QUALITY AND BIOLOGICAL SAFETY: Our products meet the following regulations
- Regulation (EC) Nº 1935/2004 on materials and articles intended to come into contact with food
- Regulation (EC) Nº 10/2011 on plastic materials and articles intended to come into contact with food
- USP Biological Reactivity Test, in vivo, for Class VI-121ºC Plastics
- Non Fiber-Realising per Title 21 of the U.S. Code of Federal Regulations (CFR)
QUALITY CONTROL: Our products have been manufactured under a quality management system certified to ISO 9001:2000
PRODUCT VALIDATION:
- Bacterial Challenge Test
- Filter Integrity Test
- Filter Extractable Test
- Raw Material Biological Safety Test
- pH, TOC and Endotoxins Test
- Steam Sterilization Cycle Test
PROCESS VALIDATION:
- Bacterial Challenge Test under certain conditions and processes
- Extractable Test
- Chemical Compatibility
- Product Pre-Wetted Integrity Test
- Adsorption Test
- Hydraulic Stress Resistance
- Thermal Stress Resistance
- Cleanliness