Document 13
Document 13
Document 13
“Company name”
Submitted By
UTKARSH SHARMA
BPYN1PY21119
Submitted to
SCHOOL OF PHARMACY
ITM UNIVERSITY GWALIOR
NH-44, BYPASS, TURARI, JHANSI ROAD,
GWALIOR - 474001
MADHYA PRADESH, INDIA
DECLARATION
Objective:
1. To Strip-pack the Tablets & Capsules & to ensure efficient running of the
machine for desired quality production with maximum output.
2. To maintain safe, clean and tidy environment during operation.
Caution :
Check Manufacturing area for cleanliness. Check that materials of only one
batch are brought in the Manufacturing area at a time. Ensure cleanliness of all
parts of the Machine.
1. Assembling : Clean and Assemble the clean and dry accessories as per
SOP No. : CPS01
2. Operation
2.1. Switch on the heater and adjust Sealing Roller Temp pre determined for
Particular product specification as per BMR & MFR.
2.2. Mount the Printed Foil Roll and Plain Foil Roll on their respective place.
2.3 Set the Printing Unit with Required Details on Rubber Stereo.
2.4 Adjust Pressure of Sealing Roller, Slitter Unit and Cutting Tool.
2.9 Continue Strip Packing Process if all preliminary checks are satisfactory.
2.10 At regular intervals of time (at least 2 hrs or whenever Packing Foil rolls are
changed and as per Specification in B.M.R. & M.F.R.) Printing checks,
Overprinting checks, and Leak test should be done on Strips.
*If the strips pass the test, strip packing should be continued. If the strips fail the
test, the strips which have been obtained between the test and previous one (in
which tablets should have passed) should be isolated for recovery of the tablets
and repacking corrective action, particularly in relation to sealing conditions
should be taken and only then should packing recommence.
2.11 If the machine is stopped for any reason and whenever the packing material
roll is changed, the following sequence of operation should be followed.
*(B) The release switch of the machine should be turned to stop the product from
being released.
*(C) Any tablets or Strips, which would have come in contact with the sealing
roller, should be removed and discarded.
*(D) The roller should be stopped by means of switch. When the machine is
stopped during tea and lunch breaks, it must be ensured that no tablets are
retained
in the feed chute. After the machine is restarted, a few empty strips should be run
initially to ensure the over printing details are clear. The empty strips should be
removed from the line and only then should strip packing recommence.
2.12 The strips should be inspected on the belt for defects such as misprint, less
no. of tablets, improper sealing, dots on foil etc. The good strips as per the
product specification should be collected for final packing. The rejected strips
should be collected separately and then taken up for recovery of Tablets.
2.13 At the end of the working shift, if the product left in hopper should be
removed.
IMPORTANT NOTE
1. If any part of Machine is found defective the. Check and record. Report
immediately the incidence to the department head.
2. Clean the Machine as per the Standard Cleaning Procedure. Ref. SOP
No.: CPS01.
1. Take regular rounds of Dept. and ensure that the machine must be operated
in accordance with Standard procedure.
3. Check that safe working environment without any cross contamination are
maintained.
: STRIP PACKING MACHINE
Objective:
1. To ensure efficient running of the machine for proper drying the material
to achieve desired quality production with maximum output.
Caution :
1. Check and certify that the area and equipment are clean and suitable
for starting the operations.
2. Ensure that the main switch is in “Off” position before dismantling the
F.B.D. for loading.
3. Start the compressed air supply by opening the compressed air valve. (75 –
100 PSI). Any leakage in air to be checked.
1. Assembling
Assemble the clean and dry accessories in the following manner:
1.1 Unclamp the fixing bolts of retarding chamber and allow it to rest on the
trolley. Take out the trolley along with the retarding chamber by lowering the
trolley by operating the compressed air valve.
2.1 Check and certify the cleanliness, integrity and suitability of the clean finger
bag.
3.1 Fix the finger bag in the S. S. hanger. Fix the loops of each individual finger
to the hooks of the steel hanger/shaker.
4.1 Place the bag in between the retarding chamber and the D. B. Chamber.
5.1 Clamp the retarding chamber to the D.B chamber with fixing clamps while
holding the outer periphery of the finger bag outside the diameter of the
retarding chamber
2. Operation
2.1 Load the bowl with the material to be dried. Do not load excess material into
the bowl.
3.1 Rake the product to be dried uniformly in the bowl to avoid lumps formation.
4.1 Move the product bowl below the retarding chamber keeping the window in
the front, in viewing position.
5.1 Position the bowl.
6.1 Lift the bottom of the F.B.D. by uplifting the knob and seal trolley to the
retarding chamber.
7.1 Check and ensure that there is no leakage.
8.1 Water discharge bolt of jack chamber to be tightened.
9.1 Set the timer/shaker/Inlet air temperature to the desired setting as per the
product Specification.
10.1 Open the inlet air valve of the clamper.
11.1 Switch on the F.B.D. by pushing the green "Blower `ON” button and start
the fluidization. Put the heater main switch to `3' position and set the
thermostat knob at the desired inlet air temperature setting.
12.1 Watch the fluidized flow through the toughened glass window to see
fluidization is proper.
13.1 Take out the trolley and rake the granules as often as needed to avoid
formation of lumps.
14.1 Record the inlet and outlet temperatures at pre-determined intervals in the
records
3. Unloading‚
3.1After drying is complete put off the heater switch and continue air drying as
required and put off the blower switch.
4.1 Shake the finger bag vigorously and dedust retarding chamber with Teflon
hammer before removing the bowl.
5.1 Release the bowl pressure knob to down position and then withdraw the bowl
by pulling it forward.
6.1 Remove the adhered material on the bowl with Teflon scrapper.
4. Dismantling
4.1 It is just the reverse process of assembling.
5. OPERATIONAL CHECKS,
5.1Check for proper fluidization of the material to be dried by viewing through
the glass window.
6.1 Make sure that the inlet temperature rises steadily and reaches the desired
inlet temperature setting quickly.
7.1 Check outlet temperature as frequently as needed so as to stop the drying at
the desired outlet temperature.
8.1 Dedust finger bags frequently to avoid trapping of wet material.
9.1 Raking is to be done frequently and big lumps are to be broken into smaller
pieces as per product Specification.
6. SAFETY,
6.1Check that the earthing stud is properly touching the retarding chamber and
the other earthing stud is touching F.B.D. Drying bowl properly.
7.1 Check that the equipment viz. F.B.D. has a proper electrical
earthing. 8.1Retarding chamber grooves to be fixed properly.
8. SAFETY CHECKS,
8.1Check L.O.D. and granules quality after drying to determine if drying
operation was satisfactory.
9.1 Validation of F.B.D. is to be carried out every 6 months to check accuracy of
temperature indicators of inlet & outlet air.
1. Take regular rounds of Dept. and ensure that the process must be in
accordance with Standard procedure.
Caution :
1. Check and certify that the area and equipment are clean and suitable
for starting the operations.
2. Ensure that the main switch is in “Off” position before for loading.
1. Operation
1.1 Take out the trays from drier.
2.1 Place the material in the Trays. The material should be filled in half to 3/4th
quantity to overall capacity of each tray to avoid material loss during handling.
3.1 Put each tray in holding assembly of drier properly and close the drier gate.
6.1 Set temperature according to BMR & MFR with the Temp. Controlling Unit..
7.1 Run the dryer for specific period as prescribed in BMR & MFR.
8.1 Check L.O.D. and granules quality after drying to determine if drying
operation was satisfactory.
9.1 Then take out individual tray and collect the material in a suitable container.
2. Cleaning
Dismantle and Clean the Mixer as per the Standard Cleaning Procedure. Ref.
SOP No.: CPG06
Precautions
1. Check that the damper flap should be half open.
2. Check intermittently that the material kept for drying should be safe.
Responsibility : Production Chemist / Q.A. Chemist
1. Take regular rounds of Dept. and ensure that the machine must be operated
as per standard procedure.
: TRAY DRIER
Objective:
1. To maintain clean, safe & tidy environment during operation.
2. To clean the machine for desired quality production with maximum output.
Procedure :
(A) PROCEDURE FOR PRODUCT TO PRODUCT CHANGEOVER
STEPS OPERATIONS METHOD/TECHNIQUES
1. Cleaning external Clean the body of the sifter with moist duster and
surface dry with a clean dry duster.
2. Dismantling Loosen the holding clamps and remove the:
a) Sieve holding rings, b) Sieve, c) Hopper, d)
Gasket
3. Cleaning sieve Take the holding rings, hopper and gasket to the
holding rings, washing area. Wash them with 0.1% Teepol
hopper and gasket solution scrubbing with clean nylon scrubber.
Wash thoroughly with water.
4. Cleaning of sieve Take sieve to washing area. Wash it with 0.1 %
Teepol solution scrubbing with nylon brush.
Wash thoroughly with water.
5. Confirming a) The D.M water rinse of parts as mentioned in
effectiveness of step 2, is sent to Quality Control dept. to
cleaning confirm the absence of previous product.
b) Sieve is checked against the light for any
blockage of openings.
6. Drying a) Dry all the parts by using a clean lint free
duster.
b) Air dry the sieve.
7. Assembling Fix the sieve, rings and hopper on the sifter
body.
Tie a clean polythene bag on the chute to cover
the opening. Cover the sifter with lid.
Note :
1. Fix the “CLEANED” tag (duly filled with date and initials and name
of Previous Product.
2. *Step No.5a is validatory exercise to be conducted once in 6 months at the
time of product changeover.
3. If the cleaned sifter is not used within 24 hours after cleaning or there are
signs of dust or powder settled on the sifter dismantle the sifter and
dedust the dismantled parts and body by using a clean lint free duster.
: VIBRATORY SIFTER
Objective:
1. To maintain clean, safe & tidy environment during operation.
2. To ensure cleaning of the machine for desired quality production.
Procedure :
(A) PROCEDURE FOR PRODUCT TO PRODUCT
CHANGEOVER
1. After completion of batch compression machine should be cleaned.
2. Release pressure by revolving the pressure wheel anticlockwise.
3. Take out all powder with the help of air blower and cloth/Nylon brush.
4. Dismantle the machine remove guards, punches, dies, feed frame etc.
5. Cleaning of Dies & Punches
a. Clean the dies and punches with a duster.
b. Thereafter wash them with Liquid soap and followed by Isopropyl
Alcohol.
c. Wipe with a clean & dry duster.
d. Buff and polish if necessary.
e. Store aside after applying grease / liquid paraffin / oil
6. Vacuum clean the turret, punch guide holes & die holes
7. Clean thoroughly the turret; punch guide holes and other parts of the
machines with Kerosene or petrol use a nylon brush to remove adhering
material.
8. Clean the hopper & feed frame with a duster & then with water &
detergent solution. Next wipe it with clean & dry cloth.
9. Refit the machine for use and cover it.
10.If not to be used for more than two days apply liquid paraffin / oil on the
turned punch guide hole die holes & cam tracks.
11.Clean dust collector and tablet deduster thoroughly
Note :
1. Fix the “CLEANED” tag (duly filled with date and initials and name of
Previous Product.
2. If the cleaned Machine is not used within 24 hours after cleaning or there
are signs of dust or powder settled on the Machine dismantle it and dedust
the dismantled parts and body by using a clean lint free duster.
Precaution :
1. Handle all the change parts carefully.
2. Periodically oiling & greasing should be done after cleaning.
1. Loading
1.1 Ensure that the Coating Pan is cleaned and in correct position.
2.1 Load the Dedusted Tablets from the containers into the Coating Pan as
per specification of product BMR and MFR.
2. Operation
o Switch on the main of the Blower & Exhaust System and start the
preheating of tablets as per specification of Product BMR and MFR.
o Set all parameters (for eg. Speed of Pan, Spray Distance, Spray
Pattern, Compressed Air Pressure, Blower Temp. etc) & start the
Coating of Tablets
NOTE :
During Coating operation attach a in process label to the Coating Pan
specifying the name of the product, batch no. , manufacturing date, exp. Date,
stage and its status along with signature of production Chemist.
3. Unloading
5.1 Unload the Coated tablet in to polythene lined cleaned plastic container.
6.1 Label the product container for product, batch no, date. Status next stage
4. Cleaning:
Clean the Coating Pan as per the Standard Cleaning Procedure. Ref. SOP No.:
CPC01A
Precaution :
1. Due to excess load or power failure when pan stopped, stop spraying
coating solution immediately.
2. Precaution should be taken to see the tablets for their coating appearance
in between coating operation.
1. Take regular rounds of Dept. and ensure that the process must be in
accordance with Standard procedure.
Note :
Ensure that the S.S.Tank is cleaned as per the standard cleaning procedure.
Ref. : SOP No.: CPC03
1. Operation
2.1 Pour required quantity of Solvent into the S.S. Tank as per Specified in the
Product BMR & MFR
3.1 Pour or add Materials to solvent with constant stirring to get desired Solution.
4.1 Clean the Paste Vessel as per Cleaning Procedure No. CPC03
Caution :
Check Manufacturing area for cleanliness. Check that materials of only one
batch are brought in the Manufacturing area at a time. Ensure cleanliness of
all parts of the Machine
1. Assembling
Assemble the clean and dry accessories in the as per SOP. No. CPP04:
2. Operation
2.1 Check the direction of flow of the solution with compressed air.
2.2 Fill the Solution to be sprayed always as much as can be work and close the
Knob, and Open the Air Supply for stirring Solution and to get sufficient
Compressed air for process as per Product Specification in MFR & BMR.
2.3 Start process after all Parameters are checked and found OK.
2.4 *In the case the compressed air stops due to power failure, immediately stop
the flow of Solution to the coating Pan.
IMPORTANT NOTE
1. If any part of Machine is found defective the. Check and record. Report
immediately the incidence to the department head.
2. Clean the sifter as per the Standard Cleaning Procedure. Ref. SOP No.: CPC04.
Precautions
1. Check the direction of flow of Solution in forward direction.
1. Take regular rounds of Dept. and ensure that the process must be in
accordance with Standard procedure.
: SPRAY GUN
Objective:
1. To compress the granules & to ensure efficient running of the machine for
desired quality production with maximum output.
2. To maintain safe, clean and tidy environment during operation
Caution :
Check Manufacturing area for cleanliness. Check that materials of only one batch
are brought in the Manufacturing area at a time. Ensure cleanliness of all parts of the
Machine.
OPERATION:
1 Examine and make sure that the punch die set to be fitted in the machine as
specified for the tablets to be compressed are:
(1) Not worn out or damaged
(2) Cleaned and polished Buff and polish if necessary
2 Lubricate the upper and lower punches with oil.
3 Remove the guards (covering the lower punches) hoppers and feed frames.
4 Rotate the machine by turning the flywheel to bring one of the punch stations in
the turret directly in line with the punch loading position
5 Clean the upper & lower guide holes.
6 Clean the die & place on die plate & drive in to position, so that the top face of
the die is perfectly match with the die plate surface
7 Tighten the die holding screw
8 Insert the lower punches in to the lower punch insert guide hole, the punch must
slide freely
9 Fit the remaining punches and dies in similar manner & place the plug
10 Insert the upper punches from the upper punch guide hole, the punches should
work freely up & down without any tightness
11 For the tablet other than round, first feed the upper punch and then place the die
on the die plate, enter the upper punch tip well into the die hole & drive the die
down. Check that the upper punch will enter freely into the die to the full depth
and after tightening the die holding screw
12 After fitting the lower punch insert the nylon brake plugs and tighten the anti-
turning spring tips
13 Check the lower punch tips protrude slightly above the top face of dies, adjust if
necessary
PRECAUTION :- .
1. Check that the dies are flush with die plate.
2. Do not over tighten the dies screws.
3. Check that the punches are: -
1. Free in punch guides.
2. Drop freely on their own weight.
3. Move freely through cam track.
4. Smear punch heads with oils.
3. Check that safe working environment without any cross contamination are
maintained.
: PUNCH SET
Objective:
1. To ensure efficient running of the machine for proper mixing to get
desired quality production with maximum output.
Caution :
Check Manufacturing area for cleanliness. Check humidity in the area, if
necessary for moisture sensitive materials. Check that materials of only one
batch are brought in the Manufacturing area at a time. Ensure cleanliness of all
parts of the Mixer.
1. Assembling
Assemble the clean and dry accessories in the following manner:
1.1 Fix the bowl of Planetary Mixer in correct position and lock it by two flaps
on either side.
2.1 Fix the beater in slot of central shaft of lid. Ensure that beater is fixed in
correct position.
2. Loading of material
Load the Materials in the following manner
2.1Open the lid of Mixer by turning on the switch and then ensure that the mains
of the machine are “OFF”.
3.1 Load the materials into bowl of Mixer from container with the help of S.S.
Scoop.
4.1 Lock the bowl with lid by turning on the Switch.
NOTE:- Before loading the material, ensure that all the parts i.e. bowl, cover, lid
and its inner portion are cleaned as per standard cleaning procedure and there are
no traces of the previous product.
3. Operation‚
3.1Before starting the operation, ensure that the bowl, lid, beater are assembled
properly.
5.1 Set the timer and adjust speed to slow and then to fast speed as required.
Note:- Speed and time for mixing will vary from product to product.
4. Unloading,
4.1Open the lid of Mixer by turning on the switch and then ensure that the mains
of the machine are “OFF”.
5.1 Unlock the bowl by with the help of flaps on either side turning the wheel
manually in anticlockwise direction Remove the beater by unlocking it.
6.1 Unload the mixed material in a container lined with single/double polybags
with the help of S. S scoop.
Note:- Use latex gloves and nose masks during loading and unloading of
materials.
5. Dismantling & Cleaning
Dismantle and Clean the Mixer as per the Standard Cleaning Procedure. Ref.
SOP No.: CPG03
Precautions
2. In case of motor tripping due to over loading or supply failure, do not start
beater in mass; take the beater drive assembly up. Restart the beater drive
and bring the drive assembly “Down” with beater in motion.
1. Take regular rounds of Dept. and ensure that the process must be in
accordance with Standard procedure.
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