UNPACKING Thank you for purchasing the Manual Capsule Filling Machine from KARISHMA PHARMA MACHINES. Please take sufficient time and read this manual carefully before you start installation and operation of the Manual Capsule Filling Machine to avoid any mishap and to ensure you get the best performance possible. INSTRUCTIONS FOR UNPACKING AND CHECKING Unpack the wooden case carefully under supervision of a responsible person and remove the contents without trying to force open any package. Tally all the contents with the packing list. If a component or a part is found missing or not tallying with the packing list, please report the same immediately to us or the supplier giving full details of the material supplied. Incase if there is any damage observed immediately after opening the package, document in detail the nature and extent of damage occurred in clear and precise terms and send the report to the supplier within a week of receipt of consignment. All the parts and components should be thoroughly cleared of packing materials before doing assembly, especially the moving parts. All contact parts should be washed thoroughly with warm water and detergent before the equipment is put in use for production. 1
INTRODUCTION The Manual Capsule Filling Machine is one of the oldest as well as the most popular and widely used form of capsule filling. The machine is designed and manufactured with utmost care to handle all sizes ranging from 00 to 5 and to give you trouble free service year after year. Though all the operations involved are manual, the machine calls for precision machined components and is assembled with highly skilled personnel. The Manual Capsule Filling Machine is widely used in research laboratories, academic institutions, and medium to small manufacturing pharmaceutical industries. The manual Capsule Filling Machine can accommodate 300 capsules at a time. FEATURES The machine is simple in construction and compact in size. The machine can be easily shifted from one place to another. All the parts coming in contact with the capsules are made of stainless steel or approved material. Changeover from one size to the other is simple and consumes very little time. The Manual Capsule Filling machine is very simple to operate and requires practically no training. 2
SPECIFICATION OUTPUT For 300 holes 50,000 to 60,000 capsules per 8 hrs. shift. NO. OF CAPSULES/ 300 holes LOADING TRAY MACHINE DIMENSIONS 395mm x 240mm x 500mm (Approx.) MACHINE WEIGHT 45Kg. (Approx.) SHIPPING DIMENSIONS 533mm x 400mm x 609mm (Approx.) SHIPPING WEIGHT 70Kg. (Approx.) 3
OPERATION In the Manual Capsule Filling Machine, all the operations beginning with the loading of empty capsules in the loading tray to capsule separation, filling, closing and ejection are done manually in a sequential manner. The Manual Capsule Filling Machine is normally supplied with three loading trays. For optimum utilization of the machine, it is advisable to engage three operators; two operators for loading of capsules in the loading tray and the third operator to operate the machine. For fast loading of empty capsules you may use automatic capsule loader. 1. Fill up the empty capsules in to the holes of the loading tray with cap up and body down position. Maximum loading output can be obtained using both the hands for loading the capsules into the tray simultaneously. This technique can be achieved easily with a regular practice. To maximize production, the loading of empty capsules into the loading trays and filling of the formulation into the capsules in the machine, should be matched in such a way that the machine does not remain idle for want of filled loading trays. 4
2. Ensure the correct position of the eccentric pin handle. The marking on the eccentric pin should be matched with that on the pin spacer of the sliding sheet and the eccentric pin handle position should be away from the operator. Sliding sheet Eccentric pin handle Eccentric pin After filling the loading tray, place the tray with empty capsules on the machine. Locate it by the four locating pins with respect to the holes provided on the Top section, with side marked as Front towards operator. 3. Turn the inner slide knob anti-clockwise. Inner slide knob Eccentric Pin handle 4. Turn the eccentric pin handle towards front, thus moving the sliding sheets in opposite directions. The bottom half of the capsules (Body) get tightly and evenly gripped by the sheets. 5. Turn the inner slide knob clockwise direction. 5
6. Depress lifting plate handle with the eccentric pin handle position towards the front, thus lifting the loading tray up and separating the capsule caps from the bodies. Holding the lifting plate handle in the depressed position lift the loading tray containing the caps and place it on the working table beside the machine. Care should be taken while handling the plate so that the caps do not come out and get displaced. Release the handle, which automatically returns to its original position. Top section Loading tray Eccentric Pin handle Lifting plate handle 7. Return eccentric pin handle to its original position. With this all the capsule bodies that remain slightly above the top section automatically drop down and sit in level with the top section. Capsule bodies, which do not drop in, may gently be tapped down. Check whether the entire capsule caps and bodies are separated. Separate the un-separated capsule bodies, by holding the tray with one hand and removing the capsule body by the other hand. Then insert these separated capsule bodies in to the remaining empty holes of the top section. If too many capsule bodies have not been separated from the capsule caps, it is an indication that the eccentric pin handle has not been pulled to the required extent. 6
8. Place the powder tray on the machine ensuring the tray is properly located in the holes provided in the top section. Pour the pre-weighed powder required for 300 capsules into the powder tray. Using the Teflon powder dispenser sheet gently spread the powder over the top section holes till all the capsule bodies are full. Important: The Nylon Brush provided with the machine must NOT be used for spreading the powder as it may cause weight variation. However, the brush can be used for spreading granules or pellets or spheroids into capsule bodies. The brush is actually provided for cleaning the machine. Pin plate Assy. Powder tray Pin plate handle Top section Pin plate locking lever 9. Generally all the powder does not go into the capsule bodies at first shot. Take aside the excess powder with the powder dispenser sheet on to the platform provided on the right of the powder tray. Lower the Pin Plate Assembly and lock it in position using Pin Plate Locking Lever. Ensure that the Pin Plate is properly locked in position as otherwise even compression cannot be applied on the powder and further operation may damage the Top section. 7
Please note that the Pin Plate should be taken down or lifted up only after ensuring that the Pin Plate is at the extreme upward position. This is done by rotating the Pin Plate handle anticlockwise. 10. After locking the Pin Plate assembly with the locking lever rotate the Pin Plate handle clockwise so that the Pins compress the powder in the capsule bodies. After compression, rotate the Pin Plate handle anti-clockwise to remove the Pins from the capsule bodies. Release the locking lever and push the Pin Plate assembly back to its original position. Spread the remaining powder, which is collected on the platform of the powder tray on to the capsule bodies with the Teflon dispenser sheet till they are full. If there is still some powder left, the compression cycle should be repeated until all the powder is filled into the capsule bodies. Important: The supervisor or operator during trials should determine the number of compression required. To obtain a uniform fill weight and minimize weight variation, it is important to use sufficient powder to allow for at least one compression. It has been found from experience that if the powder is not compressed at least once, then air pockets get formed in some of the capsule bodies which give rise to weight variation. Hence, the quantity of drug to be filled should be adjusted in such a way, that it allows for at least one compression. 11. Once all the powder is filled, remove the powder tray and replace with the previously taken out loading tray with the capsule caps. Important: Ensure that the marking Front on the loading tray matches the Front marking on the machine. Failure to comply with above may lead to- a. Mismatching of printing on the capsule cap and body. b. Increase in the rejection rate. 8
12. Turn the inner slide knob anti-clockwise. Lower the pressure plate and lock in position with locking lever. Gently move the lifting plate handle downwards and applying just sufficient pressure ensure proper locking of the capsules. Pressure plate Inner slide knob Locking lever Eccentric Pin handle Lifting plate handle 13. Unlock the Pressure plate and take it back to its original resting position. Turn the inner slide knob in clockwise direction and depress lifting plate lever. Lift the loading tray up with the locked capsules and empty them into a suitable container by tapping it to drop. The machine cycle is now complete and can be repeated for the next loading tray for best result with smooth production. 9
PROCEDURE FOR CHANGE OF SIZE Changeover from one capsule size to another requires procedure for change of size. 1. Loosen the eccentric pin-tightening nut. Match the mark on eccentric pin face with sliding sheet washer by turning the pin after removing the eccentric pin handle and nut. Gently tap out the eccentric pin. 2. Loosen four top section knobs, which lock the top section to the body. Top section comes out along with the sliding sheet and support plate etc. 3. Replace the top section of correct size on the body and clamp it by the four top section knobs. Top section comes as an assembly of sliding sheets, support plate and top plate. 4. Insert the eccentric pin carefully by matching the mark on pin top with sliding sheet washer mark and gently press it. Fix the eccentric pin handle and tighten the nut. Nut Spacer Pressure plate Locking lever Inner slide knob Eccentric Pin handle Lifting plate handle 5. Loosen the pressure plate clamping nuts and take out the spacers between pressure plate and pressure plate bracket. Replace the spacers by new spacers of correct size (marked on the top surface of spacer) of capsule. Refit the pressure plate and fix the earlier removed spacers between the clamping nuts and pressure plate bracket. Adjust the pressure plate stopper so that it is parallel to the top section when hinged and locked. 6. Use correct size loading trays and you are ready for production of next size. 10
DO AND DON T ON THE MACHINE 1. Clean the machine by a brush to remove all drug powder from all parts of the machine. This should be done daily at the end of the shift. 2. If parts of the machine, which comes in contact with powder, are washed then dry them completely before refitting. 3. If the machine is not in use for long time, then swing in the Pin plate bracket and lock it by locking lever. Turn the screw handle and push the Pin plate pin just inside the top section. Swing the pressure plate bracket and gently drop pressure plate assembly on the Pin plate bracket. Keep the machine in this fashion. This minimizes the chance of any damage to the machine. 4. Keep the bolt and washer of the handle always tight to avoid loosening of handle and breaking of shaft. 5. Do not remove Pin plate locking lever from the machine. 6. Do not try to pull the sliding sheets from the top section without removing top section screws. 7. If you remove handle from the shaft match the O marks to refit to the shaft. 8. Do not force anything, which does not move freely. 11
MAINTENANCE The machine should always be kept clean and free from excessive powder. Proper maintenance is required at all times to ensure efficient functioning and rejection free operation of the machine. Maintenance as listed below should be carried out every day. If a very sticky product is being filled, it may be necessary to clean the machine ones a day. Clean the pins of the Pin plate with Nylon brush. Remove Top section and slide out sliding sheet after removing the top section screws. Clean them separately using warm water. Clean Eccentric pin and oil it before replacing. Clean the top face of the Lifting plate with Nylon brush. Assemble entire machine and keep ready for next day s production. Care should be taken not to damage / bend any of the plates of the Top section or the Sliding sheets. Carry out lubrication of the machine as given in the lubrication chart. If it is necessary to wash the machine please read the instruction under Washing & Cleaning of the Machine. 12
LUBRICATION All moving parts of the machine should be periodically lubricated as per the chart given below: No. Lubricating Point Oil/Grease Frequency Fig.No. 1 Eccentric Pin SAE-40 Oil Daily - 2 Hinge Pins of Pin plate and pressure plate 3 Bushes of Pin plate Guide Pillars SAE-40 Oil Daily - SAE-40 Oil Daily - 4 Bushes of Lifting plate Guide Pillars Grease Lithon-2 NLGI-2 Servogem-2 Daily - 5 Hinge screw of Pin plate lock lever 6 Hinge screw of pressure plate lock lever SAE-40 Oil Daily - SAE-40 Oil Daily - 7 Lead screw of Pin plate SAE-40 Oil Daily - 8 Rack and Pinion Grease Lithon-2 NLGI-2 Servogem-2 Daily - 13
WASHING & CLEANING OF MACHINE Machine must be thoroughly cleaned by a brush to remove all accumulated drug powder. This should be done daily at the end of the shift. For through cleaning, machine Top section can be dismantled (Refer to instructions for capsule size change-removal & refitting of Top section) and all components can be cleaned with brush. If washing of the machine is necessary please note that for standard models we do not recommended washing of the main body as it is made of Cast Iron with Chrome Plating. Adopt following procedure for washing of the Top section, Pin plate assembly, Lifting plate assembly etc. Remove the Top section by the same procedure as described in size change procedure. Wash the section separately. Remove the Lifting plate assembly by loosening four nuts from the bottom of the machine body. Remove the nuts and four springs and pull out the Lifting plate assembly. Wash this separately. NUT Remove the Pin plate assembly by loosening the Socket head screw and detaching the Pin plate screw from Pin plate. Wash it separately. Dry all the components completely before reassemble. For reassembling fit the Lifting plate and engage it in the four bushes of the body; also see that the front knob is kept correctly so as to engage the slide pin into slot on the Lifting plate bracket. Engage the O mark on the rack with the mark on the gear and then slide the Lifting plate down. 14
TROUBLE SHOOTING Defects: Capsules not getting separated. Cause: Eccentric pin handle not pulled fully. Remedy: Pull the eccentric pin handle to the max. position. Cause: Eccentric pin block of sliding sheet worn out. Remedy: Replace. Cause: Eccentric pin worn out. Remedy: Replace. Defects: Cause: Remedy: Cause: Remedy: Weight variation. Height of pins of Pin plate uneven. Repair / Replace. Insufficient powder. Quantity of powder should be adjusted in such a way that it allows for adequate compression. Defects: Capsules fail to lock. Cause: Misalignment of Loading tray and Top section. Remedy: Set it right. Cause: Wrong spacer used on Pressure plate. Remedy: Put the right spacer. Cause: Uneven length of pins of Lifting Plate. Remedy: Recondition / Replace. Cause: Lifting plate lever not pressed to required extent. Remedy: Press the lever to the required extent. 15
Defects: Pins not entering Top section. Cause: Pins bent. Remedy: Rectify / Replace. Defects: Cause: Remedy: Cause: Remedy: Cause: Remedy: Capsule rejection due to telescoping splitting. Misalignment in Loading tray holes and Top section. Recondition the plates. Match the Loading tray holes with Top section holes. Hard particles in powder. Pass through lower mesh Excessive clamping by sliding sheet. Place the eccentric pin handle correctly. Defects: Uneven closing length of capsules Cause: Improper spacer used on Pressure plate. Remedy: Correct spacer to be used. Cause: Rubber sheet on Pressure plate dented. Remedy: Replace. 16
RECOMMENDED SPARE PART LIST Sr.No. Description Part No. Qty. 1 Eccentric Pin - 2 2 Eccentric Pin Nut - 1 3 Eccentric Pin Washer - 2 4 Top plate knob - 4 5 Top plate screws - 24 6 Dowel pin for hinge bracket - 4 7 Pin plate lock bolt - 1 8 Pressure plate lock bolt - 1 9 Rubber sheet - 3 10 Aluminum knob small - 5 11 Aluminum knob big - 1 12 Big handle bolt with washer - 2 13 Pressure plate nut - 2 14 Lifting plate leg spring - 4 15 Lifting plate spring nut - 4 16 Socket head screw for Pin plate washer - 8 17 Allen key 4mm - 1 18 Pin plate screw cap rubber - 3 17
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