We are in Aprilia, in the brand-new laboratories of Angelini Fine Chemicals, Business Unit of Angelini Pharma specialized in the production of active ingredients, for the installation of a High Containment Isolator Series (HC-IS), compliant with GMP Directives and certified class 2 tightness, according to ISO 10648-2.
We reached out to Angelini Pharma’s Fine Chemical Process Development Manager – Guido Furlotti – to get his unique perspective. The result was a captivating report on the role that a high-performance containment system can have in the management of a state-of-the-art laboratory such as that of Angelini Fine Chemicals, committed to the production of active ingredients for private brands and research, development, and production of chemical processes for the preparation of active pharmaceutical ingredients (API) or advanced intermediates on behalf of other pharmaceutical companies.
What are the production requirements that brought you to look for containment devices on the market?
Angelini Pharma is investing in the Aprilia site, implementing production plants for “High Potent” products both on an industrial scale and on a kilo scale. The unit I manage, Fine Chemicals – Process Development, deals with the research and development of new synthesis processes ranging from the laboratory scale to the kilo scale. Currently, not having systems allowing for the manipulation of High Potent products, we decided to purchase a Tema Sinergie isolator.
Why did you choose an isolator system instead of other, perhaps cheaper, containment technologies?
The isolator is the most appropriate system to ensure the safety of operators who manage high potent substances. In choosing the technology to be acquired, the Company decided to consider the protection of workers’ health as a top priority.
What are the main issues related to the development and production of products with high pharmacological potency? How can an isolator with such a high level of safety help in preventing or solving these issues?
The use of an isolator, which provides containment up to OEB5, greatly expands the range of chemicals that can be prepared in our laboratories. The isolator expands the business potential of a CDMO structure like ours. In addition, we have improved a technological aspect that will allow us to ensure operational continuity from R&D laboratories to production.
Has the introduction of an HC-IS series containment isolator with these features and performance changed your working methods? If so, how?
The introduction of an HC-IS series isolator, not only changes our working methods but above all, it will allow us to broaden the spectrum of chemicals on which we could carry out our research and development activities. Previously we couldn’t perform experimental activities on certain classes of pharmacologically active products (e.g. anti-cancer, hormones). Now, with the introduction of this new collective protection system, we can do that.
What are your plans for the use of the recently installed HC-IS Series containment isolator? How will you use it? For what kind of activities? Which substances in particular?
In compliance with the obligation of confidentiality, I can say that the projects currently underway in our laboratories are several. In addition, we are considering the study of a synthesis process for a pharmacologically active product acting on the central nervous system that requires a very high level of containment (OEL 0.5 μg/m³). Only with the availability of an isolator like the one Tema Sinergie supplied us, we can approach a synthesis process of this type of compound.
How was the collaboration with Tema Sinergie?
The collaboration with Tema Sinergie was a great opportunity. Right from the beginning, the economic and technological aspects have been dealt with clarity and in detail. In the design phase there was maximum availability in responding to our needs, which were defined as the project progressed and which had as their goal the achievement of a “flexible” machine that could be used on different projects. The technicians of Tema Sinergie proved to be perfectly “at ease” in managing the installation and the training in a site unknown to them and in a period of heavy “Covid constraints”.
It’s too early to say, but are you satisfied with the operation and performance of the HC-IS isolator for this first training period? Does it meet your needs and expectations?
Yes that’s true, It’s only been a short time since the implementation of the isolator and, above all, we haven’t tested it enough yet. For now, however, the machine has fully met our needs.