AEP, Inc. specializes in the precision machining of thermoplastics which are particularly well-suited for the very high demands of medical, pharmaceutical and food processing applications. These engineering grade plastics possess properties which enable them to meet specific standards including:
- Biocompatibility and FDA conformity
- Very high resistance to cleaning agents, disinfectants and many solvents
- Resistance to common sterilization processes including super-heated steam, ethylene oxide, hot air or gamma rays
- Electrical properties: good electrical insulation for high-frequency surgery
- Precision and stability of the finished parts and components
This combination of properties extends the useful service life of the parts and decreases the total cost of ownership.
See below for more information on the six most common agencies and available compliant materials. Or feel free to download our PDF on FDA and medical-grade plastic materials.
FDA (Food & Drug Administration)
Takes responsibility for determining whether and how manufactured materials may be used in contact with food products. Definitions for proper use are found in a series of regulations published annually under Government Regulations CFR 21. The FDA provides certain specifications regarding composition, additives, and properties. A material which meets these standards can then be stated as FDA COMPLIANT. End-users should note that it is their responsibility to use the product in a manner compatible with FDA guidelines. There are also approvals which may comply with the Food Contact Notification (FCN) of the American Food and Drug Administration of effective premarket notifications for Food and Contact Substances (FCS).
USDA (U.S. Department of Agriculture)
Has jurisdiction over equipment used in federally inspected meat and poultry processing plants, and over packaging materials used for such products. Materials used in this equipment are approved on an individual basis. Determining suitability for use of components and the materials from which they are made is the responsibility of the equipment manufacturer.
NSF (National Sanitation Foundation)
Sets standards for all direct and indirect drinking water additives. Manufacturers who provide equipment displaying the NSF symbol have applied to the NSF for device approval to a specific standard. The approval is issued for the finished product (device) in a specific use (application). To obtain device approval, all components within the device must comply with the Standard. Establishing compliance of the equipment’s components can be accomplished in one of two ways:
- The component has been tested to the Standard by the component supplier and is certified as such.
- The equipment manufacturer must supply documentation that the component meets the Standard, If any testing is required, it must be completed by the equipment manufacturer.
3A-Dairy
Is a voluntary organization that provides standards of construction for milk, cheese, butter and ice cream processing equipment. The organization covers the requirements of plastic materials for multiple-use as product contact surfaces in equipment for production, processing, and handling of milk and milk products. The criteria for approval of plastic materials are specified in 3A standard 20 latest revision, and include: cleanability, bacterial treatment, repeat use conditions, and FDA compliance. Materials are tested for compliance by the material supplier. Supporting documentation must be available as required by a food inspector.
Canada AG
Food Production and Inspection Branch of the Canadian Government is the Canadian government agency equivalent to the USDA. As with the USDA, plastic materials are approved per material for a group of related applications, such as Acetron® GP acetal (material) for meat and poultry processing (application).
USP (U.S. Pharmacopoeia)
Class VI judges the suitability of plastic material intended for use as containers or accessories for parenteral preparations. Suitability under USP Class VI is typically a base requirement for medical device manufacturers.
All information contained on this site is supported by research believed to be reliable but Applied Engineering Plastics, Inc. assumes no liability whatsoever in respect to application, processing or use made of the aforementioned information or products, or any consequences therefore.
