Validation
News
Vaisala organises seminar on mapping and monitoring in GMP environments – 8-May-2013
Free event in Birmingham is aimed at professionals involved in measuring or monitoring in regulated life science environments
Cherwell to exhibit at Pharmig PCT Contamination Control event – 8-Feb-2013
Improving microbiological quality in pharmaceuticals, cosmetics and toiletries
Ceram adds detergent analysis to cleaning validation service – 7-Feb-2013
Uses LC-MS to identify detergent residues
SafeBridge to merge with Trinity Consultants– 17-Dec-2012
Trinity Consultants plans to provide the resources to expand SafeBridge
Vaisala announces new webinar series – 7-Nov-2012
Webinars offer advice on best practices in validation methods for life science applications such as warehouses, cold rooms, refrigerators, chambers and cleanrooms
Microbiological services provider MVS moves to Sheffield – 5-Jul-2012
The specialist medical support services company has moved from Maltby to a new purpose-built facility
SmartLab EM offers paperless environmental monitoring– 28-Jul-2011
Reduces errors and the risk of batch rejection in aseptic processing
Telstar's life sciences services offerings under a single brand– 17-Feb-2011
New structure emphasises the ability to offer complete integrated solutions for the pharmaceutical and biotechnology industry
ShangPharma opens pilot plant in Shanghai– 17-Jan-2011
For pharma development and cGMP manufacturing
Contamination control – crucial training for the life science sector – 14-Jan-2011
Focus will be on those problems that occur frequently in pharmaceutical production
Astell wins large order in the fight against cancer– 12-Jan-2011
Installation and validation has been completed on an autoclave installation at cancer research centre
Validated monitoring system for new IVF facility– 16-Dec-2010
Includes a fully validated, independent monitoring system
Articles
Making the grade in filters– 3-Dec-2012
The removal of micro-organisms from fluids by passage through filters is a very complex process and is dependent on interactions relating to the chemistry and surface characteristics of the membrane, the micro-organisms, and the suspending fluid. The selection of a membrane filter for a particular product or process is an important choice and one that requires an assessment of the filter, the chemical nature of the product and the physical demands that will be placed on the filter.
Safe selection of biocides– 27-Mar-2012
Consideration of the antimicrobial efficacy of different biocides is an important basis on which to choose an effective disinfectant regime appropriate to the hygiene requirements in a production plant. Alcohols act rapidly and effectively against bacteria, mycobacteria, fungi and viruses but do not possess sporicidal efficacy. Quaternary ammonium compounds have no effect against bacterial spores or mycobacteria, while guanidines have better efficacy against Gram-negative bacteria, but are poorer against yeasts and moulds. Sources of contamination are also a crucial factor.
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.
ISO updates with the BSI– 26-Apr-2011
With ISO 14644 in a state of flux, cleanroom users need to stay informed and contribute to the development of all parts of the standard. Jane Ellis attended the BSI’s recent Cleanrooms Consultation seminar to hear views about the latest changes and their impact
Validation strategy for a sterility test suite– 4-Mar-2011
James Rickloff, Advanced Barrier Concepts, provides an overview of how to validate sterility test isolator systems and, using a case study, how to streamline the process when equivalent isolators are installed in a sterility test suite