Caleva Process Solutions Tablet coater Mini Coater Drier-2 Mini Coater Drier-2 General Description Single tablets and small quantities of spheroids can be coated and dried in minutes, potentially saving significant amounts from your R&D budget. Tablet and pellet coaters generally require a minimum batch of between 300g and 500g to work effectively, but this robust, simple-to-operate, bench-top unit provides a cost-effective solution for drying and coating particles. Batches from as small as a single tablet or a few grams. The MCD-2 can coat from one to about 150 tablets a world first - thus cutting quantities of expensive pharmaceutical ingredients required for trials. It offers excellent uniformity within and between batches, allowing technicians to trial all possible combinations and variables without cost or product availability being a limiting factor. The practical unit, which is fully compliant with principles of Good Laboratory Practice, can satisfy other applications such as the experimental coating of granules with catalytic material, food material and fluid-filled gelatin capsules. Use: Laboratory & Development: Pilot plant: Production: Minimum batch size:One tablet or a few grams of pellets Maximum capacity:About 150 standard sized tablets or about 60 g of pellets Contents General Description ........................................ 1 The Basic Machine ......................................... 2 Main Uses ......................................................... 5 Standard Design Configuration ................... 6 General Arrangement Diagram ................... 7 Options Overview ............................................ 8 Training and Validation Options................. 9 Accessories included ...................................11 Consumables (optional) ..............................12 Recommended Spares ................................13 Recommendations ........................................14 Tel: +44(0) 1258 47-11-22www.caleva.com1 27 Feb 2013 Tablet coater Caleva Process Solutions Mini Coater Drier-2 The Basic Machine Production capacity: Tablets or pellets (spheroids) are coated in batches. Maximum and minimum batch sizes are shown below. Typically batches take about 15 to 30 minutes to achieve a suitable coating. Minimumbatch: Coat from a single tabl et Coat very small quantities of tablets saving expensive or scarce material Coat from 1 to about 150 tablets (dependent on tablet size) A practical batch size giving representative samples Excellent uniformity within and between batches Results show that uniform and high quality coatings can be obtained Coat from a few grams of pellets (spheroids) Coat from a few grams of pellets Coat up to about 60 g of pellets A practical batch size ideal partner for the Caleva MBS Spheronizer 120 or the Caleva Multi Lab (CML) Static generation problems with some spheroid formulations of small pellets can be minimized with the optional anti static system Dry pellet batch sizes up to approximatel y 100g Ideal size capacity for the Caleva Spheronizer 120 Cost effective laboratory drying apparatus Save time and costs during early stages of product development Partner equipment for other Caleva products. Contact us for small scale extruders and spheronizers for R&D and teaching.Scale-up: The desire for a scalable process is understandable but not always relevant. The Caleva Mini Coater/Drier has the unique ability to coat very small samples sizes and is typically used at a very early stage in the development of new products and new formulations. A typicalproblem ( from a real case) The development scientist working on formulation development with a new experimental active ingredient. As part of this program 8 possible formulations and 10 possible coating materials were available. That is, 80 different combinations! This situation is probably not uncommon and if the number of variables to be looked at increases only slightly then the possible number of combinations will increase dramatically. For these trials, six tablets from each of these combinations were required to do a preliminary dissolution test. Using the Caleva Mini Coater/Drier six tablets of each combination could be made quickly and easily without any wastage of material. 2Tel: +44(0) 1258 47-11-22www.caleva.com 18 Aug 2010 Caleva Process Solutions Tablet coater Mini Coater Drier-2 The tablet coater available in the laboratory could work effectively with a minimum batch size of 3 kg. The choice was:- To make 80 batches of 6 tablets each with the Caleva MCD-2 (a purchase cost involved!); or to make 80 batches of 3 kg each with the equipment he had in his laboratory (no additional purchase cost). The logistics of coating either 480 tablets (using the Caleva MCD) or 240kg of tablets (using the coater in his laboratory) demonstrated that the Caleva MCD-2 has significant advantages.The active ingredient being tested might be a new experimental material and as such was not only expensive but also scarce. In this circumstance it was very easy to do a quick calculation of the cost saving that could be achieved by making 80 samples of six tablets (approximately 0.1kg of tablets) compared with making 80 samples 3 kg (approximately 240kg of tablets!). The Conclusion This real example shows that the savings made in this single experiment alone would more than pay for the cost of the MCD-2.This did not take into account the savings in time and effort of using the Caleva MCD-2 and the additional cost savings that that would be made in future work with this or other products. The question of scale up did not arise. This is irrelevant at this early stage of product development. Once the material is tested and the properties are established on small scale (proof of concept) then the issues of scale up to production can be subsequently addressed. Restrictions: Considerations when making a risk assessment for the use of organic sol-vents Product Statement The airflow into the spray chamber passes an electrical heating element. Caleva cannot give any ATEX rating or recommendations for the use of spray solutions containing flammable organic solvents with the Caleva Mini Coater Drier. Caleva has not designed the equipment to any ATEX rating. Before considering the use of coating materials with solvents the user should undertake their own risk assessment. The following key points can be considered when a risk assessment is being compiled by a user, the information offered is not exhaustive and in no way underwrites the safe operation of organic solvents with this equipment. Considerations Ai rflow direction: The airflow only flows into the spray chamber after it has passed over the heating element. There is a theoretical potential for the spray solution to flow down the inlet tube to the heating element. The chance of this hap-pening is low as the airflow is moving in the opposite direction. The ma-chine has a safety feature designed to cut power to the heating element should the fan stop moving air. Flow rate: The normal flow rate for application within the Caleva Mini Coater Drier would be about 12 to 15 ml per hour. If a spray solution was made up of Tel: +44(0) 1258 47-11-22www.caleva.com3 27 Feb 2013 Tablet coater Caleva Process Solutions Mini Coater Drier-2 20 % organic solvents then at the higher flow rate about 3 ml of solvent per hour would be released into the spray chamber. This is about 0.25 ml of solvent every 5 minutes. This quantity of solvent is released into an air stream, blowing away from the heating element and would be dispersed by around 12 and 32 litres of air moving away from the heater during this 5 minute period. Therefore the risk of significant solvent accumulation within the equipment is small. Cleaning: The Mini Coater Drier should be cleaned and emptied of product at the end of every working session. If this is not done and a spray solution containing organic solvents has been used then it is possible that spray solutions could drip from the nozzle (if left over the spray chamber) into the spray chamber and then evaporate into the air inlet pipe and then in-to the internal area of the equipment. If this were to happen solvent ac-cumulations could build up within the air inside the equipment. The chance of this is considered low because: The spray head has a needle value to close the spray opening to prevent product dripping The material in the spray head is not under any pressure The amounts of materials are very small.The internal area of the equipment contains numerous electronic connec-tions and a potentially dangerous situation could arise the next time the machine is switched on and the equipment is full of fumes. This will not happen if the equipment is cleaned properly. Summary 1.The MCD-2 is not designed to any ATEX rating or classification. The key areas of risk for use of spray solutions containing organ-ic solvents are given above but they are not exhaustive. 2.The user should fully consider the points made above, make and adopt their own risk assessment before making a decision on the use of spray solutions containing flammable materials. 3.For further information or if you require further guidance you must contact Caleva directly before using the equipment.Documentation package: Full pharmaceutical industry qualification documentation packages are available if required. Materials certificates: Certified copies of original mill certificates for all product contact parts are available as an option if required. Availability It is our intention to keep one or more machines in stock at all times. However, stock machines may be sold or may not be the specifications that you require.The actual delivery date will depend on the level of work that we have at the time of order. In general if we do not have a suitable machine in stock then delivery will be between 2 and 6 weeks. Please contact us for an exact delivery date when the required specifications are known. 4Tel: +44(0) 1258 47-11-22www.caleva.com 18 Aug 2010 Caleva Process Solutions Tablet coater Mini Coater Drier-2 Main Uses Tablet and pellet coaters generally require a minimum batch size of about 300 to 500g to work effectively. With the Caleva Mini Coater/Drier2 (MCD-2) it is possible to dry and coat as little as a single tablet or a few grams of spheroids. The apparatus is a robust, simple to operate and practical unit that is easy to place within a laboratory The coaster is currently used in several industries ranging from pharmaceuticals, catalysts and food items as well as R&D and teaching in Universities. It is an ideal companion to the Caleva Multi Lab The MCD-2 can satisfy other applications such as experimental coating of; granules with catalytic material, food material and fluid filled gelatin capsules Tel: +44(0) 1258 47-11-22www.caleva.com5 27 Feb 2013 Tablet coater Caleva Process Solutions Mini Coater Drier-2 Standard Design Configuration SizeApproximately 50 x 55 x 60 cm. WeightApproximately 32kg. MaterialCabinet is 304 stainless steel. Contact parts316 stainless steel, PTFE & polypropylene, food grade polymer. Coating solution flow Controlled by an Integrated Watson-Marlow Peristaltic pump Important note The coating spray is generated by an atomizing spray nozzle. This requires an external supply of compressed air (see below).Utility requirements Electrical suppl y Electrical supply single phase. Voltage according to customer requirements. Please inform us at the time of order if you require 220/240 or 110 volts (we are able to offer the voltage that you specify). If voltage is not specified at time of order, then 220/240V equipment will be supplied.Ai r Suppl y The user will need to provide an external air supply with the following minimum characteristics:- Compressed air up to 2.5 bar required. A 4mm external diameter supply pipe.Flow required =60l/min at 2 bar.A small compressor or a cylinder or by preference a standard laboratory piped supply is suitable. Please take note of the flow volume requirement Operation and controls Custom designed micro controller based system with monochrome LCD graphic display Mechanical agitation control variable from 10 to 25 Hz. Airflow control variable up to 60CFM at source Peristaltic pump variable from 5 to 50ml per hour (dependant on delivery pipe diameter). Different diameters are supplied. Air temperature variable from ambient up to 60 degrees C with feedback loop control. Count up timer with start/stop and reset controls. A wakeup condition.The last used experiment parameters will be stored and when the machine is switched on all parameters will start set at their last used condition. All controls are soft for future development such as PC control and data logging Standard documentation supplied Installation and operation Manual. Completed quality control check sheet. CE declaration of conformity 6Tel: +44(0) 1258 47-11-22www.caleva.com 18 Aug 2010 Caleva Process Solutions Tablet coater Mini Coater Drier-2 General Arrangement Diagram Pipework and anti-static unit not shown Tel: +44(0) 1258 47-11-22www.caleva.com7 27 Feb 2013 Tablet coater Caleva Process Solutions Mini Coater Drier-2 Options Overview All machines are supplied suitable for use with tablets and pellets. If it is foreseen that pellets are to be coated then some additional options are recommended. Please ensure that you discuss with us about your intended use. There are no required options. A set of recommended spares/consumable items is available. 8Tel: +44(0) 1258 47-11-22www.caleva.com 18 Aug 2010 Caleva Process Solutions Tablet coater Mini Coater Drier-2 Training and Validation Options Installation/commissioning/training at the customer site Training within the UK or in any European country.Including one day installation and training and two days travelling is available if required. All travel and subsistence costs are included in the cost if this option is chosen. Please contact us for a cost if this is required. Training outside Europe. Including one day installation and training and four days travelling is available if required. All travel and subsistence costs are included in the cost if this option is chosen. Please contact us for a cost if this is required. Training includes installation, commissioning and training at customer site of up to one day, but does not include IQ/OQ which is separately chargeable. The customer will provide local transport for the Caleva technician if required. The customer will supply all consumable products required according to further discussion. Trained electricians will be provided by the customer if required (generally not required). Installation does not include any alteration to the customer site and does not include installation of any electrical services. The customer will be responsible for the unpacking and location of the machines at the site. This is not included in the quotation. If more than one item is purchased then training can be done together for other equipment with considerable savings in cost. Contact us for details. Factory acceptance test at Caleva UK site We make our own quality check before the extruder is shipped (a copy is supplied to the customer) and thus a separate FAT is not normally necessary but the quality check at the Caleva site can be completed with the customer if required. The customer will be responsible for all expenses incurred in getting to and from the Caleva site. Customer training at the Caleva site (overseas customers) Training is recommended to the company but it is not essential. Contact us for additional information and options. Customers from outside the UK will be collected at any London main airport and transferred to Bournemouth, accommodation and all meals for one trainee whilst in Bournemouth, UK. Transport to and from the Caleva site is included. Any extras (such as phone calls etc.) at hotel are for guests account. One night bed & breakfast in London hotel before return flight to home country can be included if requested. Up to two days training (as required) can be provided at the Caleva site on customers own equipment prior to shipment. Please contact us for a cost if this is required. Transport to and from the customers own country to a London main airport is not included and is for the customers account. If more than one item is purchased then training can be done together with considerable savings in cost. Contact us for details. Tel: +44(0) 1258 47-11-22www.caleva.com9 27 Feb 2013 Tablet coater Caleva Process Solutions Mini Coater Drier-2 Validation and IQ/OQ documentation package Recommended if required for regulatory purposes. At Caleva site: The IQ/OQ package completed at the Caleva site by us. The customer can attend if he or she wished to do so at their own cost. An additional set of blank documents will be provided to allow the customer to re-do the IQ/OQ in their own facility if required. At customer site: IQ/OQ and installation completed at the customer site as part of the training (training will be charged separately). The cost shown is an additional cost for the IQ/OQ in addition to the costs for installation and training. Note: there may be additional country-specific charges depending on location. Contact us for details. Material certificates In line with current standards Caleva does not automatically supply copies of material certificates for product contact parts. If requested, Caleva will provide, free of charge, a certificate naming the product contact parts and confirming that we or our suppliers can provide full traceability to original certificates if this is requested. If certified copies of material certificates are required then these can be provided at the additional cost. 10Tel: +44(0) 1258 47-11-22www.caleva.com 18 Aug 2010 Caleva Process Solutions Tablet coater Mini Coater Drier-2 Accessories included Anti -Static system Some formulations of spheroids are prone to generate static electricity. This can cause the pellets to stick together or to the sides of the application chamber.The effect of this can be minimized by use of the included anti-static gun incorporated into the design of the Mini Coater/Drier.The gun is mounted into a custom built mount incorporated into the spray head and the required high voltage electronics and controls are incorporated in the body of the MCD-2.The use of the antistatic system is not required for coating of tablets. Drying hood If more than a few grams of pellets are to be dried or if the pellets to be dried are not >1.0 mm in diameter then a drying hood unit can be used on the top of the drying cone.This use is recommended if drying of spheroid (or other light-weight items) is a foreseen use.If the foreseen use is only for the coating of tablets using the provided sleeve is not required.Spheroid coating sleeve If the unit is to be used for the coating of spheroids the spheroid coating sleeve unit is normally required if the pellets are below 1.0mm in diameter or very light..If the foreseen use is only for the coating of tablets this option is not required.This option will be supplied as standard. Tel: +44(0) 1258 47-11-22www.caleva.com11 27 Feb 2013 Tablet coater Caleva Process Solutions Mini Coater Drier-2 Consumables (optional) Teflon sealing ring for spray nozzle Teflon sealing rings for inside the spray nozzle. These can be damaged accidentally or lost as they are quite small and we would recommend that an additional 10 be purchased with the machine especially if this is to be used (and cleaned) by students or several different people. Replacement spray chamber discs (Pol yethylene) Replacement disc for base of the spray chamber. These items can be again, damaged or lost. We would recommend that an additional 50 be purchased with the machine. Replacement silicon tube for peristaltic pump Silicon tube (0.8mm internal diameter) for the peristaltic pump. We recommend that an additional 15m is purchased Silicon tube (01.6mm internal diameter) for the peristaltic pump. We recommend that an additional 15m is purchased Replacement cone assembl y Replacement lower cone including made to fit mesh retainer Drive collar for the base of the cone (temperature probe not included). This is taken off the machine to be washed and could be lost or damaged Replacement upper cone Replacement connecting ring for upper and lower cone 12Tel: +44(0) 1258 47-11-22www.caleva.com 18 Aug 2010 Caleva Process Solutions Tablet coater Mini Coater Drier-2 Recommended Spares Spare parts utility pack A single pack containing all recommended options as shown below: Some of these items are considered consumable in normal operation.This spare parts pack is particularly recommended (but not essential) for purchases outside the EU and where supply might be difficult. All these items can be priced separately if required. Contact us for details Teflon sealing rings for inside the spray nozzle. These can be damaged accidentally or lost as they are quite small and we would recommend that an additional 10 be purchased with the machine especially if this is to be used (and cleaned) by students or several different people. Replacement disc for base of the spray chamber. These items can be again, damaged or lost. We would recommend that an additional 50 be purchased with the machine. Silicon tube (0.8mm internal diameter) for the peristaltic pump. We recommend that an additional 15m is purchased Silicon tube (01.6mm internal diameter) for the peristaltic pump. We recommend that an additional 15m is purchased Replacement thermocouple (temperature sensor). Can be broken by careless use. Replacement lower cone including made to fit mesh retainer Drive collar for the base of the cone (temperature probe not included). This is taken off the machine to be washed and could be lost or damaged Replacement upper cone Replacement connecting ring for upper and lower cone Tel: +44(0) 1258 47-11-22www.caleva.com13 27 Feb 2013 Tablet coater Caleva Process Solutions Mini Coater Drier-2 Recommendations1 Options There are no required options. The basic equipment as offered is fully functional. If you require any advice regarding the options or wish us to make any recommendations based on your planned use then please contact us. Anti static option If it is foreseen that only tablets are to be coated then the use of the included anti-static option is not required. However, if pellets are to be coated then the anti-static unit is strongly recommended. Spares and consumables We recommend you consider the spare parts utility pack. This is a single pack containing all recommended spares options, as shown above. This option is recommended for users outside of the EU and suggested for other users. IQ/OQ before shipment Installation can be provided at customer site if required but is not considered necessary for this equipment. Installation charges are listed in Training and Validation Options on next page. This option is recommended only if required for regulatory purposes. TrainingTraining in the use of the equipment at the customer site or at our site in the UK prior to shipment is available and this is recommended. 1Strongly recommended: We consider that this option is a must for most cases unless you have specific reasons why this option is not needed. Highly recommended: Most users would consider this option as something that they would want. Recommended: We consider that it is sensible to purchase these options. Suggested: We suggest that you consider these options according to circumstances. Please contact us for any advice. 14Tel: +44(0) 1258 47-11-22www.caleva.com 18 Aug 2010