Capsule

B.Pharm Sem VII RPCP

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CONTENT

1. INTR INTROD ODUC UCTI TION ON TO CAPSU CAPSULE  LE  1.1 HARD GELA GELATIN TIN CAPSU CAPSULE  LE  1.1.1 PREPARA PREPARATION TION OF HGC WITH PLANT LAYOUT  LAYOUT  1.1.2 INDUSTRI INDUSTRIAL AL SCALE EQUIPMEN EQUIPMENTS  TS  1.1.3 1.1. 3 ST STANDARD ANDARD OPER OPERA ATING PROCED PROCEDURE  URE  1.1.4 QUALITY CONTROL TESTS  1.2 SOFT GELATIN CAPSULE  2. STUDY QUESTIONS  3. REFERENCES 

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1.1 HARD GELATIN CAPSULE

CAP BODY

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HARD GELATIN CAPSULE SIZES AND THEIR APPROXIMATE CAPACITIES

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CHANGE ROOM(M)  

OFFICE

DISPENSING MAT.

DISPENSING AREA

FILL MATERIAL

EMPTY CAPSULE STORE

STORE ROOM ROOM

STORE

CAPSULE FILLING AREA

CHANGE ROOM(F)  

UNCLEANE

A I  R

L   O  C K

A I  R

CONTAINER

L   O  C K

SERVIC

Environment condition

Humidity: Not more than 35% RH

BLISTER

I.P.Q.C

DRYING

Temperature: Not more than 25%

PACKING PACKAGING

STORE ROOM STRIP PACKING

OFFICE

AREA SPARE PARTS

INTERMEDIATE

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STORE

COMPOSITION OF HARD GELATIN CAPSULE SHELL 1) GELATIN

-- BLENDS OF BONE AND PORK SKIN GELATIN

2) COLORANTS

--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

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Here, the capsules are moulded onto stainless steel

Pin Bars which

are dipped into the gelatin solution.

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 Once dipped, pin

bars rise to upper deck allowing the cap and body to set on the pins.

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 Temperat ure and humidity controlled air is

blown over the mould pins to remove excess water content f rom the capsule halves.



Humidity, temperature and gelatin viscosity is precisely monitored throughout the process. 11

 Once drying is complete, the

Pin Bars enter the Table section which positions the capsule halves f or stripping f rom the Pins in the automatic section. 12

Automatic section, capsule halves are individually stripped f rom the Pins.

 In the

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The cap and

body lengths are precisely trimmed to a ±0.15 mm

tolerance. 14

 The capsule

bodies and caps are joined automatically in the joiner

blocks.

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

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.

Perf ect capsules are imprinted with the client logo on high-speed capsule printing machines. Capsules are now ready to be sterilized and packaged. 17

Special computer controlled process system monitors and controls total capsule manuf acturing 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 f illing machine Check weigher

Empty capsule sorter elevator 22

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 f or elevating f rom a lower level to higher level.

unit is extremely useful in fully automatic lines where the output f rom the exit chute of a f illing/sorting machine, which is at a lower level, is connected to the inlet chute of a polishing machine which is at a higher level.

This

Out put: 1,00,000 capsules/hour

Can convey all capsule sizes f rom

Inbuilt blower unit GMP conf orming design

00 to5 24

 For more no. of f illing machines see

www.made-in-china.com www.fuchang.com More than hundereds of f illing machines are there.

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 The AF-90T is a





fully automatic capsule f illing machine that can f ill a large variety of powder f ormulations into hard gelatin capsules. A pellet f illing / tablet f illing / capsule in capsule device is available as an optional attachment.

Output : Up to 90,000 capsules / hour f or powder f illing Up to 80,000 capsules /hour f or pellet f illing Up to 75,000 capsules /hour f or tablet f illing

 Conf orming to cGMP 

Savings in manpower costs 26

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 Output: 33,000 capsules per hou  Self -contained horizontal

hydraulic closing system which eliminates the need f or compressed air .  Internal vacuum pump  TFR

8 Tablet Filling Ring f or inserting tablets into capsules 28

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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 f or collecting loose powder f rom the polishing chamber of the DP-100. It is also used f or cleaning operations on automatic capsule f illing machines. The unit removes loose powder, caps, bodies, and capsules lying around the machine. It can also be coupled with tableting machines f or dust 31 collection

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100% online metal detection with automatic capsule f illing machine

The Metal

Detection system works on the Eddy Current Principle using a f ocused electromagnetic f ield.  Dual Channel Phase Sensitive systems are used. It detects all metals (Ferrous, non-f errous / non-magnetic stainless steel). It detects very minute particles of 

stainless steel and metal flakes Inadvertently present in f ormulations All contact parts are manuf actured

with SS:318 as per GMP standards 32