Quality

An outstanding commitment to excellence is what makes Silicone Altimex a partner you can trust. Through a systematic process of continuous improvement and performance optimization, Silicone Altimex maintains a steadfast focus on providing customers with products that exceed expectations.

Certifications

Standards

Silicone Altimex materials meet or exceed the following standards:

  • USP 23 Class VI
  • European Pharmacopoeia
  • BGVVXV Silicones
  • ISO 10993
  • FDA Food Grade (21 CFR 177.2600)

Quality System

Independent of all manufacturing and production facilities, the quality department defines procedures for each step of manufacturing and produces the required documentation to ensure quality is consistent for every order.

The department is fully equipped with an extensive range of measuring and test instrumentation which is calibrated and traceable to national and international standards.

Cleanroom manufactured products all have a final batch release from the quality department. Every stage of manufacture is reviewed and approved prior to the release of the certificate of conformance and final release of the product.

Technology

Silicone Altimex uses the latest in technology to ensure product specifications are met or exceeded:

  • Laser micrometer inspection of products to extremely tight tolerances
  • Extrusion lines fitted with loop control laser inspection systems which constantly monitor and adjust the extrusion parameters to ensure extremely tight operational tolerance
  • Cleanrooms are ISO Class 7 facilities, guaranteeing production, inspection and packaging are performed in a hygienic environment
  • Cleanrooms are all validated and are under routine viable and nonviable monitoring and annual re-validation

 

Product and Material Testing

To ensure our pharmaceutical and medical cleanroom products meet standards required by customers, Silicone Altimex continuously tests both materials and finished products.

By carefully blending raw materials, we can produce and test materials specific to their requirements, i.e. flame retardant rubbers, optimised extended life in peristaltic pump tubing and high-pressure silicone tubing.

Whatever your testing requirement, Silicone Altimex can provide the solution:

  • Pump life
  • Burst pressure
  • Flow rates
  • Non-contact laser measurement
  • Flammability tests
  • Elongation and tensile break