QUALITY AND BIOLOGICAL SAFETY: Our products meet the following regulations

1. Regulation (EC) Nº 1935/2004 on materials and articles intended to come into contact with food
2. Regulation (EC) Nº 10/2011 on plastic materials and articles intended to come into contact with food
3. USP Biological Reactivity Test, in vivo, for Class VI-121ºC Plastics
4. 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:

1. Bacterial Challenge Test
2. Filter Integrity Test
3. Filter Extractable Test
4. Raw Material Biological Safety Test
5. pH, TOC and Endotoxins Test
6. Steam Sterilization Cycle Test

PROCESS VALIDATION:

1. Bacterial Challenge Test under certain conditions and processes
2. Extractable Test
3. Chemical Compatibility
4. Product Pre-Wetted Integrity Test
5. Adsorption Test
6. Hydraulic Stress Resistance
7. Thermal Stress Resistance
8. Cleanliness