HAND-HELD CAPSULE FILLING SYSTEM For Use in R&D Pharmacy Compounding Nutritional Supplements Clinical Studies

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1 HAND-HELD CAPSULE FILLING SYSTEM For Use in R&D Pharmacy Compounding Nutritional Supplements Clinical Studies Powder Tray Options Orienter Caps Tray Bench-Top Filler Upgrade Filler Push Plate Vibrator Capsule Locking Plate See Page 3 Capsule Locker Spreader The ProFill 3006 is the first stainless steel hand-held 300-hole filler that can be used under a powder hood or in a glove box. The and Orienter can also be used with the ProFill 3007 bench-top filler for maximum flexibility. Easier To Use Easier to use than any other 200 or 300 hole hand-held system. Four exclusive indicators to assist in capsule orientation, separation, tamping/tapping and locking. Fits under powder hoods and in glove boxes. Shipped fully assembled with a How-To video CD. Pharmacopoeia Compliant Fill weights, USP/EP method within ± 1-3% of average. Typically all 300 capsules/batch are within ± 5-7.5% of target. For more visit www. capsuleworld.com/3006/fwdata Can be used with different brands and types of capsules including gelatin, vegetarian/hpmc and starch capsules. Higher Output Unique features include Orienter Locator, 60-pin, Capsule Locker, Capsule Measuring Bowls & Push Plate. Capsule Locker enables you to fully lock capsules after filling, unlike other hand-held 200/300 hole fillers - saving you time and frustration! Compatible with Bench-top Filler ProFill 3006 grows with your requirements. Get the ProFill 3007 Bench-top Filler for larger batches and use the same and Orienter purchased for the Continue to use the 3006 Filler Base for smaller batches or production under a powder hood or in a glove box. Faster Size Changes & Cleaning for sizes & 00el-2el sizes. Size changeover in only 5 minutes. Most parts are dishwasher safe. For more details visit Can be dried in a hot-air oven or with a portable hair dryer. The T fastest and easiest to use 300-hole 3 hand-held filler! Up to 4500 to 6900* capsules/hour *based on powder, operator speed & number of taps/tamps. Exclusive Options Stainless Steel (Inox) 316 Caps Tray available. Partial Batch Kit for filling less than 300 capsules / batch. Over-encapsulation attachments for tablets, capsules and caplets. Distributed By: Glenvale Packaging Unit 3 Edison Close Park Farm Industrial Estate Wellingborough Northants.. NN8 6AH Phone Fax skype : garry.coleman61 ProFill 3006 Brochure

2 Key Features 100% separation due to dual sliding sheet design Height adjustment to assist in over-filling Cam position indicator, great for training new operators Fast action Cam Handle Fast action Locking Plate for Caps Tray with reinforced stainless steel edges to prevent bending 25-hole Capsule Locker is size-specific. Speeds locking, and prevents over-locking and capsule denting Capsule Locker includes Spacer Plate Height adjustment marking Locked Capsule Indicator Capsule Locker position indicators on under side of Caps Tray Locating holes in Orienter and tapered locating pins for fast & accurate orientation of capsules into Caps Tray Patented Orienter slot design and depth for faster operation Powder Tray includes indicators for positioning 60-pin Empty Capsule Measuring Bowls (3) Full size Powder Spreaders (4) Multi-use Push Plate speeds operations 60-pin in optimum size ranges 00, 0-1, 2-3, 4 Shipped Fully Assembled 5 minute Size Changeover Ease of Use Speed ProFill 3006 Brochure

3 3006 Ordering Information - System Full System for One Capsule Size Capsule Size ProFill 3006 System Item Number 000 M6 HHS M6 HHS 00 0 M6 HHS 0 1 M6 HHS 1 2 M6 HHS 2 3 M6 HHS 3 4 M6 HHS 4 For 00el - 2el sizes contact us. For capsule size chart see page 5. Comes with option of 192 or 180-hole Filler. ProFill 3006 System includes everything you need to fill one capsule size: Hand-Held Filler Base, Orienter Base, for one capsule size, Locking Plate, 60-pin, Powder Tray, Powder Spreaders, Push Plate, Capsule Locker, empty capsule Measuring Bowls, empty and locked Capsule Bins, and a Storage Box. To fill additional capsule sizes, order and, if required, a. If changing to or from sizes 000 or 4 additional parts are required. See page 4. Upgrade Option to a Bench Top System Optional Vibrator ProFill 3006 grows with your requirements. Get the ProFill 3007 Bench-Top Filler for larger batches and use the same Change Parts & Orienter purchased for the You can continue to use the 3006 Filler Base for smaller batches or production under a powder hood or in a glove box. Purchase an additional Orienter Base and have a full second system. For a video and more information on the ProFill 3007 visit The optional ProFill MPC6 Vibrator offers faster filling of powders that bridge or are granular, fluid or flour-like. It also reduces weight variation for fine powders. If you already have a vibrator (ProFill 100 or FMC Syntron) you can order a mounting plate for use with the ProFill See page 9 for ordering information. ProFill 3006 Brochure

4 3006 Ordering Information (M6 CPS) (M6 T60P) Orienter Base (M67 HOB) Locking Plate (MX CLP) Includes Caps Tray, Orienter Change Part, Capsule Locker and Body Sheet Set. Specific to each capsule size: 000, 00, 0, 1, 2, 3, 4 60-pin Orienter Base Capsule Locking Plate In Capsule Size Ranges 000, 00, 0-1, 2-3 and 4 In Capsule Size Ranges 000, 00-3 and 4-5 In Capsule Size Ranges 000, 00-5 For Capsule sizes 00el, 0el, 1el & 2el please contact us for item codes and pricing. Steps to order for sizes 000 to 4: 1) Identify what capsule sizes you can fill with the equipment you now have. 2) Find the table below for the additional capsule size you want to fill. 3) is optional if you prefer to fill capsules using only tapping or a vibrator. = You have all the parts you need to fill one or more of the sizes in one of the cells below. To Fill Size 00 M6 CPS 00 M6 T60P *,0,1,2,3,4 Yes Optional To Fill Size 1 M6 CPS 1 0 Yes M6 T60P *,00,2,3,4 Yes Optional To Fill Size 3 M6 CPS 3 2 Yes M6 T60P *,00,0,1,4 Yes Optional To Fill Size 0 M6 CPS 0 1 Yes M6 T60P *,00,2,3,4 Yes Optional To Fill Size 2 M6 CPS 2 3 Yes 000*,00,0,1,4 Ye s To Fill Size 4 M6 T60P 2-3 Optional M6 CPS 4 Additional Parts Required M6 T60P 4 00, 0, 1, 2, 3 Yes M67 HOB 4-5 Optional M67 HOB Yes MX CLP 00-5 Optional To Fill Size 000 (specify 180 or 192 hole ) M6 CPCK 000 M6 TXXP Yes Optional * If you have Size 000 System only, to fill any of the capsule sizes 00 thru 3 you also need to order M67 HOB 00-3 and MX CLP If you have Size 4 System only, to fill any of capsule sizes 00 thru 3, you also need to order M67 HOB M6 CPCK 000 includes Change Part Set, Orienter Base & Capsule Locking Plate. M6 TXXP has 60 pins for 180 holes & 48 pins for 192 holes. Parts with prefix M67 and MX may refer to Size 5 as they are also used with the Profill 3007, which is available in Size 5. ProFill 3006 Brochure

5 Capsule Sizes / Weight & Dimensions Capsule Sizes 25mm Approximate Locked Capsule Sizes 1 20mm 15mm 1/2 10mm 5mm 0 0mm Approximate Locked Capsule Sizes (in mm) *For size 5 ask for information on ProFill 100 or ProFill * Weight & Dimensions Filler Orienter Item Boxes Shipping Wt. Net Wt. Kg Lbs Kg Lbs Complete System M6 with Accessories Box 1/ Extra Box 1/ Extra Box 1/ Extra and Orienter Base Box 1/ Vibrator MPC6 Box 1/ ProFill 3006 Brochure

6 Quick Start Guide Overview A) Orientation 1. Place Caps Tray onto Filler. Place Orienter onto Caps Tray. Fill the Measuring Bowl with empty capsules and pour capsules onto Orienter. 2. Lift Orienter and shake capsules into slots. 3. Press thumb tab to lift gate and pour off excess capsules. 4. Place the Orienter on the Caps Tray so it is in position marked "I". Push the sliding portion of the Orienter to drop capsules into the Caps Tray. Every third row is filled with capsules. 5. To fill remaining rows repeat steps 1-4 except in step 4 align the Orienter on Caps Tray in position marked "II". Repeat again and align in position marked "III". 6. Remove the Orienter and set it aside. B) Separation 7. Hold the Locking Plate by the 2 handles and place it onto Caps Tray. The 4 posts of the Caps Tray should enter the 4 larger holes in the Locking Plate. 8. Holding the Locking Plate by the handles, twist the Locking Plate clockwise to lock it into place. 9. Pull the Cam Handle toward you to secure capsule bodies in the Filler. 10. Push down on Locking Plate handles while pulling up on the Locking Plate to separate capsule caps and bodies. Set aside Caps Tray with Locking Plate. 11. Release Cam Handle back to the 0º position. 12. Use Push Plate to press capsule bodies level with Filler top sheet. ProFill 3006 Brochure

7 Quick Start Guide Overview C) Filling 13. Place Powder Tray onto Filler. Pour premeasured powder onto Filler. Optional Tapping 14. Spread powder into the capsule bodies using the Powder Spreader. 15. Use 60-pin to pack powder. The markings on the Powder Tray helps guide placement. Spread remaining powder. Repeat as necessary. Optional Vibrator 15a. Instead of tamping, hold the Filler and gently tap against the table a few times to settle the powder. Note: Squeeze Cam Handle gently to hold bodies in Filler 15b. Spread remaining powder and tap again. 15c. Use the optional Vibrator as an alternative to tamping or tapping (see page 3). D) Re-Assembly 16. Remove Powder Tray. Place Caps Tray with Locking Plate onto Filler. 17. With the palm of your hand, press down on Locking Plate while pulling up on the Lifting Plate to re-assemble capsules. 18. Repeat step 17 with hands positioned in opposite corners as shown. Repeat for the other 2 corners. The caps & bodies are re-assembled. E) Locking Capsule Locker 19. Remove Caps Tray with Locking Plate and turn them over onto table. Use the 25-hole Capsule Locker to lock capsules. Apply pressure with both hands until you feel the capsules snap and lock. 20. Flip Caps Tray over. Rotate the Locking Plate counterclockwise and remove it. You have 300 filled, locked capsules! 21. Turn over the Caps Tray into the red capsule bin and use the Push Plate to eject capsules. Capsules are now ready for packaging. ProFill 3006 Brochure

8 Frequently Asked Questions 1. What is the output and why is it faster than other systems? The ProFill 3006 fills up to capsules per hour for most powders. Our engineers have included features, some patented, that make the 3006 the fastest and easiest to use 300-hole 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 & technique and use of excipients. 2. How accurate are fill weights? Fill weights, USP/EP method, are within ± 1-3% of target. Typically all 300 capsules/batch are within ± 5-7.5% of target. For more visit 3. What types of capsules can I fill? ProFill 3006 has been tested with different brands and types of capsules including gelatin, vegetarian / HPMC and starch capsules. 4. What size capsules can I fill? You can fill sizes 000, 00, 0, 1, 2, 3, 4, 00el, 0el, 1el and 2el. If filling more than one capsule size, see page 4 for ordering guidelines. 5. Why Might I Need a different, Orienter Base or Capsule Locking Plate? The, Orienter Base and Capsule Locking Plate are made in capsule size ranges. If the new are within your existing size range, these parts are not needed. If the new capsule size is outside the size range, a new part must be ordered. 6. Can I see the system before I buy? Yes, you can view our online videos at 7. How big is the system and how can I store it? The largest piece is the assembled Filler, which measures for storage approximately 13 x 10 x 4 inches, or 33 x 25 x 10 cm (see page 5). The entire system can fit in one deep desk drawer or 2 regular drawers. A storage box for all parts is included with your system. 8. Can I fill liquids or sticky powders? Yes, you can fill capsules with sticky powders or non-aqueous liquids. Capsules filled with liquids for stability or clinical trials, if not sealed, will need to be kept vertical to minimize leakage between the cap and body. Capsules filled with non-aqueous liquids for commercial sale require sealing using equipment purchased separately. Contact us for more information. 9. Can it be cleaned in an automatic dishwasher or autoclaved? All parts are dishwasher safe except the anodized aluminum Caps Tray, Lifting Plate & Cam Handle Knob. The Body Sheet set, Caps Tray, Push Plate, Orienter Change Part, Powder Tray, and are autoclave safe. For more information on cleaning visit What are the Materials of Construction? For a full description of the Materials of Construction visit What are the maintenance requirements? We recommend daily cleaning and preferably washing of the machine to remove any powder. At a minimum, after each use the Body Sheets should be removed and cleaned using a brush, cloth, compressed air or vacuum. The cam, cam hole, and cam bush should be lubricated with a food grade lubricant such as Vaseline. 12. Is there a faster ProFill available? Yes. The ProFill hole bench top model fills capsules per hour. The ProFill 3007 is suitable for continuous full shift production with less operator fatigue. You can also upgrade the ProFill 3006 at any time for use with the ProFill 3007 Filler Base. See page 3 for more information. 13. What are the installation and utility requirements? No utilities (electricity, compressed air or water) are required unless using the optional Vibrator, which requires V / 60 Hz or V / 50Hz. 14. Does the ProFill 3006 come with a CE certificate? A "Declaration of Conformity" can be provided on request. ProFill 3006 Brochure

9 Accessories Optional Accessories Item Description Voltage/Frequency Capsule Size Item # Vibrator The use of a vibrator can reduce weight variation and filling time for powders that "bridge" or are granular, fluid or flour-like. CE certificate provided Volts/60Hz Volts/50Hz all sizes all sizes MPC6 VIB 110 MPC6 VIB 230 Mounting Plates for MPC VIB or FMC Syntron Vibrator. All sizes MPC6 VIB PLT Common for Upgrade your ProFill 100 MPC Vibrator to Volts/60Hz work with the ProFill 100 & ProFill Volts/50Hz Convert your FMC Syntron Vibrator for use All sizes MPC6 FMC PLT with ProFill 100 & Stand for 300-Hole System Reduce the space required to operate the Profill The stand organizes and provides easy access to all the loose parts. All Sizes MX STAND Stand only. Parts shown for illustration. Partial Batch Kit Fill fewer than 300 capsules per batch. Includes 1 each of Orienter Divider, Powder Tray Divider & Mini Powder Spreader. Order 30-pin separately. 30-pin tamper Stainless Steel CapsTray All Sizes M67 PBK 00 M67 T30P M67 T30P M67 T30P M67 T30P , & 00el-2el 00-4 M67 CT CS Specify Capsule Size M67 CT CS Specify Capsule Size Over-encapsulation Accessories Item Description Capsule Size Item # Orienter for Capsule-in-Capsule* This allows you to put capsules inside capsules using your existing ProFill System & 0el-2el M67 NEC OCPOB CS Specify Capsule Size Tablet Fill Attachment (Standard) Over-encapsulate round tablets between mm in diameter and mm in height. Includes stainless steel base and 2 Tablet Sheets for different tablets in size range indicated. 00, 0, 0el MX TFA STD Tablet Fill Attachment (Custom) This allows you to put tablets inside capsules using your existing ProFill System. 00-4, 0el-2el Engineering drawing of Tablet required Delivery 6-8 weeks Caplet Attachment* This allows you to put caplets inside capsules using your existing ProFill System 00-4, 0el-2el Engineering drawing of Caplet required Delivery 6-8 weeks Over-Encapsulation Frame Required for use of Orienter for Capsule-In- Capsule over-encapsulation. All Sizes MX OEF *Requires an over-encapsulation frame (M67 OEF). ProFill 3006 Brochure

10 ProFill Products Capsule Fillers Handheld 100-hole Capsule Filler with Orienter Up to Capsules per hour. Easy to operate and up to 35% faster than similar fillers due to its patented design. and a full range of accessories are available. Offered in Sizes and all el sizes. Over 5000 in use globally! Handheld 300-hole Capsule Filler For the growing company and for use under powder hoods or in glovebox isolators. Fully locks capsules after filling. The only 300-hole handheld you can upgrade as the of the 3006 also fit the 3007 bench-top Filler. The same Orienter works with 3006 & Output up to Capsules per hour. Available in Sizes & all el sizes. Bench-top* Capsule Filler & Hand-held Orienter Easiest bench-top system to set-up and use. Includes a hand-held Orienter. Up to capsules per hour. Options include Partial Batch Kit and Vibrator. Available in Sizes and all el sizes. Bench-top* Capsule Filler & Semi-automatic Orienter Our bench-top system for those who prefer the traditional European style semi-automatic Orienter. Up to capsules per hour. Optional Vibrator. Available in Sizes Other sizes use a hand-held orienter. *Bench-top Systems are designed for easier operation to enable continuous production. The 3007 includes our innovative hand-held orienter. For customers who use the traditional European style semi-automatic orienter we offer the Other Equipment Capsule / Caplet Film Coater For R&D. Ideal for enteric or film coating small batches of capsules and caplets with solvent based coatings. ProCoater Filling Funnels For precision capsule filling on a balance. Includes. Made from stainless steel 316. Available in all capsule sizes including veterinary sizes. ProFill 3006 Brochure