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News News 2011-05-03 11:May:rd 2011-05-03 11:May:rd http://www.kenelec.com.au info@kenelec.com.au Copyright 2011 Kenelec Scientific Tue, 03 May 2011 11:52:32 +1000 Tue, 03 May 2011 11:52:32 +1000 http://www.kenelec.com.au/news/id/31 TSI Launches Newly Redesigned Test Ventilation & Indoor Air Quality Shoreview, MN—TSI Incorporated is proud to launch a newly redesigned line of thermal anemometers and indoor air quality instruments, including the VelociCalc® Multi-Function Ventilation Meter Model 9565 and the Q-TRAK™ Multi-Function IAQ Monitor Model 7575. Backed by proven technology and TSI’s commitment to innovation, the recently updated products provide highly accurate, fast, and easy-to-use measurement instrumentation for building service contractors, commissioning specialists, facility engineers, HVAC experts, and research professionals. Based on an ergonomic design scheme, TSI’s handheld ventilation meters include a comfortable probe holder and feature a large display screen for viewing key IAQ measurement parameters effortlessly. Menu prompts and step-by-step instructions guide the user through operation, instrument setup and field calibration in one of 12 different languages, ensuring ease-of-use; while additional “plug and play” sensors and probes can easily be swapped out to further augment the instruments’ usability and range of measurement capabilities. Now equipped with the expanded storage capacity of TRAKPRO™ data analysis software and the straightforward LogDat2™ downloading software program, TSI’s newest instruments make data logging and analysis more convenient than ever before. In fact, users can opt for data to be recalled, reviewed on screen, downloaded, or printed in real-time; alternatively, measurements can be tracked for longer term trending and later graphed for more effective reporting. Long trusted by professionals the world over for best-in-class indoor air quality measurement instrumentation, TSI’s newly redesigned ventilation meters raise the bar yet again. Tue, 03 May 2011 11:43:39 +1000 Tue, 03 May 2011 11:43:39 +1000 http://www.kenelec.com.au/news/id/30 New TSI VelociCalc® with Plug-in Probes <img alt="" src="/sb_cache/news/id/18/f/9565-VelociCalc-medium.jpg" style="width: 98px; height: 145px; float: right;" />Shoreview, MN – TSI Incorporated, a worldwide leader in performance measurement solutions for 50 years, announces its newly redesigned VelociCalc® Multi-Function Ventilation Meter Model 9565. This best-in-class ventilation meter is a multi-function anemometer that accurately measures air velocity, air flow, temperature, humidity, and pressure simultaneously, presenting these five parameters on a large graphic display with on-screen messages and instructions in customizable local languages. Additional “smart” plug-in probes and sensors, including VOC, CO2, and rotating vane probes, make the Model 9565 flexible enough to handle a wide range of additional measurement applications, including: HVAC Testing and balancing, clean room testing, biological safety cabinet, and laboratory fume hood testing, IAQ investigations, and many more. Equipped with LogDat2™downloading software and TRAKPRO™ Data Analysis Software, the new VelociCalc® Ventilation Meter Model 9565 allows for easy data logging, recall, review, and downloading of up to 38 days of stored data for robust documentation. Wireless Bluetooth® technology further enables remote polling and onsite printing to an optional portable printer, making reporting convenient and effortless. <a href="/products/id/912/cid/243/parent/0/t/products"><img alt="" src="/sb_cache/news/id/4/f/More Information Button.JPG" style="width: 174px; height: 34px; float: right;" /></a> Tue, 03 May 2011 11:40:10 +1000 Tue, 03 May 2011 11:40:10 +1000 http://www.kenelec.com.au/news/id/29 New TSI Q-Trak IAQ Monitor with Plug-in Probes <img alt="" src="/sb_cache/news/id/16/f/7575_Q-Trak-I-VOC-medium.jpg" style="width: 131px; height: 150px; float: right;" />Shoreview, MN – TSI Incorporated, a worldwide leader in performance measurement solutions for 50 years, announces its newly redesigned Q-TRAK™ Multi-Function IAQ Monitor Model 7575. This new indoor air quality monitor builds upon trusted technology to provide real-time, simultaneous display of up to five key IAQ parameters including temperature, relative humidity, CO2 and CO quickly and accurately. The Model 7575 also calculates dew point, wet bulb temperature, and percent outside air, helping to assure comfortable, safe and healthy indoor environments. Adding additional measurement parameters is easy with the optional “plug & play” probes- including Volatile Organic Compound (VOC) probes- in turn offering more thorough assessment of indoor air quality often required for industrial hygiene surveys, baseline trending and screening, building commissioning, and tracking down emissions to their source--all with one, handheld instrument. The new Q-TRAK™ Model 7575 boasts a large, intuitive graphical interface with 12 different language options for enhanced ease-of-use; and features TrakPro™ and LogDat2™ software with expanded data logging capacity for simplified recall, review and downloading of up to 38 days of measurement records. <a href="/products/id/981/cid/237/parent/0/t/products"><img alt="" src="/sb_cache/news/id/4/f/More Information Button.JPG" style="width: 174px; height: 34px; float: right;" /></a> Mon, 17 Jan 2011 11:29:07 +1000 Mon, 17 Jan 2011 11:29:07 +1000 http://www.kenelec.com.au/news/id/28 FDA to Officially Join PIC/S Dec 30, 2010 By: Angie Drakulich ePT--the Electronic Newsletter of Pharmaceutical Technology   After five years of discussions, the US Food and Drug Administration is joining the Pharmaceutical Inspection Convention (PIC) and the Pharmaceutical Inspection Cooperation Scheme (PIC Scheme), known together as PIC/S. The agency submitted its application in September 2005 and will be an official member as of Jan. 1, 2011. PIC was established in 1970 and the Scheme was launched in 1995. Together, the two bodies serve as the foremost international collaborative body on pharmaceutical manufacturing inspections and as a major supporter of GMP training and harmonization. The organization, which now has 39 members, functions as a cooperative arrangement among global regulatory and health authorities. Other PIC/S activities and benefits are listed on the organization’s website. The PIC/S Audit team gave FDA an approval during a follow-up visit to the agency’s Silver Spring, Maryland, headquarters in August 2010. In November 2010, at the organization’s leadership meeting in Malaysia, FDA’s accession to PIC/S was formally accepted. The Ukraine’s State Inspectorate for Quality Control of Medicines is also becoming a new member as of January 2011. According to the PIC/S website, the application-review process includes a detailed assessment to determine whether the regulatory authority is able to apply an inspection system comparable to that of current PIC/S members. The assessment involves “an examination of the authority’s GMP inspection and licensing system (or equivalent), quality system, legislative requirements, inspector training, etc. It is followed by a visit by a PIC/S delegation to observe in particular inspectors carrying out routine GMP inspections.” The full guidelines for joining PIC/S are here. It typically takes two to three years for a membership application to be completed, with a maximum allowable timeframe of six years. Many European regulatory authorities are members. The European Medicines Agency, European Directorate for the Quality of Medicines, UNICEF, and World Health Organization are partners with PIC/S. Of interest, the regulatory agencies of Japan, China, and India are not yet members. In November 2007, former FDA Commissioner Andrew C. von Eschenbach noted to Congress that the agency was in the process of joining PIC/S to ultimately “enable the exchange of inspection reports and other inspection information with regulatory authorities.” It’s hoped that PIC/S membership will help fill a gap in the number of overseas inspections conducted by FDA. Mon, 18 Oct 2010 09:46:29 +1000 Mon, 18 Oct 2010 09:46:29 +1000 http://www.kenelec.com.au/news/id/25 ISO 14644 Standards Update <h1>Cornerstone Cleanroom Standards Under Revision</h1> IEST-STD-1246E to Simplify Particle Counting Process The purpose of IEST-STD-CC1246D, Product Cleanliness Levels and Contamination Control Program, was to provide a uniform method for specifying product cleanliness levels and contamination control program requirements, with an emphasis on contaminants that may impact product performance. However, confusion had arisen among users of the standard due to inconsistencies in nomenclature and ethodologies within and across industries, according to Joyce Steakley, Chair of the Working Group (WG-CC901) that is revising the standard. Steakley said IEST-STD-CC1246E, which she expects to be completed this fall, will establish greater uniformity and clarity in several key areas............ Tue, 31 Aug 2010 10:05:41 +1000 Tue, 31 Aug 2010 10:05:41 +1000 http://www.kenelec.com.au/news/id/24 New 100 LPM Microbial Air Sampler from PMS <img alt="" src="/sb_cache/news/id/6/f/MiniCapt.jpg" style="width: 200px; height: 176px; float: right;" /> The MiniCapt® Portable Microbial Sampler enables an operator to collect biocontamination samples throughout cleanrooms and clean air devices. The slits in the BioCapt® Impactor Head are precision cut to ensurelaminar flow, thus maximizing collection efficiencies for viable particles of interest in accordance with ISO 14698-1. Biological efficiency is guaranteed by ensuring optimal impaction velocity, also giving statistical control over false positive results. Sampling intervals are completely customizable by the user to start and stop multiple times per run so the entire process can be monitored. The fully autoclavable BioCapt Impactor Head, highly sanitizable sampler case, and HEPA filtered outlet air ensure that the MiniCapt Portable Microbial Sampler does not contaminate the cleanroom environment. Monitoring of compressed gases or remote sampling of aseptic environments is possible with the purchase of the optional compressed gases kit or isolator kit. The MiniCapt 100 allows sampling of 100 liters per minute for faster collection of 1 cubic meter microbial air samples. The popular 50 liter per minute model continues to be offered for those customers who want a lower flow rate and a lower entry price unit. The MiniCapt 50 and MiniCapt 100 units use the same enclosure and both incorporate the same benefits as the previous generation MiniCapt Microbial Air Sampler by: <ol> <li>Using the BioCapt® Impactor design to reduce false positives</li> <li>Having a filtered exhaust, which eliminates adding contamination to the room</li> <li>Utilizing a small footprint that reduces air flow disruptions in the room</li> <li>Having the ability to connect to a Compressed Gasses Kit, reducing the amount of equipment that must be purchased at a facility</li> <li>Having the ability to use the Remote Isolator kit, which allows for remote sampling inside Isolators</li> <li>Incorporating removable pins to allow for the use of a variety of different size media plates  </li> </ol> <a href="/products/id/303/cid/283/parent/0/t/products"><img alt="" src="/sb_cache/news/id/4/f/More Information Button.JPG" style="width: 174px; height: 34px;" /></a> Mon, 14 Jun 2010 10:28:13 +1000 Mon, 14 Jun 2010 10:28:13 +1000 http://www.kenelec.com.au/news/id/23 TSI Announces New FHC50 Fume Hood Controller <img alt="" src="/sb_cache/news/id/2/f/fhc50.jpg" style="width: 165px; height: 177px; float: right;" />TSI Incorporated, the leader in products for critical environment applications, proudly announces its new FHC50 Fume Hood Controller. The FHC50 provides the ultimate in flexibility, safety and energy savings. Input measurement options include sash sensors, side-wall velocity sensors and flows from venturi valves, pressure- or thermal-based flow stations. The FHC50 can control valves or dampers with a fast-acting actuator for containment during sash movements. Versions of the FHC50 seamlessly integrate to Building Management Systems via BACnet®, LonWorks®, or Modbus™ to document alarms and trend data. Visual and audible alarms provide a local indication of unsafe conditions. Additional inputs and outputs make it easy to configure options like remote alarms and unoccupied modes. The FHC50 now allows engineers the flexibility to design laboratories the way they should be designed. For more information on critical environments instruments, contact Kenelec Scientific, 1300 732 233 or visit www.kenelec.com.au <a href="/products/id/908/cid/288/parent/0/t/products/title/Fume%20Hood%20Controller"><img alt="" src="/sb_cache/news/id/4/f/More Information Button.JPG" style="width: 150px; height: 29px; float: right;" /></a> Mon, 19 Apr 2010 16:43:33 +1000 Mon, 19 Apr 2010 16:43:33 +1000 http://www.kenelec.com.au/news/id/22 Denver Instruments Analytical Balances The precision analytical balance has been in continuous manufacture by Denver Instrument in Colorado since 1880. Today, Denver analytical balances offer an unmatched combination of precision, accuracy and value. From basic to advanced analytical weighing applications, Denver Instrument balances are the solution for your lab Also available are pH meters and Moisture Analysers Now available from Kenelec Scientific click on Cleanroom & Laboratory for the complete product range or download our brochure here Mon, 19 Apr 2010 14:07:47 +1000 Mon, 19 Apr 2010 14:07:47 +1000 http://www.kenelec.com.au/news/id/21 TGA Mandatory Enforcement of PE-009-08 Annex 1 Sterile Products July 2 • TGA announces enforcement of the PIC's EUGMP Annex 1 update Feb 2008 • TGA Expectations from July 2010 "The manufacturer has incorporated new and changed requirements for sterile manufacture" • Continuous Particle Monitoring required in Grade A Environments • Requirement to monitor Transfer Tunnels • Transfer of Freeze Dried Products • Crimping & Capping Equipment • Need to upgrade your monitoring requirements ? • Talk to us we will guide your through the new regulations with ease • Want to learn more then contact our Cleanroom Monitoring Specialist for more information regarding TGA expectations or download our latest Newsletter below Tue, 06 Apr 2010 14:25:11 +1000 Tue, 06 Apr 2010 14:25:11 +1000 http://www.kenelec.com.au/news/id/20 Particle Counter Products Kenelec Scientific is Proud to announce the arrival of the latest Particle Counter Products from Particle Measuring Systems. For Portable Monitoring the Lasair III Airbourne Particle Counter and MiniCapt Air Sampler meet regulatory cleanroom certification requirements with ease. For remote and continuous monitoring the Airnet II and BioCapt automated sampling systems safeguard your products and improve quality and monitoring plans with efficient and economical results. Book a consultation with our experts and see how you can easily meet FDA / TGA requirements with minimum ease.