WHAT IS USP CLASS VI MATERIAL?
USP stands for – The United States Pharmacopeia (USP), which is a non-government organisation that endorses public health by establishing up to the minute standards to safeguard the quality of medicines and other health care technologies.
What is USP Class testing?
‘Class VI’ means USP Plastic Class VI, one of six designations for plastics from General Chapter of the United States Pharmacopeia and National Formulary (USP-NF). In this chapter, a set of tests for determining basic safety are laid out, along with guidelines for how to test and how to certify a material to USP Plastic Class I-VI.
USP Class VI requires the most testing of the six USP class plastic groups. The following tests are needed for USP Class VI plastic certification:
- Extract of sample in NaCl, Systemic Injection Test in mouse (intravenous)
- Extract of sample in NaCl, Intracutaneous Test in rabbit
- Extract of sample in 1:20 solution of alcohol in NaCl, Systemic Injection Test in mouse (intravenous)
- Extract of sample in 1:20 solution of alcohol in NaCl, Intracutaneous Test in rabbit
- Extract of sample in polyethylene glycol 400, Systemic Injection Test in mouse (intraperitoneal)
- Extract of sample in polyethylene glycol 400, Intracutaneous Test in rabbit
- Extract of sample in vegetable oil, Systemic Injection Test in mouse (intraperitoneal)
- Extract of sample in vegetable oil, Intracutaneous Test in rabbit
- Extract of sample in vegetable oil, Systemic Injection Test in mouse (intraperitoneal)
- Extract of sample in vegetable oil, Intracutaneous Test in rabbit
- Implant strip of sample in rabbit
- Implant sample in rat
The USP defines six plastic classes, from I to VI. Consequently, a plastic resin material that has passed Class VI certification is expected to be more likely to produce favourable biocompatibility results.
SO WHO USES USP CLASS VI PLASTIC MATERIALS?
Primarily biopharmaceutical manufacturers use USP Class VI for their process equipment. Sterile and diaphragm valves have USP Class VI PTFE material in them, and sanitary pumps require Class VI O-Rings and sealing material.
AFT Fluorotec can manufacture a wide range of components using our USP Class VI PTFE compliant material and are supplying customers worldwide to meet their requirements. Please get in touch to discuss your project.
