news
Cherwell appoints Harshad Joshi as new Quality Manager
7 September 2015 | By Cherwell Laboratories
Company maintains focus on quality to meet customer expectations...
List view / Grid view
Microbiology
article
Rapid methods update: revisions to a United States Pharmacopeia chapter
3 September 2015 | By Michael J. Miller, PhD Microbiology Consultants, LLC
From 2010 to 2013, European Pharmaceutical Review published a very successful series on rapid microbiological methods (RMM) that included hot topics such as the European Medicines Agency’s and US Food and Drug Administration’s expectations, implementation strategies, scientific principles behind the technologies and validation.
news
Cherwell launches refreshed website for Cleanroom Microbiology Solutions
30 July 2015 | By Cherwell Laboratories
Cherwell Laboratories, specialists in cleanroom microbiology solutions for the pharmaceutical and related industries, have announced the launch of a refreshed website....
article
Issue #3 2015 – Digital edition
In Issue #3 2015: Regulatory Insight, Microfluidics, PCR in-depth focus, Drug Delivery, Content Uniformity, HPLC, Microbiology in-depth focus, NMR, PAT and much more...
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Microbiology In-Depth Focus 2015
In this Microbiology In-Depth Focus: Diversity of bacteria in pharmaceutical water: significance and impact on quality, Risk-based environmental control and monitoring and Microbiology Roundtable...
article
Issue #2 2015 – Digital edition
In Issue #2 2015: Outsourcing, Drug pricing reforms, Stem Cells in-depth focus, Microbiology series, Environmental monitoring, LC-MS in-depth focus, Manufacturing solutions, PAT series and much more...
article
Outsourcing in the analytical and microbiology area
20 April 2015 | By Roger A. Stroud, R Stroud Pharmaceutical Quality Solutions Limited
Increasing numbers of pharmaceutical companies are considering outsourcing in the area of analytical and microbiological testing, from the very smallest start-up, virtual, or small company up to the largest multinational. This article will examine the factors that lead to a company deciding to outsource, and provides invaluable guidance on the…
article
Reducing microbial contamination via sterile risk assessment
20 April 2015 | By Guenther Gapp, Lachman Consulting Ltd/Independent Consultant
Several years ago, microbiologist Guenther Gapp created a new sterile risk assessment tool (based on a hazard operability analysis [HAZOP] approach) to identify and reduce the microbial contamination and compliance risk of aseptically-produced sterile products and production plants. The following article describes the operating principle of three risk analysis tools…
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Issue #1 2015 – Digital edition
In Issue #1 2015: Regulatory Insight, Biologics, NIR in-depth focus, Raman in-depth focus, PAT, Drug Delivery, Microbiology Series and much more...
article
The role of water activity in the microbial stability of non-sterile pharmaceutical drug products
Aqueous, multiple-use, non-sterile drug products are susceptible to microbial contamination during their shelf life. To protect these products from this potential hazard to patients, they are formulated with antimicrobial preservatives. Other product attributes employed using the hurdle concept to prevent microbial contamination include: low pH, low redox potential, reduced storage…
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Issue #6 2014 – Digital edition
In Issue #6 2014: Polymerase Chain Reaction, Imaging, PAT in-depth focus, Screening in-depth focus, Microbiology Series and much more...
webinar
Practical Application of RMM in Pharmaceutical Manufacturing
15 December 2014 | By BD Diagnostics
Discussion on how a rapid method can provide a solution to a common microbiological testing problem for pharmaceutical manufacturers – process water microbiology testing.
product
bioMérieux’s Jennifer Garrett interviewed at PDA conference on Pharmaceutical Microbiology
Graeme Cathie speaks with Jennifer Garrett, Regional Business Manager, BioPharma, bioMérieux at the PDA conference on Pharmaceutical Microbiology...
video
TSI’s Troy Tillman interviewed at PDA conference on Pharmaceutical Microbiology
Graeme Cathie speaks with Troy Tillman, Global Marketing Manager, TSI inc. at the PDA conference on Pharmaceutical Microbiology...
article
Issue #3 2014 – Digital edition
In Issue #3 2014: Pharmaceutical freeze-drying, Self-amplifying mRNA vaccines, Polymorph myths, Microbiology focus, NMR for isotope profiling, Manufacturing with QbD 2.0, Single-cell mRNA-Sequencing, qPCR focus, Powder Flow...
