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Biological Analysis

News

VITEK 2 Compact GP card gains international approval – 27-Apr-2012

Card used to identify Gram-Positive bacteria now has AOAC OMA approval for food safety testing

Opinion: Mastering microbes– 26-Apr-2012

Rapid Microbial Methods are enabling companies to take fast action to stop contaminated products reaching the public

Rapid Micro Biosystems to launch Growth Direct test systems next year– 17-Apr-2012

For environmental monitoring and sterility applications

Nelson Laboratories acquires new building – 11-Apr-2012

US microbiology lab continues growth in-line with increased requirements for medical device testing

Bristol Myers-Squibb recalls Viaspan– 2-Apr-2012

Bacteria found during media fill test

Opinion: Looking for fingerprints– 29-Feb-2012

The recent deaths of three infants at a neonatal unit in a Belfast Hospital bring into sharp relief the importance of contamination control in hospitals

LAL testing: endotoxin detection– 14-Feb-2012

The Endosafe PTSª provides quantitative results in 15 minutes

Robert Mondavi Research Institute installs ProtoCOL colony counter– 13-Jan-2012

To speed up studies on the growth of bacterial pathogens in food

EnSURE hygiene quality monitoring system is suitable for brewery use– 10-Jan-2012

According to The Campden BRI Instrument Assessment Service, which provides a full report on its website

UK IAH opens £10m IS4L lab for virus research– 9-Jan-2012

Best engineering standards applied to ensure no pathogens can escape into the environment

Jamjoom Pharma installs ProtoCOL– 16-Dec-2011

Colony counter enables the Saudi Arabian firm to assess the quality of products

MicroVal certifies GreenLight TVC method– 30-Nov-2011

Automatically detects microbial contamination in food and drink samples

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Articles

Trending and strain-typing microbes– 4-May-2012

In industrial settings characterisation of micro-organisms is an important part of the comprehensive environmental monitoring programme. Strain-typing is the best resource in the case of a major excursion or sterility failure where characterisation to the strain level can be critical. Currently, there are two methods primarily used to differentiate accurately and reproducibly between closely related micro-organisms: ribotyping and single- and multi-locus sequence typing (S/MLST).

The pre-sterilisation paradox– 26-Mar-2012

Apart from the legal need to comply with the regulatory requirements governing sterile manufacturing of medical devices, manufacturers need to appreciate the inactivation kinetics of sterilisation technologies. They must also understand the types of viable and non-viable contamination and their effects on the human body. Manufacturers are advised to determine their cleanliness requirements as a result of a formal risk analysis exercise. A review and assessment of control plans with microbiologist support is strongly encouraged.

Reading the MFT signs– 23-Mar-2012

Pharmaceutical manufacturers using an aseptic filling process must prove that this practice is under control using a Media Fill Test (MFT). Qualification of an aseptic filling line requires three successful MFTs in a row, in addition to a periodic re-evaluation of lines at least twice a year. Reading a MFT result is a delicate exercise and can be prone to human error. bioMérieux, has developed TSB 3P with Vegetable Peptones, which offers a growth-based colour indicator as well as an optimised formulation for the growth of a broad range of environmental micro-organisms studied under aerobic and anaerobic conditions.

Identifying microbes in non-sterile facilities– 29-Feb-2012

A well-designed environmental monitoring programme should detect the presence of bacteria, filamentous fungi and yeasts before product contamination occurs. It is important to be able to identify accurately the organism to the species, and possibly strain level, to track the potential origin of the contamination. Three methods are currently used in commercial settings: genotypic, proteotypic and phenotypic.

Microbiology: failings and best practice– 21-Dec-2011

Microbiological issues in pharmaceutical plants can result in plant shutdowns and products withdrawn from the market. Failures are common in environmental monitoring, media fill, sterilisation, aseptic practice and gowning. Introducing lean practices can determine optimal batch size and lead to a decreased number of test sessions for bioburden, endotoxins and sterility testing, while taking a risk-based approach to determining objectionable micro-organisms may ease the cost and burden of unnecessary testing but requires a better understanding of the processes and risks involved.

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