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Tim Sandle

 

Environmental Monitoring In-Depth Focus 2018

In this issue: the importance of culture media selection, control…

29 August 2018 | By

In this issue: the importance of culture media selection, control and realease, how the new draft of Annex 1, Manufacture of Sterile Medicinal Products is impacting environmental monitoring programmes, and software tools that enable confident GC-MS analysis of extractables in pharmaceutical products.

Strategy for the adoption of single-use technology

Recent technological advances are enabling manufacturers to move away from…

22 March 2018 | By

Recent technological advances are enabling manufacturers to move away from equipment that must be sterilised or consumables that are recycled or pose a risk with their transfer into cleanrooms, towards the adoption of disposable and single-use sterile items. This article considers the advantages of implementing single-use technology and outlines a…

The people factor: investigating the gown

An effective environmental monitoring programme is designed to estimate the…

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.

Microbiology In-Depth Focus 2017

In this Microbiology In-Depth Focus: Endotoxin masking hold-time study performance…

13 April 2017 | By

In this Microbiology In-Depth Focus: Endotoxin masking hold-time study performance parameters; Microbiological monitoring pharmaceutical water systems; The rush to rapid microbiological methods - or not; and an expert view with Charles River Laboratories...

Environmental Monitoring In-Depth Focus 2016

In this Environmental Monitoring In-Depth Focus: Bacterial endotoxin contamination and…

24 August 2016 | By European Pharmaceutical Review

In this Environmental Monitoring In-Depth Focus: Bacterial endotoxin contamination and testing limits in ophthalmics; The basics of environmental monitoring in aseptic units; Environmental Monitoring Roundtable...

Real-time biological particle counting in environmental monitoring

The methods for monitoring air in cleanroom environments: viable counting…

20 April 2015 | By

The methods for monitoring air in cleanroom environments: viable counting techniques (settle plates and biological air samplers) and particle counters, are long established technologies and have been widely used in pharmaceutical manufacturing environments for decades. Although innovations have taken place with both particle counters and biological air samplers, primarily in…

Fungal contamination of pharmaceutical products: a growing menace

Any pharmaceutical product, whether manufactured in the hospital or industrial…

19 February 2014 | By

Any pharmaceutical product, whether manufactured in the hospital or industrial environment, has the potential to be contaminated with microorganisms. With sterile products, any microbial contamination presents an unacceptable risk; with non-sterile products, the implication of the contamination is dependent upon whether the microorganism can be considered ‘objectionable’, and then to…