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Regulatory
News
Celerion adds Containment Room at Belfast facility– 5-Jun-2013
Will allow firm to carry out live biologics and vaccine studies
Thermo Fisher opens second PASS facility in US– 4-Jun-2013
Offers rapid product evaluation to address safety and quality issues
Cleanroom chemicals added to ECHA authorisation list– 14-May-2013
Environmental health concerns will require permission for use
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
Putting the 3Rs of biomedical research into action – 29-Apr-2013
Charles River representatives looking to elevate the importance of animal welfare in laboratory animal research
Successful FDA inspection for UK contract laboratory company – 26-Apr-2013
Wickham Laboratories receives positive feedback on its excellent facilities, staff expertise and GMP systems
Noroclear kills hospital bugs in 60 seconds– 25-Apr-2013
Available in three formats of surface wipes, hand wipes and a hand rub
Needle-Trap protects healthcare workers from sharps injuries– 23-Apr-2013
Schreiner MediPharm syringe label has an integrated plastic trap
Labconco biosafety cabinet balances comfort and precision– 15-Apr-2013
Features Inclination Technology and MyLogic operating system
SureLife Filter Calculator helps simplify respirator filter selection– 10-Apr-2013
To ensure that users get the appropriate level of protection
Empowering the regulatory affairs professional– 8-Apr-2013
High Edge Consulting launches six new training courses in 2013
Vetter South now ready for cGMP filling– 8-Apr-2013
New line able to handle mid- to large-volume batches
Articles
Prepared for medical needs of tomorrow– 30-Apr-2013
The medical device market continues to grow, boosting demand for sterilisation services. The introduction of technically enhanced instruments has increased the need for advanced sterilisers that are compatible with such devices, marking a shift away from steam sterilisers to technologies such as ethylene oxide, vaporised hydrogen peroxide, hydrogen peroxide gas plasma, and ozone gas-based sterilisation
Biocontamination control – moves toward a better standard – 28-Mar-2013
A review process of the biocontamination control standard ISO14698 has begun. The standard is chiefly concerned with environmental monitoring, but has not been widely adopted because it is not mentioned in any GMP guidance, not does it offer details on how environmental monitoring should be undertaken. The comprehensive review should raise its profile.
Planning a facility upgrade without service interruptions– 28-Mar-2013
Catalent decided to undertake a fundamental redesign and improvement in the layout of its facility in Schorndorf to meet the latest standards, including a radical change to the air handling systems. The major project was planned and implemented with minimal disruption to the site's customer base
How to prevent drug shortages yet sustain quality– 25-Mar-2013
The US FDA reported that 251 drugs went into shortage during 2011, of which 73% were sterile injectables. The shortages followed a common pattern: one or more manufacturers temporarily stopped production to address a manufacturing quality problem, most often caused by microbial or particulate contamination. Sterility assurance, especially in facilities that are not fully automated, can be difficult to accomplish, but at the heart of the drug shortage problem is the inability of the market to observe, and therefore, to reward quality
Designing facilities for aseptic filling– 27-Feb-2013
China has implemented a new version of its Good Manufacturing Practice (GMP) standard, and has completely adopted EU GMP cleanliness standards and introduced the “in operation” classification. Annex 1, on the manufacture of sterile medicinal products, led to a new challenge, addressed by students in a project to design a hypothetical facility for the aseptic product of an antibiotic.
Events
Cleanroom cleaning and validation– 3-Jun-2013
20 - 21 June 2013
Training course
Paris, France
How to successfully implement a disinfectant into the pharmaceutical, healthcare, cosmetics and NHS industries– 3-May-2013
20 June 2013
One-day seminar
Northampton, UK
Risk Assessments for Cleanrooms and Controlled Environments– 26-Apr-2013
23 - 24 July 2013
Two-day course
Arlington Heights, Illinois
Infection Prevention 2013– 23-Apr-2013
30 September - 2 October 2013
Conference and exhibition
ExCeL London, UK
R3 Nordic 44th Symposium – 21-Jan-2013
20 - 21 May 2013
Symposium and exhibition
Chalmers, Gothenburg, Sweden
Water systems: Principles in Practice– 29-Oct-2012
15 - 17 October 2013
Three-day course
Barnard Castle, UK
Pharmaceutical Sterilisation: Principles in Practice– 29-Oct-2012
10 - 12 September 2013
Three-day course
Barnard Castle, UK
Good Engineering Practice– 29-Oct-2012
19 - 20 June 2013
Two-day course
Barnard Castle, UK