Sterilization

We provide sterilization services for various companies, both those producing medical devices and the pharmaceutical industry.

Data regarding the ethylene oxide sterilization service:

  1. chamber capacity: 8.78 m3
  2. the chamber holds 5 pallets with the following dimensions: length 1200 mm, width 800 mm, height 1200 mm (height of products without pallet)
  3. sterilization parameters: temperature 52 °C, pressure 320-330 kPa, humidity: 70%

We have a current validation of the sterilization process of medical products for compliance with the currently applicable PN-EN ISO 11135-1:2014-08 wraz z PN-EN ISO 11135-1:2014-08/A1:2020-04 standard.

We use microbiological indicators for each batch to confirm the effectiveness of the ethylene oxide sterilization process.

After completing the sterilization service, we provide:

  • a copy of the sterilization process parameter printout
  • a protocol of biological test results from the sterilization effectiveness check
  • a product sterilization certificate.

Our additional advantage is the location of the company. Bełchatów is located in central Poland, 60 km from Łódź and 70 km from Częstochowa. Fast transport is guaranteed by the A1 motorway and the S8 expressway, located next to Bełchatów.