SMALL SCALE AND LARGE SCALE CAPSULE FILLING MACHINES

Under the esteemed guidance of

Dr.Bhanja M.pharm., Ph.D

Presentation By

Sandeep Undavalli

Capsules are solid dosage forms in which one or more medicaments are enclosed in a water-soluble, biodegradable shell made up of gelatin.

Depending upon their formulation, the gelatin capsule shells may be hard or soft.

CAPSULES

Components Of Capsules1. Gelatin

2. FD & C and D & C colorant

3. Sugar

4. Water - 12 to 16 % but may vary depending on the storage condition

5. Sulfur dioxide (0.15%) - prevent decomposition during manufacture

6. Opaquants/Opacifying agent - titanium dioxide

HARD GELATIN CAPSULESAlso referred to as “DFC” Dry Filled Capsule.

CAPSULE SIZES

For human use, empty capsules ranging in size from 000 (the largest) to 5 (the smallest) are commercially available.

For veterinary use: No.s 10, 11and 12 having capacities of 30, 15 and 7.5 g, respectively

Filling operation ofhard gelatin

capsules

Filling hard capsule shells

The process of working:• Rectification• Separating the caps from empty capsules• Filling the bodies • Scraping the excess powder • Replacing the caps • Sealing the capsules • Cleaning the outside of the filled capsule

6

RECTIFICATION

• The empty capsules are oriented so that all point the same direction i.e. body end downwards

• In general, capsule pass one at a time through a channel just wide enough to provide grip at cap end

• The capsules will always be aligned body end downwards, regardless of which end entered the channel first with the help of specially designed blades

7

Separation of caps from body

• The rectified capsules are delivered body end first into the upper portion of split bushings or split filling rings

• A vacuum applied from below pulls the body down into the lower portion of the split bushing

• The diameter of the bush is too large to allow them to follow body

• The split bushings are separated to expose the bodies for filling

8

FILLING

DIRECT FILLING METHODS:

1. The Punch MethodPowder is placed on a sheet of a clean paper or porcelain plate.

It is formed into a cake having a depth of approximately one-fourth to one-third the length of the capsule body.

Then empty capsule body is held between the thumb and forefinger and punched vertically into the powder cake repeatedly until filled.

2. Feton capsule fillingwith empty capsule in the loader tray, the tray placed on top of the filler unit

the loader inserts the capsules into the filling unit and is removed, and the top plate is lifted to separate the caps from the bodies

the powder is placed on the unit and the capsule bodies filled

the top plate is returned to the unit and the caps placed on filled capsule bodies

Eg: ProFill 100

ProFill 100

INDIRECT FILLING METHODS:Auger-Filling Principle

• Powder or granules are contained in mass flow hoppers with rotating augers

• Powder is fed continuously out of the hopper outlet due to the rotation of the auger.

• Amount of powder fed into the body depends on the time capsule body spends underneath the hopper outlet and auger speed

- slower rotation increases the fill weight

Auger- Filling Principle

• Vibratory fill principle: In the powder, a perforated resin plate is positioned and connected to a vibrator

• The powder blend tends to be fluidized by the vibration of plate and assists the powder to flow into the bodies through the holes in resin plate

15

Vibration-assisted Filling

• Piston tamp principle: • In this pistons or tamping pins lightly

compress the individual doses of the powders into plugs( also called as slugs) and eject the plugs into empty capsule bodies– DOSATOR PRINCIPLE– DOSING DISC PRINCIPLE

17

– DOSING DISC PRINCIPLE: A solid ‘stop’ brass

plate is sliding down the dosing disc to close off the hole. Five sets of pistons compress the powder into cavities to form plugs

– DOSATOR PRINCIPLE: It consists of cylindrical

dosing tube fitted with movable piston. The position of the piston is preset to a particular height to define a volume. Powder enters the open end of dosator and is slightly compressed against the piston into a plug

18

Filling of Pellets

• Double Slide Method• Vacuum-assisted Method

Double Slide Method

• Pellets flow from pellet magazine to dosing chambers

• Dosing slide is closed to separate dosing chamber and pellet magazine

• Outlet slides open

Double Slide Method

Vacuum-assisted Method

• Dosing tube enters pellet bed• With the help of vacuum, the pellets are

sucked into the dosing tube• Excess pellet are scraped off the end of

the dosing tube• Dosing tube is lowered and pellets

released into capsule body

Vacuum-assisted Method

Filling of Tablets• Dosing slide which can accommodate exactly 1

tablet moves underneath tablet feeder• Slider moves over the capsule body where tablet

simply drops into it• If properly filled, the pin dropped into the capsule

body will have limited movements, the horizontal bar connected to the pin touches the sensor

• If not properly filled, horizontal bar will switch the sensor indicating incorrect filling. Empty capsules can be detected and eliminated from the product.

Filling of Tablet

Dosing slide

Tablet feeder

sensor

CAPSULE FILLING MACHINES

• Eli Lilly and company, Indianapolis, IN• Farmatic SNC, Bologna, Italy• Hofliger and Karg, Waiblingen, Germany• Macofar SAS, Bologna, Italy• mG2 S.p.A., Bologna, Italy• Osaka, Osaka, Japan• Parke-Davis and company, detroit, MI• Perry Industries, Green Bay,WI• Zanasi Nigris,S.p.A., Bologna, Italy

Lilly/Parke-Davis

Storage hopper

Rectifying unit

Two piece filling ring

Powder hopper

Peg ring

Closing plate

Collecting chamber

•Pelletised or granular materials are readily filled.•Auger principle•A relatively high speed, automatic, continuous machine called the ROTOFIL specifically designed to fill pellets is available.•Capacity: 1200 capsules per minute

FARMATIC SNC

Model Capacity 40000 capsules

per hour 80000 capsules

per hour 160000

capsules per hour

Farmatic Model 2000/60Capsule filling machine

Farmatic offers three models of filling equipments

2000/15

2000/30

2000/60

Working of Farmatic machine model

Continous motion with dosator type feeding units Totally enclosed for dust and noise control Adjustable vacuum for separating the capsules after

rectification Product hopper: powder is moved by a screw conveyer to the

operating tower. Dosators: Measure and deliver the powder as a slug to the

capsules. Digital display: indicates the status of the weight and

compression.

Hofliger and Karg

HOFLIGER KARG AUTOMATICCAPSULE FILLING MACHINE

H & K line consists basically of four machine models.

GKF-303GKF-602GKF-1500GKF-2500

Capsules,pelletsAnd tablets

Thixotropic liquids

H & K model GKF-602

Empty capsule storage hopper

Rectifier

Bulk powder storage hopper

Capsule body transport segment

Closing station

Filled capsules ejection station

Working of Hofliger and Karg model

Empty capsule storage hopper: holds the empty capsule shells.Rectifier: rectifies the capsules.Faulty capsules are removed and checked by a vacuum system, which provides a signal upon feed interruption.Bulk powder storage hopper: holds the bulk powder and delivers following AUGER principle.Capsule body transport system: holds the separated bodies and caps individually and transports to various working stations.Completely automatic and require only compressed air and a power for operation.

Macofar

• Macofar line of equipments consists of three models.• Low to medium capacity machines

MT-12 35,000 capsules per hour

MT-13/1 5,000 capsules per hour

MT-13/2 10,000 capsules per hour

MODEL CAPACITY

WORKING OF MACOFAR EQUIPMENT

• Similar method of rectification and filling.• Separation accomplished by vacuum.• Follows dosator principle.

mG2

• Five models of continuous motion filling machines are offered by mG2.

• G36/4 150 capsules per minute• G36/2 300 • G36 600• G37N 1600• G38 1000

MODEL CAPACITY

mG2 model:

• Similar method of operation as macofar model.• G37 modified to G37N to• continuous motion providing 2 ½ times the filling rate of

G36• Improved handling of empty capsules.• Lessened power dusting and noise reduction.• External adjustments of weight control and powder

compression.

• G38 slightly slower than G37N

OSAKA

High capacity, continuous motion machine. The only model available is

R-180 : 70000 to165000 capsules per hour

Follows vibratory filling principle Two rows of capsule bodies External adjustment of fill weights Can be modified to 400000 capsules per hour with some

auxiliary equipment.

OSAKA MODEL R-180 SEMI AUTOMATIC CAPSULE

FILLING MACHINE

PERRY

• Model: CF ACCOFIL• Capacity: 60000 capsules per hour

• Capsules rectified into 24 vertical tubes• Sensor system assisted rectification• Screw feeder• High pressure air assisted bushing clean up.

ZANASI

• Nine different units in four model lines• LZ-64 : 4000 capsules per hour• AZ-20 : 9000 TO 20000 capsules per hour• BZ series• BZ-40 : 30000/hr• BZ-72 : 60000/hr• BZ-110 : 110000/hr• BZ-150 : 150000/hr• Z-5000 series• Z-5000-R1 : 70000/hr• Z-5000-R2 : 110000/hr• Z-5000-R3 : 150000/hr

ZANASI AUTOMATICCAPSULE FILLING MACHINE

CAPSULE SEALING

1. sealing the joint between the 2 capsule parts

2. Sealing them with colored band of gelatin (Kapseals).

3. Through a heat welding process that fuses the capsule cap to the body through the double wall thickness at their juncture - distinctive ring around the capsule where heat welded

Example: Weld’s gelatin seal

4. Liquid wetting agent that lowers the melting point in the contact areas of the capsule’s cap and the body using low temperatures (40-450C)

5. Lightly coating the inner surface of the cap with a warm gelatin solution immediately prior to placement on the filled capsule body.

Weld’s Gelatin seal fuses the two capsules halves to create one piece capsule that is tamper-evident

SEALING OF CAPSULE

Recent Filling Equipments

• Roto-fill: - 2 lakh capsules/day• Acco-fill: - 75,000 capsules/hr• Roto-sort: - 1,50,000 capsules/hr

Soft gelatin capsule

SOFT GELATIN CAPSULES

Also referred to as as Soft Elastic Capsule. Are prepared from shells of gelatin plasticized by the addition of glycerin, sorbitol or polyol.

The shell may contain preservatives to prevent from fungi.

A soft gelatin capsule has a seam at the point of closure of the 2 halves, and the contents can be liquid, paste or powder.

Methods For commercial Manufacture Of Soft Gelatin Capsule

1. Plate-Process.

A warm sheet of prepared gelatin is laid over the lower plate and the liquid is poured on it.

A second sheet of gelatin is carefully put in place and this is followed by the top plate of the mold.

The set is placed under the press where pressure is applied to form the capsule which are washed off with a volatile solvent to remove any trace of oil from exterior.

Rotary Die Method Liquid gelatin flowing from an overhead tank is

formed into two continuous ribbons by the rotary die machine and brought together between twin rotating dies.

At the same time, metered fill material is injected between the ribbons precisely at the moment that the

dies form pockets of the gelatin ribbons. These pockets of fill-containing gelatin are sealed by

pressure and heat and then severed from the ribbon.

The capsule is washed with organic solvent and pre-dried

• Advantages:- capsules can have all kinds of shapes and sizes- different colors for both sides- wide variety of fills

• Disadvantages:- high amount of shell waste material- longer drying time compared to Globex Method

54

Rotary die soft capsule machine The dies for production of soft

capsule

Globex Method

• Filling is pumped through the inner capillary of a concentric double capillary

• Shell forming solution is pumped through the outer capillary of the concentric double capillary

• The soft capsules are then immersed in a cooling bath of about 4oc (usually liquid paraffin).

• Cooling bath ensures immediate sol-gel transformation, hence formation of flexible yet firm robust outer film.

• Soft capsules are collected, washed with organic solvent to remove residues of cooling liquid, and gently dried at a relative humidity of 20% in infrared tunnels.

• Advantage: production of seamless capsules which are tamper-evident and free of contamination or entrapped air.

Globex Method

Cooling bath

REFERENCES

• The Theory and Practice of Industrial Pharmacy by Leon Lachman and Herbert A. Lieberman (Special Indian Edition 2009) Page No: 374-412

• http://www.wohlassociates.com/used-encapsulators-capsule-fillers/parke-davis-type-8-capsule-filling-machine-miscellaneous-tooling.html

• http://www.ebseos.com/file/629.pdf• www.pharmagupshup.com• www.google.com• www.pharmech.com

58