Quality / Regulatory

Extrusions

Extrusions:

  • ‘In process’ laser monitoring of tube ODs
  • Post production ID QA checks with standard & custom pin gauges
  • Extruding & cutting takes place in cleanroom to ISO 14644-1:1999 Class 8 (FED 209E Class 100,000)

 

Inspection

Tip forming / Assembly / Inspection
/ Packaging:

  • Tip forms visually checked ‘in process’ using stereomicroscopy
  • ‘In process’ component development photography for Customer ‘distance’ checking
  • Verniers & micrometers regularly calibrated in accordance with ISO 9001:2008 SOP
  • Post production ID QA checks with standard & custom pin gauges
  • All four operations carried out in our cleanroom to ISO 14644-1:1999 Class 7 (FED 209E Class 10,000)

 

Clean Room

Cleanroom Management:

  • Rotational biocide cleansing program
  • Historical particle count database
  • 6 month maintenance schedule + annual re-validation
  • Bio-burden sampling regime using NHS approved Third Party
  • ULPA filtered process zone / HEPA filtered inspection & packaging area
  • Class 4-6 cleanroom produced packaging always used

 

Medical

Medical Tubing Materials - General:

  • Compliant with FDA 21 CFR regulations
  • Compliant with numerous parts of BS EN ISO 10993:2009
  • USP Class VI conforming
  • ADCF materials available
  • REACH & RoHS compliant
  • Non-DEHP, Phthalates/Bisphenol-A free materials
  • Full resin data, CofCs & traceability with each product shipment

RoHS and Reach logoDEHP FreeADI freeUSP

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Contact Us

Polyflon Technology Limited16 Raleigh HallEccleshallStaffordST21 6JLUnited Kingdom