Every year, CSL Behring races against a tight schedule to complete qualification activities during the summer shutdown. Assisting with the qualification work, NNE helps to make sure that production restarts right on time, every time.
Each summer, CSL Behring needs to shut down its blood plasma production facility for requalification, change qualification and qualification of new equipment. The entire qualification process needs to be completed within a set timeframe, so that the facility can begin production right on schedule.
Working to a deadline
Since 2000, NNE has supported CSL Behring with this annual task. NNE’s qualification team works closely with CSL Behring’s team to help ensure that the qualification work is completed in time for the scheduled production restart. The project typically takes 5-6 months from start to finish. Specifically, NNE’s consultants are responsible for preparing and executing qualification protocols.
Another challenge facing CSL Behring is preparing for the bi-annual FDA inspection. Here, NNE’s team provides support by reviewing the existing qualification documentation, preparing a GAP analysis, and making appropriate improvement recommendations.
Partnering for success
During the working relationship, the partnership between the two companies has gone from strength to strength. Over the years, NNE has helped with the qualification of more than 100 different process systems and utilities for CSL Behring's plant.
CSL Behring GmbH
2000 – 2011
Qualification of process equipment and utilities (IQ, OQ, PQ), review of existing qualification documentation