Development of surface swabbing procedures for a cleaning validation program in a biopharmaceutical manufacturing facility

Lombardo, Silvia; Inampudi, Prasad; Scotton, Anthony; Ruezinsky, Gary; Rupp, Randall G.; Nigam, Somesh

doi:10.1002/bit.260480514

Cited by 11 publications

(3 citation statements)

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“…Furthermore, it offers low detection limits in the range of ppb, and is less time consuming in the set-up and execution compared to more specific techniques [51][52][53]. Furthermore, it offers low detection limits in the range of ppb, and is less time consuming in the set-up and execution compared to more specific techniques [51][52][53].…”

Section: Practical Applicationmentioning

confidence: 99%

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First comprehensive view on a magnetic separation based protein purification processes: From process development to cleaning validation of a GMP‐ready magnetic separator

Ebeler

Pilgram

Wellhöfer

et al. 2019

Engineering in Life Sciences

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Magnetic separation processes are known as integrated bioanalytical protein purification method since decades and are well described. However, use of magnetic separation processes in a regulated industrial production environment has been prevented by the lack of suitable process equipment and prejudice against the productivity of the process and its qualification for cleaning‐in‐place operation. With the aim of overcoming this prejudice, a comprehensive process development approach is presented, based on a GMP‐compliant magnetic separator, including an optimization of the batch adsorption process, implementation into a technical‐scale, and the development and validation of cleaning routines for the device. By the implementation of a two‐step counter‐current binding process, it was possible to raise the yields of the magnetic separation process even for very low concentrated targets in a vast surplus of competing proteins, like the hormone equine chorionic gonadotropin in serum, from 74% to over 95%. For the validation of the cleaning process, a direct surface swabbing method combined with a total organic carbon analysis was established for the determination of two model contaminants. The cleanability of the process equipment was proven for both model contaminants by reliably meeting the 10 ppm criteria.

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Section: Practical Applicationmentioning

confidence: 99%

“…Total organic carbon (TOC) analysis is simple to implement as it does not require the development of a dedicated method. Furthermore, it offers low detection limits in the range of ppb, and is less time consuming in the set-up and execution compared to more specific techniques [51][52][53].…”

Section: Practical Applicationmentioning

confidence: 99%

First comprehensive view on a magnetic separation based protein purification processes: From process development to cleaning validation of a GMP‐ready magnetic separator

Ebeler

Pilgram

Wellhöfer

et al. 2019

Engineering in Life Sciences

View full text Add to dashboard Cite

show abstract

“…Such information is useful but is not directly applicable in general to pharmaceutical and biotech processes where soils are different and the cleaning requirements are far more stringent. What meager information there is concerning pharmaceutical and biotech soils has been obtained from experiments done on single soil components and/or studies done under conditions not truly representative of the process conditions (59,60). There have been no significant attempts to develop systematic analyses based on experiments done with complex mixtures typical of real fermentation soils under conditions found in real processes.…”

Section: Cleaningmentioning

confidence: 99%