Sterile production no problem for the WAB-GROUP

The particle size distribution of the active ingredients has a central influence on solubility and permeability. With smaller particle sizes, the surface area of the active ingredients is increased. This can increase efficiency, solubility and bioavailability. Active ingredients in the second class have good permeability per se, but are very difficult to dissolve. Wet milling involves the precise comminution and dispersion of these active ingredients to bring them into a well-soluble form.

Active pharmaceutical ingredients are widely used in the pharmaceutical industry. They are used in various sectors, including ophthalmology, injectables, otic, oral applications, veterinary medicine, dermal applications and, last but not least, in the field of cell disruption for vaccine production.

The active pharmaceutical ingredients are mixed with a carrier liquid and then finally ground with one agitator bead mill of the WAB-GROUP^®. During this process all parameters, such as the maximum process temperature, must be maintained in order to achieve the desired particle properties.

It is important to note that processing of the active pharmaceutical ingredients must be carried out in strictly controlled environments and in compliance with all relevant regulatory requirements, as it is a critical step in drug manufacturing. WAB-GROUP has been providing the necessary process technologies to accomplish this key step in processing and the active pharmaceutical ingredients for over 50 years.

In the application areas of ophthalmic drugs, ear remedies and injectables, active pharmaceutical ingredients are produced in an aseptic environment. In order to comply with these criteria, agitator bead mills from WAB-GROUP are used, which meet the requirements of Cleaning-in-Place (CIP) as well as Sterilization-in-Place (SIP) and are qualified for these processes.

With the Cleaning-in-Place (CIP) process, we ensure that the operator of the system does not come into contact with the active pharmaceutical ingredients. Complete cleaning of the agitator bead mill ensures that the dangers of highly active ingredients are always under control. Sterilization using steam at temperatures of up to 135° makes the system completely sterile and ensures germ-free production. The technical solutions required for this have been developed and perfected over decades by the engineers at WAB-GROUP. Parameters such as sterilization, consistently safe cleaning, validation and qualification, temperature monitoring, requirements for technical components when handling heat, sterilization times, integration into existing automation chains, requirements electronic records and electronic signatures, seamless tracking of production, ensuring material quality, certification of parts in contact with the product and much more are an absolute standard of the WAB-GROUP in connection with the processing of active pharmaceutical ingredients.

Are you interested in the production of active pharmaceutical ingredients and would like to learn more about our solutions on this topic? Then contact us via the contact form and talk to one of our process experts worldwide.