Validation & Qualification
A plant for the industrial production of bulk materials always consists of a large number of individual units and machines. These include mixers, vacuum dryers and synthesis reactors. However, the latter are relatively expensive components in relation to their construction volume. In addition, they usually directly determine the quality of the end product. If such process machines have defects, this cannot be compensated for by other plant components.
The decisive factors are their functional quality and their ability to be integrated into the overall system. amixon® supplies the engineering, the manufacturing know-how and many years of field experience along with the process machine. This accelerates the commissioning of a new system. amixon® engineers can adapt the qualification procedures to the customer's validation concept. Every piece of equipment manufactured by amixon® is unique.
Do you have any questions about amixon® qualification and validation concepts? Then we look forward to hearing from you!
The Food and Drug Administration of the United States is responsible for ensuring the safety and efficiency of food and pharmaceutical products meant for human and animal consumption within the USA. amixon® mixing equipment aligns with FDA guidelines for validating commercial manufacturing processes.
The European Hygienic Engineering and Design Group is a coalition of food processors, equipment manufacturers, and research institutions dedicated to promoting the advancement of food safety and hygienic design in the food manufacturing industry. amixon® mixers are built in accordance with EHEDG guidelines for hygienic design and are appropriate for CIP (clean in place) and SIP (sterilize in place) techniques.
3-A Sanitary Standards Inc. is an independent interest group that develops hygienic design standards for processing and manufacturing equipment used in the food, beverage, and pharmaceutical industries.
All amixon® mixing machines are built in accordance with these standards in order to protect food from contamination. All product contact surfaces can be easily and mechanically cleaned, as well as easily dismantled for manual cleaning and inspection.
The United States Department of Agriculture oversees the certification of all equipment used to process dairy, meat, and poultry products to be sold in the USA.
Their certification processes specify guidelines for sanitary design and fabrication of all machines used in these applications, standards which amixon® mixing equipment fulfills.
Good Manufacturing Practices are a set of guidelines for the design and fabrication of equipment to be used to manufacturing medicinal products and active pharmaceutical ingredients.
amixon® mixing equipment are designed to comply with GMP equipment guidelines that ensure that the system does not negatively impact product quality and can be easily sanitized.
ATEX derives its name from the French Appareils destinés à être utilisés en Atmosphères Explosives and consists of two European Union directives describing the types of equipment that are suitable for use in potentially explosive production environments.
amixon® 3-in-1 vacuum dryers, mixers, and reactors are built in accordance with ATEX standards to prevent dust explosions.
The American Society of Mechanical Engineers is a non-profit organization with more than 600 voluntary codes and standards for technical fixtures and components.
Each pressurized mixer from amixon® is built according to the guidelines of ASME Boiler and Pressure Vessel Code (BPVC).