Freeze-drying of biohazardous products

Adams, G.D.

doi:10.1007/978-94-011-1352-6_10

Cited by 7 publications

(1 citation statement)

References 27 publications

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“…[6] Crude in-line filters have been shown to prevent microbial contamination of the freezedryer condenser [7,8] and indeed the use of filter boxes have been suggested to contain product, thus preventing contaminating the freeze dryer by ablation. [9] Currently, however, containment systems that are specifically designed for containment of aerosols and particles generated by ablation during freeze drying of microorganisms do not exist.…”

Section: Introductionmentioning

confidence: 99%

Proof of Concept: Containment Systems that Prevent Freeze-Dryer Contamination When LyophilizingEscherichia coli(JM 109)

Cherry¹,

Cooper

Millward

et al. 2015

Drying Technology

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This study describes the use of containment systems to prevent escape of microorganisms during lyophilization, thereby avoiding contamination of freeze-drying equipment. Cultures of Escherichia coli (JM 109) of an approximate cell concentration of 10 9 cfu/mL were suspended in 0.9% saline, aseptically dispensed into vials, double-wrapped in either medical-grade paper or Tyvek sterilization pouches and freeze-dried. An intentional collapse phenomenon was observed during the freeze-drying process, ejecting debris and aerosols from the vials, thus representing a worst-case challenge for containment. Following freeze drying, the layers of the pouches were tested for microbial contamination using 3 M Clean-Trace surface ATP analyzer swabs, surface swabs, and tryptone soya agar contact plates. The paper and Tyvek pouches were able to contain a maximum cell concentration of 1 x 10 6 cfu/mL of E. coli recovered from ejected debris. Some penetration through the first paper pouch layer was observed (although not Tyvek); however, this was successfully retained by the second, outer layer preventing contamination of the lyophilization apparatus and laboratory environment.

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Section: Introductionmentioning

confidence: 99%

Proof of Concept: Containment Systems that Prevent Freeze-Dryer Contamination When LyophilizingEscherichia coli(JM 109)

Cherry¹,

Cooper

Millward

et al. 2015

Drying Technology

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Biosafety

Chisti¹

1998

Bioseparation and Bioprocessing

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The Principles of Freeze-Drying

Adams¹,

Cook

Ward

2014

Cryopreservation and Freeze-Drying Protocols

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This chapter provides an up-to-date overview of freeze-drying (lyophilization) with particular relevance to stabilizing live cells or viruses for industrial applications as vaccines or seed culture. The chapter discusses the importance of formulation, cycle development, validation, and the need to satisfy pharmaceutical regulatory requirements necessary for the commercial exploitation of freeze-dried products.

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Freeze-drying of biohazardous products

Cited by 7 publications

References 27 publications

Proof of Concept: Containment Systems that Prevent Freeze-Dryer Contamination When LyophilizingEscherichia coli(JM 109)

Proof of Concept: Containment Systems that Prevent Freeze-Dryer Contamination When LyophilizingEscherichia coli(JM 109)

Biosafety

The Principles of Freeze-Drying

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