B.Pharm Sem VII RPCP
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
1.1 HARD GELATIN CAPSULE
HARD GELATIN CAPSULE SIZES AND THEIR APPROXIMATE CAPACITIES
EMPTY CAPSULE STORE
STORE ROOM ROOM
CAPSULE FILLING AREA
A I R
L O C K
A I R
L O C K
Humidity: Not more than 35% RH
Temperature: Not more than 25%
STORE ROOM STRIP PACKING
AREA SPARE PARTS
COMPOSITION OF HARD GELATIN CAPSULE SHELL 1) GELATIN
-- 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
-- BENZOIC ACID -- PARABENS -- SULPHUR DIOXIDE
-- 12 ± 15 %
(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.
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.
The cap and
body lengths are precisely trimmed to a ±0.15 mm
bodies and caps are joined automatically in the joiner
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.
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.
CAPSULE FILLING EQUIPMENT
Daily output 200,000 capsules
2000/15---40,000cap/hr 2000/30---80,000cap/hr 2000/60---1,60,000cap/hr
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
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.
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.
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
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
This machine can pack granular such as salt, sugar, medicine etc.
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
100% online metal detection with automatic capsule f illing machine
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