Our Commitment to Quality

Quality is not just a by-word within Silicone Altimex, it’s a culture that exists throughout our workforce. Due to the critical nature of the products we make for customers, we cannot leave quality to chance; we engineer quality into products at the design stage.

Whether material-related or process-related, we take advantage of the latest innovations to ensure the quality of the material used is maintained at the highest standard throughout the production process.

Certifications

• ISO9001/2008 Certified Company (FM 01482)
• BS EN ISO 13485:2003 and EN ISO 13485:2012 Certified
• BS ISO14644-1:1999 ISO Class 7 Cleanrooms

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
• For extremely close tolerance silicone tubing, complete closed-loop laser control systems monitor and adjust equipment settings 30 times every second for absolute control
• Statistical Process Control ensures products continually remain within specification
• Complete traceability from raw material to finished product is built into the process
• Capability to print batch numbers, date of manufacture, sizes etc. directly onto tubing
• Complete product validation packs are available upon request
• 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 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.

In addition to testing the physical characteristics of material, Silicone Altimex also carries out a wide variety of tests on finished products. Some tests are used to validate products, others are for internal research.

We have a fully equipped laboratory and outsource to external test facilities when required, or in some cases, when we need to call on the expertise of someone in a particular field or science.

Testing solutions:

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