GMP-compliant integration
Production facilities for powdered active ingredients consist of numerous individual units. The machines that modify or enhance the substances are particularly critical. These include, for example, mixers, agglomerators, vacuum dryers and synthesis reactors. They have a direct impact on product quality. Errors cannot be compensated for.
amixon® delivers more than just equipment. Each piece of equipment is unique and designed based on your URS (User Requirement Specification). Manufacturing also takes place in-house. This ensures seamless quality control.
Our systems are qualifiable, validatable and precisely tailored to your plant.
We support you with DQ, IQ and OQ. Documentation and execution comply with EU GMP, FDA 21 CFR Part 11 and GAMP 5, and integration follows your validation concept from URS to commissioning.
amixon® industrial mixers meet internationally applicable standards on request:
FDA
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.
EHEDG
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
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.
USDA
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.
GMP
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
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.
ASME
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).
Consult with a processing compliance expert
amixon GmbH
Halberstaedter Strasse 55
33106 Paderborn
Germany
Telephone: +49-5251-688888-0