Pharmaceutical

Industry estimates indicate that more than 80% of new chemical entities exhibit low solubility, low bioavailability and / or low or inconsistent dissolution rate. Micronization is one of the most utilized solutions for particle size reduction and consequently bioavailability enhancement or drug substance vehiculation to lungs. It is a process that requires a pressurized gas (e.g. compressed air or nitrogen) in order to collide particles against each other. The performances of the machine, strongly vary according to powder properties (flowability, strength, etc.) and it is therefore necessary to be able to adapt the process to each product characteristics.

The key to a consistent quality in drug formulation relies on homogenized ingredients in terms of particle size.

Milling is one of the most common techniques to help break down large particles to finer ones, which is used for formulations of different drugs.

The pin mill and hammer mill is a mechanical process used for gross milling of large particles greater than 1mm, crushing them into small powder form, usually below 100 microns.

A homogeneous particle size distribution is key to a predictable and consistent dissolution profile. Given a certain particle size distribution, the classifier separates either fine or gross particles from a certain particle size distribution. The process uses the same classification principle of the opposite jet mill.

The dynamic classifier uses the same particle separation principle of the opposite jet mill, to separate particles of significant different particle size distribution. It can be used to separate or remove a portion (either fine or gross) of a certain particle size distribution from the final product. It also helps with removing agglomerates or un-micronizable particles from the final micronized powder.

For aseptic manufacturing, we design and provide micronization systems and tailored isolators. A series of solutions which may include either steam, VHP, or others are designed and tailored according to customers’ requirements.

In case of sterile micronization, the jet milling system is designed according to the environment in which it is positioned, whether the set-up is a Class A isolator in a Class C room, or a jet mill specifically designed for manufacturing in a class A room.

With the demand for high potent API (HPAPI) constantly increasing it is key to develop specific solutions for the protection of the operator against operative exposure levels (OEL) that become more and more challenging each year.

Micronization is the most challenging process to be contained due to its heavy creation of ultra-fine particles. Our innovative technology and expertise help us with fully tailored and top-tier containment solutions, specifically designed according to process and product characteristics. Thanks to these solutions, we are able to provide contained jet mills reaching an OEL of up to 10 nanograms/m³ (0.01 microgram /m3), and other contained processes (e.g. reactor loading with an OEL of up to 1 nanogram /m³ (0.001 microgram/m3).

Safety has always been the priority, built in our culture and in every aspect of the design of all our machines. When operating machines, safety must be guaranteed not only from procedures in the technical manual, but also in case of eventual human error.

“A machine must be designed for being intrinsically safe, not only when the operator follows the manual in full, but also when mistakes are made, or procedures are not properly followed.“

We can either collaborate on existing processes or start from scratch to develop new processes. Either way, our goal is to improve the containment level and reduce the exposure of the operator to high potent compounds. We can either collaborate on existing processes or start from scratch to develop new processes. Either way, our goal is to improve the containment level and reduce the exposure of the operator to high potent compounds.

In most cases we do an assessment of the current status, and through a risk analysis we determine which are the weak points of the machines, or those with risk of exposure, and tailor a series of solutions to close open parts of the process. These solutions may include rigid or flexible isolators, liner systems, airlocks, localized suction systems, rapid transfer ports (RTP), etc.

For process products which are flammable or machines that must be washed with solvents or are installed in areas with risk of explosion, we collaborate with customers to address these specific elements and evaluate the risk associated with each situation.

We help you to address their AtEx marking, along with estimating the risk generated by the machine itself (in case it needs to process flammable compounds). Flammable compounds, if ignited (e.g. by a spark), cause explosions, which may be fatal.