Journal contents list

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Issue 24: October 2015

Main features

Airborne particle deposition in cleanrooms:

Deposition mechanisms

W Whyte, K Agricola and M Derks

Abstract →

Abstract

This article discusses the mechanisms of particle deposition onto cleanroom surfaces. The main mechanism for particles above about 0.5µm is gravitational settling. Turbulent deposition and electrostatic attraction can also occur at all particle sizes, and for particles below 0.5µm Brownian diffusion is important. Measurements of particle deposition rates (PDRs) were made of particles ±10µm on witness plates orientated in different directions and exposed in different ventilation conditions, and it was concluded that over 80% of particles were deposited by gravitational sedimentation, and probably more than half of the remainder by turbulent deposition.

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Product Oriented Contamination Control (POCC)

Koos Agricola

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Abstract

Product Oriented Contamination Control (POCC) is a systematic method to determine contamination causes of product failure and to determine potential critical control points. A risk assessment then helps to prioritise the critical control points and to determine the type of contamination control solution that would reduce the risk of product failure due to particle contamination during manufacturing.

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Importance of risk assessment for aseptic transfer in pharmaceutical compounding

Tim Sandle

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Abstract

Aseptic transfer is a critical contamination control issue, carried out over a series of stages. If any stage is performed in an uncontrolled manner then microbial contamination of a product can occur. Contamination risks can arise from a number of sources, including incoming materials, air and personnel. To address these risks appropriate controls include controlled environments, personnel gowning and behaviour, and the use of disinfectants. This article considers the key risks and risk mitigation strategies using a case study of aseptic transfer within a pharmacy unit for the purpose of preparation or compounding of a medicinal drug product.

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Containment and Ebola in an outbreak setting

Allan Bennett, Simon Parks and Tom Pottage

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Abstract

This article describes the diagnostic laboratories commissioned by PHE in Sierra Leone to support Ebola treatment Centres. Specialised isolators were designed, assembled and tested in the UK before being dismantled and shipped to site for reassembly. The isolators were designed and constructed based on the experience of HPE Porton in containment.

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Regulatory reflections

EU GMP Annex 1

Tim Eaton

Life-lines

News

Contec ProChlor validated for sporicidal transfer disinfection

New isolator half-suit from Pharminox Isolation Ltd

DOP Solutions introduces a new cleanroom Airflow Mapper

Edinburgh Molecular Imaging is first customer for Envair Lab’s brand new safety cabinet

Clean Room Construction completes flagship projects in record-breaking year

CHTS helps CL3 lab managers meet increasing demands for evidence of fumigation efficacy

Cleanroom Guangzhou Exhibition 2015 Post-Show Report

Ecolab helps reduce exposure to cytotoxic drugs

Validair launch EasySense wireless sensors for use with ViGIE 2.0 software

Events and Training Courses