STANDARD OPERATING PROCEDURE FOR TABLET

GRANULATION, COMPRESSION AND COATING

1.0 OBJECTIVE:
To provide detailed procedure for Tablet granulation, compression and coating.
2.0 SCOPE:
This SOP will be applicable for all the process, from granulation to the coating including the
changeover for the next batch at production department.
3.0 RESPONSIBILITY:
3.1 Execution: Operator
3.2 Checking: Operator & Production Pharmacist
4.0 ACCOUNTABILITY:

Assigned Designee

5.0 PROCEDURE:

5.1 WET GRANULATION

5.1.1 After getting the line clearance form QA person for the area and for the equipment,
bring the dispensed material of the batch to the manufacturing area by Checking and
assuring that the balance is calibrated. Then check all the ingredients for name,
weight, and batch number against the bill of material and sign on the checked by the
column of Bill of material and dispensed slip.
5.1.2 Flush first few liters of the DM Water and collect and use fresh DM Water for the
manufacturing process.
5.1.3 Give Product status label to all the pieces of equipment.
5.1.4 Check all the pieces of equipment for proper assembly and run it in empty condition
to check for friction or abnormal sound or presence of foreign material, if any of the
abnormalities observed, inform the maintenance, get it rectified and re-clean the
equipment after maintenance.
5.1.5 Change the DM Water from the hygrometer on daily basis.
5.1.6 Check and record temperature, relative humidity and pressure differential in the area.
5.1.7 Check intactness of the screen & sieves of the Multi mill and sifter before & after
completion of the work.
5.1.8 Refer the instructions given in the batch manufacturing record and make all the
entries timely in good and clean handwriting.
5.1.9 Avoid the overwriting while making the entries in the batch manufacturing record. In
case of the error, it is to be cut with a single line and to be re-entered with counter
sign and date.
5.1.10 During material handling and carrying out the manufacturing process, the operator
should wear mask and gloves.
5.1.11 Any deviation during manufacturing process should be immediately informed to shift
in-charge and QA person.
5.1.12 No material should be kept on the ground or unlabeled during the manufacturing
process.
5.1.13 The required cleaned empty utensils should be kept in an area for carrying out the
manufacturing operation.
5.1.14 After completion of sifting of the material should be added in the mixer as per the
sequence is given in the batch manufacturing record.
5.1.15 Operate sifter as per SOP; sift the Raw material / granules as per instructions given in
BMR.
5.1.16 Operate the Multi mill / cad mill as per SOP, during milling operation check the
appearance of discharge material as per requirement of individual products.
5.1.17 Operate the PLM or RMG as per respective SOP. Dry mix & granulation the material
as per instruction given in BMR.
5.1.18 After achieving the end of the granulation, the time and other details should be
recorded for wet mixing in the batch manufacturing record.
5.1.19 Operate the FBD as per SOP. Dedicated finger bags of the fluidized bed dryer should
be used for individual products. During fitting and before starting the fluidized bed
dryer check the finger bag for intactness. Any damage if observed, the respective
fluidized bed dryer finger bag should be rejected and should be reported to shift in-
charge.
5.1.20 If the drying is continued for more than three days, the bag should be removed,
cleaned and then to be used.
5.1.21 During drying procedure check and record the inlet air temperature and outlet air
temperature as per the batch manufacturing record.
5.1.22 Before lubrication, check the weight of dried granules and record it in the batch
manufacturing record. Lubricate the batch as per instruction given in BMR.
5.1.23 After completion of the manufacturing process, unloaded material should be checked
for proper labeling, closing of the bags and the lids of the container before sending it
to the storage area.
 5.1.24 After completion of manufacturing activity, the equipment use logbook is to be
entered with all the details including stoppage of activity and equipment breakdown if
any in "Equipment Log Book" (Annexure I).
5.1.25 The equipment stoppage during the manufacturing activity should be immediately
informed to shift in charge and maintenance department by filling equipment
breakdown form.
5.1.26 After repairing of the instrument/ equipment the line clearance is to be taken from
quality assurance person to restart the activities and recalibration of the same should
be carried out if applicable.
5.1.27 If the manufacturing of the new product is to be carried out in the same area follow
the standard operating procedure for change over as per the SOP.
5.1.28 Remove all the documents, left over material and status label of the previous product
from the area.
5.1.29 Put "To be cleaned" label on all equipment’s and area.
5.1.30 Remove all the deposited material from the electrical parts like motor, panel and
switches and cover with poly bags.
5.1.31 Clean all the equipment’s as per standard cleaning procedure.
5.1.32 Remove riser filter of the air handling unit and clean after every Product changeover
and after completion of three consecutive batches of same product or if required.
5.1.33 Before fitting check the filter for cleanliness, intactness and absence of leakage, if
any, record the same in respective records.
5.1.34 Clean door frame, walls, tables, chair, tube light covers and floors and filters of return
air supply ducts as per standard cleaning procedure.
5.1.35 After completion of cleaning check all the equipment’s and the area for cleanliness
and give technical information sheet for swab test to quality control department.
5.1.36 The filled containers should be stored in the storage area in segregation.
5.1.37 The racks and the drums in the storage area should be in clean condition.
5.1.38 The recoverable residue if any should be entered in recovery register & containers
should be stored under lock and key.
5.2 COMPRESSION:
5.2.1 After cleaning the compression machine as per respective SCP, clean the compression
area, dust extractor and its pipe, racks, door frames, diffusers and return filters of Air
Handling Unit.
5.2.2 While fitting the return filters, check it visually for intactness and absence of leakage.
5.2.3 Intimate quality control department to collect swab samples/rinse water as per
requirement.
5.2.4 After receiving the approval from quality control department put 'cleaned label' to all
the equipment’s.
5.2.5 If a machine is to be kept ideal, then the turret of the machine is to be covered with a
thin layer of food grade oil with the status label `to be cleaned'
5.2.6 It is to be cleaned with 70 % isopropyl alcohol before taking clearance from quality
control department.
5.2.7 If the compression of a product is to be started, remove the 'cleaned' status label and
affix the status label to the machine along with product name & Batch details, which
is to be compressed.
5.2.8 Issue the punch set suitable for the product to be compressed as per the description of
the punch set in the compression record of the batch manufacturing and as per SOP.
5.2.9 Fill up the punch tool record with all the details of the punch set issued.
5.2.10 Set the compression machine as per SOP and check the setting of the machine by
rotating hand wheel.
5.2.11 Bring all the containers of lubricated granules of respective batch along with the
batch manufacturing record to the area. Counter check the labels of all the containers
for correct batch details as per the batch manufacturing record.
5.2.12 Set the machine as per the tablet parameters given in batch manufacturing record.
5.2.13 Destroy the tablets of first few rotations before starting the machine for the
compression of the batch as per the SOP.
5.2.14 Collect the tablets generated during machine setting in a container as Utilisable
residue and keep it duly labeled and packed. It should be used in same batch or next
batch.
5.2.15 At the end of the compression, when the material in the hopper reaches to the lowest
level stop the compression and destroy the left over from the feed frame or use it as
an utilizable residue.
5.2.16 After completion of the compression of the batch weigh the containers of the
compressed tablets and record the same in the batch manufacturing record and do
reconciliation of the same.
5.2.17 Clean all the containers from outside and transfer it to in process store with the label
having all batch details.
5.2.18 If next batch of same product is to be taken follows the above steps from 1 to 17.
5.2.19 If the batch of the new product is to be taken for compression remove all the left
leftover materials and record of the previous batch from the area and put "to be
cleaned" label to all equipment’s and area.
 5.2.20 Remove the punch sets and record the same in punch tool record. Clean the punch set
as per respective SOP and store the punch set in punch tool cabinet as said in SOP.
5.2.21 At the time of setting and checking the in-process parameters of the tablet assure the
I.P.Q.C.
5.2.22 Ensure that equipment’s like hardness tester, friability test apparatus, disintegration
test apparatus and Vernier caliper are calibrated.
5.2.23 For disintegration test uses fresh water every time and discards the previously used
water.
5.3 COATING:
5.3.1 Clean the coating pan as per the SOP and intimate quality control department to
collect swab samples/rinse water as per requirement.
5.3.2 After receiving the approval from the quality control department put' cleaned' label to
all the equipment’s.
5.3.3 Assemble the hot air blower assembly. Start the exhaust and coating pan and check it
for proper working.
5.3.4 Set the rpm of the coating pan and the temperature of the inlet air as per instruction
given in the batch manufacturing record.
5.3.5 Assemble the spray gun assembly with a peristaltic pump or dosing pump and check
it for proper working.
5.3.6 Write the Status on coating pan, other equipment’s and the area.
5.3.7 Bring all the containers of the batch to be coated and batch manufacturing record.
Check all the containers detailed label as per the batch manufacturing record.
5.3.8 Load the tablets from the containers serially and check the labels accordingly.
5.3.9 Weigh 100 tablets before coating and record the same in the batch manufacturing
record.
5.3.10 Coat the tablets as per the parameters given in batch manufacturing record.
5.3.11 During coating, frequently check the splay gun nozzles for correct spraying, inlet air
temperature and exhaust.
5.3.12 Clean the compressed air filters before starting the coating.
5.3.13 Check the appearance of the tablets for smoothness and intactness of edges.
5.3.14 Abnormality if any, observed stop the coating procedure and inform it to shift in
charge. If the coating is to be stopped in between, dry the tablets in the pan inching at
35°C to 40°C for 30 minutes.
5.3.15 After completion of coating procedure check the tablets for desired appearance and
weight gain as per the BMR.
5.3.16 After completion of a coating process, dry the tablets as per instruction given in BMR
and allow it to come to room temperature and then unload it in the containers lined
with double poly bags.
 5.3.17 Clean the spray gun assembly as per respective SCP.
5.3.18 If the next batch of the same product is to be taken, check the inner surface of the
coating pan for cleanliness. If required clean the pan and spray guns.
5.3.19 If the batch of the new product is to be taken for coating remove all the left over
materials and record of the previous batch from the area and put "To be cleaned" label
to all equipment’s and area.
5.3.20 Clean the air inlet and exhaust assembly and check the air inlet filters for the absence
of leakages if any and intactness.
5.3.21 After completion of cleaning of the area and the equipment give intimation to quality
assurance department for collection of swab/rinse water sample as per requirement.
6.0 ABBREVIATIONS
6.1 SOP: Standard Operating Procedure
6.2 BMR: Batch Manufacturing Record
6.3 Q.A.: Quality Assurance
6.4 HOD: Head of The Department