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This ebook from Sartorius takes an in-depth look at how…
This ebook from Sartorius takes an in-depth look at how the quality control (QC) microbiology laboratory plays a critical role in control of the pharmaceutical manufacturing environment and product release.
Researchers have shown that microbial surface recovery using contact plates…
Researchers have shown that microbial surface recovery using contact plates was superior on vinyl than stainless steel.
In this issue: the importance of culture media selection, control…
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.
Recent technological advances are enabling manufacturers to move away from…
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…
In this in-depth focus: Compressed gases - an important component…
In this in-depth focus: Compressed gases - an important component of an environmental monitoring programme; The people factor - contamination of cleanrooms caused by personnel...
An effective environmental monitoring programme is designed to estimate the…
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.
In this Microbiology In-Depth Focus: Endotoxin masking hold-time study performance…
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...
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...
In this Microbiology In-Depth Focus: Risk-based microbiological testing; Improving microbiological…
In this Microbiology In-Depth Focus: Risk-based microbiological testing; Improving microbiological assurance for bioburden testing; Microbiology Roundtable...
The methods for monitoring air in cleanroom environments: viable counting…
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…
Any pharmaceutical product, whether manufactured in the hospital or industrial…
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…
