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Microbiology - Articles and news items

Microbiological environmental monitoring features in two national conferences supported by Cherwell Laboratories

Microbiological environmental monitoring features in two national conferences supported by Cherwell Laboratories

Supplier news / 9 August 2016 / Cherwell Laboratories

Cherwell to offer expert insight in environmental monitoring and process validation to both NHS and industrial pharmaceutical manufacturers…

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Joint article on hydrogen peroxide efficacy published in letters in applied microbiology

Supplier news / 8 August 2016 / Wickham Laboratories

Wickham Laboratories Ltd is pleased to announce the publication of a joint study with Bioquell on the efficacy of disinfection by hydrogen peroxide…

Method suitability in microbiology: understanding complex cGMP guidelines

Method suitability in microbiology: understanding complex cGMP guidelines

Microbiology / RMMs, Whitepapers, Z Homepage promo / 15 July 2016 / Wickham Labs

Particularly in the pharmaceutical industry, microbiological method development and, specifically, method suitability is often overlooked or left until the end of a project. However, it is important to give both method suitability and development due consideration as it can be a complicated process involving wide specifications, vague parameters and the inherent variation that comes from working with living organisms…

Microbiology In-Depth Focus 2016

Microbiology: In-Depth Focus 2016

Issue 3 2016, Microbiology / RMMs, Supplements, Z Homepage promo / 30 June 2016 /

Featuring: Risk-based microbiological testing; Improving microbiological assurance for bioburden testing; Microbiology Roundtable.

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Eppendorf expands single-use vessel portfolio for microbial fermentation

Supplier news / 31 May 2016 / Eppendorf

Eppendorf’s BioBLU 3f Single-Use Vessels specifically address the demands of high cell density fermentation of bacteria, yeasts and fungi…

A novel approach in assessing the antimicrobial efficacy of eye drop products

A novel approach in assessing the antimicrobial efficacy of eye drop products

Issue 2 2016, Microbiology / RMMs / 4 May 2016 / Mostafa Eissa, Hikma Pharmaceuticals

The microbial contamination of medicinal products constitutes a continuous threat to the health of consumers, which may negatively impact pharmaceutical companies’ reputability. However, multidose sterile pharmaceutical products are prone to contamination either from the normal flora of the human body or from the surrounding environment, following their misuse by patients. With the absence of strict medical supervision from medical professionals, patients can infect themselves with such a contaminated product. The study described in this article provides a new prospective view on the preservative efficacy test (PET) to assess the potency of antimicrobial agent(s) in two formulae of eye drops as well as quantitatively determining the risk of recontamination by the consumer…

Cherwell introduces new Redipor® prepared media products to support customer needs

Cherwell introduces new Redipor® prepared media products to support customer needs

Supplier news / 22 March 2016 / Cherwell Laboratories

New 2016 Redipor® price list available on request…

The challenges of riskbased environmental monitoring in sterile product filling

The challenges of riskbased environmental monitoring in sterile product filling

Issue 1 2016, Microbiology / RMMs / 29 February 2016 / James L. Drinkwater, Chairman, Pharmaceutical and Healthcare Sciences Society

Completing risk assessments is an inherent part of good manufacturing practice (GMP) and risk-based environmental control and monitoring (EM) in sterile product filling within isolators and restricted access barrier systems (RABS). This article considers the challenges the pharmaceutical industry faces in characterising conventional risk assessments like failure modes and effects analysis (FMEA) for determination of risk-based EM programs, considering aspects of the filling machine, barrier separation technology, surrounding cleanroom environment, monitoring methods/systems and process operations. The requirement for process monitoring for the manufacture of sterile medicinal products is starting to be discussed in the revision of EU GMP Annex 1, so as to bring together all EM data and hence consider the process holistically…

Whitepaper: Is it essential to sequence the entire 16S rRNA gene for bacterial identification?

Whitepaper: Is it essential to sequence the entire 16S rRNA gene for bacterial identification?

Whitepapers / 1 February 2016 / Charles River

The biopharmaceutical industry, especially manufacturing facilities, needs to implement bacterial identification to avoid the occurrence of a problematic microorganism in the final product that could be harmful for the end user and detrimental to a company’s finances and reputation…

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Emerging trends in microbiological diagnostics: an introduction to rapid microbiological methods

Blog / 29 January 2016 / Adewale Joseph Ogunleye, Adekunle Ajasin University, Akungba Akoko, Ondo State, Nigeria

This article explores how scientists are developing a fast, qualitative and specific technique for the detection and classification of microorganisms…

The limitations of the colony-forming unit in microbiology

The limitations of the colony-forming unit in microbiology

Issue 6 2015, Microbiology / RMMs / 6 January 2016 / Tony Cundell, Microbiological Consulting LLC

The recent revision to USP General Informational Chapter <1223> Validation of Alternative Microbiological Methods that became official on December 1, 2015 contained a section discussing the limitations of the colony-forming unit (CFU) in terms of enumerating only those microorganisms that readily grow on solid microbiological media. The section highlights its inappropriateness as a gold standard for method validation when there are many signals available other than CFUs for the detection, enumeration and identification of microorganisms in water, air, pharmaceutical ingredients and drug products…

Cherwell strengthens team with Microbiology Product Specialist appointment

Cherwell strengthens team with Microbiology Product Specialist appointment

Supplier news / 14 December 2015 / Cherwell Laboratories

Company boosts industrial microbiology expertise to enhance customer support…

 

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