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.

In Process Checks QAD Analysis

Dispatch Leak Test

FLOW DIAGRAM OF CAPSULE FILLING MACHINE

Capsule Hopper

With empty gelatin shells

Storage/R.M

Weighing

Filling and Sealing

Physical Area Inspection

Blending

Storing & polishing

Final Packing stripping

Empty GelatinCapsule

Chute Finger Rectifier

Cap Plate Vacuum Cap. Holding Plate

Power or Drug Hopper Body Plate or Powder Filling