77 production lines, over 150 customers, more than 400 products manufactured, 21,000 square meters for plants in Nembro, Brembate and Zingonia, over 100 million Euros of turnover. These are the numbers for Fine Foods & Pharmaceuticals NTM, innovative Contract Development & Manufacturing Organization (CDMO) of Pharmaceuticals, Nutraceuticals and Medical Devices in solid oral forms. Beyond the numbers, a vision. Research for quality and compliance with the most restrictive standards characterize Fine Foods’ production: tablets, capsules, granules and powders, packaged in sachets, sticks, strips, blisters, jars and bottles, produced in ranges from 50 kg to 2,000 kg. And the numbers are expected to increase further: the company has planned a significant expansion of the pharma production, which could be followed shortly by an expansion of the food line of business. Fine Foods in fact is increasingly directing its production towards the acquisition of medium-large batches of solid dosage forms. «Fine Foods has been very successful in expanding the pharmaceutical revenues via the growth of existing customers, acquisition of new customers and new production», says Giorgio Ferraris, CEO of Fine Foods. «To support our historical trend, we plan to expand the plant in Brembate, on the one hand to merge the production currently located in Nembro, on the other hand to increase our production capacity by at least 30%». It is in this context that took place the installation of new coating equipment in the site of Brembate. «We were looking for a coating system that would ensure us four advantages: full adherence to GMP standards, ability to handle from medium to large batches, ease of cleaning operations and efficiency in the production cycle management. We found them all four channelled into Perfima».
Perfima is the top of the range of perforated coating pans made at IMA. The key feature in a coating process is the mixing efficiency. Combined with effective spraying and drying systems, an efficient mixing capability allows to uniformly distribute the solution on the cores, minimizing the losses of coating and the contamination of the coating pan. It is following this input that IMA Active designed Perfima: the shape of the pan combined with the mixing baffles positioning on the central sector of the drum ensure a perfect and uniform mixing of the cores. The mixing capability is assured in case of minimum or maximum quantity of product, allowing a wide range of batches to be processed in the same machine (from 25% to 100% of the pan capacity). Perfima spray guns feature an Anti-Bearding-Cap (ABC) system avoiding guns clogging while the machine is working. Fitted on a sliding support arm adjustable from the outside, the spray guns can be easily changed, calibrated and cleaned. The machine is equipped with a completely automatic Clean In Place system validated by IMA in collaboration with the University of Parma (Italy). The cleaning cycle can start immediately after the process without any need to install additional devices: cleaning nozzles and spray balls cover all the machine’s areas to be cleaned. «Pefima’s Clean In Place system has modernized our approach to the cleaning phase», says Mario Barbini, Director of Pharmaceutical Activities of Fine Foods. «Thanks to Perfima, we halved the washing time, gaining a batch of production a day. In just over two hours the pan is washed and the room stays clean». It is not only for the technological advantages of its machines that Fine Foods chose IMA. «IMA Product Managers networked excellently with our technicians», continues Mario Barbini. «Our installers and IMA designers worked side by side to define the project specifications. All the machine’s devices have been explained and tested in such a way that, during the installation, there was good familiarity with the system». The timing, afterwards, is self-evident. «Three and a half weeks after the machine’s delivery we were ready for the SAT (Site Acceptance Test)».
During the session of preliminary tests held on the Perfima 200 installed at the IMA Active Laboratory, some of the most challenging Fine Foods’ processes were tested. The first step was to test both on minimum and on maximum batches a very diluted nutritional coating solution. The result of the test conducted on the minimum batch has allowed to achieve a weight gain of 3.7% in about one hour of spraying.
The second step was to test an active ingredient sensitive to light and to acid rate to be coated with three different layers to ensure both the total protection and the gastric resistance of the tablet.
The collaboration between IMA process technologists and Fine Foods’ specialists has led to excellent results from the very first tests, optimizing the use of the three suspensions in sequence and the related processing times.
The challenge has been to check the performance in a three-layer film coating process both on minimum and on maximum batches in the same pan, without any changes in the machine’s set up. The excellent results gained during the preliminary tests were confirmed afterwards, once the equipment was installed and put into production: the processes have been easily transferred from the old technology to Perfima, allowing a reduction in process time of 30% compared to the past.
|Batch size (kg/L)||38.8/65.7|
|Pan speed (rpm)||1||4||1|
|Inlet air quantity (m³/h)||2,500|
|Pan neg. pres. (Pa)||-30|
|Inlet air T° (°C)||70||60 – 75||10|
|Cores T° (°C)||up to 40||42-46||up to 30|
|Atomis. pressure (bar)||–||2||–|
|Pattern pressure (bar)||–||2||–|
|Spray quantity (g/min)||–||167||–|
|Gun type (-)||4 – ABC on PCA arm|
|Nozzle diameter (mm)||1.5|
|Gun distance (cm)||22|