SteriPack has more than two decades of experience in consulting, implementing and overseeing sterilisation validation and the routine sterilisation management process for medical devices.
Sterilisation Management for medical devices is an indispensable step in the supply of disposable single-use medical devices. Therefore, by managing all of the sterilisation processes, SteriPack Group is able to provide turnkey solutions.
SteriPack recognises the value of efficient sterilisation management for medical devices and provides the following services
- Gamma sterilisation
- E-beam sterilisation
- Ethylene Oxide (EtO) sterilisation
- X-ray sterilisation
- Steam sterilisation
A 360° approach to the sterilisation process
SteriPack has the capabilities to coordinate all the relevant quality assurance tests and provide the documentation needed to complete validation of the sterilisation management for medical devices.
The SteriPack Group experts are accredited to ISO 17025 microbiological lab, which means the company can perform bioburden, sterility and endotoxin testing in-house for both the validation and routine sterilisation release processes.
By sharing expertise from across the company, the SteriPack Group can tailor solutions to individual Customer needs and recommend the most:
- Appropriate sterilisation method for a specified device
- Suitable and cost effective packaging materials that are compatible with a chosen sterilisation method
The flexibility to work with a Customer’s existing partner
Customer projects can be part way through their lifecycle when they engage with the SteriPack Group. That is why the SteriPack Group offers the opportunity for existing Customer partners – who are already involved with the sterilisation cycle but not yet validated – to achieve the status of approved supplier.
As existing partners gain the necessary qualifications, the SteriPack Group will take on full responsibility for them and perform the necessary audits.
all sterilised products are delivered with complete documentation and can be
traced back to source.