Micronization is undertaken using a range of fluid jet mills, conceived and designed by us and our services are requirable for APIs, steroids, cytotoxics and cytostatics, HPAIs, antibiotics (not Beta-lactams). Our spiral jet mills have been designed to guarantee precise scalability. This enables the active ingredient to be followed from its first R&D phases through to commercial launch; it allows us to operate with the same product from batches of 0.2 g up to several tons. We guarantee to reduce product build-up and achieve yields higher than 99% for the industrial process, starting from quantities of 1 kg. Thanks to our technology, we are able to obtain a very fine and precise particle size distribution with only a single micronization passage for nearly all pharmaceutical ingredients. Thanks to the isothermal feature of our jet mills, we can micronize any pharmaceutical ingredients, even those with a very low melting point (30-40 °C).
RANGE OF SERVICES
Beside micronization using jet mills, JETPHARMA SA is able to perform mechanical milling with a hammer mill or a pin mill for processes in contained environment.
Spiral jet mills and a hammer mill can be used successfully not only to reduce the particle size, but also to remove lumps and agglomerates.
Our clean rooms and isolators can be used to dispense and re-pack bulk APIs into small containers of any amount.
PACKAGING UNDER AN INERT ATMOSPHERE
Packaging under nitrogen or argon offers the highest degree of powder preservation to guarantee the integrity of the API.
Blending of APIs with excipients can be offered to our customers as a standalone process, or in conjunction with the micronization process.
The sieving process can be offered to our customers as standalone process, or in conjunction with the micronization process to obtain a characteristic particle size profile.
Blending and particle size reduction of an API and excipient(s) as a single process step.
CONTRACT ANALITICAL SERVICE FOR PSD ANALYSIS
We provide service for PSD Analysis and related activities (method validation, method transfer, ecc.)
To prevent the degradation of highly sensitive products, to avoid polymorphic changes, to avoid an increase in amorphous particles, to allow the micronization of polymers.
Quality control laboratory activities:
- Identification analysis
- Cleaning validation study
- Particle size distribution analysis
- Microbiological monitoring of environment, water and equipment surface
- Analytical method transfer
- Analytical method comparison study
- Contract laboratory for PSD analysis
- Process parameter study, to define and support the validation activity
- Process validation
- Analytical method validation
- Analytical method correlation study