Regulatory testing: REACHREACH is the European Community Regulation on chemicals and their safe use (EC 1907/2006). It deals with the Registration, Evaluation, Authorisation and Restriction of CHemical substances. The law came into force on 1 June 2007 with the sole aim of placing greater responsibility on industry to protect human health and the environment. The number of scientific facilities offering genetic toxicology services for REACH testing is steadily expanding. The 31st of May 2013 is the deadline for industry to register all phase-in substances manufactured or imported in the EU above 100 tonnes a year under REACH. Enforcement of REACH and CLP (Classification, Labelling and Packaging of chemical substances & mixtures) means generally a range of actions that national authorities initiate to verify the compliance of the duty holders with REACH and CLP Regulations. For example, this includes checking whether the substance has been registered or pre-registered or verifying the presence and correctness of the Safety Data Sheets. REACH requires that studies should be conducted in a Good Laboratory Practice (GLP) accredited laboratory, and in addition, the REACH initiative strives to minimise the number of animal tests. The REACH regulation provides a number of possibilities to adapt the testing requirements and to use alternative assessment approaches. One such approach is the Ames Test (Bacterial Reverse Mutation Assay). GLP compliant software solutions for REACH testing
Perceptive Instruments are able to offer a suite of products which can be used by laboratories conducting the Ames Test to coincide with the REACH guidelines. Our world-renowned colony counter Sorcerer 3 is able to effortlessly and automatically determine the number of bacterial colonies per plate using powerful image analysis. In addition, the Ames Study Manager can be used in conjunction with Sorcerer to effectively manage the data generated within Ames Test investigations. The Ames Study Manager has been designed to work alongside protocols developed to regulatory guidelines e.g. OECD 471, ICH S2(R1) etc. It is used in pharmaceutical, medical and chemical companies as well as contract research organisations. Therefore, when conducting the Ames Test, the Sorcerer colony counter and Ames Study Manager are clearly the products of choice. The combination of one of the most powerful and flexible image analysis systems on the market with the most versatile and well-regarded study management system, gives unparalleled data control. The software complies with GLP guidelines & FDA 21 CFR Part 11 Final Rule on Electronic Records & Electronic Signatures and boasts exceptional database security and excellent flexibility in data entry configuration. Users can be prompted to justify all auditable actions in a customised manner, resulting in a robust, but adaptable, approach to achieving compliance. Perceptive Instruments have installed integrated Sorcerer and Ames Study Manager systems in contract research organisations and scientific institutes all over the world. Please contact us if you would like to keep up with the cutting edge of data management with the Ames test, and bring Perceptive Instruments’ software suite into your laboratory. References |
