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Microbiology - Articles and news items

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Wickham Labs to Exhibit at Pharmig 2016

Supplier news / 3 November 2016 / Wickham Laboratories Limited

Wickham Laboratories will be on Stand 8 at the 24th Annual Pharmig Conference in the Nottingham Belfry Hotel, November 16th & 17th…

Demand for Cherwell’s SAS Air Sampler Calibration service continues to rise year-on-year

Demand for Cherwell’s SAS Air Sampler Calibration service continues to rise year-on-year

Supplier news / 30 September 2016 / Cherwell Laboratories

Overall demand up by 15% with on-site calibrations showing most significant rise…

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Joint article on hydrogen peroxide efficacy published in Letters in Applied Microbiology

Supplier news / 23 September 2016 / Wickham Laboratories Limited

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

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Current activities of the USP general chapters

Issue 4 2016 / 24 August 2016 / Radhakrishna Tirumalai, PhD, United States Pharmacopeial Convention

From a microbiological perspective, pharmaceutical products fall into two categories – nonsterile and sterile. For both categories manufacturers must eliminate, or minimise, potential health risks to patients related to microorganisms and the toxins they produce, whilst maintaining product quality. Many contributing factors may affect the quality of a medicine or its ingredients, but microbial bioburden […]

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 / European Pharmaceutical Review

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…

 

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