Q&A

09/17/2021|Custom or standard isolator: which is the best solution?

Sometimes a standard isolator is all you need especially if your process is very short and simple, if quantities are very small and you don’t need to integrate any equipment. But you need to make some compromises and you will have to adapt your process to that standard equipment.

09/24/2021|How can process equipment be integrated into an isolator?

First of all, the design team must fully understand the process and have a lot of experience integrating various kinds of processing equipment into isolators.  The design must be committed to build the custom isolator around your process and not the other way around. 

10/04/2021|Can hard-wall isolators be ergonomic?

When best practices are followed during the design phase and when you deal with a very experienced manufacturer, this combination will produce great ergonomics. Here are some considerations.

10/26/2021|When are open RABS used?

OPEN RABS are classified as “passive or active open RABS sterile systems” and systems for the containment of HPAPI products – also called “active open RABS”.

Both systems are usually installed in cleanrooms and use the room filtered air.

11/03/2021|How does a jet mill work?

Contrary to a traditional mechanical mill, a jet mill uses a high-pressure process gas (usually compressed air or nitrogen) as milling energy.

Particle-to-particle collision is what reduces the powder size. No mechanical crushing is involved.

The most important part of a Jet Mill is the grinding chamber. If is fitted with a series of calibrated nozzles that distributes the process gas inside (at high pressure, high speed and obviously at a high kinetic energy).

02/11/2022|Can I use a mechanical mill instead of a jet mill?

Yes in some cases you can. It’s going to depend on the process and the product. But first let’s start with some definitions.

A mechanical mill grinds the product by crushing the particles between 2 mechanical parts: a static part called the stator and a moving part that rotates around it (called the rotor). Both are in the milling chamber.

02/25/2022|How do you define a containment strategy?

The definition of the proper containment strategy is a necessary requirement for the correct design of the facility and the process equipment. Containment is necessary to reduce the exposure of operators to potent products.

The starting point is the sound knowledge of the products to be handled and their specific characteristics as well as their occupational exposure limits (OEL), the quantities involved and the duration and the frequency of each process to be contained.

03/29/2022|Sterility testing: which technology to choose?

Sterility testing is a crucial step in aseptic manufacturing. It is a process designed to demonstrate the presence or absence of external contaminating microorganisms in substances that are intended for human use.

What happens during sterility testing? Well samples of a batch are checked to verify the sterility of the entire batch.

Of course it is crucial that the working environment for testing is free from any contaminant that could invalidate the results.

03/29/2022|Which is the best way to transfer potent powders?

Powder transfer is a common operation in the pharmaceutical and in the fine chemical industries. Powder gets transferred at different steps during the manufacturing process: first when raw materials are first introduced in the production equipment, then intermediates are transferred from one vessel to another and finally when the final product is collected and dispensed.

05/11/2022|Is it possible to handle potent compounds under sterile conditions?

Containment is the separation of hazardous areas from sensitive areas by means of physical or aerodynamic barriers. It can have two applications: sterile containment and potent containment. In the first case, a positive pressure regime ensures the protection of the working environment from external contamination, while in the second case a negative pressure regime keeps the API confined within the working environment to protect the operators.

05/11/2022|Which is the best way to transfer potent powders?

Powder transfer is a common operation in the pharmaceutical and in the fine chemical industries. Powder gets transferred at different steps during the manufacturing process: first when raw materials are first introduced in the production equipment, then intermediates are transferred from one vessel to another and finally when the final product is collected and dispensed.

05/31/2022|Can jet mills handle explosive powders?

A spiral jet mill is a piece of equipment used to reduce the particle size of pharmaceutical and fine chemical powders down to few micrometers.