Aflex Hose Ltd Anti-static (carbon filled) PTFE hose passes USP Class VI and Elution Test Protocols.

To compliment our existing USP Class VI and Elution Test validation reports for our NATURAL PTFE hose products, Aflex Hose Ltd are now pleased to announce that our ANTI-STATIC (carbon filled) PTFE hose has also been successfully tested and validated in accordance with:

USP 28, NF 23, 2005 for Class VI Plastics Biological Reactivity Test, In Vivo <88>

• Systemic Injection Test
• Intracutaneous Test
• Implantation Test

USP 28, NF 23, 2005 Biological Reactivity test, In Vitro <87>

• L929 MEM Elution Test
  
  
  

The above tests also conform generally to ISO 10993 - 5, 6, 10 & 11.

Historically the Biotech industry has often only requested and received USP Class VI validation from hose manufacturers. Some elastomers however can pass the USP Class VI plastics tests but still have a cytotoxic, negative effect on mammalian cell growth!

To increase confidence in the biocompatibility of our antistatic PTFE hose therefore, Aflex Hose Ltd commissioned an Elution Test to confirm our product was non-cytotoxic.

The Elution Test report states: "No biological reactivity (Grade 0) was observed in the L929 mammalian cells at 48 hours, post exposure to the test article extract... The test article, Antistatic PTFE (Carbon Filled Polytetrafluoroethylene), is considered non-cytotoxic and meets the requirements of the elution test, USP 28".

Testing for cytotoxicity is the estabished initial method of ensuring the biocompatibility of a product. A negative result (Grade 0), such as ours, indicates that a material is free of, or has insignificant quantities of, harmful extractables that could potentially damage or degrade transfer product directly or in downstream processes.

Aflex Hose Ltd are constantly striving to improve the quality, suitability and acceptance of our products for use in Pharmaceutical, Biotech and Biopharm manufacturing applications.