SIPPEX is ISO 9001 certified since 1998 and ISO 15378 since 2009.

ISO 15378 is a specific international standard for primary packaging for the pharmaceutical industry, including GMP requirements:

  • Ongoing Staff training on GMP
  • Product compliance with applicable requirements
  • Contamination control
  • Implementation of a validation policy
  • Change control
  • Risk analysis

Products provided by SIPPEX are mainly aiming at customers in healthcare fields, and most of the time in the pharmaceutical industry. Therefore, we expect to offer high-quality products to customers, and satisfy their current and future needs, thus winning long-term cooperation with them.

The high quality production of Sippex satisfies all European Pharmacopoeia requirements. The products are USP class VI certified. Sippex has D.M.F.registration numbers at the United States F.D.A.
Sippex Kejie in China is certified by SFDA.

Traceability at every stage of the manufacturing process

Our production is recorded, validated and controlled throughout the process to ensure the expected level of compliance by our customers.

  • Physico-chemical
  • Mechanical (pressure, drop tests, …)
  • Microbiological
  • Visual
A suitable working environment

Our machinery is built in cleanroom ISO Class 8 (Class 100 000).