Containment

Jetpharma is fully equipped for the micronization of highly active and cytotoxic ingredients. The Company has been authorized by Swissmedic to manipulate such substances since 2004. The adopted isolators have been designed to guarantee not only the maximum containment possible, but also to offer the largest flexibility of use combined with the ergonomic handling of the micronization process.

Isolators

Jetpharma is equipped with two negative pressure isolators for the micronization of highly active and cytotoxic ingredients.

•          A Glove Box (reference: picture 1) equipped with a MC Jetmill® 50. This mill allows the micronization of small size batches, from 25 g up to 20 kg per batch.

•          An Half Suit Box (reference: picture 2) equipped with a MC Jetmill® 200, Mc Jetmill® 300, Pin Mill UPZ 160. These mills allow the micronization or milling of quantities from 500 g up to 1,000 kg and more.

The two plants have been developed in close co-operation with our technical area managers in charge of the micronization process and with the engineers in charge of the plants design. Thanks to the synergies and specific expertise of the two working groups, we have succeeded in keeping a peculiar feature and strong point of Jetpharma constant: the flexibility in complying with and satisfying our customers’ specific requests.

Containment

Our isolators have been qualified in compliance with GMP requirements and with reference to their containment capacity. After the Containment Performance Assessment, both isolators showed a

Level of Containment < 25 ng/m3 (8h-TWA)

This assessment, measured by using a surrogate during the plants certification process, showed a very lower value during the tests performed on specific substances.The containment capacity of our isolators is periodically assessed according to in-house protocols in compliance with the highest international standards.

Categorization and Classification

Jetpharma performs an accurate analysis of the risks connected with the micronization of the different products that the Company is charged to micronize also through an assessment of the exposure level to be complied, in order to guarantee the safety of its staff. Depending on the assessment result, a proper level of containment is defined so as to guarantee safety through every stage of product manipulation. The Company has also implemented an in-house safety procedure in co-operation with external consultants. Our procedures system for safety and environment, consistent with state-of-the-art international standards, allows to help and maintain under control the training of our production team. The several audits by our customers allow us to constantly test and improve our goals of safety and environment safeguard. A programme of environmental monitoring is periodically implemented to assess and guarantee the maintenance of standards which the Company pursues as its primary goal.

Conclusions

The methods and procedures above described have allowed us to develop specific micronization processes for highly active and cytotoxic ingredients which, following the different stages of clinical experimentation, were successfully launched on the market all these years. In this natural process of a pharmaceutical product’s development, Jetpharma has always been up-to-date providing its customers with the best performances and the highest co-operation in order to guarantee the success of their investments.

 

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