Dear Sirs, In this paper we would like to present you parameters and capabilities of our process-homogenizing devices for pharmaceutical and cosmetic products manufacturing. Among the machines we produce you can find homogenizing and processing mixers, preheating vessels and storage tanks as well as transfer systems for liquid and paste-like high viscosity products. In order to meet the market requirements we introduced into production the homogenizing mixers in accordance with scale-up procedure which means that every essential parameter such as: anchor agitator and homogenizer linear velocity, construction of the vessel as well as heating-cooling jacket are designed in a way to make possible to transfer the production formula from small capacity mixers into larger ones in conformity with FDA. We are the first company in Poland (third in Europe) which manufactures devices based on these rules. This conception enables user to elaborate new recipes and prepare new technological assumptions on laboratory mixers and proportionally transfer them to bigger mixers. These innovative solutions have following advantages: savings in raw materials as well as utilization costs (thus minimizing the environmental pollution) and savings in energy required to manufacture products based on new formulas where, for instance, in 5 liters mixer much less amount of components is need than in factory scale machine. Nowadays all our processing devices are made in accordance with these rules, and homogenizing mixers have been split into two series of types: MZUTL homogenizing mixers with integrated cover lifting system e.g. 200 liters MZUTS homogenizing mixers with cover screwed to the vessel including CIP system e.g. 3000 liters Firm Urliński. Manufacturer of process machinery for cosmetic and pharmaceutical industries. Polska, 04-987 Warszawa, ul. Wał Miedzeszyński 172, tel. /+4822/ 893 82 10 12, fax /+4822/ 893 80 65, www.urlinski.com.pl, e-mail: export@urlinski.com.pl PEKAO S.A. w Warszawie, ul. Grochowska 124/126 Acc. No 55 1240 6133 1978 0000 4802 8550 VAT PL 113-011-29-33
Homogenizing mixers type MZUTL with cover lifting system (from 5 to 1500 liters) have been successfully produced by us for many years. Laboratory homogenizing mixer type MZUTL 5 C They have important advantages: - unlike many competitors, the number in type of homogenizing mixer, informs customer about mixers work volume e.g. MZUTL 1000 C means 1000 liters of useful volume while total volume is 1450 liters - mixers are equipped with cover lifting system (the lid can be raised together with stirrer over the vessel) which makes possible to examine the cleanliness condition of the machine as well as inspection of mixing subassemblies. Cover lifting system solution allows the machine to work in clean zone. All our lifting systems are equipped with overload valves and protection against lid falling down in case of leakage in the system Homogenizing mixer type MZUTL 1000 C - for small capacity homogenizing mixers MZUTL 5-15-30) we use standard, proven lifting systems based on pneumatic actuators of reputable manufacturers - in order to lift the cover of mid-size homogenizing mixer (MZUTL 50-100-200-250) we constructed special device which is a combination of pneumatic actuator including stable slides of Urliński with additional hydraulic suppressor to ensure smooth lifting and lowering - in factory scale homogenizing mixers (MZUTL 300-600-750-1000-1500) we install hydraulic lifting system including two slide columns fixed to stable machine base - anchor type agitator with wave breakers (work effect is the same as in case of contra-rotating stirrer) and directing mixing blades for ensuring intensive mixing of the product in vertical and horizontal direction. During clockwise rotation product goes from the bottom, along the vessel walls, then down directly to the center where homogenizer is installed. This direction of rotation ensures there are no dead zones in the whole mixing area. Construction and work principles of URLINSKI homogenizing mixers 2 of 11
- use of wave breakers apart from their great influence on efficiency during mixing of elevated viscosity products, allows also for aseptic way of Pt 100 sensor installation and direct product temperature measurement without thermal permeation of the jacket - product scrapers are made of PTFE high chemical and thermal resistance material; their shape and special mounting on the anchor stirrer causes the product is scraped from the vessel walls either during left or right direction with the same high efficiency Two ways acting PTFE scrapers - thanks to infinitely variable regulation of the stirrer s rotations the Operator can adjust mixing intensity to product this system features machines identical construction in this series of types including different capacities mixers with maintenance of linear velocity ranged from 0,5 to 2.5 m/s Pt100 temperature sensor in wave breaker - change of the stirrer rotations direction (clockwise or counter-clockwise) enables to introduce components and mix them together with the mass inside vessel especially useful by powder form raw materials; it also allows user to clean the mixer accurately after process - strong gear motor of the stirrer ensures rotational speed is maintained independently on the product viscosity or density - new, highly efficient, four comb shape homogenizer of Urlinski company (x) adjusted to work in by-pass circulation pipe tangential to the vessel and made with inclination, secures gentle, without foaming flow of the product over the batch surface inside vessel Construction and work principles of URLINSKI homogenizing mixers 3 of 11
- optional short by-pass pipe helps in production of small batches as well as product-into-product recirculation/homogenization, which is especially important by foaming products manufacturing - short by-pass also allows user to introduce components directly into the product stream with use of sucking lance for instance powders/liquids or through optional, overhomogenizer inlet which enables to join/homogenize different initial temperature phases Homogenizing short by-pass Homogenizing long by-pass Homogenizing short by-pass + introducing components into by-pass Homogenizing short by-pass + feeding directly over homogenizer Homogenizing short by-pass + introducing components (powders) under product surface CIP cleaning in place with use of shower heads Construction and work principles of URLINSKI homogenizing mixers 4 of 11
- Urlinski company, in order to meet a scale-up requirements, designed 6 dimensions of homogenizers rotor-stator, 4-comb shape type with linear speed in range 6-26 m/s which can be raised up to 30 m/s if needed. It gives us the possibility of manufacturing homogenizing mixers with useful capacities from 5 to 5000 liters in accordance with above mentioned rules including motors from 4 kw to 55 kw - homogenizer sealing system SIC/SIC with blocking fluid and protection against dry work of the homogenizer (flow sensor) as well as optional monitoring of the level and pressure in alternative closed system, guarantees proper quality of the final product - easy to disassemble by-pass pipe gives possibility to examine the gaskets on pipe connections - complex system of optional auxiliary stub pipes and additional instrumentation offers the technologists an easy way to adjust the production process to wide range of products: funnel for liquid components introduction of small quantities of liquid raw materials during production process through stub pipes on the vessel lid or with use of CIP connection on the by-pass pipe sucking of powder components under the product surface helps to avoid dusting and production loss additional sight-glass on the by-pass pipe allows user to observe the product during homogenization process equipping by-pass pipe with heating jacket enables recirculation / homogenization of high point solidification products sterile and easy disassembled sampling valve, used to collect the product samples during production process without necessity of unsealing the vessel; easy manual washing and disinfection equipping venting stub pipe with sterile aeration filter, ensures the whole process runs in sterile conditions - in standard, homogenizing mixers of our production are vacuum proof which makes possible to run the process in vacuum conditions - overpressure proof performance of the vessel is in accordance with the directive 92/23-PED and makes possible it run the process at high temperatures and allows SIP sterilization - homogenizing mixers of Urlinski can also be designed to work with products from 1 class liquids dangerous fluids in accordance with directive ATEX 94/9/EC Important issue in pharmaceutical and cosmetic industries is to secure efficient and accurate cleaning after production process: - equipping our machines with CIP cleaning system shortens the washing time after production and saves media. Thanks to the fact that homogenizer is used as a pump for washing media circulation, there is no need to use additional pumps, which minimizes purchasing and maintenance cost - CIP installation is designed in such way it ensures accurate cleaning of all elements which have contact with product or its vapours through defined path of valves; example procedure: preliminary/rough washing: short by-pass, long by-pass, over homogenizer sucking pipe basic cleaning: washing with use of rotational CIP spray balls air adding stub pipe cleaning vacuum group cleaning Construction and work principles of URLINSKI homogenizing mixers 5 of 11
- construction of the vessel and homogenizer installed in the bottom center as well as whole process and cleaning installation design, helps in accurate discharging from the final, even high viscosity product and washings after cleaning cycle The lowest mixer point By pharmaceutical and cosmetics products manufacturing a thermal processing (heating / cooling) is often required therefore we equip our machines with channel jacket for liquid or gas form (steam) thermal agents. As far as heating and cooling conception are concerned, Urlinski company always installs the optimal solution for customer e.g.: - direct steam heating cooling with ice water including compressed air blow between thermal cycles; by direct steam heating we recommend divided jacket offering two zones of heating: only bottom or bottom and vessel - heating with hot liquid agent cooling with cold liquid agent - forced circulation with use of electric heaters cooling with cold liquid agent - heating: forced circulation with use of heat exchanger supplied with customer media: steam or hot water cooling by direct flow of liquid cold medium through the jacket - cooling: forced circulation with use of heat exchanger supplied with customer media such as ice water electrical heating - heating: forced circulation with use of heat exchanger supplied with customer media: steam or hot water cooling: forced circulation with use of heat exchanger supplied with customer media such as ice water Fully operational device, thorough manufacturing, effective mixing and highly efficient homogenizer together with the CIP cleaning system are the main advantages of our homogenizing mixers but not the only ones. Construction and work principles of URLINSKI homogenizing mixers 6 of 11
Our 25-years experience in designing and manufacturing of process machinery as well as many helpful remarks of our customers has contributed to creation of simple and clear for the Operator control system with a use of touch screen panel. The standard size of TOUCH 5,7 or 7 offers ergonomic and user friendly placement of functions setting and readout. Multi language interface All necessary parameters to set/readout and function touch buttons are available on one page Wide range of function modification and process parameters recording possibility Hysteresis setting Touch panel can be extended to 10 for control over machine s parameters including active process paths visualization: Construction and work principles of URLINSKI homogenizing mixers 7 of 11
or even 15 / 19 when few machines are considered to be controlled from one panel: Our offer comprises machines from MZUTS series of types including 100 up to 5000 liters mixers. These devices have their lid screwed with the vessel and features: - identical capabilities as in case MZUTL series of types but without possibility of cover lifting which significantly decreases price of the machine without quality and production ability loss - possibility to install the machine in low ceiling room - this series of types, in standard are equipped with rotational CIP spray balls and together with proper installation and use of homogenizer as a pump for recirculation of washing media, ensures fast, economic, accurate and what is the most important repeatable cleaning process of every part inside the vessel which has contact with the product or its vapours Homogeniznig mixer type MZUTS 5000 and MZUTL 5 Construction and work principles of URLINSKI homogenizing mixers 8 of 11
It is recommended to equip homogenizing mixer with an auxiliary phase mixer which can be built as mobile machine or become a processing set together with main process mixer. Processing set MZUTS 1000 and two chase mixers MZUTW 800, MZUTT 400 Urlinski individual approach to every customer and his product specification gives us the possibility to choose the optimal equipment allowing user to manufacture desire products currently produced as well as planned ones. Processing set MZUTS 1000 and two phase mixers MZUTW 1000, MZUTT 1000 Process mixer type MZUT 1000 Construction and work principles of URLINSKI homogenizing mixers 9 of 11
In order to convince our customers to Urlinski products quality and to show them great efficiency and possibilities of our solutions, we offer cost free test batch at our laboratory in Warsaw. Presently we can propose to make a test on: laboratory homogenizing mixer MZUTL 5 C with useful capacity 3 5 liters or homogenizing mixer MZUTL 15 C with useful capacity 7 15 liters. Construction and work principles of URLINSKI homogenizing mixers 10 of 11
For more information regarding quality and efficiency of our devices please refer to the website www.urlinski.com.pl where the full reference list can be found. Our customers from that list can confirm Urlinski s machines reliability. We also kindly invite you to visit our factory in Warsaw where you will have a chance to see currently manufactured machines for our customers. We also would like to inform you, that we are accredited manufacturer in Polish Agency of Enterprises Development ( PARP ) under number: 988/2005, which institution is a distributor of union subsidies for investments. We hope, you will take an interest in our offer and kindly invite you to visit our firm or contact us in order to specify your needs. Yours sincerely, URLINSKI Company Construction and work principles of URLINSKI homogenizing mixers 11 of 11