Compounding Centre Standards
What makes Fresenius Kabi facilities unique?
At Fresenius Kabi, we believe that regulation is important to ensuring all industry parties are meeting safety standards in sterile compounding. Historically, there has been limited regulated standards guiding commercial compounding operations, something that Fresenius Kabi continues to advocate for.
There has been a clear need for defined standards in this sector, which is why all of our compounding centers are designed and operated following stringent internal guidelines based on GMP (Good Manufacturing Practice), USP <797> and ISO requirements.
- World class facilities and technologies
- GMP compliant clean room design
- Highly trained and qualified personnel
- Modern laminar air flow safety cabinets
- Comprehensive media fill and process validation
- Strict environmental controls monitoring viable and non-viable bioburden
- Stringent garbing regimens
- Validated environments, equipment and processes
- Controlled documented procedures
- Regular audits by Fresenius Kabi Global Quality group
- Detailed batch record reviews and final solution inspection protocol
- High quality starting materials including PVC free, DEHP free freeflex® minibags and a comprehensive range of IV drugs
- Customer-centric engaged staff, working with healthcare partners to support the needs of their patients
Fresenius Kabi – The Complete Solution in Compounding.
For more information please contact your local Fresenius Kabi representative.