Quality Certifications

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