Operating Manual 100 hole hole

Transcription

1 Operating Manual 100 hole hole CAPMA01-NF V. 1.0

2 Table of Contents Overview Features: CapsiCards System CapsiCards System Assortment CapsiCards Machine Optional Accessories Replacement Parts How to Order Before you begin Initial Assembly / Capsule Size Change Operating Instructions Stages in Capsule Locking Special Fill Materials When to Use a Vibrator Filling Liquids Filling Sticky Powders Materials of Construction Cleaning Cleaning Guidelines Cleaning Schedule Cleaning Tips Drying Environmental Conditions and Capsule Performance Storage Work Area Packaging of Filled Capsules Frequently Asked Questions User Tips Weights and Dimensions Declaration of Conformity Terminology Contact Information CapsiCards System Operating Manual V

3 Overview Features: CapsiCards System CapsiCards Machine CapsiCards Easy to use and flexible With 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 hardto-fill powders. The CapsiCards Machine has been developed especially for CapsiCards. CapsiCards System Operating Manual V

4 CapsiCards System Assortment CapsiCards Machine Filler Base Kit Lifting plate 1. Filler Base Post Cam lever 2. Powder Tray, Powder Spreader and Powder Tray Clamps 3. 5-pin Tamper 4. Adapter and Pusher 5. Capsule Locker 6. Quick Start Manual and USB Filler Change Parts for one capsule size (available: 00, 0, 1, 2, 3, 4) 7. Caps Tray with Locking Plate 8. Body Sheets (3) 9. Spacer Plate CapsiCards System Operating Manual V

5 CapsiCards System Assortment 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 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. How to use: Place Filler on Vibrator. Use vibration to pack powder in step 10, see chapter Operating Instructions, page Volts/50-60Hz or Volts/50Hz. CapsiCards System Operating Manual V

6 CapsiCards System Assortment Replacement parts Some replacement parts are shown below. For other parts see Contact Information on the last page of this manual or call or 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. Locking plate Caps Tray Spacer Plate Body Sheet (b) Cam Handle Assembly Rubber Foot 5-pin Tamper Capsule Locker Adapter Pusher Powder Spreader Powder Tray Powder Tray Clamps CapsiCards System Operating Manual V

7 CapsiCards System Assortment How to order Please 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 Kit Filler Base, Powder Tray, Powder Tray Clamps, Powder Spreader, 5-Pin Tamper, Capsule Locker, Pusher, Adapter. 100 hole Suitable for: 00, 0, 1, 2, 3, 4 n/a Filler Base Kit Filler Base, Powder Tray, Powder Tray Clamps, Powder Spreader, 5-Pin Tamper, Capsule Locker, Pusher, Adapter. 120 hole Suitable for: 00, 0, 1, 2, 3, 4 n/a CapsiCards Machine Filler Change Parts Filler Change Parts Body Sheets (3), Caps Tray, Spacer Plate. Filler Change Parts Body Sheets (3), Caps Tray, Spacer Plate. Filler Change Parts Body Sheets (3), Caps Tray, Spacer Plate. Filler Change Parts Body Sheets (3, Caps Tray, Spacer Plate. Filler Change Parts Body Sheets (3), Caps Tray, Spacer Plate. Filler Change Parts Body Sheets (3), Caps Tray, Spacer Plate. Filler Change Parts Body Sheets (3), Caps Tray, Spacer Plate. Filler Change Parts Body Sheets (3), Caps Tray, Spacer Plate. Filler Change Parts Body Sheets (3), Caps Tray, Spacer Plate. Filler Change Parts Body Sheets (3), Caps Tray, Spacer Plate. Filler Change Parts Body Sheets (3), Caps Tray, Spacer Plate. Filler Change Parts Body Sheets (3), Caps Tray, Spacer Plate. 100 hole 00 n/a 100 hole 0 n/a 100 hole 1 n/a 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 00 Clear, white, ivory CapsiCards System Operating Manual V

8 CapsiCards System Assortment Capsule no. Capsule size Colour CapsiCards (950 capsules) 50 capsules/card 0 CapsiCards (1100 capsules) 50 capsules/card 1 CapsiCards (1200 capsules) 50 capsules/card 2 CapsiCards (1300 capsules) 50 capsules/card 3 CapsiCards (1400 capsules) 50 capsules/card 4 CapsiCards (1020 capsules) 60 capsules/card 00 CapsiCards (1140 capsules) 60 capsules/card 0 CapsiCards (1320 capsules) 60 capsules/card 1 CapsiCards (1440 capsules) 60 capsules/card 2 CapsiCards (1560 capsules) 60 capsules/card 3 CapsiCards (1680 capsules) 60 capsules/card 4 Clear, white, ivory Clear, white, ivory Clear, white, ivory Clear, white, ivory Clear, white, ivory Clear, white, ivory Clear, white, ivory Clear, white, ivory Clear, white, ivory Clear, white, ivory Clear, white, 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 hole Available in: 00, 0, 1, 2, 3, 4 n/a Spacer Plate 100 hole, 120 hole Available in: 00, 0, 1, 2, 3, 4 n/a Locking Plate 100 hole, 120 hole Available in: 00, 0, 1, 2, 3, 4 n/a Body Sheets (b) 100 hole, 120 hole Available 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 CapsiCards System Operating Manual V

9 Before you begin First time use: trial run through Once 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 check The 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 locations Each 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. Capsule size Capsule size Capsule size Serial number underneath CapsiCards System Operating Manual V

10 Initial Assembly / Capsule Size Change 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. CapsiCards System Assortment Filler Base Kit Filler Base Powder Tray Powder Tray Clamps Powder Spreader 5-Pin Tamper Capsule Locker Pusher Adapter Available in capsule no. Available in capsule size 100 hole 120 hole Suitable for: 00, 0, 1, 2, 3, 4 Filler Change Parts Body Sheets (3) Caps Tray with Locking Plate Spacer Plate Capsicards 50 or 60 capsules/card a b Step 1: Spacer Plate Step 2: Sheet a Step 3: Sheet b c Step 4: Sheet c Step 5: Caps Tray with Locking Plate CapsiCards Machine CapsiCards System Operating Manual V

11 Operating Instructions a b c d 1 Open Locking Plate (a). Place adapter (b) on Caps Tray. Check that Cam Lever is set to three o clock. 2 Place CapsiCards (c) on Adapter with capsule bodies down. Use Pusher (d) to push capsules down into Caps Tray. 3 Remove empty CapsiCards cardboard and Adapter. 4 Close the Filler Locking Plate and secure it by turning the two tabs. 5 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. 6 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. 7 Release Cam Lever to allow capsule bodies to drop into Filler. If some capsules sit higher than others, gently pat them into place. 8 Place Powder Tray onto Filler. Optionally, attach Powder Tray Clamps. For filling sticky powders, see chapter Special Fill Materials, page 14, following these instructions. CapsiCards System Operating Manual V

12 Operating Instructions a b 9 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. 10a Tapping Pull 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. 10b Vibration Use 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. 10c Tamping To fill additional powder, use Tamper. Repeat spreading and tamping as necessary. 11 Remove Powder Tray. Place Caps Tray onto Filler. c 12 To lock capsules, press down on 13 Remove Caps Tray and turn over 14 Locking Plate with thumbs while pulling up Lifting Plate. Repeat several times, with thumbs positioned in different areas of Locking Plate. 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. CapsiCards System Operating Manual V

13 Operating Instructions Stages in capsule locking There 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. Lock ring Cap Body Filled Reassembled Locked Approximate locked capsule sizes 25 mm 20 mm 15 mm 10 mm 5 mm 0 mm 1 1/2 0 CapsiCards System Operating Manual V

14 Special Fill Materials When to use a Vibrator The 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 liquids After 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 powders Separate 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. CapsiCards System Operating Manual V

15 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 CapsiCards System Operating Manual V

16 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 Automatic dishwasher Cleaning agents Isopropyl alcohol Hot air drying Autoclave All parts are fully dishwasher safe. Plastic parts should be placed in top rack of dishwasher < 70 C (160 F). 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. 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. Up to 60 C (140 F). Remove plastic parts from oven after minutes. If using portable hair dryer, keep a distance of 30 cm (12 inches) from all items. Do not autoclave Capsule Locker or Powder Spreader. Other parts may be autoclaved at 121 C (250 F), 15 psi pressure for 15 minutes. Cleaning schedule Three cleaning schedules are recommended: run time cleaning, daily cleaning, and weekly/lot change cleaning. Spacer Plate Run time Daily Weekly / lot change 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 CapsiCards System Operating Manual V

17 Cleaning 1. Run time cleaning During 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 cleaning Daily 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 methods 1. 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 cleaning Weekly, 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). CapsiCards System Operating Manual V

18 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 methods 1. 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 a. 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. CapsiCards System Operating Manual V

19 Cleaning Cleaning Tips Avoid damage to surface of parts Do 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 powder Remove all loose powder before cleaning with water. Wet powder can harden and stick to parts. Cleaning Cellulose Cleaning 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 techniques 1. 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 Powder Cleaning 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 tips 1. 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 tips 1. 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. CapsiCards System Operating Manual V

20 Cleaning 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 techniques 1. 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. Drying Always 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. CapsiCards System Operating Manual V

21 Environmental Conditions and Capsule Performance Both 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 22 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) 22 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. CapsiCards System Operating Manual V

22 Environmental Conditions and Capsule Performance 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 22 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. 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. 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. CapsiCards System Operating Manual V

23 Frequently Asked Questions 1. What is the output? Output is capsules per hour for the 100 hole CapsiCards Machine and 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 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. CapsiCards System Operating Manual V

24 User Tips Issue Possible cause Suggested remedies Capsule separation Capsules difficult to separate. Capsules fail to separate. Capsule filling Capsule body open end not level with top of Body Sheet set after separation. Cam Lever over-tightened. Cam Lever not tightened enough. Cam Bush in Body Sheet b or Cam is worn. Powder deposits between sliding Body Sheets. Capsule body diameter and lengths vary slightly. Powder accumulated on spacer plate. Loosen up Cam lever slightly until capsules separate more easily. Pull Cam Lever further, but not so much that capsules are squeezed to oval shape. Replace Cam or Body Sheet b. Clean Body Sheets with brush or compressed air. Refer to chapter Cleaning, page 16. 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. 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. CapsiCards System Operating Manual V

25 User Tips Issue Possible cause Suggested remedies Capsule locking Capsules are difficult to lock. A few capsules not locked when using Capsules Locker. Dent in capsule cap or body dome. Too much resistance to lock capsules using only Locking Plate. Not enough pressure applied to Capsule Locker during locking. One row or column was missing when placing Capsule Locker. Powder or foreign object stuck inside Capsule Locker. Use capsule locker to fully lock capsules. See chapter Operating Instructions, page 11. Press on Locker until it cannot go further. Place Capsule Locker along the edge and into the corner so that all capsules are locked. 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. Soft capsules (exposed to high humidity). Brittle capsules (exposed to low humidity). Remove powder. Refer to chapter Cleaning, page 16. Use fresh CapsiCards. Refer to chapter Environmental Conditions and Capsule Performance, page 21. 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. CapsiCards System Operating Manual V

26 Weights and Dimensions Weights and Dimensions 100 hole 120 hole Item Boxes Ship weight Net weight Ship weight Net weight Kg Lbs Kg Lbs Kg Lbs Kg Lbs Filler Base Kit 1/ Filler Change Parts 1/ Vibrator (optional) 1/ Line Drawings Line Drawing Front view Line Drawing (100 hole) Top view Line Drawing (120 hole) Top view CapsiCards System Operating Manual V

27 Declaration of conformity DECLARATION OF CONFORMITY Product name Model Manufacturer Hand operated capsule filling machine CapsiCards Machine Custom Capsules Pvt. Ltd. B 8/1 Camlin Naka, Tarapur MIDC, Boisar, Dist: Thane, Maharashtra, India, Contact person Customer support For contact details of your local supplier, please see page 29. CE certification questions Mr. A.H. Varma Phone: Fax: 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 EN349:1993 Safety of machinery - Basic concepts and general principles for design. 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. To: The product carries the CE mark. Signed: Place: MIDC Tarapur, India Name: A.H. Varma Position: Assistant manager Q.A. Date: 14 Jan CapsiCards is a trademark of Fagron Group BV. CapsiCards Machine EU Doc CapsiCards System Operating Manual V

28 Terminology Capsule Size Ranges Change Parts Filling Locking Reassembly Separation Tamping / Tapping / Vibration The CapsiCards Machine is designed to fill capsule sizes 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. 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. The process by which the powder or liquid is inserted into the capsule bodies is called filling, and is done using your CapsiCards Machine. 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. 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. 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. 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. CapsiCards System Operating Manual V

29 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 & International Patents Pending. Copyright: Torpac, Inc. USA. CapsiCards System Operating Manual V

30 capsicardssystem.com Performing quality, enhancing efficiency