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Environmental Laboratory
Environmental Monitoring in Pharmaceutical, Biotechnology or Medical Device Manufacture
Essential Environmental 2016/17
To cope with the vast array of environmental factors and challenges, there must be a comprehensive guide to UK and EU environmental protection law and pollution control legislation. The 38th edition of Essential Environment 2016/17 is just that and it’s available to purchase now. Accessible to users with widely varying knowledge and expertise this guide is an indispensable aid for any environmental professionals and is the only reference resource you will ever need. Companies are under increasing pressure and scrutiny to operate in a way that is responsible to the environment, from the search for sustainable energy to recent debates on fracking and the constant global threat of climate change. Even as individuals we have a duty to play our part - most recently the rejection of plastic bags and bottles to reduce the threat to our oceans and marine life.
Both air and water pollution had been identifi ed as problems many hundreds of year before the Industrial Revolution and the consequential early pollution control measures it bought with it. Fast forward some 250 years and regulators are still struggling with regulations that keep abreast of developments and processes. Look no further than the Paris Agreement in December 2015 or the increasingly likelihood that the Great Barrier Reef could be listed as ‘In Danger’ due to the coral bleaching epidemic. Closer to home, UK water fi rms are facing record pollution fi nes while the London Major plans to bring London’s increased ultra-low emissions zone into force early. Regulations and protection law have never been so important if we are to have a world that can survive and fl ourish in the long term.
Environmental Monitoring is an essential part of any pharmaceutical, medical device or biotechnology manufacturing process in order to show that the microbial and particulate content of all clean room air and work surfaces is below acceptable levels. Matrix Gemini EM from Autoscribe Informatics (UK) provides all the functionality to defi ne a complete environmental monitoring protocol. It can be used in an FDA regulated environment and fully supports the requirements of 21CFR Part 11.
Matrix Gemini EM is a specifi c confi guration of the very successful Matrix Gemini LIMS (Laboratory Information Management System). It will support a typical EM workfl ow “out of the box”, but can easily be confi gured to match the exact needs of different laboratories. The entire process from sample planning and testing schedule to reporting is done in a secure, compliant system.
In order to support an EM workfl ow, Matrix Gemini EM can associate a group of sampling sites within multiple Controlled Environments (CE), together with the tests and test schedule for each site. It also provides the screens necessary to collect all sample results and meta-data important to microbiological tests. Once a sampling event is scheduled, labels are printed to speed sample collection and ensure that each sample point is collected.
One or more tests are then assigned to each sample. Tests contain a result entry grid that is defi ned by the user along with limits (specifi cations). Work is then assigned to individuals, incubation dates are entered, and the samples are marked as collected. If results are produced on an automated reader, they may be transferred to the Matrix database electronically, thus speeding the process and eliminating paperwork and transcription errors. Any violation of alert limits or action limits is notifi ed immediately.
Once the results are validated then reports can be generated very quickly and easily, including trend plots fi ltered by selectable fi elds, without passing the information to a separate, non-validated spreadsheet programme. Possible trend plots include: for a specifi c room (CE) over a chosen time, for a specifi c batch/lot, or by microbiologist to identify training needs, and many more.
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Solid phase microextraction (SPME) automated sample preparation reduces sample handling and solvent consumption, and it has many applications in environmental, food, clinical, and other industries. New Restek (USA) PAL SPME fi bers are high-performing fi bers that meet or exceed
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High-Performing SPME Fibers Now Available
The latest addition to the Thomas Cain range of sample preparation equipment, the DEENA II from SEAL Analytical (UK), is fi nding global success in environmental laboratories because automation saves time and money, improves safety and lowers the risk of human error. “These benefi ts appeal to the managers of every laboratory in every country,” says SEAL President Stuart Smith. “So there has been a high demand for these instruments in labs with a regular requirement for the analysis of metals.”
the performance of other brands. Their reliable SPME fi bers feature an aluminum hub that is more durable than plastic. These fi bers are optimised for PAL system autosamplers and are compatible with most GC inlets. Restek SPME fi bers are suitable for a wide range of analyte chemistries and sample matrices. The Restek SPME product line is continually expanding and currently includes SPME fi bers for both polar and nonpolar target analytes across a wide range of molecular weights and volatilities.
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39466pr@reply-direct.com IET Annual Buyers’ Guide 2016/17
www.envirotech-online.com
The DEENA ll is a sample digestion system that fully automates the digestion process ensuring that each sample is treated exactly the same. Pre-programmed, but customizable software manages accurate dispensing of small volumes of reagents into sample tubes, ensuring thorough mixing, correct heating, and fi lling to a prescribed volume once digestion is completed. The intuitive DEENA software also enables overnight digestions.
A variety of models are available, ranging from a 96 position block for 15ml tubes, to a 30 position block for 50ml tubes. An auto syringe accessory is also available which accurately dispenses standards and automatically spikes samples.
“Automating digestion results in less handling of acids, which is always preferable,” adds Stuart. “However, automation also improves lab effi ciency, and unattended operation frees staff for other work.”
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Essential Environment 2016/17 takes readers through conservation bodies, local authorities and regulatory agencies in England, Scotland, Wales and Ireland. Topics include hazardous substances; air emissions, including the concern over transboundary air pollution; climate change and air quality and their corresponding earth summits and agreements; transport pollution and strategies to limit vehicle; sustainable waste management, landfi ll and hazardous waste to name just a few; agricultural pollution and efforts to cut emissions while balancing the need to produce food; water pollution and protecting the marine environment; and many other topics await readers in this extensive guide published in partnership with Environment Protection UK and Environmental Protection Scotland.
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When contacting companies directly from this issue of International Environmental Technology please tell them where you saw their product.
Metals Digester – an Automatic Success
Thank you
New, Modular and Highly Versatile System Platform for the Determination of Total Organic Carbon, Total Nitrogen, and Total Phosphorus
Well-known as innovation leaders in elemental analysis of organic materials, Elementar (Germany) have used their industry-leading technology to develop the acquray series: a new innovative system platform ideal for a multitude of different applications.
The TOC module is based on a chemical oxidation process supported by high-energy UV radiation. This combination ensures complete digestion of all organic compounds. The modular concept allows the attachment of optional extra modules for the additional determination of total nitrogen and phosphorus (patent pending). For increased sample throughput, an autosampler is available, offering several carousels for different sample vial sizes.
Furthermore, a combustion furnace module for solid samples can be attached as well. The dynamic heater design allows TOC analysis of solids via acidifi cation prior to combustion at constant temperature, but also the determination of TOC, TIC and ROC with the new, more advanced method via temperature ramping without acidifi cation.
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