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Regulatory
News
ISPE updates water and steam systems guide– 14-Nov-2011
Addresses changes to industrial practices and global regulations
IEST revises IEST-RP-CC031.3– 28-Oct-2011
New appendix provides reference table that lists materials found in cleanrooms
FDA warns SmithKline Beecham of CGMP violations– 19-Oct-2011
Inspection found failings with microbiological contamination and laboratory control procedures
Hygiene certificate checks disinfection in laundries– 19-Sep-2011
Adds to Hotelcheck Hygiene scheme that checks cleanliness of main hotel areas
DEKRA to acquire Chilworth Global– 16-Aug-2011
Will become a leading international provider of quality and safety services
Revised standard addresses medical device issue – 15-Aug-2011
The AAMI standard makes it easier to use a less-restrictive SAL for sensitive medical devices
German medical device testing lab acquired by UL– 4-Aug-2011
The company’s services include validation of cleaning, reprocessing, sterilisation and packaging
ASTM approves chemical permeation testing standard– 6-Jul-2011
Computer software takes seconds to perform calculations
US FDA aims to increase safety of imports – 21-Jun-2011
Sets out four-point plan of collaboration with other regulators worldwide
Porton Group sues 3M over MRSA detection device– 17-Jun-2011
Seeks damages of £41m for breach of contract
US FDA publishes draft guidance on nanotechnology– 10-Jun-2011
First step towards providing regulatory clarity on FDA’s approach to the subject
Ansell publishes guide to EN Standards for Gloves– 31-May-2011
Also offers information on how to protect hands against a number of hazards
Articles
Applying ISO methods to counter calibration– 21-Nov-2011
International standards for the monitoring of airborne particles apply to all cleanrooms or clean zones. The international committee, TC209 Working Group 1, has been examining potential revisions to the first two sections of the ISO 14644 document. One key change in the proposed revision is the normative reference to a calibration standard for the instrument to be used for cleanroom classification. Although calibration will probably create some additional cost, there will be noteworthy benefits in both the repeatability and the reproducibility of the measurements obtained
Bribery law: time to act– 11-Aug-2011
The UK's new Bribery Act applies not only to UK-based companies but also to those carrying on business in the UK, and to any persons 'associated' with such a business, including employees, agents and joint venture partners. Companies must therefore implement urgently a compliance programme to minimise the risk of bribery - which may be corrupt payments, lavish hospitality or small, unofficial payments - being undertaken on their behalf
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
Pharmaceutical plant disinfection: the acid test– 5-Nov-2010
Choosing a suitable disinfectant for a pharmaceutical operation can be a complex process. Christopher Fournier* and Dominique Leclercq** of Mar Cor Purification, outline the main considerations
Get calibration up to ISO standard– 2-Sep-2010
ISO 21501 for particle size determination has a particular section that is of relevance to the cleanroom sector. Steve Kochevar, Particle Measuring Systems, reviews Part 4 on calibration procedure and verification method for airborne particle counters
Events
IIR Cleanroom and lab forum – 26-Jan-2012
12 - 14 March 2012
Technical forum
Vienna, Austria