CONTRACT MANUFACTURING CHART

The company advanced fiber tools GmbH offers its customers comprehensive application advice on the application possibilities of our products and the solution of customer-related problems.

advanced fiber tools GmbH
customer
confidential agreement

product and technical file with customer specification

definition of the intended purpose and the essential requirements

Contract Manufacturing Agreement

production of medical fibers by advanced fiber tools GmbH under following conditions/requests

  • quality management system according to EN ISO 13485
  • process risk management according to DIN EN 60812
  • applied materials according to USP class VI, EN ISO 10993 ff
  • manufacturing in a clean room according to class 100.000 (US-Norm Federal Standard 209 E) and class 8 (EN ISO 14644-1) respectively according to GMP, Annex 1, class D
  • packaging medical fibers in sterile bags according to EN ISO 11607-2
  • standard operating procedures for manufacturing, packaging and inspection
  • ETO-sterilization based on a validation report according to EN ISO 11135

delivery of medical fibers to customer with following documents for each charge

  • certificate of conformance according to directive 93/42/EWG
  • sterilization certification according to EN 556-1 certificate of conformance:
    Bioburden determination according to DIN EN ISO 11737-1, endotoxin test (LAL-Test according to European Pharmacopeia 10.0), EO/ECH - sterilization residual analysis according to EN ISO 10993-7