The Chemist FOCUS Newsletter September-October 2014 A monthly newsletter published by Tupimo Chemicals and Laboratory Services, providing To Validate or Not, Is That the Question? informed commentary and news on current and new developments in the analytical testing industry. I particularly find method validation to be extremely boring; you do the same thing over and It is aimed at promoting over just to prove the method is working. Once you find that it is working for intended knowledge sharing, identifying purpose, that will be the end of the show; see how boring it is. But do not take this lightly; trends and practices that affect our day to day business. the objective of any analytical measurement is to obtain consistent, reliable and accurate data. Validated analytical methods play a major role in achieving this goal. The results from method validation can be used to judge the quality, reliability and consistency of analytical results, which is an integral part of any good analytical practice. Validation of analytical methods is also required by most regulations and quality standards that impact laboratories. Editor’s desk: I thank you all on behalf of our Analytical methods need to be validated, verified, or revalidated in the following instances: before initial use in routine testing and when transferred to another laboratory team for your continued support. Your engagement in uplifting the Whenever the conditions or method parameters for which the method has been validated testing industry in Namibia is change (for example, an instrument with different characteristics or samples with a indeed a motivation to us. In this different matrix) and the change is outside the original scope of the method. Validation is issue we debate your concerns on well described in the ISO 17025 document Method validation occurs between analytical method validation and instrument calibrations. Please join us in November for our yearly Good Laboratory Practices course; this year’s event should be bigger and better. See you there. Enjoy! Moses Pius [email protected] www.tupimo.com July-August 2014 instrument qualification and system suitability testing and is linked to all other quality elements. Methods should be validated using qualified instruments. During method validation, parameters and acceptance criteria for system suitability checks and quality control checks should be defined. For established facilities, you may like to review your methods once again just to make sure you have not been analysing biasedly for years. It is a very tedious must-do process but the relief from finally getting it right is rewarding. Moses Pius, [email protected] Also in this issue: 1. Why calibrate instruments 2. Digital Laboratory Solutions 3. Chemist of the month: Paulus Kapolo Why calibrate instruments? “out of cal” or vice-versa. Let’s look at how that works. Over the years I have been told I need a good calibration curve for reliable results. But in as much as this is true, a critical look at everything that contributes to a good calibration should be appreciated. How often do you calibrate your instruments? Who calibrates them? Are the calibrators certified to do the calibration? Is your calibration range suitable for sample concentrations that you are working with? These are valid concerns especially if you are testing products on a daily production line. What is Calibration? If you do a field comparison check of two meters, and call them “calibrated” if they give the same reading, this isn’t calibration. It’s simply a field check. It can show you if there’s a problem, but it can’t show you which meter is right. If both meters are out of calibration by the same amount and in the same direction, it won’t show you anything. Nor will it show you any trending — you won’t know your instrument is headed for an “out of cal” condition. For an effective calibration, the calibration standard must be more accurate than the instrument under test. Calibration typically requires a standard that has at least 10 times the accuracy of the instrument under test. Otherwise, you are calibrating within overlapping tolerances and the tolerances of your standard render an “in cal” instrument Two instruments, A and B, measure 100 V within 1%. At 480 V, both are within tolerance. At 100 V input, A reads 99.1 V and B reads 100.9 V. But if you use B as your standard, A will appear to be out of tolerance. However, if B is accurate to 0.1 %, then the most B will read at 100 V is 100.1 V. Now if you compare A to B, A is in tolerance. You can also see that A is at the low end of the tolerance range. Modifying A to bring that reading up will presumably keep A from giving a false reading as it experiences normal drift between calibrations. Calibration, in its purest sense, is the comparison of an instrument to a known standard. Proper calibration involves use of a traceable standard, one that has paperwork showing it compares correctly to a chain of standards going back to a master standard maintained by a reputable institution. In practice, calibration includes correction. Usually when you send an instrument for calibration, you authorize repair to bring the instrument back into calibration if it was “out of cal.” You’ll get a report showing how far out of calibration the instrument was before, and how far out it is after. Calibration of frequency varies by instrument, quality requirements, frequency of instrument use, after an event (power failure, instrument fall), after heavy measurement loads etc. The question isn’t whether to calibrate — we can see that’s a given. The question is when to calibrate. There is no “one size fits all” answer. The NSI Metrology facility is a good choice for calibration of thermometers, balances and ovens. For other instruments, please contact specific product manufactures. Tupimo Chemicals and Laboratory Services Hosts a Training Course In Presented by Mr. Moses Pius Good Laboratory Practices-Understanding ISO 17025—Mr. Pius will share his knowledge on ISO/IEC 17025: 2005 and how Analytical Laboratories can use this approach to better their laboratory quality management systems. Your Guest Speaker Good Laboratory Practices Dr. Eino Mvula Understanding ISO 17025 T Chief Executive Officer: NCRST he main intent of this course is to give a practical understanding of how good laboratory behaviour influ- ence outputs of laboratories and production facilities: reliable results and safe products for consumers. Dr. Mvula holds a MSc, PhD in Chemistry and an MBA. He previously led the Namibia Standards Institute. His collection The course will concentrate on ideas established in the ISO/ of exposure in laboratory management is unparalleled. IEC 17025 Standard to address challenges faced by scientists in solving laboratory management, operation and safety issues. This will include recent developments regarding multi- Your Presenter site studies and their practical interpretation. Mr. Moses Pius Emphasis will then be placed on the practical implementation Executive Chairman: Tupimo Chemicals and Laboratory Services of GLP and discussions including problems that the participants bring to the course . The course will be supplemented by a question and answer session including problem-solving exercises. DATE: 6-7 November 2014 Time: 09:00 am-17:00pm Place: Windhoek-Namibia (Venue TBA) He holds a BSc Chemistry and Geology and currently pursing MEng Process Engineering, with vast experience in laboratory sample preparations, method development, validation, uncertainties. Mr. Pius also attended various conferences and training workshops on ISO 17025/9000 Who Should Attend? standard, giving him great exposure to the best world class laboratory practices. This course is intended for all management within industry, government, academia and/or testing facilities especially: • Scientists, Chemists, Analysts • Regulatory/Compliance Personnel • Quality Assurance Staff • Those newly assigned GLP responsibilities • More experienced personnel needing to update their knowledge REGISTRATION:    Mr. Haikali Alfeus Tel: +264 81 33 29293 [email protected] Kindly RSVP as space is limited. RSVP by October 2014, 2014 ● ● ● “No one is born an expert analyst. Training is absolutely necessary to produce a knowledgeable, competent laboratory worker” Allan Fraser, Consulting Chemist Allan Fraser and Associates ● ● ● Digital Laboratory Solutions As a chemist, chances of considering using anything other than word processing software, excel publishers, a pen and calculator for reviewing, saving and processing data are very slim. We may not be very fond of Information Technology. However, the IT industry has advanced over the years bringing us technology that make our work in the laboratory easier and efficient. more time to conduct time consuming activities such as method validation and verification and estimation of method uncertainties or even use it to grab a beer if that is allowed at your workplace. (Photo credits- Archiweb Design – Dreamstime International) Information technology is so advanced that scientists can automate the process of accessing, analysing and reporting scientific data by creating individualized automatic workflows. The protocols can be saved in libraries, and searched and accessed by authorized users in a centralised local system. These helps scientists build off of each other’s core competencies and saves time that is frequently lost in redundancies. Current technologies have evolved to help us be more efficient through digital laboratory solutions. By saving the time typically lost in performing tedious, repetitive and poorly executed tasks, more energy can be saved for - The most efficient laboratories typically automate as many manual processes and workflows as possible to optimize lab productivity. Electronic management of chemical inventories and instrument can be integrated to data management software commonly referred to as Laboratory Information Management Systems. These paperless technologies are also reliable for data storage in the event of disaster. They also free up valuable lab resources, eliminate duplicate work across locations. Although they might require you to dig a little in the pocket this is an investment worth spending on. But who buys software when you can get them for free? Here are some of the best web-based softwares that have proven to be equally efficient: 1. 2. 3. 4. 5. Bika OpenELIS FreeLIMS MSLims YourLabData Which one do you prefer? Let us know. _______________________________________________ Chemist of the month Full Name: PAULUS KAPOLO Education: B SCIENCE (HONORS) BIOCHEMISTRY AND CHEMISTRY, UNAM Institution you are working for: University of Namibia Position: TECHNOLOGIST Career History: I started my role as a technologist Chemistry University with and of the department Biochemistry Namibia soon of at the after my graduation. Which analytical instrument is unique to you and Why? TLC plates, they are very simple, but efficient. They give answers on the number of components in any given mixture in a short period of time and their operation procedures are not as complicated. Do you think it really necessary to introduce a strict QA policy in academic laboratories? Yes! QA highlights all aspects of chemical analysis from sampling and selection methods to reporting of events affecting the quality of analytical data! So it will assure quality in any analytical experimental data obtained. You participated in our 2013 GLP course; did it change your overview on laboratory management? Yes it did change my overview on laboratory management, but there are some aspects that are sometimes difficult to implement in our labs due to costs e.g. engineering problems (how the building was structured, one have less to nothing to do on such issues) If you had a choice, what will you introduce to the analytical testing industry? I would enforce strict and law binding quality assurance regulations?