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Filling & Sealing Equipment
Xcelodose® S System FAQ & Useful Links
Please select a section below: FAQs
What is the difference between the Xcelodose and the Xcelodose S? What is the difference between the Xcelodose and the Xcelodose S? The Xcelodose® S has 50% increase in throughput rate for filled capsules. Additional improvements include greater robustness over longer filling runs, an integral High Throughput Unit, expanded software functionality and elimination of pneumatics. View brochure for other features and benefits. Can I purchase the older model Xcelodose? No, the Xcelodose available is the Xcelodose S. Do I have to purchase the Integral HTU? No, but we advise that you do. Is the older model Xcelodose retrofitable? No Can I use the existing change parts? Some, please call to discuss. Will Capsugel continue to support the older model Xcelodose? Yes. What are the specifications of the balances used in the Xcelodose system? The balances are made by Sartorius Ltd and have been specially modified by them for use in the Xcelodose system. An SE2 (2g) and an ME5 (5g) version are available and are interchangeable within the Xcelodose system. The specifications for these are as per the attached datasheet. What materials are used for the dispensing arm? 316 Stainless steel What is the volume of the dispense head? The Standard Dispense Heads have a powder storage volume of approximately 3000 mm2. There is also a Hopper Extension that will enable approximately an extra 5000 mmsup>2 to be held in addition to this amount. For extended high weight filling runs the Xcelodose system Integral High Throughput Unit (HTU) should be utilised. Can the visible components under the front cover of the machine be made from stainless steel rather than anodised aluminium? Yes it is theoretically possible to make components such as the deck plate and bulkhead out of stainless steel but Capsugel has specified clear anodised aluminium for the product. Please contact us with any special requirements. What capsule sizes is the machine compatible with? Currently standard variant sizes 00 through 4. Should you wish for other sizes we are happy to investigate the design and production of these. Can the dispense arm be adapted to raise and lower as well as performing its standard lateral movement? Yes it can. However, the machine has been designed in such a way that no vertical adjustment of the dispense arm is required whichever set of capsule size change parts are used. If there was a special need to raise and lower the arm as part of the machine's automatic cycle, then a special mechanism is required. Please discuss your requirements with us. Can you provide a description of the machine's operational cycle? The pre-closed capsule shells are placed into the feeder hopper on the top of the machine. At the bottom of the hopper is a rotational agitating mechanism, which causes the shells to drop down into a size specific cassette mounted on the feeder engine. The cassette contains a rectification mechanism to orientate all the shells 'cap up' as they are pushed through by a linear shuttle arrangement. The capsules then fall from the feeder through an in-feed tube in the machine front cover into a dial plate (the main indexing wheel). The dial plate contains three identical stations, which rotate to align with the three operational stations within the machine: in-feed, dispense, and out-feed. The capsule falls through the drop tube into one of three bush assemblies located in the dial plate (the main indexing wheel). A vacuum probe then draws the bottom of the capsule into the puck (effectively the equivalent of a bottom bush in a conventional capsule filling machine). The puck is held loosely in a swinging arm. The dial plate then indexes through 120 degrees to locate the capsule bottom above the balance pan. During this index, the swinging arm moves radially outward by means of a cam system and suspends the puck over the top of the balance pan. The index is performed using a motorised drive system. The complete dial plate and arm assembly then lowers so that the puck rests freely on the balance pan without being in contact with the swinging arm. The puck containing the lower half of the capsule is then tared on the balance and dispensing commences. The dispensing of powder is achieved by sending mechanical shock waves down the dispense arm from a solenoid. When current is passed through the coil of the solenoid, the iron armature is drawn inwards and impinges on a mechanical stop. It is the impact of the armature on the stop that creates the mechanical shock wave. This system has been rigorously life-tested. The rate of shock waves is nominally 25Hz at fast rate and 6Hz at slow rate. The control system monitors the incremental increase in balance reading following each individual shock and predicts the actual weight dispensed. Using this prediction, it controls the transition from fast to slow tap and it controls the time when dispensing is stopped. When the tapper stops, the dispense head moves aside to eliminate the chance that additional powder drops into the capsule. The increase in weight (that is the weight of the dispensed powder) is then measured by the stabilised balance and the dial plate elevates. The dial plate then indexes a further 120 degrees and, during this motion, the swinging arm moves the puck back so that it is located directly under the top bush once more. The bottom of the capsule is then pushed up into the top half of the capsule by means of a closing pin and conventional capsule closing bush geometries. The top half of the bush is held in position during this process step by means of a flat surface on the capsule turret. The capsule turret then rotates by means of a motorised drive system so that the capsule can be pushed upwards by the same closing probe into a pocket in the turret. The turret then rotates again so that the capsule drops from the pocket into one of the discharge hoppers according to whether the control system is satisfied the cycle has produced a satisfactory capsule. A sensor checks that the capsule has been correctly delivered. The dial plate then indexes a further 120 degrees and the cycle repeats itself. There are three bushes in the dial plate and so appropriate stages described above are actually performed simultaneously on one of the three capsules that are being processed at any one time. This increases the overall output rate of the machine. How does the dispensing take place? The Xcelodose system has a unique patented dispensing head which meters out discrete amounts of powders under software control. The weight of powder dispensed is continuously measured using a microbalance and this information is fed back to the control computer to control the final amount dispensed. The dispensing head itself is constructed in 316 Stainless Steel and has no moving parts which could damage the powder, for example by shearing action. The head is selected to allow the right amount of powder to be dispensed according to the required dose weight. What weights can be filled? The system can fill weights in the range 100 microgram to several hundreds of milligrams depending on the capsule size and powder density. The system can also be specified to fill higher weights if so desired with a higher weight balance option. With this option weights in the range 1 milligram to 3 gram depending on the capsule size and powder density.
What is the weighing accuracy? Common results usually give an RSD of 2 to 3% and a mean weight of typically within 1% of target. Dispensing control limits are fully software settable at a percentage of target weight. What is maximum height of container that can be filled on an Xcelodose® 120 S system machine? 50mm How many capsules an hour can it really do? System speed depends on required accuracy and also on powder material behaviour. The Xcelodose S system is capable of filling up to 620 capsules per hour. What particle size range can it handle? The system has been successfully tested with micronised lactose (3 micron MMD) and other micronised powder. It has also been used with powders containing much larger particles, up to 500 microns, (500 micron MMD). Is there a segregation effect in the dispensing head as evidenced by the particle size distribution of dispensed powders? No such effect has been observed or reported to date. Can it handle very free flowing powders? Yes however there may be limits to the speed of dispensing. Capsugel is generally happy to test out prospective customers' samples as part of a demonstration of the Xcelodose system, subject to certain caveats i.e. verification of type of compound, safety arrangements, confidentiality, availability of Capsugel personnel etc. Can it handle cohesive or caking powders? Yes, unless the caking is extreme, for example Maize Starch (MMD 13 microns) has been dispensed very successfully. Capsugel is generally happy to test out prospective customers' samples as part of a demonstration of the Xcelodose system, subject to certain caveats i.e. verification of type of compound, safety arrangements, confidentiality, availability of Capsugel personnel etc. Can it handle beads? The system has successfully trialled beads and pellets of varying types. Capsugel is generally happy to test out prospective customers' samples as part of a demonstration of the Xcelodose system, subject to certain caveats i.e. verification of type of compound, safety arrangements, confidentiality, availability of Capsugel personnel etc. Could the dispensing head be fitted with a larger hopper, for extending operating time with large dose weights? The standard hopper can be fitted with an extension unit that increases the dispensing volume without the need to refill (see Q2). For larger doses and/or longer runs the Xcelodose system High Throughput Unit (HTU) should be used. This is available as an optional extra. How do I change the dispensing head to accommodate different powders or target weights? Capsugel has a full range of dispensing heads. When you specify your equipment Capsugel will offer a selection of heads, which appear best matched to your requirements. Further heads can be purchased if your requirements vary. Guidance as to which dispensing head to use for specific weight is given in the User Manual. What assurance is there that what is in the capsule is correctly recorded? The system has been designed to minimise any spillage during operation and the amount of powder lost during extended running has been observed and measured as insignificant. The dispensing process is designed to be GMP compliant and dose accuracy is validatable. Doses weighed directly into a puck has been cross-checked using a second balance, the weight difference was no greater than that of a control (i.e. the puck weighed twice). How do I calibrate Xcelodose system? The microbalance is calibrated in the same way as any other laboratory balance. The accuracy of the weighing and dispensing processes is assured as part of the system validation. Will the equipment have a complete IQ/OQ package? Yes, there will be a complete validation package for all areas of the machine including software, and assistance with PQ if required at additional cost. Will the equipment have full validation documentation for GMP compliance? Yes, but this will be an additional cost. As standard you receive validation for non GMP. Is the electronic data record compliant with 21 CFR part 11? Yes. The data recorded during a batch run is fully compliant with 21CFR part 11. What environmental restrictions are there to the process - for example humidity, temperature or vibration? The equipment is designed to operate in a normal laboratory and process development facility environment. Because each dose is weighed individually, the dispensing process is very tolerant of changes in powder flow behaviour caused for example by humidity. Problems can occur at very low humidity (e.g. less than 30% RH) however when static will take effect. Additionally, the balance will not settle in an area where the room pressure is constantly being disturbed however although this may slow the throughput, it will not cause the system to give incorrect weight data. The equipment is compatible with clean room working to class 10,000. Class 1,000 or sterile suite operation may be possible depending on the exact customer needs. The system also requires sitting on a rigid base or support structure in an environment that is free from excessive vibrational interference. Capsugel manufacture bespoke XcelotableTM for the system that minimises these effects and can be purchased as an extra. Sites with suspended or heavily insulated floors should be avoided for locating Xcelodose as these cause slow running of the system due to their unstable nature. The customer must satisfy itself as to the sitting and operation of the machine on its site to comply with Health & Safety and other legal and regulatory requirements. Xcelodose will operate within a variety of containment/isolator systems, inc Low RH - details on request. What containment systems can be filled? The Xcelodose 120 S system is designed to fill capsules, in any size from 00 to 4 as standard and has been previously been adapted Capsugel to fill other containment systems specified by customers. This could include for example filling receptacles such as blisters, special vials, tubes or cassettes. The Xcelodose 600 S system whilst also designed for these capsule sizes as standard, cannot be readily adapted to other dose containers at present. Capsugel would be pleased to discuss customer's individual requirements on a one to one basis. How easy is it to clean? The system is designed to meet GMP cleaning validation requirements and has been improved with feedback from existing customers. Can it handle cytotoxic drugs or radioactive substances? Yes, but once used with such substances, the system cannot be used with other classes of drug compound. The process could operate within a glove box or similar containment providing air pressure is constant, however arrangements for periodic maintenance should be reviewed in detail with Capsugel before designing any such installation. A full product contact change part set can be purchased to ensure no cross contamination, please contact us for a quotation. Can equipment go in an aseptic environment and tolerate peroxide sterilisation? The system can be adapted for hydrogen peroxide sterilisation to special order. Can more then 4m separate the dosing unit from the control equipment? This can be done to special order, with some minor changes to layout. What arrangements are in place for servicing or repair? A maintenance programme will be offered to the customer at the time of sale of the equipment. The validity of the warranty provided to the customer is contingent upon the customer having the equipment serviced and maintained in accordance with the maintenance programme. Can it work with blends? Trials have indicated that the amount of segregation is dependent on the difference in particle size of the respective powders and the filled volume of the dispense head. Is it fully automated? How much labour is required? The system is designed for 'walk away' operation rather than 'lights out' fully unattended running. The system requirement is for supervision roughly every 15 minutes. Can you grind up tablets and use the resulting powder? The resulting powder must have an adequately fine particle size distribution and you must ensure adequate homogeneity to meet dose uniformity requirements. Can the system be used with other balances? No. The microbalance is specially tailored for use on the Xcelodose system. It is vitally important that should the user require advice about the balance from the manufacturer that it is specified it is an Xcelodose balance. Can the system identify individual capsules so that the dose weight is known exactly? If the user collects the capsules in the sequence that they are produced by the machine, then this is fully achievable as each capsule weight is detailed on the run log. This, however, is most easily accomplished on Xcelodose 120 S system. On this system the filled capsules are returned to the operator in a set of ten, each in an individual puck. The operator can then store the capsules in any format. Can the system deliver variable weights within a single run? No. This is not possible under a single machine run on the Xcelodose system. Report format/customisation? No. The 21CFR11 run record is of standard format. This may be possible as a special order, please contact us with your requirements. Is it portable? The machine is designed to be easily movable with the Control Cabinet being mounted on castors. The system becomes easily transportable using the Xcelo Table which can be purchased as an additional item. What services are used / specification? The system is designed to be self-contained with on board utilities as required. The only external service a one standard single-phase outlet at 240V/50Hz, or 110V/60Hz. Can the system do double filling? No. The Xcelodose 600 S system is not designed to do this, however this can be performed on the Xcelodose 120 S system with a suitable controlled procedure in place. Can the system fill liquids? No, not currently. Please contact us if you have a requirement for liquid filling - the Capsugel CFS1200 may be appropriate for your needs - more information is available on www.capsugel.com. What are the Xcelo Table® dimensions? Width = 600mm What roughness (RA value) is the stainless steel finish on Xcelodose system? RA 1.6 Useful LinksFor further information on Aptuit, who are currently showcasing the Xcelodose 600 system, please visit http://www.aptuit.com For further information on the weighing technology that Sartorius offer, please visit www.sartorius.com and www.sartorius.co.uk For information on the availability of GMP micro-dosing using Xcelodose system in the USA, please visit www.xcelience.com Intelligence Applied to Pharmaceutics Newsletter - Early Stage Development Pharmaceutics |
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