Expertise in Synergy - Glatt

More documents

Recommendations

Info

EXPERTISE IN SYNERGY As over fifty years ago Werner Glatt switched his production from oven pipes to fluid bed dryers, he would never ever have dreamt that his small company consisting of 12 employees would, within half a century turn into a group of companies employing over 1500 staff. Having become internationally renowned as one of the world’s major manufacturers of fluid beds for the pharmaceutical industries, with equipment meanwhile extended to a wide range of processing lines, including product handling systems and related logistics for all powder processing industries, where processes add considerable value to the product. List of contents Expertise In Synergy 2 page PAT Integration Into Process Automation 3 - 4 Test Instruments / Customer Data Base 5 About TTC 6 Extended Services: Software Hotline 7 hollomet, Innovations In Cellular Materials 8 - 9 Genzyme And Glatt 10 - 11 ADD Technologies Ltd, Reinach, Switzerland 12 Glatt Builds Sodium Cyanid Factory For Lukoil Glatt – New Filter Design For More Flexibility 13 Of Continuous Production Plants 14 Spotlights TTC 146 15 -16 Multiparticle Dosage Forms TTC 150 17 Functional Filmcoating 18 TTC Program 2009 19 Glatt Group Service Range 20 Published by: GLATT INTERNATIONAL 79589 Binzen, Germany Ph: + 49 (0) 76 21 / 664 319 Fax: + 49 (0) 76 21 / 16 799 200 E-Mail: bianca.nowak@glatt.com http: www.glatt.com Editor: Klaus Eichler Production: Bianca Nowak Alison Russell By Klaus Eichler, Editor This may well be a sophisticated controlled release drug tablet or pellet, but also a functionally coated food or feed product, or a delivery system for a cosmetic product. In the millennium of communication neither the equipment manufacturers, nor their customers are reluctant to share and use the know-how and process understanding acquired by other industries. Nevertheless, true process understanding is only gained by extensive own use of the processing equipment manufactured at the various Glatt sites; warranted by our IPC division, contract manufacturing food, feed, fine chemical and cosmetic products 24 hours a day, 7 days a week for the past 15 years. The empirical know-how can thereby be gained and converted into equipment specific for each project by our engineers. In contradiction to certain contemporary statements, I believe that quality is not achieved by design, but by continuous improvement, as nature did for the last 4.5 billion years. Hence, it was just a logical conclusion that we got involved in process and product optimization, and finally the formulation of own and contracted products, which also requires sound process understanding if one wishes to formulate around a robust and economical technology, presently being achieved by our divisions ADD and Glatt Pharmaceutical Services with great success. No wonder we then created our division Pharmatronic, which qualifies and validates processes; and TTC, which stages regular international workshops on process technology. No surprise, that there is also an industrial engineering company in our group, having designed and built numerous processing plants worldwide, and is currently in the process of building a blood plasma separation plant for the Russian Health Ministry. It may however be surprising to find a company such as Hollomet in our group, developing new construction materials. The riddle is easily solved. If one considers that Hollomet’s first new materials were based on one of our Glatt technologies, which subsequently unite all others in the group, they can always call on specific know-how available within the various divisions to continuously improve their products or services, by means of a quite easy formula: Success through Synergy. 2 International Times No. 27 · March 2009
PAT Integration Into Process Automation Raw materials API’s Identification Humidity, Quantities Wet Granulation Oral Dosage Forms – typical process steps & their PAT application By Ralf Kretzschmar, Glatt Dresden, and Thomas Hofmaier, Glatt Binzen In recent years near-infrared spectroscopy, as well as other online measurement systems (e.g. particle size or solid flows) have gained growing interest within the pharmaceutical industry for both quality control and process monitoring [1]. In order to understand the process, one main key of the PAT initiative, online measurement is an important parameter for a successful PAT implementation. The second, with at least similar importance is the processing of these measurement results to reliable rules for the process and finally the control of the process accordingly. Typically these online measurements not only generate one ingle signal – such as the product temperature PT100 probe - but generate a set of actual values in a “spectrum” which typically do need some sort of “multi parameter interpretation” to be able to generate some reliable algorithms for the final process control. GLATT has integrated these systems into process automation solutions such as MegaView or EcoView. With an increasing number of projects, we have started to develop and maintain standard interface modules for these PAT applications – for example for solid flow measurements within the Wurster tubes, particle size measurements with the PARSUM devices or for NIR/MW systems in various process applications. Besides our solutions customers worldwide are typically requesting their favorite sub-supplier to be integrated. We do recognize an increasing number of NIR or microwave system suppliers, each of them having their strengths and weaknesses depending on the specific application and product. Therefore, we have not just focused on one system, but have rather added most of them into our application library. For example NIR/MW: Pharmaceutical applications of near-infrared and/or Microwave spectroscopy present both chemical and physical information in development or production. “Nowadays NIR/MW is used in both off and on-line applications in various pharmaceutical industrial process control applications. Continuous monitoring of quality is essential for PAT. The power of NIRS for PAT is based on its speed and nondestructive nature, which allows the analysis of intact dosage forms or intermediate forms (e.g. granules, pellets) for chemical and physical information [1]. Besides NIR you might see similar benefits in online particle size measurements. Pellets Drying Granulation, Coating, Milling Humidity, Endpoint of Wetting and Drying, Pellet Agglomeration Particle Size Control Particle Size Distribution (Fluid Bed, Milling) Fluidization Control Monitoring against Reference Batch But how to implement them into the process controls? Below, the 4 typical areas of integration: 1. Automation of reading cycles and management of cleaning cycles 2. Systems setup 3. Signal processing and data interpretation 4. Implementation into process control (trip points, monitoring and alarming) Ad 1. Cleaning of the sensor head is essential in most cases. This can either be achieved with liquid (the sensor is flushed in cycles) or compressed air. Process automation manages the valves for the cleaning media and their cleaning cycles, and reactivates the measurement once the cleaning has been carried out. Very often these cycle parameters are product related, and therefore become part of the Megaview or EcoView recipe system. Ad 2. Typically the sensor works with a set of parameters defined during setup/calibration of the system. In some cases these parameters for each product have to be defined individually and are stored and maintained within the sensor device. Here the setup of the system has to be triggered by the GLATT control system before starting the batch. In these cases we download the actual Fig. 1: Monitoring with NIR at a GLATT fluid bed Photo with courtesy from Sentronic GmbH Blending Compressing Homogeneity Hardness, Compression Rate Coating Coating Thickness, Dissolution Profile International Times No. 27 · March 2009 3
Page 1: International Times No. 27 · March
Page 5 and 6: Test Instruments / Customer Data Ba
Page 7 and 8: Extended Services: Software Hotline
Page 9 and 10: globomet ® are metallic hollow sph
Page 11 and 12: esponsibility have to be defined, q
Page 13 and 14: Glatt Builds Sodium Cyanid Factory
Page 15 and 16: SPOTLIGHTS ”Yes we can“ UL Cert
Page 17 and 18: Background More and more pharmaceut
Page 19 and 20: TTC PROGRAM 2009 NO. WEEK DATE TOPI

Expertise in Synergy - Glatt

You also want an ePaper? Increase the reach of your titles

Delete template?

Save as template?