The Romaco Group, a leading global supplier of processing and packaging equipment, predominantly for the pharmaceutical industry. will present highly efficient solutions for primary packaging, aseptic filling, granulation, coating and tableting of pharmaceutical products based on the Noack, Macofar, Innojet and Kilian brands at CIPM China in Chongqing from April 20 to 22, 2018
The Romaco Noack NBP 950 rotary sealing blister machine is suitable for a wide range of products. The blisters can be arranged either lengthwise or crosswise to the running direction. Numerous blister layouts with different cavity geometries can be realised in this way. This extraordinary flexibility as regards the format design opens up countless possibilities for manufacturers of blister packaging. The cGMP compliant machine impresses with an advanced level of automation and format changes can be completed in a very short time. The fully interchangeable QuickFeed unit speeds up product changes by providing a second unit. QuickAdjust – the automatic station control system – adjusts the sealing, coding and perforation processes. This saves time and materials during the run-in following a job change. The blister machine is soon prepared for the next job thanks to the optimised retooling and cleaning times. With a maximum output of 500 blisters per minute, the Noack NBP 950 is the ideal solution for small to medium sized batches.
The Romaco Macofar MicroMaxX 18 microdosing machine processes pharmaceutical powders with different flow properties as well as freeze-dried products and sterile liquids. The system is equipped with a dual dosing disc which allows multiple dosing into the same vial; alternatively, the product can be filled in two separate process steps. Furthermore, even very small product quantities right down to 25 mg can be dosed precisely. Thanks to an innovative in-line weighing system, one hundred percent weight control is now possible for the first time. The machine achieves a maximum filling speed of 12,000 vials per hour. Up to 18,000 vials an hour are possible in the version with statistical weight control. The Romaco Macofar MicroMaxX 18 can be supplied in different containment designs. Automated processes ensure reliable operation and meet the high cGMP requirements for dosing sterile powders and liquids.
The laboratory-scale version of the Romaco Innojet Ventilus V 5 is used for granulating, drying and coating particle sizes from 10 µm to 2 mm. Due to its special design and enhanced processing efficiency, the Ventilus V 5 allows up to 25% shorter batch times. The homogeneous flow conditions inside the cylindrical product container enable extremely gentle intermixing of the batch. The process air is controlled by the Orbiter booster, an ingenious container bottom consisting of overlapping circular plates. Together with the Rotojet, the central bottom spray nozzle, the Orbiter booster forms an innovative functional unit that meets all the requirements for linear scale-ups. The air flow bed technology ensures accurate control of the product movement and equally precise application of the spray liquids. The resulting formulations can achieve the required release profile with between 10 and 15% less spray liquid.
The Romaco exhibit will also include the innovative Innojet IHD 5 hot melt device for pharmaceutical applications. This CIP capable device complies with all GMP requirements for coating and granulation with organic waxes and fats. The fact that there is no evaporation during the hot melt process is a crucial advantage. The processing times are up to 85 per cent shorter as a result. What’s more, since there is no need to heat the air in order to dry the product, energy efficiency is improved. The IHD 5 features a design with all components – including the valve block, dosing unit and melting container – integrated in a compact, block-like housing. This makes it easy to connect the mobile device to the Ventilus® V 5 whenever this is called for by the formulation. All laboratory equipment in the Ventilus V 5 series can simply be fitted with the spray air heater which is essential for hot melt applications. Heating the system to 120°C prevents the coating liquid from cooling down in the feeding channels and clogging the spray nozzle. The pulsation-free application of the pharmaceutical hot melt coating ensures outstanding precision and product quality.
The Romaco Kilian STYL’ONE Evolution single-stroke press is the ideal solution for laboratory applications, whether for developing new formulations or for scale-up tests. It achieves a maximum output of 1,750 tablets per hour in configurations for mono-layer, multilayer or core tablets. The compression cycles have been speeded up by more than 60% and the maximum compression force increased to 50 kN in order to simulate high speed presses. Compression force profiles for all standard rotary presses like the Romaco Kilian KTP 420X can now be determined at full power. ANALIS, the intelligent PAT software, calculates all relevant tableting parameters based on compression force or displacement controlled cycles. The remarkable precision of the test batches means powder properties can be analysed very realistically. The STYL’ONE Evolution can thus also be utilised to optimise processes or troubleshoot errors.