T TECNOLOGIA MECCANICA www.tecnologia.it Process Solution = ( - - PowerPoint PPT Presentation

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T TECNOLOGIA MECCANICA www.tecnologia.it Process Solution = ( - - PowerPoint PPT Presentation

Oct 20, 2023 791 likes •1.01k views

T TECNOLOGIA MECCANICA www.tecnologia.it Process Solution = ( Mechanical Technology, Process Knowledge, Experience, Prototypes ) History Founded in 1970 by Renato Locatelli. Grown up devoting itself to the construction of the

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www.tecnologia.it

TECNOLOGIA MECCANICA

Process Solution = ʃ (Mechanical Technology, Process Knowledge, Experience, Prototypes )

T

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History

 Founded in 1970 by Renato Locatelli.  Grown

up devoting itself to the construction

  • f

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.

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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

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Micronization

With the term micronization it is indicated a method

  • f reduction of the dimensions that results in

powders under the 10 µm in size.

This technology is extremely important in different industrial fields, in particular in the druggist field where the reduction of the active principles (the so- called API and HPAI) to such dimensions increases exponentially the characteristics of Bioavailability,

  • f Bioequivalence, and the surface area available
  • f the product.

Tecnologia Meccanica fluid jet micronizers are able to obtain an extremely narrow tight particle size distribution curve of d100<5 µm (100% below 5 µm) and d99<3 µm (99% below 3 µm) or even less depending on the nature of the product.

Our laboratory units can actually handle batches as small as 0.2 grams and produce results of D99<3 micrometer granulometry! With the milligram kit option even batches of 0.1 grams are possible.

Sympatec GmbH System-Partikel-Technik HELOS Particle Size Analysis WINDOX 5 HELOS (H1674) & RODOS, R2: 0.25/0.45...87.5µm 2005-01-24, 17:22:40 Fluticasone x10 = 0,69 µm x50 = 1,24 µm x90 = 2,04 µm SMD = 1,11 µm VMD = 1,31 µm x16 = 0,78 µm x84 = 1,83 µm x99 = 2,79 µm SV = 5,40 m²/cm³ Sm = 68404,38 cm²/g 10 20 30 40 50 60 70 80 90 100 Cumulative distribution Q3 / % 0.10 0.10 0.5 1 5 10 50 100 particle size / µm cumulative distribution x0/µm Q3/% x0/µm Q3/% x0/µm Q3/% x0/µm Q3/% 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 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 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 % Copt= 0,41 % 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
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The Process

Every technician involved in the micronization sector knows that the micronization process in the pharmaceutical industry is a critical, expensive and definitely complicated process. Even if a technician tries to find a solution by researching the enormous amount of literature available about size reduction, there is no single theory comparable to those existing for the other industrial processes, and consequently this requires that the problem be solved empirically and by utilizing years of experience. Now that the modern global economy transfers the pharmaceutical processes from one side of the Earth to the other at warp speed, technicians need to implement both new and old process technology based on the existing technical literature without the comfort of years of experience. They find themselves mainly unprepared for the complexity

  • f

the micronization process, so the mix between the micronization process and globalization creates a difficult situation.

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The Solution

Tecnologia Meccanica has addressed these troubles by developing a new family of Spiral Fluid Jet Mills with enhanced characteristics based on the following processing principles:

inexpensive and easy to operate

able to process products with high solvent content (around 3000 ppm)

able to process sticky powders which do not flow well

Our Jet Mills are based on a sound original statistical matrix model implemented

  • n

computer software which allows us to approach the micronization process based on proven methodology and in a comprehensive manner. Briefly we can say that we have the technical capability to make the micronization process an easy process routine to validate/revalidate.

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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

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Let’s see our Advantages in detail

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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

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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

  • f

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.

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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

  • perate in a worldwide market.

We are prepared to commission and finalize our machines to your process requirements at your facility.

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Prototypes

We are able to handle projects which do not seem to be practicable and we address the problems by sharing knowledge gained in

  • ther 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

  • ne of these.
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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.

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Milestones & References

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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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References

 BRAZIL

Cristalia Produtos Quimicos Farmaceuticos Ltda

EMS S/A

IIPF – Instituto Internacional de Pesquisas Farmaceuticas

Libbs Farmaceutica Ltda

 CHINA

Army Medical University

Asymchem Life Science Co. Ltd

Harbin University

Jiangsu Aosaikang Pharmaceutical

Jiangsu Chia-Tai Tianqing Pharmaceutical Co. Ltd.

Shandong Bio-Drug Study and Research Institute

Shanghai Chenpon Pharmaceutical Co. Ltd

Shanghai Fosum Omni Pharmaceutical

  • Co. Ltd

Shenzhen Wanhe International Co. Ltd.

Yancheng Xinyi Pharm & Chem Co. Ltd.

 CROATIA

Pliva

 GERMANY

Wolff Cellulosics

 HUNGARY

Xellia Pharmaceuticals Ltd

 INDIA

Aarti Healthcare Ltd

Apex Laboratories private limited

Aventis Pharma Ltd

Panacea Biotech Ltd

Shasun Chemicals and Drugs Ltd

Sparc Ltd

Sun Pharmaceutical Industries Ltd

 INDONESIA

Bernofarm Pt.

 IRAN

Aryan Beris Co. Ltd

Azad University of Tehran

B.P.O. Research Center

 JORDAN

Polyplain Industries

 ITALY

3V Sigma Spa

A.C.R.A.F. Spa – Angelini

Arsonsisi Spa

Barilla Spa

Chemessentia Srl

Ciriaf – Università di Perugia

Dipharma Francis Spa

Directa Plus Spa

I.N.F.N.

Henkel Spa

Lundbeck pharmaceuticals Spa

Microchem Srl

Pemco Emails Srl

Phytoremedial

Polimeri Europa Spa

Pulverit Spa

R&D Innovaction Srl

Società Chimica Larderello Spa

Solmag Spa

Soremartec Italia Srl

Università di Salerno – Dip. Scienze Farmaceutiche

Vamp Tech Spa

 MEXICO

Helm de Mexico

 SINGAPORE

3M Innovation Pte Ltd

 SYRIA

Asia Pharmaceutical Industries

 SWITZERLAND

Flarer Sa

Helsinn Chemicals Sa

Jetpharma Sa

Micro-Sphere Sa

Nestlè

Nestec Sa

Solmer Sa

 TURKEY

Kontrol Kymia AS

 UK

Genesis Biosciences

Resolution Chemicals Ltd

 U.S.A.

3V Inc. Georgetown

Technic Inc. Engineered Powders Division

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Case of Study

Inhalers

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Inhalers

Our customer is active in the market of pharmaceutical lactose, of dry powder inhalers and development of drug delivery systems. The specific product was Fluticasone Propionate CAS registry number [80474-14-2] and according to international Pharmacopeia (FDA BA-BE Draft Guidance 2003) it needs to be micronized in the range of 1 to 5 micrometer under identical parameters for suspension formulations. According to our customer’s past experience:

 Jet Milling was a technology with limitations on

producing the correct particle size distribution for inhaled APIs.

 It produced material with a significant amorphous

content, which in turn can influence the stability of the finished formulation.

 The

micronization process can lead to reproducibility problems and creates the potential for metal contamination from the milling machine.

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Inhalers

Tecnologia Meccanica was able to give a working process solution:

Our micronization technology with high pressure at reduced energy consumption was able right from the beginning to process the product and avoid the creation of amorphous content.

Our rheology analysis made clear that the product flow ability had not been previously considered during process development.

Consequently reproducibility and incorrect PSD were addressed by supplying our fluid jet mill with the correct feeding technology.

No metal contamination was found when using our process.

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Partners

Tecnologia Meccanica works worldwide in cooperation with:

for process gas technology and process gas supply

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Thank you

We thank you for your time & attention, We look forward to meet you in our workshop soon or at the next coming CPhI.