operating manual 100 hole - 120 hole - fagron · capsicards® system – operating manual v. 1.0 |...

Operating Manual100 hole - 120 hole

V. 1.0

CAPM

A01-

NF

CapsiCards® System – Operating Manual V. 1.0 | 2

OverviewFeatures: CapsiCards® System

CapsiCards® System AssortmentCapsiCards® Machine

Optional Accessories

Replacement Parts

How to Order

Before you begin

Initial Assembly / Capsule Size Change

Operating InstructionsStages in Capsule Locking

Special Fill MaterialsWhen to Use a Vibrator

Filling Liquids

Filling Sticky Powders

Materials of Construction

CleaningCleaning Guidelines

Cleaning Schedule

Cleaning Tips

Drying

Environmental Conditions and Capsule PerformanceStorage

Work Area

Packaging of Filled Capsules

Frequently Asked Questions

User Tips

Weights and Dimensions

Declaration of Conformity

Terminology

Contact Information

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4

5

6

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9

10

11

13

14

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Table of Contents


Overview

Features: CapsiCards® System

Easy to use and flexibleWith its innovative design, the CapsiCards® Machine is easy to handle and ensures quick, safe and hygienic capsule production.

Key features at a glance:• Filler Base Kit available in 100 or 120 hole.

Works with capsule sizes 00, 0, 1, 2, 3 and 4. • Order Filler Change Parts for each capsule size

when you need them. • Inox sheets for reduced static, long-life

and dishwasher cleaning.• Adapter and Pusher speed capsule ejection

from CapsiCards®.• Fast lock cam design.

• Three plates for 100% capsule separation.• Includes Powder Tray and Clamps to minimise

powder loss.• Includes Capsule Locker for fast and easy capsule

locking.• Size change requires no tools or adjustments.• Easy cleaning as powder contact parts are Inox

and dishwasher safe polycarbonate.• Pharmacopoeia compliant for fill weight (USP/EP

method).• Filler Divider available for less than full batch

of capsules.• Powder Vibrator available for faster filling of hard-

to-fill powders.

The CapsiCards® Machine has been developed especially for CapsiCards®.

CapsiCards® Machine CapsiCards®


CapsiCards® System Assortment

CapsiCards® Machine

1. Filler Base

4. Adapter and Pusher

7. Caps Tray with Locking Plate

Lifting plate Post Cam lever

2. Powder Tray, Powder Spreader and Powder Tray Clamps

5. Capsule Locker 6. Quick Start Manual and USB

8. Body Sheets (3)

3. 5-pin Tamper

Filler Base Kit

9. Spacer Plate

Filler Change Parts for one capsule size (available: 00, 0, 1, 2, 3, 4)



Optional Accessories

Partial Batch Filler Divider Fill fewer than the maximum capsules per batch. Use filler divider to block empty holes during powder filling. Works with 100 and 120 hole fillers.

Material: Inox (SS316), PET and silicone rubber.

How to use: 1. Cut CapsiCards® to desired number of capsules.2. Follow steps in Capsule Filling Instructions to separate

capsules, see page 11.3. Place Powder Tray onto Filler.4. Place Filler Divider onto Filler to cover empty holes. 5. Follow steps 9-14 in Capsule Filling Instructions to fill

powder and lock capsules, see page 12.

Vibrator Recommended for faster filling of powders that bridge or are granular, fluid or flour-like. Reduces weight variation of fine powders. Works with 100 and 120 hole fillers.

100-120 Volts/50-60Hz or 220-240 Volts/50Hz.

How to use:Place Filler on Vibrator. Use vibration to pack powder in step 10, see chapter Operating Instructions, page 12.


Replacement parts

Some replacement parts are shown below. For other parts see Contact Information on the last page of this manual or call or email us.

To order, specify the following:

1. Assembly or part name.2. Number of holes.3. Serial number of the Filler Base.4. Serial number and capsule size, if marked on the part or assembly.


Caps Tray

Locking plate

Spacer Plate Body Sheet (b)

Cam Handle Assembly Rubber Foot 5-pin Tamper

Powder Spreader Powder Tray Powder Tray Clamps

Capsule LockerPusherAdapter


How to orderPlease contact your local supplier (see chapter Contact Information, page 29 for orders). To order replacement parts, specify the part name, serial number on the Filler Base, capsule number and capsule size.


Capsule no. Capsule size Colour

CapsiCards® Machine – Filler Base Kit Combine a Filler Base Kit with Filler Change Parts for a full machine.

Filler Base KitFiller Base, Powder Tray, Powder Tray Clamps, Powder Spreader, 5-Pin Tamper, Capsule Locker, Pusher, Adapter.

100 holeSuitable for: 00, 0, 1, 2, 3, 4

n/a

Filler Base KitFiller Base, Powder Tray, Powder Tray Clamps, Powder Spreader, 5-Pin Tamper, Capsule Locker, Pusher, Adapter.

120 holeSuitable for: 00, 0, 1, 2, 3, 4

n/a

CapsiCards® Machine – Filler Change Parts

Filler Change PartsBody Sheets (3), Caps Tray, Spacer Plate.

100 hole 00 n/a


100 hole 0 n/a


100 hole 1 n/a

Filler Change PartsBody Sheets (3, Caps Tray, Spacer Plate.

100 hole 2 n/a


100 hole 3 n/a


100 hole 4 n/a


120 hole 00 n/a


120 hole 0 n/a


120 hole 1 n/a


120 hole 2 n/a


120 hole 3 n/a


120 hole 4 n/a

CapsiCards®

CapsiCards® (850 capsules) 50 capsules/card 00Clear, white,

ivory



Capsule no. Capsule size Colour


ivory


ivory


ivory


ivory


ivory


ivory


ivory


ivory


ivory


ivory


ivory

Optional accessories

Partial Batch Filler Divider Suitable for all no. Suitable for: 00, 0, 1, 2, 3, 4

n/a

Vibrator Suitable for all no.Suitable for: 00, 0, 1, 2, 3, 4

n/a

Replacement parts

Caps Tray 100 hole, 120 holeAvailable in:00, 0, 1, 2, 3, 4

n/a

Spacer Plate 100 hole, 120 holeAvailable in:00, 0, 1, 2, 3, 4

n/a

Locking Plate 100 hole, 120 holeAvailable in:00, 0, 1, 2, 3, 4

n/a

Body Sheets (b) 100 hole, 120 holeAvailable in:00, 0, 1, 2, 3, 4

n/a

Cam Handle n/a n/a n/a

Rubber Foot for Filler Base n/a n/a n/a


First time use: trial run throughOnce your CapsiCards® System is unpacked, run through the capsule filling procedures without using powder to ensure that everything is in working condition. Use CapsiCards® from a box opened no longer than three months to avoid poor results due to capsule quality. Once powder is used in this CapsiCards® Machine, it cannot be returned for credit or for restocking. Any manufacturing defects will continue to be covered under our one-year warranty.

Capsule number and size checkThe CapsiCards® Machine is designed to handle capsule sizes from 00 to 4. Both Base Kit and Filler Change Parts must be of the same number of holes (100 or 120) and the same, correct size for your capsules. If your CapsiCards® Machine is new or if you have changed capsule sizes, please check the size markings on all the parts indicated below.

Capsule size marking and serial number locationsEach size-specific part is marked with its capsule size. The Filler Base is marked with a serial number. Refer to these diagrams to locate the size markings.

Before you begin

Serial number underneathCapsule size

Capsule size Capsule size


To set up the CapsiCards® Machine to fill one capsule size, the following parts of your filler must be placed in the sequence given. To change capsule sizes, remove these parts and replace with new capsule size parts. Please refer to the table below for an overview of the size-specific parts.

Initial Assembly / Capsule Size Change

Available in capsule no. Available in capsule size

100 hole 120 hole 00 0 1 2 3 4

Filler Base Kit

Filler Base

Suitable for: 00, 0, 1, 2, 3, 4

Powder Tray

Powder Tray Clamps

Powder Spreader

5-Pin Tamper

Capsule Locker

Pusher

Adapter

Filler Change Parts

Body Sheets (3)

Caps Tray with Locking Plate

Spacer Plate

Capsicards®

50 or 60 capsules/card


Step 1: Spacer Plate

Step 4: Sheet c

Step 2: Sheet a

Step 5: Caps Tray with Locking Plate CapsiCards® Machine

Step 3: Sheet b

a b

c


1

3

6

Open Locking Plate (a). Place adapter (b) on Caps Tray. Check that Cam Lever is set to three o’clock.

Remove empty CapsiCards® cardboard and Adapter.

To separate capsules, press palms down on handles while lifting Caps Tray (top metal piece) up with fingers. Remove Caps Tray with caps from Filler. If whole capsules are pulled up, the cam lever should be pulled tighter in step 5. If just a few capsules fail to separate, check that they were not already locked.

Place CapsiCards® (c) on Adapter with capsule bodies down. Use Pusher (d) to push capsules down into Caps Tray.

Close the Filler Locking Plate and secure it by turning the two tabs.

Release Cam Lever to allow capsule bodies to drop into Filler. If some capsules sit higher than others, gently pat them into place.

Gently pull Cam Lever toward the post to secure bodies in Filler. Capsules should be held firmly but should not be squeezed to an oval shape.

Place Powder Tray onto Filler. Optionally, attach Powder Tray Clamps. For filling sticky powders, see chapter Special Fill Materials, page 14, following these instructions.

a

bc

d

2

4

7

5

8

Operating Instructions


9

10b 10c

Pour powder onto Filler. Use Powder Spreader to move powder from center towards all four edges of Powder Tray Frame. Use tapping, vibration or tamping to settle powder. Repeat spreading and tamping as necessary.

VibrationUse optional Vibrator as an alternative to or in addition to tamping or tapping (see chapter Optional Accessories, page 5). Powder Tray Clamps are recommended. Repeat spreading and tamping as necessary.

TampingTo fill additional powder, use Tamper. Repeat spreading and tamping as necessary.

TappingPull Cam Lever to gently hold bodies in place. Hold Filler Base Frame and gently tap against table a few times to settle powder. Powder Tray Clamps are recommended when tapping. Do not hold Filler by Lifting Plate (moveable plate) as capsule bodies will be pushed up out of the Filler. Repeat spreading and tamping as necessary.

Remove Powder Tray. Place Caps Tray onto Filler.

a

b

10a

11

12 13 14To lock capsules, press down on Locking Plate with thumbs while pulling up Lifting Plate. Repeat several times, with thumbs positioned in different areas of Locking Plate.

Remove Caps Tray and turn over onto table. Use Capsule Locker to lock capsules. Apply pressure until you feel capsules snap and lock.

Capsules are fully locked. Check that capsules are fully locked using Locked Capsule Indicator. A locked capsule should pass through the Locked Capsule Indicator on Caps Tray.

c



Stages in capsule lockingThere are three stages of capsules in the locking process:

• Filled: the capsule bodies have not entered the caps.• Reassembled: the capsule bodies have pushed to the lock ring of the cap.• Locked: the lock ring on the body enters the matching lock ring on the cap.

Approximate locked capsule sizes

Filled

Body

Lock ring Cap

Reassembled Locked


25 mm1°

1/2°

0°

20 mm

15 mm

10 mm5 mm0 mm


When to use a VibratorThe optional Vibrator is especially helpful when filling certain materials:• Fluffy and fine powders, such as charcoal. • Powders that bridge, such as tyrosine and calcium carbonate. • Powders that can stick to tamper pins, such as frankincense or

dolomite. • Granules where tamping can cause granules to break or compress

such as omeprazole.

Please refer to chapter Optional Accessories, page 5 for more information on the Vibrator.

Filling liquidsAfter separating capsules (step 6 of chapter Operating Instructions, page 11) leave capsules in raised position. Fill capsules with a pipette or syringe. After filling, slowly push Cam Lever back to release capsule bodies so they are level with top surface of Filler.

Filling sticky powdersSeparate the capsules (step 6 of chapter Operating Instructions, page 11) and release the Cam Lever so the bodies are flush with top surface of the Filler. Before tamping the powder (step 10 in chapter Operating Instructions, page 11), pull the Cam Lever towards you until a gentle pressure holds the capsules in place. When filling sticky powder, this will prevent the capsule bodies from being pulled up with Tamper after powder compression.

Special Fill Materials


Materials of Construction

Metal parts are Inox (SS316) 1 Polycarbonate 2 Acrylic 3 Nylon 4 LDPE 5 Silicone rubber 6 Inox (SS304)

• Parts not otherwise labeled are made of Inox (stainless steel 316). • Nylon parts are known to discolour when used with erythrosine. • The Powder Spreader is known to discolour when used with beta-carotene or sunset yellow.• No animal derived materials are used.

5

6

1 2

1

35

3

11

4

1

1


Cleaning

Proper cleaning and lubrication of your filler will significantly increase its useful life. Powder and broken capsule pieces can be very abrasive and can wear the parts down if not removed. Follow these cleaning and lubrication guidelines to maximise the life of your CapsiCards® Machine.

Cleaning guidelines

Cleaning scheduleThree cleaning schedules are recommended: run time cleaning, daily cleaning, and weekly/lot change cleaning.

Automatic dishwasher All parts are fully dishwasher safe. Plastic parts should be placed in top rack of dishwasher < 70 °C (160 °F).

Cleaning agents We recommend cleaning using household hand dishwashing liquid. All items may be cleaned with NaOH (caustic soda) 1 - 2% solution, 1% sodium thiosulphate solution, or liquid detergents with up to 4% sodium hypochlorite.

Isopropyl alcohol Wipe parts with a cloth dipped in isopropyl alcohol, then immediately wipe dry with a clean cloth. Do not use on acrylic Capsule Locker. Acrylic parts can be cleaned with a solution of 15% ethyl alcohol (ethanol) and 85% water.

Hot air drying Up to 60 °C (140 °F). Remove plastic parts from oven after 15 - 20 minutes. If using portable hair dryer, keep a distance of 30 cm (12 inches) from all items.

Autoclave Do not autoclave Capsule Locker or Powder Spreader. Other parts may be autoclaved at 121 °C (250 °F), 15 psi pressure for 15 minutes.

Run time Daily Weekly / lot change

Spacer Plate

Body Sheets (3) Optional

Caps Tray with Locking Plate

Powder Tray

Powder Tray Clamps

Powder Spreader

5-pin Tamper

Capsule Locker

Separation Cam Head

Cam Shaft

Cam Handle

Pusher

Adapter

Filler Base


Cleaning

1. Run time cleaningDuring production, if powder accumulates within the CapsiCards® Machine, or if you see or suspect broken capsules are caught in the CapsiCards® Machine, you will need to perform a quick cleaning of the Body Sheets and Spacer Plate. Use a brush, cloth, vacuum, or compressed air to remove accumulated powder.

2. Daily cleaningDaily cleaning an preferably washing of the CapsiCards® Machine to remove all powder is recommended. After cleaning, lubricate cam bush.

1. Remove the three Body Sheets.2. Remove Spacer Plate. 3. Remove excess powder from Filler Base, Spacer Plate, Body Sheets And 5-pin Tamper using a brush, cloth, vacuum,

or compressed air. 4. Clean system using one of the methods below. Recommended parts for daily cleaning are listed in the cleaning schedule

(see paragraph Cleaning Schedule). After cleaning.5. Lubricate cam head and cam bush (underside of Sheet b) with Dow Corning 111 grease or any other food grade lubricant,

such as Vaseline petroleum jelly. 6. Position Spacer Plate onto Filler Base (see chapter Initial Assembly / Capsule Size Change, page 10). 7. Position Sheet a, Sheet b, then Sheet c onto Filler. 8. Replace Caps Tray. Your CapsiCards® Machine is ready for use.

Daily cleaning - cleaning methods1. Automatic dishwasher

• All parts are fully dishwasher safe using automatic dishwasher detergents. Plastic parts should be placed in top rack (<70 °C / 160 °F).

2. Manually• Clean all parts using nylon brush. Clean top and bottom of Body Sheets, Caps Tray and Spacer Plate. Make sure

holes in Caps Tray and Body Sheets are free of powder.• To clean flat parts like Powder Tray and Locking Plate, wipe with clean cloth or sponge. Also wipe clean the cam and

top of Lifting Plate. • Optionally, hand wash parts using hand dishwashing soap and water.

3. Vacuum or compressed air• If you have vacuum or compressed air available, you can use either to clean each part of the CapsiCards® Machine.

If using compressed air, pass air through all holes and corners. Be sure to wear eye protection when using compressed air.

• To remove sticky powder between Tamper Pins and inside holes of Caps Tray and Body Sheets, use nylon brushes along with vacuum or compressed air. To remove traces of sticky powder from flat parts you may need to clean with cloth or sponge.

3. Weekly/lot change cleaningWeekly, or whenever there is a lot or formula change, an extensive cleaning should be done. After washing parts, they must be lubricated to ensure proper operation of the CapsiCards® Machine.

1. Remove the three Body Sheets.2. Turn Filler over and pull off the four Rubber Feet. 3. Separate Lifting Plate from Base Frame. 4. Clean system using one of the methods below. Recommended parts for daily cleaning are listed in the cleaning schedule

(see paragraph Cleaning Schedule). After cleaning.5. Lay base frame on table with posts pointing up. Place Lifting Plate onto Filler with Spacer Plate locating pins face down.

Press on Rubber Feet. 6. Turn Filler Base over. Lubricate cam head and cam bush (underside of Sheet b) with Dow Corning 111 grease or any other

food grade lubricant, such as Vaseline petroleum jelly. 7. Position Spacer Plate onto Filler Base (see chapter Initial Assembly / Capsule Size Change, page 10).


Cleaning

8. Position Sheet a, Sheet b, then Sheet c onto Filler. 9. Replace Caps Tray. Your CapsiCards® Machine is ready for use.

Weekly / lot change cleaning - cleaning methods1. Automatic dishwasher• All parts are fully dishwasher safe using automatic dishwasher detergents. Plastic parts should be placed in top rack

< 70 °C (160 °F).

2. Manuallya. Clean parts with help of nylon brushes. You can use different sized brushed for the various hole sizes or gaps

between the pins or parts. Put nylon brush between pins and in holes and gaps; rotate for maximum powder removal.

b. Mix a cleaning solution or soap (hand dishwashing soap recommended) and water in a tub or tray of suitable size to dip all parts. The powder being cleaned must be soluble in the cleaning solution, and the solution should not react with metals and plastic parts used in the CapsiCards® Machine.

c. Dip all parts in the solution and shake to allow solution to pass through them. d. Use nylon brush to remove powder from corners and nooks while dipping in solution. e. Use cloth/sponge to remove powder from flat parts. f. Remove all parts from solution and rinse with fresh water or water jet so that all residual powder and cleaning

solution flows down.g. Wipe with clean cloth and allow to dry. You can use alcohol to speed drying on all parts except those made of

acrylic (see chapter Materials of Construction, page 15).

3. Autoclave sterilisation• After cleaning your CapsiCards® Machine, you can sterilise it using an autoclave at 121 °C (250 °F), 15 psi pressure for 15

minutes. Do not autoclave the Capsule Locker, Powder Spreader and Powder Tray.


Cleaning

Cleaning TipsAvoid damage to surface of partsDo not use acidic or caustic cleaning solutions. Do not clean with abrasive cloth, gritty materials, or steel wool. Use only plastic brushes or nylon pads. Do not apply excess force when cleaning plastic parts.

Avoid caked on powderRemove all loose powder before cleaning with water. Wet powder can harden and stick to parts.

Cleaning CelluloseCleaning your CapsiCards® Machine after filling with a cellulose powder can be difficult as this type of powder can form a gel in cold water. The tips below can help speed the cleaning process.

1. Dismantle the CapsiCards® Machine. 2. Use a brush or cloth to remove as much dry powder as possible.3. Soak the parts in 60 to 70 °C (140 to 160 °F) for a minimum of 10 minutes. We recommend 40 minutes for easier cleaning

in step 5. While soaking, periodically shake the container or water and shake each part to loosen the gel. Use heat protective gloves for safety.

4. Shake each part while removing it from the water.5. Clean with brush/sponge/wet cotton cloth under continuous flow of hot water at around 40 to 50 °C (100 to 120 °F)

to remove all remaining powder (see Cleaning techniques below).

Cleaning techniques1. Use two types of nylon brushes:

• Use regular nylon brush for flat surfaces and between pins.• Use nylon bottle brush of suitable size for the holes and gaps between parts where the regular brush cannot reach.

2. Use regular nylon brush to clean part surfaces so that bristles go into the holes and between the pins while cleaning. 3. If gel is hard to remove from flat surfaces use a plastic scraper to remove it. 4. For cleaning around circular parts like rubber foot or cam, a wet cloth is preferable to a sponge as the cloth allows you

to press more firmly and with greater precision.

Caution: use heat protective gloves and eye protecting goggles while shaking parts in the hot water and while removing the parts out of hot water.

Cleaning Magnesium Oxide PowderCleaning your CapsiCards® Machine after filling with magnesium oxide (MgO) powder can be difficult as MgO powder sticks to CapsiCards® Machine parts and remains insoluble in water. Filling tips below will help reduce or prevent sticking. Cleaning tips will help remove any powder that does stick.

Filling tips1. Use heavy MgO powder instead of light MgO powder if possible. Heavy MgO powder is free flowing. Heavy MgO

powder helps achieve target weight more easily and substantially reduces powder sticking to CapsiCards® Machine parts.

2. Do not expose MgO powder to high relative humidity above 60% during storage or while filling capsules. 3. Add 1% talc and 0.5% magnesium stearate to the powder during blending. This may slightly reduce the stickiness of

the MgO powder. 4. Use a Vibrator (see chapter Special fill materials, page 14) while filling to avoid tamping entirely or to reduce the

number of tamps. This eliminates or reduces the powder sticking to the Tamper Pins, and also reduces the spreading required to achieve target weight.

5. Clean the CapsiCards® Machine immediately after filling. Do not let powder harden on parts.

Cleaning tips1. Once filling is complete, dismantle the CapsiCards® Machine.2. Use regular flat brush or cloth to remove as much dry powder as possible from parts.


3. Wash normally with water.4. If powder does not wash off with water, wash using an acetic acid cleaning solution.

a. Make 3% acetic acid solution of one part vinegar to two parts water. b. Soak parts in this solution for 10 to 15 minutes at room temperature. c. Remove parts and clean with nylon brushes. See the techniques given below. d. Rinse parts with water to remove all trace of vinegar solution.

Cleaning techniques1. Use two types of nylon brushes:

• Use regular nylon brush for flat surfaces and between pins.• Use nylon bottle brush of suitable size for the holes and gaps between parts where the regular brush cannot reach.

2. Use regular nylon brush to clean part surfaces so that bristles go into the holes and between the pins while cleaning. 3. After cleaning regular brush, use the bottle brush to clean the holes and between pins where traces of powder remain. 4. For cleaning around circular parts like rubber foot or cam, a wet cloth is preferable to a sponge as the cloth allows you

to press more firmly and with greater precision.

DryingAlways dry parts fully before reassembling the CapsiCards® Machine.

Methods When the CapsiCards® Machine is washed by hand for a formula or lot change, you can reduce drying time to 15 to 20 minutes by following one of these methods.

Use a kitchen drying rack to keep the parts upright, on a slant, and separated. Optimal slant is 30 to 60 ° and the distance between rack partitions should be 7.5 to 10 cm (3 to 4 inches). If you cannot find a rack with correct partition spacing, purchase a standard rack and remove partitions as necessary.

• After cleaning the CapsiCards® Machine, do the final rinse in warm water at 40 to 50 °C (104 to 122 °F) so evaporation is faster.• Shake the parts to remove excess water so there is less water to evaporate. • Place the parts on a slant for drying so the water drains off.

The CapsiCards® Machine can be dried in the open air, next to a fan or in a hot air oven for faster drying.

1. Open area or near fan• Place the rack loaded with parts in an open area. Optionally, place next to a fan for increased air circulation. • After 20 minutes remove parts from rack. • Wipe any remaining water droplets with dry cloth or paper towel.

If you need the parts sooner, start wiping after 5 minutes. Allow to dry for another 5 minutes after wiping.

2. Hot air oven• Preheat oven to 60 to 70 °C (140 to 160 °F) to speed up drying time. • Place the rack (metal rack only) loaded with parts in the oven. • Remove the parts after 12 to 15 minutes and wipe any water droplets with dry cloth or paper towel.

Allow to dry for another 1 to 2 minutes after wiping.

Further drying tips• The Caps Tray takes the longest to dry. Wash that part first to begin the drying process sooner. Remove those parts last

for wiping dry. • While placing the parts for drying, take care that parts are as open as possible for optimal water drainage and air

circulation. • You can use a hair dryer to remove water from deep holes. Hold the dryer at least 30 cm (12 inches) from all parts.• You can use solvents like acetone or isopropyl alcohol for drying metal parts. Do not use solvents on plastic parts.

Cleaning


Environmental Conditions and Capsule PerformanceBoth temperature and humidity affect capsule performance (use of CapsiCards®, separation, filling and locking). The major cause of problems with capsules is improper conditions during storage and filling or inadequate final packaging.

When capsules are empty (unfilled) they are most susceptible to damage as the capsule walls are unsupported and there is a tremendous volume of air contained inside the capsule that can extract or release moisture from the capsule walls. Once the capsule is filled the walls are supported and the air inside the capsule is essentially eliminated. Thus, the sensitivity of capsules to environmental conditions is reduced.

Storage• The room temperature where capsules are stored should be from 15 to 25 °C (60 to 72 °F), and the relative humidity (RH)

from 35 to 65%. • Do not store CapsiCards® where they may be exposed to direct heat e.g. sunlight (windows, skylights), radiators, air vents

or near ceilings (store CapsiCards® nearer to the ground). • Store CapsiCards® away from hot water, air radiators, hot water pipes and steam pipes. • Do not allow CapsiCards® to freeze. If CapsiCards® are frozen you can usually fill them on hand-filling machines if you

allow them to return to normal temperature naturally. Do not apply any form of direct heat.

CapsiCards® Storage Conditions

Min. Ideal Max.

Relative humidity 35% 50% 65%

Temperature 15 °C (60 °F) 19 °C (66 °F) 25 °C (72 °F)

Damage to capsules Probable cause Capsule moisture

Softening and loss of shape. Storage at high RH. Increased.

Difficult to separate; lumps of capsules; condensation on surface of box; some capsules slightly reduced in size (possibly fallen out of the card).

High temperature or temperature cycling during storage.

Decreased.

Capsules shatter when pressure applied; all capsules slightly reduced in size (possibly fallen out of the card).

Storage at low relative humidity. Decreased.


Work area• The capsule filling and packaging (“work area”) should have a RH of 40 to 60% as the empty capsules are exposed directly

to the air during filling and packaging. The temperature should be the same as in the storage area of 15 to 25 °C (60 to 72 °F).• Keep empty and filled capsules covered when not being filled to minimise moisture loss. • Close boxes containing the CapsiCards® during production breaks or at the end of the day. • Store filled capsules in plastic drums with lids or plastic bags until they are packed in their final container. • High temperature or high RH in the work are can cause the CapsiCards® shells to become soft or sticky impacting their

performance at all stages of the filling process. Use an air conditioner or dehumidifier (residential or commercial) to keep the temperature and humidity within the recommended conditions. You may need to use a dehumidifier in addition to an air conditioner depending on the amount of moisture removal required to reduce the RH.

• Low RH and static. At below 40% RH the air is less conductive and static charges can build up on capsules and plastic items. This causes capsules to stick to plastic items such as the plastic containers and scoops. At below 30% RH static build up is immediately noticeable.• Air humidification is recommended using a humidifier (e.g. a residential room humidifier). • If you cannot humidify the air as you are filling a hygroscopic powder, it is recommended to use talc powder and an air

ioniser to reduce any static electricity present on the capsules. • Do not apply alcohol or acetone based anti-static sprays to plastic items (see chapter Cleaning, page 16).

• Low RH and capsule breakage (brittleness). At below 35% RH the air absorbs moisture from the empty capsule shells and their moisture content can drop by 1 - 2% within a few hours. This leads to dry, brittle capsules that can crack or even shrink in size, impacting their performance at all stages of the filling process. Use a humidifier (e.g. a residential room humidifier) to add humidity to the air.

• If conditions are not optimal, do not expose CapsiCards® to air for more than one to two hours.

Packaging of filled capsules• Always protect capsules from moisture loss or gain by using at least one layer of plastic packaging e.g. bag, bottle, blister

pack, etc.• Do not use desiccants or other moisture absorbers as these absorb moisture from the capsule shell leading to brittleness. • Eliminate unnecessary headspace in the packaging. However, avoid the use of excess cotton and do not use cotton

treated with furfural (interacts with the gelatin shell). • If you pack in bottle and have reports of capsule breakage, add a sheet of corrugated cardboard between the bottle and

the bottom of the outer carton to act as cushion.

Filling problem Environmental cause Solution

Capsules soft or sticky; denting during locking.

High temperature or high relative humidity, or both.

Air condition and dehumidify.

Capsules cling to each other or plastic surfaces due to static electricity.

Relative humidity below 40%. Humidify.

Capsules crack or shatter when pressure applied.

Relative humidity below 40%. Humidify.

Environmental Conditions and Capsule Performance


Frequently Asked Questions

1. What is the output? Output is 2000 - 3200 capsules per hour for the 100 hole CapsiCards® Machine and 2400 - 3600 per hour for the 120 hole CapsiCards® Machine. Our engineers have designed over 15 features that make the CapsiCards® System the most efficient and easiest hand-held filling system on the market. The lower output is for fine powders. The higher output is for coarse free-flowing powders. Your results will vary based on the powder flow properties, operator speed and technique and use of excipients.

2. What size capsules can I fill? The CapsiCards® System is available in capsule sizes 00-4. Change parts can be ordered so you can fill additional sizes on the same machine (Filler Base Kit).

3. How big is the system and how can I store it? The entire system can comfortably fit in a regular office desk drawer. See chapter Weights and Dimensions, page 26, for detailed measurements.

4. Can I fill liquids or sticky powders? The CapsiCards® Machine can be used to fill capsules with non-aqueous liquids or sticky powders. See chapter Special Fill Materials, page 14, for tips.

5. Can the CapsiCards® Machine be cleaned in an automatic dishwasher? Yes, the entire system can be placed in an automatic dishwasher and is safe for use with automatic dishwasher detergents.

6. What is the CapsiCards® Machine made of? See chapter Materials of Construction, page 15, for the materials of construction.

7. What are the shipping weight and size? See chapter Weight and Dimensions, page 26, for weights and dimensions.

8. What are the maintenance requirements? Daily cleaning, preferably washing, of the machine to remove any powder is recommended. At a minimum the cam and the cam bush on the underside of Sheet “b” should be wiped clean of powder and lubricated with a food grade lubricant (e.g. Vaseline petroleum jelly).

9. What fill materials are known to discolour the CapsiCards® Machine? Most fill materials will not discolour the CapsiCards® Machine. See chapter Materials of Construction, page 15, for a list of materials known to discolour one or more parts of the CapsiCards® Machine.

10. Is a CE certificate available ? A declaration of conformity is included in chapter Declaration of Conformity, page 27. A CE certificate is included with the optional Vibrator.

If you have additional questions that are not answered here, or you would like additional information, please visit capsicards.com or contact your local supplier. Contact information is provided in chapter Contact Information, page 29.


User Tips

Issue Possible cause Suggested remedies

Capsule separation

Capsules difficult to separate. Cam Lever over-tightened.Loosen up Cam lever slightly until capsules separate more easily.

Capsules fail to separate. Cam Lever not tightened enough.Pull Cam Lever further, but not so much that capsules are squeezed to oval shape.

Cam Bush in Body Sheet b or Cam is worn.

Replace Cam or Body Sheet b.

Powder deposits between sliding Body Sheets.

Clean Body Sheets with brush or compressed air. Refer to chapter Cleaning, page 16.

Capsule filling

Capsule body open end not level with top of Body Sheet set after separation.

Capsule body diameter and lengths vary slightly.

Tap machine on table a few times or use your hand to pat the capsules into place. Capsules should settle 0.5 to 1 mm below filler surface. If capsules still sit high, the rubber feet may be improperly aligned. Check that four feet are pushed in right up to but not past the edge stop.

Powder accumulated on spacer plate.

Clean powder. Refer to chapter Cleaning, page 16.

Wrong size spacer plate. Change Spacer Plate.

Weight variation in excess of US/European Pharmacopoeia standards.

Improper quantity of powder used. Correct powder quantity.

Improper formulation. Check formulations and correct.

Powder particle distribution is not uniform.

Pass the powder through mesh to make uniform particle size.

Too much variation in capsule fill weights.

Check powder quantity. Spread powder more evenly. Spread powder from center to all four sides. Apply even pressure with each tamp. Use tapping or vibration for fine or fluffy powders. Refer to chapter Special Fill Materials, page 14.


Issue Possible cause Suggested remedies

Capsule locking

Capsules are difficult to lock.Too much resistance to lock capsules using only Locking Plate.

Use capsule locker to fully lock capsules. See chapter Operating Instructions, page 11.

Not enough pressure applied to Capsule Locker during locking.

Press on Locker until it cannot go further.

A few capsules not locked when using Capsules Locker.

One row or column was missing when placing Capsule Locker.

Place Capsule Locker along the edge and into the corner so that all capsules are locked.

Dent in capsule cap or body dome. Powder or foreign object stuck inside Capsule Locker.

Clean Capsule Locker. Refer to chapter Cleaning, page 16.

Powder or Spacer Plate.Remove powder. Refer to chapter Cleaning, page 16.

Powder on bottom surface of Locking Plate.

Remove powder. Refer to chapter Cleaning, page 16.

Soft capsules (exposed to high humidity).

Use fresh CapsiCards®. Refer to chapter Environmental Conditions and Capsule Performance, page 21.

Brittle capsules (exposed to low humidity).

Use fresh CapsiCards®. Refer to chapter Environmental Conditions and Capsule Performance, page 21.

If you have additional questions that are not answered here, please contact your local supplier. Contact information is provided in chapter Contact Information, page 29.

User Tips



Item Boxes

100 hole 120 hole

Ship weight Net weight Ship weight Net weight

Kg Lbs Kg Lbs Kg Lbs Kg Lbs

Filler Base Kit 1/1 2 4.4 1.3 2.9 2.3 5.1 1.6 3.5

Filler Change Parts 1/1 2.9 6.4 2.2 4.8 3.2 7 2.5 5.5

Vibrator (optional) 1/1 8.5 19 6.5 14 8.5 19 6.5 14


Line Drawings

Line Drawing Front view Line Drawing (100 hole) Top view Line Drawing (120 hole) Top view


Declaration of conformity

CapsiCards® Machine EU Doc

Custom Capsules Pvt. Ltd.

To:

DECLARATION OF CONFORMITY

Product name Hand operated capsule filling machine

Model CapsiCards® Machine

Manufacturer Custom Capsules Pvt. Ltd.

B 8/1 Camlin Naka, Tarapur MIDC, Boisar, Dist: Thane, Maharashtra, India, 401506

Contact person Customer support For contact details of your local supplier, please see page 29.

CE certification questions Mr. A.H. Varma Phone: +91 2525-272538 Fax: +91 2525-272537

It is hereby confirmed that the above product complies with the requirements set out in the following directive: 2006/42/EC Machinery directive

The harmonized standards applied are as follows: EN292/1 & EN292/2:1991 Safety of machinery - Basic concepts and general

principles for design.

EN349:1993 Safety of machinery - Minimum gaps to avoid crushing of parts of the human body.

I hereby declare that the above product has been designed to comply with the relevant sections of the above referenced standards. The unit complies with all applicable essential requirements of the directive.

The product carries the CE mark. Signed:

Name: A.H. Varma

Place: MIDC Tarapur, India

Position: Assistant manager Q.A. Date: 14 Jan. 2014

CapsiCards® is a trademark of Fagron Group BV.


Terminology

Capsule Size Ranges The CapsiCards® Machine is designed to fill capsule sizes 00 - 4. Some parts are size-specific while other parts are used in a range of sizes. Please refer to chapter CapsiCards® System Assortment, page 4, for more information.

Change Parts Each time a capsule size changeover is to be done, a set of parts must be changed. These parts are referred to, collectively, as change parts.

Filling The process by which the powder or liquid is inserted into the capsule bodies is called filling, and is done using your CapsiCards® Machine.

Locking A snapping sound is heard when bodies push past that initial resistance and the Body Lock Rings enter the cap lock rings. This is called locking.

Reassembly When locking capsules, the first resistance felt is when the top of the capsule body meets the Cap Lock Ring. For coarse powders, the force needed to push past that resistance may be too great to lock all capsules. At this stage the capsules are reassembled and ready for locking using your Capsule Locker.

Separation The capsule bodies must be separated from the caps to prepare for filling. This is called separation and is done using your CapsiCards® Machine. The bodies remain in the filler base and the caps are removed to the Caps Tray.

Tamping / Tapping / Vibration After powder is spread into the open capsule bodies, tamping (powder compression) helps to pack down the powder to make room for more powder, and to ensure more even capsule fill weights. Tapping the filler on the table can also settle the powder into place. Vibration (using the optional vibrator) works especially well for faster filling of granular, flour-like, or bridging powders.


Contact Information

For contact details of your local supplier please visit capsicardssystem.com

Manufacturer: Custom Capsules Pvt. Ltd. for Torpac Inc. USA. Made in India. Patented USA 7234494 & International Patents Pending.Copyright: Torpac, Inc. USA.

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