltrs.

• 2. RESPONSIBILITY  

• Assistant – Engineering  – to follow the SOP

• Executive –Engineering  – to comply the SOP

• 3. PROCEDURE                      

• Weekly Maintenance

• Check the lubrication oil in the FRL unit and if required top up with specified lubricant.

• Check the oil level in the gearbox through view glass and should be ¾^Th in level.

• Check the solenoid valves and coils condition.

• Check the chopper motor gland and if required replace.

• Check the pneumatic cylinder functioning.

• Check the Lid gasket condition.

• Monthly Maintenance

• Check the gearbox oil condition and replace if required.

• Check the tension of the motor belts and if required adjust the slackness.

• Check and clean the Teflon ring, if found damage replace with new one.

• Check the pneumatic cylinder seals and discharge chute seals and chopper motor seals, if damaged replace.

• Check all electrical starters and contactor if required clean with CTC solution.

• Check all the inter locks are working properly.

• Check the PLC lines and controls for proper functioning.

• 4. ABBREVIATIONS

• FRL  – FILTER REGULATOR LUBRICATOR

• CTC – CARBON TETRA CHLORIDE

• PLC – PROGRAMMABLE LOGIC CONTROLLER

• 5. REFERENCES         

         Nil

• 6. ANNEXURES           

• Annexure-1       Weekly preventive maintenance checklist.
• Annexure-2       Monthly preventive maintenance checklist.

1. OBJECTIVE            

1. To lay down the procedure for Preventive Maintenance of Octagonal blender 300, 500, 1000, 1500, 2250 Ltrs.

• 2. RESPONSIBILITY  

• Assistant – Engineering   – To follow the SOP

• Executive – Engineering  – To comply the SOP

• 3. PROCEDURE                      

• Monthly Maintenance

• Check the plumber block housing bolts, if required tight the bolts.

• Check the gearbox and motor fastenings, if required tight the fastenings.

• If the PCS is connected to the Blender check the vacuum pump oil level through view glass, if required top up with vacuum pump oil.

• Lubricate all the bearings by using the grease gun.

• Check the electrical lines, contactors and motor terminals, if required tighten the same.

• Check the chain for slackness, if required tight the slackness and apply grease to the chain links. 

• Check the inter locks for proper working.

• Half-Yearly Maintenance

• Check the gearbox oil viscosity, if required drain the gear oil and refill with new gear oil.

• Check the taper roller bearings and oil seals of the gearbox, if required replace with new one.

• Check the motor bearings for abnormality, if required replace the bearings with new one.

• Check the chain and sprocket assembly, if required replace the sprocket with new one.

• If the drive is motor-coupled check the coupling and the spider condition, if required replace the spider in the coupling. 

• 4. ABBREVIATIONS  

          Nil

• 5. REFERENCES         

          Nil

• 6. ANNEXURES                       

• Annexure-1     Monthly preventive maintenance checklist.    
• Annexure-2     Half Yearly preventive maintenance checklist.