T TECNOLOGIA MECCANICA www.tecnologia.it Process Solution = ʃ ( Mechanical Technology, Process Knowledge, Experience, Prototypes )
History Founded in 1970 by Renato Locatelli. Grown up devoting itself to the construction of the most advanced prototype systems for the local process industries. Making the innovation as its main focus from the very beginning. Today engaged in the Italian market for R&D in the most well known pharmaceutical/chemical/agrochemical labs. Active worldwide in the micronization technology field with its own Fluid Jet Micronizers.
Highlights Located in Northern Italy not far from Milan, It is a family owned and run company. Tecnologia Meccanica offers process support services including rheology testing and micronization trials in order to provide the properly engineered design to meet your specific needs. Equipment can be tailored to meet the customer’s requirements and specific product characteristics. Full range of capacities including lab machines that start as low as 0.5 g/hour, up to production equipment with production capacities up to 1500 kg/hour. Complete engineering design, product testing and equipment manufacturing in its own facility
Micronization Sympatec GmbH HELOS Particle Size Analysis System-Partikel-Technik WINDOX 5 With the term micronization it is indicated a method HELOS (H1674) & RODOS, R2: 0.25/0.45...87.5µm 2005-01-24, 17:22:40 of reduction of the dimensions that results in Fluticasone x 10 = 0,69 µm x 50 = 1,24 µm x 90 = 2,04 µm SMD = 1,11 µm VMD = 1,31 µm x 16 = 0,78 µm x 84 = 1,83 µm x 99 = 2,79 µm S V = 5,40 m²/cm³ S m = 68404,38 cm²/g powders under the 10 µm in size. 100 90 80 Cumulative distribution Q3 / % 70 This technology is extremely important in different 60 50 industrial fields, in particular in the druggist field 40 30 20 where the reduction of the active principles (the so- 10 0 0.10 0.10 0.5 1 5 10 50 100 particle size / µm called API and HPAI) to such dimensions increases exponentially the characteristics of Bioavailability, cumulative distribution x 0 /µm Q 3 /% x 0 /µm Q 3 /% x 0 /µm Q 3 /% x 0 /µm Q 3 /% 0,45 0,68 1,85 84,90 7,50 100,00 30,50 100,00 0,55 3,14 2,15 93,08 9,00 100,00 36,50 100,00 0,65 7,63 2,50 97,61 10,50 100,00 43,50 100,00 of Bioequivalence, and the surface area available 0,75 13,63 3,00 100,00 12,50 100,00 51,50 100,00 0,90 24,13 3,75 100,00 15,00 100,00 61,50 100,00 1,10 39,28 4,50 100,00 18,00 100,00 73,50 100,00 1,30 54,18 5,25 100,00 21,50 100,00 87,50 100,00 of the product. 1,55 70,58 6,25 100,00 25,50 100,00 evaluation: WINDOX 5.1.2.0, HRLD stabil.9 product: Fluticasone revalidation: density: 0,79 g/cm³, shape factor: 1,00 reference measurement: 01-24 17:22:17 disp. meth.: 3bar no vib contamination: 0,00 % C opt = 0,41 % Tecnologia Meccanica fluid jet micronizers are able trigger condition: tb500ms c.opt>0.2 always 20 .. user parameters: time base: 500,00 ms Operatore: QLab start: c.opt >= 0,2% ID: Fluticasone valid: always Cliente: Tecnologia Meccanica stop: 15,000s meas.time or 20,000s real time lotto: Trial2 to obtain an extremely narrow tight particle size distribution curve of d100<5 µm (100% below 5 Our laboratory units can actually handle batches as small µm) and d99<3 µm (99% below 3 µm) or even less as 0.2 grams and produce results of D99<3 micrometer depending on the nature of the product. granulometry! With the milligram kit option even batches of 0.1 grams are possible.
The Process Every technician involved in the micronization Now that the modern global economy transfers sector knows that the micronization process in the the pharmaceutical processes from one side of pharmaceutical industry is a critical, expensive the Earth to the other at warp speed, technicians and definitely complicated process. Even if a need to implement both new and old process technician tries to find a solution by researching technology based on the existing technical the enormous amount of literature available literature without the comfort of years of about size reduction, there is no single theory experience. They find themselves mainly comparable to those existing for the other unprepared for the complexity of the industrial processes, and consequently this micronization process, so the mix between the requires that the problem be solved empirically micronization process and globalization creates and by utilizing years of experience. a difficult situation.
The Solution Tecnologia Meccanica has addressed these Our Jet Mills are based on a sound original troubles by developing a new family of Spiral statistical matrix model implemented on Fluid Jet Mills with enhanced characteristics computer software which allows us to approach based on the following processing principles: the micronization process based on proven methodology and in a comprehensive manner. inexpensive and easy to operate Briefly we can say that we have the technical able to process products with high solvent capability to make the micronization process an content (around 3000 ppm) easy process routine to validate/revalidate. able to process sticky powders which do not flow well
The Performance The micronization process is always a function of the product rheology. Therefore once the fluid jet mill has reached its performance limit with a given product rheology and we need to go beyond this limit, we have a problem to be solved. Since we do not supply only machines but also process oriented solutions, we are equipped with the right mix of capabilities including: Mechanical technology Process knowledge Experience Prototypes design
Let’s see our Advantages in detail
Mechanical Technology As a manufacturer of prototype systems, we still maintain in-house all the necessary human resources and manufacturing capabilities. We have Engineering, Information technology, Testing center, Non Destructive Testing laboratory, and mechanical/carpentry/polishing capability in our own Workshop. 5000 m² area, 2000 m² covered EC Norms, TUV Inspected
Process Knowledge Developing new technologies by combining the knowhow from different application fields makes sense only with a basic knowledge of the chemical manufacturing process. We share an history of networking knowledge with our customers which assists us in designing process oriented machines. Within our team we always have the right technologist able to speak the same language as our customer. Therefore we can commit ourselves to understanding the customer’s process requirements.
Experience All of you will agree with us that technology without experience is incomplete. Our team is composed of mostly middle aged people, with plenty of experience and with all the necessary energy to operate in a worldwide market. We are prepared to commission and finalize our machines to your process requirements at your facility.
Prototypes We are able to handle projects which do not seem to be practicable and we address the problems by sharing knowledge gained in other fields. In so doing, the capability to develop working prototypes is a must and we maintain a living testing center which in reality is an effective prototype laboratory. We enjoy the challenge and a result of our experience in dealing with these often difficult problems has generated fruitful results, our micronization technology being one of these.
Conclusion We supply the best micronization technology available on the market and we continue our R&D work to anticipate our customer’s requirements. However, micronization technology has a limit which can be overcome only with the right function: ʃ (Mechanical Technology, Process Knowledge, Experience, Prototypes ) CIP/WIP/SIP , process containment, machine isolation, process validation, etc. are all important matters, but please do not forget that they come always after the process solution.
Milestones & References
Milestones 1974, birth year of the first fluid jet mill for chemicals 1980, introduction of the octagonal milling chamber 1988, design of the non tangential Venturi entry for pharmaceuticals 1994, statistical matrix implementation on computer based software 2000, single V clamp execution on all the models 2003, birth year of the J-20 laboratory fluid jet mill 2005, modular system for J-20 / J-25 / J-30 and J-40 / J-50 / J-70 milling chambers 2006, introduction of the elliptical milling chamber 2008, J-100 / J-125 / J-150 in plant execution for medium small productions 2009, high efficiency execution for sticky products and with high solvent content 2010, glass lined process side parts 2011, fluid jet combo from r&d up to production capacity in one unit 2012, super vacuum technology for even easier micronization and micro feeding technology 2013, continuous manufacturing for micronization processing
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