Sterilization management

Our established network of global sterilization partners is ready to support your specific requirements

We have over 20 years’ experience managing sterilization of medical devices

The demand for single use sterile medical devices is growing, and there are real benefits to externalizing your sterilization to a specialist service provider. SteriPack’s long-standing relationships with leading sterilizers globally enables us to facilitate a range of sterilization methods, available capacity and rapid project turnaround, while managing the whole process on your behalf.

Sterilization to suit your needs

With our interdisciplinary knowledge from different therapeutic areas, we will recommend the most suitable sterilization method and vendor for your specific device.

The most popular sterilization methods we facilitate are:

  • Gamma, X-ray and E-beam irradiation – for full penetration of your high density, final packed device.
  •  Ethylene Oxide (ETO) – for permeable packaging materials such as plastic
  •  Steam – for heat-resistant implants and reusable surgical instruments, together with vials and syringes for sterile drug products

A flexible service that meets you where you are

Is your product halfway through its lifecycle? We can take over your validated cycle and sterilization management solution, to ensure a smooth and compliant process without disruption.

Or are you taking a new product to market? Consider us consulting partners. We’ll recommend the optimal solution tailored to you – including sterilization method and compatible packaging. Then we’ll oversee the routine post-sterilization validation, approval and release of batches from your chosen provider – whether they’re your existing partner or from our trusted network.

On-site validation

Trust in our independent on-site ISO 17025 accredited microbiological testing laboratory for full validation support. We coordinate all relevant quality assurance tests and provide the documentation you need to complete validation of the sterilization process. This includes providing bespoke test method validations in addition to routine testing for bioburden, sterility and endotoxins.

Cleaning and rinsing of sterile components for Annex 1 compliance

Ready-to-use, pre-processed primary packaging components such as caps, stoppers and syringe plungers destined for distribution in the EU must comply with the updated requirements set out in Annex 1 of the European Commission’s Good Manufacturing Guidelines (GMP).

It’s why we offer cleaning and rinsing of primary packaging components in highly controlled and certified cleanroom environments prior to your final aseptic preparations and processes.

  • Comprehensive inspection of components on arrival
  • Washing and drying
  • Siliconization
  • Post pre-processing inspection
  • Packing and sterilization management
  • Infrastructure and machinery designed around your requirements
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Experience pain-free sterilization management

Regardless of your requirements, you can trust us to deliver market-ready solutions to speed your route to market.