B.

Pharm Sem VII RPCP

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1. INTRODUCTION TO CAPSULE 1.1 HARD GELATIN CAPSULE 1.1.1 PREPARATION OF HGC WITH PLANT LAYOUT 1.1.2 INDUSTRIAL SCALE EQUIPMENTS 1.1.3 STANDARD OPERATING PROCEDURE 1.1.4 QUALITY CONTROL TESTS 1.2 SOFT GELATIN CAPSULE 2. STUDY QUESTIONS 3. REFERENCES

CONTENT

1.1 HARD GELATIN CAPSULE

CAP
BODY

HARD GELATIN CAPSULE SIZES AND THEIR APPROXIMATE CAPACITIES

CHANGE ROOM(M)

OFFICE

DISPENSING DISPENSING MAT. AREA STORE

FILL MATERIAL

EMPTY CAPSULE STORE CAPSULE FILLING AREA

STORE ROOM ROOM

CHANGE ROOM(F)

UNCLEANED CONTAINER

STORE ROOM STRIP PACKING

AIR LOCK

AIR LOCK

SERVICE

Environment condition Humidity: Not more than 35% RH

BLISTER PACKING

I.P.Q.C

DRYING

Temperature: Not more than 25%

PACKAGING AREA

OFFICE SPARE PARTS

INTERMEDIATE
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STORE

COMPOSITION OF HARD GELATIN CAPSULE SHELL 1) GELATIN 2) COLORANTS -- BLENDS OF BONE AND PORK SKIN GELATIN --F,D&C COLOR --CERTIFIED DYE 3) OPACIFYING AGENT TITANIUM DIOXIDE 4) PLASTICIZERS --PHTHALATE DERIVATIVE --GLYCERIN --CASTOR OIL -- PROPYLENE GLYCOL 5) PRESERVATIVES -- BENZOIC ACID -- PARABENS -- SULPHUR DIOXIDE 6) MOISTURE -- 12 15 %
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(1) PREPARATION OF GELATIN

Here, the capsules are moulded onto stainless steel Pin Bars which are dipped into the gelatin solution.

 Once dipped, pin bars rise to upper deck allowing the cap and body to set on the pins.

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 Temperature and humidity controlled air is blown over the mould pins to remove excess water content from the capsule halves.  Humidity, temperature and gelatin viscosity is precisely monitored throughout the process.
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 Once drying is complete, the Pin Bars enter the Table section which positions the capsule halves for stripping from the Pins in the automatic section.
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 In the Automatic section, capsule halves are individually stripped from the Pins.

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The cap and body lengths are precisely trimmed to a 0.15 mm tolerance.
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 The capsule bodies and caps are joined automatically in the joiner blocks.

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Finished capsules are pushed onto a conveyer belt which carries them out to a container.

Capsule quality is monitored throughout the production process including size, moisture content, single wall thickness, and color.

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Capsules are sorted and visually inspected on Inspection Stations.

Perfect capsules are imprinted with the client logo on high-speed capsule printing machines. Capsules are now ready to be sterilized and packaged.
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Special computer controlled process system monitors and controls total capsule manufacturing to ensure optimum out-put of highest quality capsules.

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CAPSULE FILLING EQUIPMENT

Daily output 200,000 capsules

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 Farmetic 2000/15---40,000cap/hr 2000/30---80,000cap/hr 2000/60---1,60,000cap/hr

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Product conveying system

Metal detection system Dedusting & polishing machine 3.Air displacement unit Capsule sorter
Automatic capsule filling machine
Check weigher

Empty capsule sorter elevator

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1. CAPSULE ELEVATOR EQUIPMENT 2. CAPSULE FILLING EQUIPMENT 2.1 POWDER FILLING 2.2 GRANULE FILLING 2.3 PELLETE FILLING 2.4 TABLET FILLING 2.5 LIQUID FILLING 3. AIR DISPLACEMENT UNITS (ADU) 4. METAL DETECTION SYSTEM 5. DEDUSTING & POLISHING MACHINE 6. SORTER FOR DEFECTIVE CAPSULES
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The FCE-100 is a high output elevator suitable for elevating from a lower level to higher level. This unit is extremely useful in fully automatic lines where the output from the exit chute of a filling/sorting machine, which is at a lower level, is connected to the inlet chute of a polishing machine which is at a higher level.
Out put: 1,00,000 capsules/hour

Can convey all capsule sizes from 00 to5 Inbuilt blower unit 24 GMP conforming design

 For more no. of filling machines see www.made-in-china.com www.fuchang.com More than hundereds of filling machines are there.

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 The AF-90T is a fully automatic capsule filling machine that can fill a large variety of powder formulations into hard gelatin capsules.  A pellet filling / tablet filling / capsule in capsule device is available as an optional attachment.
 Output : Up to 90,000 capsules / hour for powder filling

Up to 80,000 capsules /hour for pellet filling Up to 75,000 capsules /hour for tablet filling  Conforming to cGMP  Savings in manpower costs
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 Output: 33,000 capsules per hour  Self-contained horizontal hydraulic closing system which eliminates the need for compressed air .  Internal vacuum pump  TFR 8 Tablet Filling Ring for inserting tablets into capsules
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 This machine can pack

granular such as salt, sugar, medicine etc.

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The ADU-100 is a dust extraction unit. It is used for collecting loose powder from the polishing chamber of the DP-100. It is also used for cleaning operations on automatic capsule filling machines. The unit removes loose powder, caps, bodies, and capsules lying around the machine. It can also be coupled with tableting machines for dust 31 collection.

 100% online metal detection with automatic capsule filling machine The Metal Detection system works on the Eddy Current Principle using a focused electromagnetic field.  Dual Channel Phase Sensitive systems are used. It detects all metals (Ferrous, non-ferrous / non-magnetic stainless steel). It detects very minute particles of stainless steel and metal flakes Inadvertently present in formulations All contact parts are manufactured with SS:318 as per GMP standards 32

 The DP-100 is an advanced de-dusting and polishing machine.

More flexibility & higher degree of operating efficiency and cleanliness

1,20,000 capsules/hr