Interviews: Medical

Strategy is quality

Interview with Gianfranco Citterio, Managing Director of Plastiape

Plastiape, with headquarters in Osnago, Lecco (Italy), was founded in 1970 thanks to the initiative of Mr. Citterio and Mr. Magni, that still manage the Company today. The Company has been constantly growing from its foundation to the present, reaching an annual turnover of over 22 million euros. The 700 different articles produced by the Company are mainly for the pharmaceutical (55%) and personal care sectors (35%). 70% of the production is exported. Core business: actuators – for valves and pumps – and medical devices used for inhalation therapy.

What do you think is important for a company in your sector in today’s market?
Citterio: I think that product and service quality are always the first thing that a customer requires from a strategic supplier. Furthermore to be able to work in the medical devices sector it is necessary to give a high quality level even
from a formal point of view: this means that each product and each process must be accompanied by a series of documents that meet the rules and requirements issued by the qualified corporation of each nation that you wish to export to. Besides having a system of procedures that bear a certification of the quality system, it is also necessary to develop deep competences in the editing field of Technical Files and Drug Master File, in the validating of the product, of the plants and the environments, in the processing of the risk analysis etc. Once you have reached a high quality level, I think it is of fundamental importance to be strongly committed to research and development in such a way that you are different from the competitors and so able to anticipate the market demands instead of going along with them.

Consequently, what have the choices of the Company been?
Citterio: The market is hardly predictable. Plastiape’s choice is however to continue to accompany the traditional packaging with the planning and production of complex articles, investing in highly automated productions and in work environments suitable for the production of pharmaceutical and medical articles. This strategy is closely connected to the origin of the company. Just think that the first “clean room” production for dry powder inhalers (Plastiape’s top product today) began in the early seventies, when this product typology were more or less unknown and white room productions were still few.

What are the market trends for clean room productions?
Citterio: The pharmaceutical companies are demanding more and more products that were produced in traditional environments up to now, be produced in clean room environment. It is necessary though to clarify that the concept of “clean room production” does not necessarily guarantee a sterile product in the outgoing production process.
Not all the white rooms provide the same performance level: in fact there are specific reference regulations that indicate the rules and limits for room classification. The most appropriate class is chosen according to the maximum level of particle contamination compatible with your own process. Plastiape, in this particular case, owns a molding division in the 100,000 class and various assembly divisions in the 10,000 class. We are noticing a general tendency to raise the cleaning requirements, both in the internal and foreign markets. This requirement can be satisfied only with the setting up of productions in classified environments.