MG2 Pharma Zone:

the perfect R&D environment for Chiesi Farmaceutici

 

Chiesi: a worldwide leader in the pharmaceutical industry, with both specific needs in terms of product development and the declared need to be in constant touch with the onsite engineer staff. The target? Promoting the information exchange, but also constantly keeping under control performances and technology: these are the key elements of the successful cooperation between MG2 and Chiesi Farmaceutici

The partnership with Chiesi results from the need to test those formulations which have not yet been launched on the market to study their behaviour during both the delicate capsule filling stage and the weight control phase. These are two MG2 assets, in particular as far as inhalation pharmaceutical products are concerned, on which the company, based in Pianoro, has been working for many years in cooperation with some international research associations like RCPE in Graz, in Austria and the Parma University in Italy. Beside this close cooperation with the academic community, MG2 is also cooperating with some leader producers of both excipients and capsules.

While handling DPI – Dry-Powder Inhaler –, powders for inhalation purpose and any inhalation pharmaceutical product, one of the biggest challenges consists in the development of the filling step by means of automatic machines. This is a critical phase due to both the involved product quantities, namely low dosages ranging from 5 mg to 40 mg, and to weight changes which must comply with fixed tolerances being obviously particularly tight.

In fact, the required mechanical stress to withdraw powders and then transfer them into capsules strongly affect the inhalation performances of the pharmaceutical product; this issue makes it necessary to identify the correct machine set-up to reach an accurate dosing result without compromising the aerodynamic profile.

Chiesi decided to face such a challenge in partnership with MG2 to test new products. This cooperation takes shape not only under the analytic / chemical-pharmaceutical point of view, but also under the technological profile, thus turning in an advantage for both the production standard and the products final users: the patients to be treated.

A strong point of this cooperation is represented by MG2 position on the market in that MG2 technology is chosen by most of the DPI capsules producers: a technological leadership now strengthened by a real trump card: the Pharma Zone.

The Pharma Zone area totally complies with the pharmaceutical standards, thus offering a simulation environment particularly suitable for R&D purposes. MG2 Pharma Zone means high safety level for operators in all working conditions, such as either handling dangerous powders or running tests on powder behaviour under different Hr% e T° environmental conditions.

Pharma Zone is then the perfect instrument to create a constant dialogue between technicians and researchers, thanks to the immediate access to MG2 technology, but also to the company culture which considers the cooperation with the customer as a primary asset.
The continuous changes, also in progress, together with the evaluation of both tests’ development and real productions, turn Pharma Zone into the perfect environment for 360-degree trial: a strategic instrument to also test products during the steps just before the beginning of actual production.
MG2 is therefore able to create a partnership with customers which asset is represented by the constant cooperation in technological the development of powder.

Under the operation point of view, the cooperation with Chiesi followed a standard process, which started with laboratory tests, particularly focused on machine set-up logic.

This first stage has considered manual tests, which allows MG2 to choose the best dosator and to define the necessary adjustments to arrive at the required net weight. This is an essential phase in order to identify possible problems and their solutions.

At a second stage the short run is carried out. They are small productions, made under different operation conditions and they are necessary to identify the best machine set-up by considering the particularly small quantities of the involved material. This is the closest stage to the actual technology which will be then utilized during the actual production and it is of primary importance, with its filling tests and its speed tests, to obtain the best solutions, both in terms of dosage accuracy and in terms of inhalation performances.

Each result is made available to Chiesi to be applied to their analysis on both content uniformity and compliance with the required standards, thus making it possible to identify the mechanical stresses exerted by MG2 machine dosators to both keep and dose the powder inside the capsule body.

Short run represents an essential step before the long run stage in that it is the simulation of an actual batch which will be produced by the customer at a later stage. This test allowed to find many criticalities, to face them and to defined special solutions for some dosages.

The constant cooperation with Chiesi, made it possible to reach the best results thanks to the quality of MG2 equipment on the one side and the expertise of its technicians and chemists on the other side.
A 360-degree professionality which, integrate to Chiesi researcher’s expertise, guaranteed a complete support during all experimental and operational steps of the product development.

To sum up, MG2 and Chiesi built a compact team, in the service of the result excellence: the perfect recipe delivered to whom takes care of actual production, but always assuring the presence of MG2 technicians to control all the machine operational phases.

Product development by steps and increasing complexity, where the team is who wins: this is how Chiesi and MG2 are working in a partnership.


MG2. Keeping ahead for you