2.

Mixing
The ingredients are then loaded in a mass mixer and mixed for a particular time
period which is than analyzed by QAD department .

3 . Filling & safety

The blended ingredients are brought into the capsule filling area in IPC. The
capsule filling area has a capsule filling machine which has assembled accordingly for
different of apsule.
The ingredients are loaded through drug hopper whereas empty gel tinge capsules
are loaded from other hopper . the empty gel tinge capsule are then sealed and ejected
by machine which are collected in double polyether lined fiber board drums.

4. Capsule Filling in – process cheek (IPQC)

The following are in process cheek performed for capsules:
a. Size
b. Weight variation test
c. Disintegration test

5. Capsule packing
The capsule after filling and sealing are stored in capsule Quarantine From there
it is sent to the packaging area for packing. The machines are set by introducing new
codes, rolls of PVC and alluminium foil bottle pack as per required for each batch.
 PAKAGING

1) Strip packaging

The tablets fromed by compression are enclosed in strip packages . The strip
utilizes the rolls of alluminium foils which are scaled together tablet with little
application of heat, The coding is done stereotypically. After the strip packing the
strips are checked for leak in leak test apparatus. The strips are then passed on to
the secondary packagingarea through conveyor belt.
Roller heating temperature limit -1200c-1400c

2) Blister packaging (Model – TR – 00L)

The tablet and capsule are packed in Blister packaging . Here the packaging
materials used are PVC and alluminium foil which are sealed by little application
of heat. After , packaging the strips is tested I leak Test apparatus and then passed
on to the secondary packaging area through conveyor belt.

3) Bottle packaging

First the bottle are decartioning hall then passed for Airjet cleaning of bottle .
The bottle are then checked under light and passed for filling .
The bottle are filled by Triple Head Filling Machine which is the following by capping
and screwing .
II . Secondary / final packaging Area
Here different packaging line area assigned to different i.e one packaging line
come from each strip packaging area one from blister packaging and one from bottle
packaging area.

All materials received through conveyor from the primary packing area are suitable
checked primary area are suitable checked and boxes which packed in cartons and
suitable cooled sealed.

Then operate the machine for packaging.

Roller forming temperature – 140o c
Sealing roller temperature – 220o c
Perform leak test on 10 strips at a time

6. Final packaging :

The stripped capsule arrived at the secondary packaging area through the conveyor
belt from primary packaging area. Stripped capsules undergo manual inspection for
any irregular printing or sealing or any damage. The they are packed in cartoon
which are subsequently packed in specified corrugated boxes and sealed. The boxes
are then to the finished good storeroom.

III . DRY SYRUP

Dry syrups are oral dosage forms containing drug in a bottle in powder form which
has to liquefy administration. The general steps involved in dry syrup manufacturing
are .
2. Sifting and pulverizing
The active ingredient and raw material are sifted through mechanical sifters and
pulverized through mill.
3. Blending
The sifted material are transferred to mass mixer and mixed for a particular time.
The blended is then collected in IPC and shifted to in process quarantine.
4. Bottle washing
The bottles are washed using jet bottle, washing machine. Ensure that the bottle
are cleaned thoroughly
5. Drying
The bottle are dried by keeping in inverter position in perforated trays. The
bottles are then allowed to dry at room temperature. Before filling ensure that the
bottle are dried completely by passing powder in few bottle and check for sticking of
materials to bottle wall.
6. Dry syrup
Machine used :Triple Head Filling Machine.
First of all the temperature and humidity of dry syrup and sealing area. Now
assemble the machine and operate and fill the powder in clean dry bottles.

7. Bottle sealing (modal –ROTOMAT)

Adjust the machine and seal the bottle using ROPP Caps on sealing machine.
After that put the clean measuring over the sealed and checked bottle.

FLOW DIAGRAM SHOWING STEPS IN CAPSULE MFG.

 Storage/R.M

Weighing Blending

In Process Checks QAD Analysis

Storing & Filling and Sealing Empty Gelatin
polishing Capsule

Physical Area Inspection

Final Packing stripping

Dispatch Leak Test

FLOW DIAGRAM OF CAPSULE FILLING MACHINE

Capsule Hopper
With empty gelatin shells

Chute Finger Rectifier

Cap Plate Vacuum Cap. Holding Plate

Power or Drug Hopper Body Plate or Powder Filling