Articles by Maik W. Jornitz - Pharmaceutical Technology

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Articles by Maik W. Jornitz

The role of sterile filtration in the biopharm industry

Jan 7, 2011

Biopharmaceuticals commonly cannot be terminally sterilised, as such aseptic processing using sterilising grade filtration is essential.

The Evolution of Single-Use Technologies in Aseptic Processing

The authors describe the origins of single-use components and explain their application to aseptic processes. They also show how disposable devices have changed over time and offer a glimpse of the future.
Apr 2, 2010

The authors describe the origins of single-use components and explain their application to aseptic processes. They also show how disposable devices have changed over time and offer a glimpse of the future.

A Detail View of Single-Use Equipment Opportunities

The authors propose increased use of single-use technologies in biopharmaceutical manufacturing to achieve operational excellence without compromising product quality.
Mar 1, 2010

The authors propose increased use of single-use technologies in biopharmaceutical manufacturing to achieve operational excellence without compromising product quality.

Disposable Components in Aseptic Processing

The authors discuss current and future disposable technologies and outline the validation and qualification steps that would be required for a possible disposable process stream.
May 1, 2009

The authors discuss current and future disposable technologies and outline the validation and qualification steps that would be required for a possible disposable process stream.

Improving the Integrity Test Assurance of Multiround Housings Assessments

The authors describe a novel approach for the integrity testing of large sterile filter systems such as multiround housings and describe a multipoint diffusion test capable of detecting minor failures.
Nov 1, 2008

The authors describe a novel approach for the integrity testing of large sterile filter systems such as multiround housings and describe a multipoint diffusion test capable of detecting minor failures.

The Importance of Pre-Use Integrity Testing in Sterilizing Filtration

Pre-use integrity testing of sterilizing-grade filters eliminates the potential adverse effects of filter loading on the integrity-test results, allowing unambiguous correlation with the integrity-test specification established during filter-validation studies.
May 1, 2007

Pre-use integrity testing of sterilizing-grade filters eliminates the potential adverse effects of filter loading on the integrity-test results, allowing unambiguous correlation with the integrity-test specification established during filter-validation studies.

The Relationship among Pore-Size Ratings, Bubble Points, and Porosity

Jan 2, 2007

Pore-size ratings are so unrelated to actual dimensions and so subject to anomalous interpretations as to make substantial dependency upon their values an unwise choice. Moreover, the means of measuring them are questionable. The pore-size rating system at best provides a qualitative differentiation.

The Use of Model Organisms in Sterilizing Filtration

May 1, 2006

Model organisms are useful when validating sterile filtration, but successful retention of the model organism does not always guarantee that effluent is sterile. The authors explore the various factors that influence sterile filtration.

Grow-Through and Penetration of the 0.2/0.22 "Sterilizing" Membranes

Mar 2, 2006

The authors encourage the investigation into whether the occurrence of grow-through and the diminution in the size of certain organisms when in contact with given liquids are the same phenomenon manifested under different circumstances.

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