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Are your disinfectant validation protocols fit for purpose?
In a review, Tim Sandle sets out what disinfectant validation studies should assess and why those factors are important when choosing cleanroom disinfectants.
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Bio Products Laboratory
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Burkholderia cepacia complex: review of origins, risks and test methodologies
Burkholderia cepacia complex (BCC) isolates are causes of healthcare-associated infection, especially in relation to contamination of aqueous inhalers and some intravenously administered products. The bacterial species can cause opportunistic infections in vulnerable individuals, especially those with cystic fibrosis (CF)
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Environmental Monitoring In-Depth Focus 2018
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.
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Strategy for the adoption of single-use technology
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…
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The people factor: investigating the gown
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.
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Microbiology In-Depth Focus 2017
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...
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Environmental Monitoring In-Depth Focus 2016
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...
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Microbiology: In-Depth Focus 2016
In this Microbiology In-Depth Focus: Risk-based microbiological testing; Improving microbiological assurance for bioburden testing; Microbiology Roundtable...
news
Coagadex available in the UK for patients with hereditary factor X deficiency
6 June 2016 | By Victoria White, Digital Content Producer
Coagadex is indicated for the treatment and prophylaxis of bleeding episodes and for perioperative management in patients with hereditary factor X deficiency...
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BPL’s Coagadex approved in the EU for hereditary factor X deficiency
30 March 2016 | By Victoria White
Coagadex is indicated for the treatment and prophylaxis of bleeding episodes and for perioperative management in patients with hereditary factor X deficiency...
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FDA approves Coagadex for hereditary Factor X deficiency
21 October 2015 | By Victoria White
Until this orphan drug approval, no specific coagulation factor replacement therapy was available in the US for patients with hereditary Factor X deficiency...
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Real-time biological particle counting in environmental monitoring
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…
