Clean room thermoforming is primarily used for production and packaging of pharmaceuticals, medical equipment, food products, electrical, and beauty products. This method of thermoforming is done inside of an ISO certified clean room. This means that the particulates circulating in the air are kept to a minimum count. Clean rooms are classified according to the table below.
Common types of plastic that can be sterilized are PETG, APET, and PEEK. However, there are hundreds of plastic compounds available depending on the specific needs of the product being manufactured. Thermoform packaging is widely used to protect sterile instruments and implants. This method of packaging allows for lightweight, clear plastic enclosures that prevent microbial and dust particles from contaminating the sterile item. They allow secure storage of the product for long periods of time while maintaining the sterile environment. This type of packaging must go through stringent testing to ensure the product remains sterile through packaging, transportation, and storage. Some of these tests include Atmospheric Conditioning, Handling/Drop, Vibration, Stacking, and Low Pressure. The packages seal integrity is also tested via Visual Inspections, Peel, Burst/Creep, Dye Penetration, and Bubble Tests. The website link below will direct you to specific information regarding each test and its standards.