As seen in Manufacturing Chemist – December 2022 issue.
Established in 1949, Famar is a leading European provider of pharmaceutical manufacturing and development services. For 70 years the company has been a reliable partner delivering flexible solutions, from development to production and distribution of a broad range of pharmaceutical and consumer care products.
Over the years, the company has expanded its business and today counts a network of 6 production sites and 3 R&D centres in Europe, able to supply a wide range of more than 1800 products in a variety of dosage forms, in 80 international markets, providing development, manufacturing, quality, regulatory and logistics services for a wide range of products.
In Italy the Famar Business Unit is located in Baranzate (Milan) where they produce a variety of solid oral dosage forms (hard gelatine capsules, coated tablets, uncoated tablets, sugar-coated tablets, effervescent tablets, powders, granules, pellets).
One of the company’s latest investments is an IMA Adapta 100 capsule filling machine, able to produce up to 100,000 capsules/hour. Besides excellent accessibility, the machine allows you to dose up to 5 products into the same capsule thanks to its exceptional design flexibility and ensures maximum dosing precision and reliability even for filling product combinations or for powder microdosing. “Customers see our Business Unit as a producer and supplier of high-quality pharmaceutical products and services, on time, in full, at competitive rates and in a sustainable way” states Michele Vite, Production and Product transfer Manager. “We were about to receive a transfer for a very tough product which needed to be dosed in capsules and so we started looking for a capsule filler able to dose that kind of product”.
What basic requirements should the capsule machine you were looking for have?
Michele Vite: As stated, at the time of purchase, we were facing a request for an intercompany transfer for a very tough product. So basically the capsule filler we
were looking for should have possessed three main characteristics:
• Ability to dose two different kinds of powder into the same capsule.
• Ability to manage high plug hardness: one layer of the powder required a mandatory plug hardness, in an unusual range, to comply with a specific dissolution profile (i.e. modified release drug).
• Ability to achieve a high production rate, as our goal was 100,000 capsules/hour.
What were the critical issues of the product to be dosed in the capsules?
Michele Vite: Actually there are two critical issues relating to the product. The first is that 2 different powders must be dosed into the same capsule and each powder should be duly dosed. The second and most tricky issue regards the plug hardness of one of the powders, which reaches up to 100N of core hardness. So we were looking for a capsule filler able to manage this kind of force, ensuring final product quality and also high performance in terms of production rate.
What was your main reason for choosing Adapta 100?
Enrico Russo: To be honest, IMA was not our immediate choice for this project. We scouted for different options and we made several tests. As said, the product to be filled into the capsules poses a few problems. In the end we chose Adapta for three main reasons. The first one is the speed that can be obtained even in multilayer configuration. Adapta can ensure a high production rate even when we dose more than one product into the same capsule. Tests demonstrated that Adapta was 50% faster than other capsule fillers on the market in multilayer configuration. The second reason is Adapta’s flexibility and ability to dose up to 5 products into the same capsule. Moreover, its dosing units can be easily removed and are interchangeable, making it possible to plug-and-play shift between different machine configurations and filling combinations (powder, pellets, minitablets, tablets, capsules). In the end, such a flexible machine is also user-friendly and easy to use. Once the machine doors are opened, the working area is completely accessible, also making cleaning operations very easy.
What are the three most appreciated features of the machine?
Michele Vite: easy question!
• Reliability. We are sure of producing high-quality capsules even in the most difficult conditions.
• Smartness. As said, the machine is easy to use, changeover time is very limited and maintenance operations are fast and easy. Besides that, the IMA hot line service is always available when needed.
• High-quality construction (materials fully compliant with the GMP and FDA regulations).
How about your collaboration with IMA?
Enrico Russo: IMA, for Famar Baranzate team, was a strong player and a well-known company but one we had never used in the past.
The key to the success of our collaboration with the IMA team can be split into two important phases. Firstly, price. The application that IMA proposed to us was duly quoted and in the range that we expected. Despite this, they made a strong commercial effort in order to obtain a competitive final price. After installation of the machine, I want to emphasize the huge proactivity of the IMA after-sales team. The machine needed improvements to reach the expected plug hardness: IMA service, as the first response, allowed us to close the validation batches of the product in time (with quick and successful changes) and, in a few weeks, changed the project of the machine itself, adapting the mechanical parts at the core of the process to the needs of the product powder.
Listing the main tasks performed by IMA, we can say:
• Attentive support during the verification of the results after the first production batches thanks to the constant support of lab technologists.
• Technical intervention on the machine with professional and well-trained technicians.
• Innovative solutions and modifications were introduced to reach the goal expected by Famar’s customer.
• Very positive approach, flexible and open-minded technical experts willing and keen to accept advice coming from Famar’s field: focused on core changes of the first project instead of merely technical repairs.
• Good cost management.
What are your plans for the future?
Michele Vite: We have been successful in expanding our production. To support this trend, we plan to increase the production efficiency and capacity in several production areas, also introducing the ATEX capability to produce solid oral products managed with non-aqueous solutions.