Solutions for the Pharmaceutical Industry

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.

In the ever-evolving pharmaceutical industry, achieving production goals amid strict regulations and tight deadlines is a significant challenge. Pharmaceutical manufacturers require dependable partners who not only grasp but enhance the development of processes and equipment.

Spray drying equipment solutions represent a field where innovation meets precision, catering to the industry's needs.

One of the most pressing challenges in the pharmaceutical market is the reliable encapsulation and stabilization of temperature-sensitive and volatile compounds. This challenge is effectively addressed by spray congealing, a technology that forms solid particles through the low-temperature solidification of molten solutions.

For sterile pharmaceutical manufacturing, we design tailored isolators that maintain aseptic conditions throughout the process. Configurations range from a Class A isolator within a Class C room to systems sterilizable by steam, SIP or VHP, each built to ISO 14644-1 Class 5 and adapted to your product.

As demand for highly potent APIs grows, so does the need to protect operators from ever lower exposure limits. Our containment isolators and glove boxes are engineered around each process, reaching OEL down to 1 ng/m³ on contained operations such as reactor loading, and up to 10 ng/m³ on contained jet milling.

Safety is built into every machine from the first design phase, not added later. We engineer equipment to stay safe even when procedures are not followed perfectly, protecting operators against human error across both new builds and the retrofitting of existing pharmaceutical lines.

On existing or large-scale pharmaceutical processes, we reduce operator exposure to potent compounds without rebuilding the line. Starting from a risk assessment of the current setup, we add tailored measures such as rigid or flexible isolators, liner systems, airlocks, localized suction and rapid transfer ports.

When processes involve flammable compounds or machines washed with solvents, the risk of explosion has to be designed out. We assess each situation with the client, handle ATEX marking and protect equipment up to Zone 0/20 with measures such as nitrogen inerting and continuous process monitoring.