GMP-compliant integration
Production facilities for powdery active ingredients consist of numerous individual units. Particularly critical are the machines that alter or enhance the substances. These include mixers, agglomerators, vacuum dryers, and synthesis reactors. They directly impact product quality. Errors cannot be compensated for.
amixon® provides more than just equipment. Each apparatus is a unique piece, designed based on your URS (User Requirement Specification). Manufacturing is also done in-house, ensuring seamless quality control.
Our systems are qualifiable, validatable, and precisely tailored to your facility.
We support you in DQ, IQ, and OQ. Documentation and execution comply with EU-GMP, FDA 21 CFR Part 11, and GAMP 5. Integration follows your validation concept from URS to commissioning.
amixon® industrial mixers meet internationally applicable standards upon request:
Food and Drug Administration
The U.S. Food and Drug Administration (FDA) is the food and drug regulatory agency of the United States. Its mission is to protect public health in the USA. The FDA regulates the safety and efficacy of human and veterinary drugs, biological products, medical devices, food, and radiation-emitting devices. This applies to products manufactured in the USA as well as imported products.
EHEDG
The European Hygienic Engineering and Design Group (EHEDG) is a consortium of equipment suppliers for food production, food processing companies, research institutes, and public health facilities as a foundation. It was founded in 1989 with the aim of supporting hygiene measures during the production and packaging of food.
3-A
3-A SSI is an independent, non-profit organization dedicated to the development of hygiene equipment for the food, beverage, and pharmaceutical industries. It represents the interests of three stakeholder groups with a shared commitment to promoting food safety and public health and regulatory authorities, equipment manufacturers, and processors.
United States Department of Agriculture
United States Department of Agriculture - the Department of Agriculture of the USA is responsible for food safety, promotes healthy eating, and fights hunger.
Good Manufacturing Practice
Good Manufacturing Practice" (GMP) are a set of guidelines for quality assurance in the production processes and environment in the manufacturing of pharmaceuticals and active ingredients, as well as in cosmetics, food, and feed.
Quality assurance plays a central role in pharmaceutical manufacturing, as deviations in quality can have direct effects on consumer health. A GMP-compliant quality management system ensures product quality and compliance with regulatory requirements for marketing by health authorities.
ATEX
The term ATEX is derived from the French abbreviation for ATmosphères EXplosibles. The directive currently includes two directives in the field of explosion protection, namely the ATEX product directive 2014/34/EU and the ATEX operating directive 1999/92/EG.
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A32014L0034
American Society of Mechanical Engineers
The American Society of Mechanical Engineers (ASME) is a professional association of mechanical engineers in the USA.
The association was founded in 1880 and develops technical guidelines and standards, especially for pressure vessels. In addition, it promotes science and engineering and offers continuing education courses. The knowledge and application of these standards are important for many companies based in Germany to be able to export goods and services.
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