FDA and process equipment for APE

The FDA (Food and Drug Administration) is the food and drug authority of the United States. It monitors and regulates the safety and quality of food, medicines, medical devices and cosmetics.

Particularly strict requirements apply to the production of APE (Active Pharmaceutical Ingredients). The equipment must be designed in such a way that safe, hygienic and residue-free production is possible. This means for process equipment such as mixers, vacuum dryers and synthesis reactors:

• Surfaces in contact with the product must be smooth, non-porous and easy to clean
• Avoid dead spaces and places that are difficult to access
• Materials must be FDA-compliant, e.g. stainless steel or certified seals
• A high degree of emptying and
• Reproducible cleaning (CIP/SIP) must be possible.

The following steps are carried out as part of system qualification:

• DQ (Design Qualification): Proof that the appliances have been designed in accordance with specified requirements.
• IQ (Installation Qualification): Proof that the appliances have been installed correctly.
• OQ (Operational Qualification): Proof that the systems operate reliably within the specified parameters.
• PQ (Performance Qualification): Proof that the equipment provides the desired performance in the production environment. amixon® process equipment fulfils the requirements of the FDA.

amixon® mixers, dryers and reactors are manufactured in compliance with GMP and enable the safe production of active pharmaceutical ingredients.
We support our customers in the qualification and validation of the systems supplied. In addition, we offer our pilot plants for process development and optimisation.