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Environmental Monitoring

 

Avoiding environmental monitoring ‘false negatives’: overcoming disinfectant residues with culture media neutralisers

6 September 2018 | By

Even with the rise of rapid microbiological methods, most environmental monitoring applications are undertaken using culture media, with many alternative methods also being growth-based. This makes the selection, control and release of culture media an area of great importance, given that the quality of the culture media underpins the environmental…

Issue 4, 2018

29 August 2018 | By

A US perspective on how pharma companies are preparing for Brexit, overcoming disinfectant residues with culture media neutralisers, unlocking the potential of new technology in biopharma, and much more in this issue of European Pharmaceutical Review.

Understanding current CFR 21.11 and data integrity requirements

8 August 2018 | By SUEZ

The US FDA and European Commission have defined regulations relating to the submission of electronic records in lieu of paper documents, for submission, inspection, and archiving purposes. When ageing analytical equipment is to be replaced 21CFR Part 11 and EU Annex 11 are also topics of discussion. Common questions from…

Compressed gases: an important component of an environmental monitoring programme

25 August 2017 | By , ,

The quality attributes of manufactured pharmaceutical products include the physical, chemical, and microbiological characteristics of the raw materials, excipients and active pharmaceutical ingredient (API), as well as the final drug product (see Table 1). Absence of microbiological contamination is considered a critical quality attribute due to its potential to dramatically…

The people factor: investigating the gown

1 August 2017 | By

An effective environmental monitoring programme is designed to estimate the microbial content of the room’s air and surfaces (by incident rate, against alert and action levels, and by assessment of different species) for operations performed within a cleanroom or controlled environment.