Clean Air and Containment Review

Editor: John Neiger
Publisher: Euromed Communications
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Journal contents list

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Issue 36: Autumn 2018

Main features
The statistical treatment of sampling in ISO 14644-1:2015: comments on a recent article
Niels Væver Hartvig
Abstract →

This article presents a response to the critique of the statistical principles in ISO14644-1:2015 raised in a recent paper by Dr Alexander Fedotov in the July/August issue of Clean Air and Containment Review. A distinction between the sampling uncertainty and the concentration variation is made and the assumptions in the ISO-standard of these two sources of uncertainty are discussed.

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H2O2 surface sterilization: a definitely robust process for routine use in isolators
Didier Meyer
Abstract →

Hydrogen peroxide vapor has been in use as a surface sterilizing agent for isolators since the beginning of the nineties. The robustness and validation of its use has been reported in numerous scientific and practical physical, chemical and microbiological studies. This article shares the reports of scientists, end-users, regulators and suppliers in its successful use.

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Cleanroom routine environmental monitoring - FDA Guidance on 21CFR part 11 Data Integrity
Tony Harrison
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A recent report suggests that circa 79% of 483 warning letters issued by the FDA to the biopharmaceutical industry sited deficiencies in their data integrity. Despite guidance from the FDA, cleanroom environmental monitoring remains an intensely manual process, with many opportunities for human error to create gaps and errors in the data. In their 21CFR part 11 guidance, the FDA have given recommendations on what good data integrity looks like and this article explains their advice in the context of current cleanroom environmental practices and shows how the FDA guidance can be applied to improve data integrity.

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Creating, implementing and maintaining a monitoring plan based on Risk Assessment
Hasim Solmaz
Abstract →

Clean areas used for aseptic manufacturing of sterile medicinal products are subject to standards and guidelines to ensure quality of production and to minimize risks of particulate and microbiological contamination. In recent years, a proper monitoring plan with a risk-based approach has become a part of many standards and regulations such as ISO 14644-2:2015 and ICH Harmonized Guideline ICHQ9 Quality Risk Management. However it is also obvious that there is a lack of good application practices for proper monitoring plans that are based on risk assessment. This study provides information with an example of how to prepare a risk based monitoring plan incorporating risk assessment tools, current standards, regulations and guidelines.

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Creating, implementing and maintaining a monitoring plan based on Risk Assessment
Berthold Düthorn
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Within the International Organization for Standardization (ISO), Technical Committee (TC) 209 is chartered with standardization of cleanrooms and associated controlled environments. A series of 15 international standards (thirteen parts under ISO 14644 and ISO 14698 Part 1 - 2) has been established for controlling contamination by means of cleanroom technology. The documents address design, classification and support operation of cleanrooms.

The recently published standard ISO 14644-15:2017 specifies assessment of the suitability of equipment and materials with respect to airborne chemical concentration. Three sampling procedures are described as well as calculation procedures for emission rate and specific emission rate in g/s for equipment(s) or g/(m2s) for material(s). The emission rate and specific emission rate and proscribed inspection result are used for the cleanroom suitability assessment.

The specific emission rate can be used by designers, suppliers and users for acceptance or impact evaluation of equipment and materials considered for use in existing or future applications of cleanroom technology.

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E-learning module from Pharmig supports Annex 1 disinfection requirements
Tim Sandle
Conference report
International Symposium on Contamination Control 2018 - ISCC'18 "The world behind contamination control"
Koos Agricola
Exhibition report
Mission accomplished: Cleanzone 2018 draws more international visitors to Frankfurt
Cherwell publishes guide on EM programs for revised EU GMP Annex 1
EECO2 Launches in-house research into cleanroom performance
CRC has designs on Wales
Biopharma Group launches a new era for Faster air safety cabinets in the UK
Envair Limited sells Envair Lab to Biopharma Group
Pharma Clean Tech 2019, SNIEC Shanghai, June 18–20, 2019
Events and Training courses