CHRONICAL CLIMET. April 2016 Newsletter. Celebrating Over 50 Years In Business! Tel. +1 (909) 793.

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1 CLIMET CHRONICAL Celebrating Over 50 Years In Business! April 2016 Newsletter Tel. +1 (909) Rev. 1.0 (April 2016) 1

2 Table of Contents General Manager s Message... 3 Addi onal features that you may receive when upda ng for ISO : Should we stop monitoring 5 µm par cles in Class 5 areas?... 5 ISO 9001 Cer fica on... 6 Do you have Technical Product or Service-related Ques ons?... 6 Sugges ons, Comments and Recommenda ons

3 General Manager s Message By Jim Strachan, General Manager It s not often an opportunity comes along for a business person, such as myself, to lead a company as extraordinary as Climet. After less than a year serving as General Manager, what I have seen and experienced has made me very excited for the future of our Company. Climet is an incredible brand supported by terrific employees and channel partners. I am honored to be part of such an impressive team. Climet has been in operation over 50 years, and was the first manufacturer to pioneer battery powered portable particle counters, high flow rates of 50/75/100 LPM, and other innovations too numerous to count. We will continue to translate engineering acumen and technological innovation capabilities into real-world product solutions that add unique benefits, provide high customer appeal, and high demand among our customer base. Moreover, Climet will continue this trend in both supporting legacy products, as well as provide innovative new products to market. This has been the hallmark of our organization since being founded in From a product quality perspective, Climet has the lowest interval calibration out-of-tolerance rates in the industry. Our particle counters have an out-oftolerance rate of less than 2%, and our microbial samplers are virtually perfect at 0% out-oftolerance over the past decade. Subsequently, biopharma manufacturers using Climet products can continue to experience the fewest deviation investigations, lowest scrap, lowest Cost of Poor Quality (CoPQ), and highest return on investment on their environmental monitoring equipment. Frequently, the improvement in ROI compared to other manufacturers often well exceeds tens of thousands, to hundreds of thousands of dollars in as few as three years! Climet is also a company operating in a dynamic global economy. Here in the United States, where we are headquartered, I have had an opportunity to meet personally with many of our large biopharmaceutical customers, and hope to meet with many more in the coming months and years. It is our goal to create, maintain, and grow close personal relationships with our customers, and to provide technical expertise in areas that can addvalue to our customers. Internationally, we will be focusing on continual and regular visits with our Climet distribution channel partners, as well as visit customer manufacturing sites in both Europe and Asia Pacific. Clearly these are two very important markets with growing market opportunities. Our renewed emphasis will be on the relationships we have with customers, with the knowledge that sales revenue will naturally follow. From a quality perspective, I am proud to say that in January this year Climet received its ISO 9001 certification. Our commitment will be to continue improvement of not only management and operational quality, but also other processes including sales, marketing, and channel strategies. Again, I am absolutely delighted with the opportunities the market avails and look forward to continued growth in the years to come!! 3

4 Additional features that you may receive when updating for ISO :2015 By Dave Chandler, Engineering Manager The CI-x5x series of par cle counters can be upgraded to provide a report compliant with the new ISO :2015. The firmware version that provides the new ISO reports is V3.30. Addi onal features will also be added depending on the version of firmware that you are upgrading from. The abbreviated revision history below describes the addi onal func onality that one may expect. VERSION DATE CHANGES /11/05 Firmware version at ini al release of t-family /20/08 Revised GMP limits to match new release of EU GMP /2/09 Accommodate universal main board CalPro /30/10 1. Added large font feature. If you hear a "clunk" from the printer when you turn the unit on, the printer will not support the large font feature. You will need to replace the printer with a current compa ble version P/N T. 2. There is a bu on on the ID screen to enable auto advance of ID's. 3. There is the ability to calculate and enforce the number of loca ons to take for FS-209E, ISO and GMP reports. 4. There is an op on to enable the discard of data a er a momentary flow alarm. (Similar feature is already standard where sampling stops if flow is <80% for 5 seconds.) 5. On the CI-x54 series there is a new ability to clone unit se ngs to another unit via the USB drive /17/10 Stored data memory is no longer cleared when using Stop a er N or Auto averages /21/12 1. Added Cloning feature. 2. Implemented new supervisor trap-door password that is based on unique unit informa on. 3. Shuts laser diode off (with universal main board only) when blower is off to extend life of the laser diode. (Feature originally only available for x54 models.) /29/15 1. Added Wi-Fi and related features for CI-x55/56 models. 2. Changed universal back door password /16/15 Added RS-232 commands to change user security level required for clearing stored data memory /14/16 Revised ISO to conform to new 2015 standard 4

5 Should we stop monitoring 5 µm particles in Class 5 areas? By Randy Grater, Service Manager The new revision of ISO was released in January. One of the major changes has raised questions of whether 5 µm particles should no longer be monitored in Class 5 and Class 6 areas. The new revision dropped specifications for 5 µm particles in Class 5 and Class 6 areas because the numbers were not statistically significant. The number of particles typically detected in these room classes is very small, and in Class 5 areas, it is not unusual to collect a cubic meter sample with even 0 particles. In fact, the EU GMP, Annex 1 standard originally set the limit at 1. For many cleanrooms, this is a valid change, since normal monitoring is more about trending to see whether the room is maintaining normal concentration levels, or whether there is a deteriorating trend that needs to be addressed. In Class 5 and Class 6 areas, 5 µm particles do not serve that purpose However, for life science companies, there is a different reason for monitoring 5 µm particles. The 0.5 µm and 5 µm channels roughly bracket the range of airborne viable particles; even though these nonviable counters do not provide direct evidence of microbial contamination, they do provide an indication of potential microbial contamination in the area. While the 0.5 µm channel provides background counts for trending, these background counts are too high to pick up subtle changes from microbial contamination that might be starting within the room. However, with 5 µm particles, the numbers are so small, that two or three additional particles each count cycle should raise a red flag when 0 to 1 particle in the 5 µm channel is normal. So, for cleanrooms outside the life science industries, there is no longer a need to monitor 5 µm particles in Class 5 and Class 6 areas, but life science companies should continue to monitor 5 µm particles, using the old limits as a guide. It is always important to remember why we monitor, and in the case of the 5 µm particles, it is a way of having an early warning of a potential problem, before valuable resources are wasted. Are the tests specified by ISO important? By Randy Grater, Service Manager In addition to the measurements normally taken in the course of calibrating a particle counter, the ISO standard also requires resolution testing and count efficiency testing. While these tests are performed on new instruments, we offer our customers a choice of a standard calibration, without the additional testing, or an ISO compliant calibration with the additional testing. The additional testing is intended to detect problems that can affect counts. These problems are, from our perspective, the result of poor design. We have tested units that we manufactured at least as far back as 1996, and they continue to pass the tests required by ISO and the count efficiency testing established by the Japanese Industrial Standard JIS 9921, from which the ISO standard was derived. This demonstrates the stability of our design and the reliability of our manufacturing testing. Nonetheless, even though these tests do not involve adjustments and therefore do not improve performance, the new version of ISO says that particle counters should be calibrated to ISO This has given the ISO calibration standard added force. Moreover, life science companies are beginning to be asked by auditors for evidence on the calibration certificate that count efficiency was tested. 5

6 So, even though there will be no performance improvement and even though it is a virtual certainty that the instrument will pass the resolution and count efficiency tests, there are strong reasons to request the ISO compliant calibration when sending your particle counter in for calibration. ISO 9001 Certification By Jim Strachan, General Manager As of January 7, 2016, Climet is ISO 9001:2008 Certified. The audit was conducted by NSF International Strategic Registrations, which is accredited by the ANSI-ASQ National Accreditation Board (ANAB), and the International Accreditation Forum (IAF). Our Certificate Number is C IS1. You can obtain a pdf copy of our certification by clicking the logo at Do you have Technical Product or Servicerelated Questions? We are here to help and have a knowledgeable team standing by. Randy Grater, Service Manager JGrater@climet.com Manny Patino, Applications Engineer MPatino@climet.com Company Main +1 (909) Suggestions, Comments and Recommendations We are always looking for relevant topics, and welcome your comments, suggestions, and feedback. Please contact our Sales & Marketing Team Company Main: +1 (909) sales@climet.com 6

7 Copyright 2016 All Rights Reserved., a Division of Venturedyne, Ltd (909) DO NOT DUPLICATE, SCAN, RE-PRINT, or RE-DISTRUBUTE without the express written consent of. This publication may contain other company names, and brand names, which may be registered trademarks of their respective holders. Best efforts have been used in this document to present accurate information, but inadvertently may contain typographical errors, omissions, or other inaccuracies. The author disclaims liability from any unforeseen errors and omissions; and we reserve the right to correct any errors, inaccuracies or omissions and to change or update information at any time, without prior notice. We do not generally undertake to update, modify or clarify information on this document, except as required by law. 7