Mini Coater Drier Catalogue

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Mini Coater Drier Catalogue

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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 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 requ