LALreview. The Continual Evolution of Software EDITOR S COLUMN

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1 LALreview LAL REVIEW: PUBLISHED BY LONZA 2010 Issue 1 EDITOR S COLUMN If you have visited our website recently, you may have noticed a link to the Rapid Testing Solutions (RTS) page. On that page we describe our expanded offerings and capabilities for supporting your endotoxin and rapid microbial detection needs by introducing our four platforms: Endotoxin Detection, Microbiology, Informatics, and Solutions Support. The Endotoxin Detection and Microbiology platforms include, respectively, our endotoxin detection reagents and instruments and the microcompass system for rapid microbial detection. Earlier this year Lonza acquired MODA and launched our Informatics platform. The MODA solution for paperless QC micro automates QC activities and helps with Green initiatives. The Solutions Support platform provides service contracts, equipment and software validations, LIMS support, instrument training, and lab testing services, including endotoxin detection and GMO. RTS supports the critical needs of your QC laboratory helping to control the quality and safety of products. This issue of the LAL Review features what is new in RTS for Maribeth Donovan Janke, Ph.D. Segment Manager Endotoxin Detection WinKQCL 4 Endotoxin Detection and Analysis Software The Continual Evolution of Software For years, users have come to expect excellence from the WinKQCL software from Lonza. As operating systems and databases are enhanced and the needs of our customers expand, our WinKQCL software too has changed. Table 1 briefly lists the resulting evolution of the WinKQCL software. In April 2009, WinKQCL 4 Endotoxin Detection and Analysis Software was launched. Created by our endotoxin detection software development team, the WinKQCL 4 software offers a fully-integrated solution for your quantitative endotoxin detection testing, data management and reporting needs. In June 2010, an update, version was released. The WinKQCL 4 software meets 21 CFR Part 11 technical requirements for electronic records and signature, audit trails and database archiving. It fully supports all of the quantitative endotoxin detection assays from Lonza and is compatible with readers from BioTek Instruments, Inc. and Tecan Group Ltd. The WinKQCL 4 software allows the user to run all of the endotoxin detection tests typically performed in a QC laboratory: Initial Qualification, RSE/CSE, Inhibition/Enhancement, and Routine. In addition, the WinKQCL 4 software integrates with the Tecan Freedom EVOware software allowing assay templates to be executed using robotic scripts for the Lonza PyroTec liquid handling system. Table 1 Evolution of the WinKQCL TM Software 1.0 First released Windows version 2.0 Single-user database on same computer, 21 CFR Part 11 compliant 3.0 Client-server database, export records to LIMS, full support for PyroGene rfc assay 3.1 Database optimizations, audit log entries when assays begin 4.0 Enterprise system, interactive trending, enhanced user-interface, multiple readers, multi-language 1 LALreview

2 The efficient user interface and flexibility of the Drag n Drop and SpeedFill features help enable analysts to work smarter and faster. Barcode-enabled sample and reagent entry can simplify workloads and reduce errors. Multiple readers can be connected to and run from one computer station simultaneously. Designed with the end-user in mind, the powerful and flexible trending tool not only allows you to trend more than one product, it also presents the query functions, results reports and data plots in one window. The ability to automatically view test reports from the results table and plot can help managers make intelligent decisions with the click of a mouse. The WinKQCL 4 software has been internationalized to meet the growing, global demand for comprehensive, quantitative endotoxin detection and analysis by offering the multi-language user-interface choices of English, French, German, Italian, Japanese, and Spanish. All languages are available with one installation of the software and users can switch between them as needed, without exiting the software. Supervisors can schedule the maintenance of the database from within the WinKQCL 4 software using the integrated and secure database maintenance tool. Features include database backup, record archive, database compaction, integrity verification, and index optimization. Version of the WinKQCL software is compatible with currently available operating systems and database tools. Table 2 describes operating system and database compatibility of several versions of the WinKQCL software. Keeping our software current to industry standard operating systems and databases allows the WinKQCL software to have the enhancements that the endotoxin detection industry has requested. As an example, for the security of your GMP endotoxin detec- Table 2 Operating System and Database Compatibility Comparison by Software Version: WinKQCL TM Versions: Operating System Compatibility** Windows NT SP6 Windows 2000 SP4 Professional Windows P Pro SP3 (32-bit) Windows Server 2003 R2 SP1, SP2 (32 & 64-bit) Windows Vista Business SP1 (32 & 64-bit) Windows Vista Enterprise SP1 (32 & 64-bit) Windows Server 2008 SP1 (32 & 64-bit) Windows Server 2008 R2 SP1 (32 & 64-bit) * Windows 7 Professional (32 & 64-bit) * Windows 7 Ultimate (32 & 64-bit) * Windows 7 Enterprise (32 & 64-bit) Windows 95, 98, Me, NT, 2000 Home and Starter Editions of Windows Linux / Apple OS Database Compatibility** SQL Server 2000 SP2 (32-bit) SQL Server 2000 SP3a & SP4 (32-bit) SQL Server 2005 SP2 & SP3 (32-bit) SQL Server 2005 SP2 & SP3 (64-bit) SQL Server 2008 (32-bit) SQL Server 2008 (64-bit) Oracle = officially validated; * = tested ** = install Windows updates prior to installing WinKQCL TM and SQL Server to improve compatibility LALreview 2

3 tion data, using version 4.0.2, the WinKQCL database can be deployed to a server in a controlled server room and accessed from client computers installed in the lab. This is not possible with version 2.0. Version is compatible with Windows 7. As operating systems and database vendors discontinue older versions, free support for them ceases. Expertise is needed for new versions and cannot be maintained easily for obsolete versions. Without continued support from those vendors, we must move our software and support to the industry standard products. Our Scientific Support staff is trained on and has experience in using the most current version of our software. It is our goal to keep their expertise current as the WinKQCL software is updated. Therefore, similar to the software industry, phone and support for previous versions is limited. In addition, supporting products such as installation CDs, licenses, user manuals, Qualification manuals, and Validation packages for the older versions of the WinKQCL software are no longer produced. New versions of the WinKQCL software include bug fixes as well as end-user requested features and other enhancements. For long term support, keeping current with updates to the WinKQCL software should be a part of your overall IT strategy. The new version may not be compatible with older operating systems and databases just as it may not be possible to make old versions compatible with new operating systems and databases. When a maintenance patch such as version is available, upgrading the WinKQCL software just makes sense and gives you the full benefit of the software capabilities. For a smooth and successful installation of the WinKQCL software, it is imperative that your Windows systems are updated to the current Service Packs as recommended by the Microsoft Corporation. For version 4.0.2, Windows P should be upgraded to Service Pack 3 prior to installing the WinKQCL software. WinKQCL 4, developed by Lonza s endotoxin detection software development team, delivers an open and flexible, multi-language user interface, powerful, interactive trending tools, and seamless and secure database management. It is an enterprise solution that fits all application sizes from standalone to global networks. Our Account Managers, Field Service Engineers and Scientific Support personnel are ready to help answer your software questions, as well as help you install, train and qualify a WinKQCL 4 system. Realizing the Benefits of WinKQCL TM 4 Software CASE STUDY 1: A customer was experiencing a 6% invalid assay rate in kinetic chromogenic LAL testing. Invalid assays could not be traced to any single factor or combination of factors based on numerous analyses and managerial conversations. No correlation was found between the parameters involved in the testing variability, including the analysts, pipettors, and other possible causes. The WinKQCL 4 software offers an enhanced trending module that can trend not only information generated with the current version but also data generated with previous versions of the WinKQCL software. In an effort to further investigate and potentially reduce the invalid assay rate, the customer upgraded to the WinKQCL 4 software. Using the trending feature on the assay data, the customer was able to determine that the rate of invalid assays was increasing due to an out of calibration pipettor and a novice analyst. Corrective actions were put in place including review of the calibration procedures and retraining of the analyst. The customer s invalid assay rate is now consistently under 2%. CASE STUDY 2: A customer is transitioning the production of an important product from one facility to another. The customer is at a pivotal point in the production of this product and desires a seamless transition from one site to the next. In an effort to maintain proper SOP harmonization, the new site will transition its testing protocols and reagents to match the existing site. With multiple ELx808 microplate readers in place, the new site decided to implement the WinKQCL 4 software to take advantage of the ease of the user interface and functionality. The integrated trending module can be used to help support Out of Specification (OOS) investigations that may arise during the transition. In addition, upgrading to WinKQCL 4 software will provide the customer with the ability to connect client systems across the United States to a single database server. CASE STUDY 3: A global company with research and development and production facilities in different locations requires endotoxin testing on a regular basis. Analysts at each location perform kinetic LAL assays and prefer to work in their native language. The analysts at each site do speak English, but some feel more comfortable communicating scientifically in French, given the precise terminology involved. With the multiple language interfaces offered by the WinKQCL 4 software, each analyst has the opportunity to work in his or her native language, in addition to communicating effortlessly about data analyses with Englishspeaking colleagues. 3 LALreview

4 New Products for Depyrogenation Studies by Holly Kabrick, Associate Product Manager Endotoxin, if introduced into the bloodstream, can cause fever and even death in humans and animals. Therefore, companies that manufacture injectable or implantable products have processes in place to control the level of endotoxin in their raw materials and in-process products. It is also critical that materials such as product containers be free of endotoxin before use. Depyrogenation refers to the removal or destruction of pyrogens such as endotoxin. Although several depyrogenation methods exist, a widely practiced means of destruction is heating, particularly for glassware and other non-heat-labile materials. Endotoxin indicators can be used to validate the dry heat depyrogenation process. By comparing levels of endotoxin in baked and unbaked endotoxin indicators, one can determine the effectiveness of the heating cycle. Depyrogenation is achieved if there is at least a 3-log reduction of endotoxin units in the baked vials as compared to unbaked vials. In 2008, the United States Pharmacopeia (USP) published a new draft monograph, Endotoxin Indicator for Depyrogenation, in Pharmacopeial Forum Volume 34, Number 6. The monograph, due to become effective with the publication of USP 33-NF 28, includes a section on purity indicating that endotoxin indicators should not contain fillers. Examples of fillers cited in the monograph include lactose, albumin and polyethylene glycol (PEG). In response to the now official USP monograph, in May 2010, Lonza launched two new products for depyrogenation studies: Endotoxin Challenge Vials and E. coli Endotoxin O55:B5. These new products are formulated to contain no fillers or stabilizers and replaced two existing products. They are packaged in the same convenient kit configuration as the products they replaced and retain the same potency release specifications. The table below provides information regarding the change in part number. The E. coli Endotoxin O55:B5 product (p/n ) is a high potency endotoxin commonly used to prepare endotoxin indicators. The Endotoxin Challenge Vials (p/n ) are ready-to-use endotoxin indicators. Like the previous version of the product (p/n N187), they continue to be manufactured with heat-resistant labels and stoppers and can immediately be used with no manipulation. For additional product information, please contact your local Scientific Support team or Lonza sales office or account manager. Description Old Part Number New Part Number Endotoxin Challenge Vials N E. coli Endotoxin O55:B5 N LALreview 4

5 New COA Search Function In August 2008, we began posting kit Certificates of Analysis (COA) on our Endotoxin Detection homepage. You may have saved as one of your Favorites so that you can go directly to the page and find the links for COAs. If you have used since September 2010, you may have noticed a change to the page. In order to make searching for a COA easier, we have updated the search capability of the website. Instead of clicking a link for the product type, scrolling to find the kit lot number and clicking the link, we have created a simpler search function. To find the COA for your Lonza endotoxin detection kit, you simply need the catalog and lot numbers printed on the kit box label. For accessory items, you will need similar information. For instance, if you have a 500 ml bottle of LAL Reagent Water, you can use the catalog and lot numbers on the label of the water bottle. Enter the two numbers in the boxes on the webpage and click Send. A PDF of the COA will open and will be ready for printing or saving to your computer. We hope you find this new search function on more user-friendly than our previous system. If you have any trouble getting a COA, please contact your local Scientific Support team. 5 LALreview

6 The MODA Paperless QC Micro Solution by Bob Toal, Segment Manager, Informatics Lonza s Rapid Testing Solutions now features mobile and wireless technologies by MODA, a paperless QC Micro solution. What started as a company-wide initiative to eliminate waste, reduce lead and labor time, and improve overall compliance, inspired a robust informatics platform for the life sciences industry. The MODA solution automates the manual, paper-based QC Micro tasks for environmental monitoring, utility testing and product testing. It also provides integration with commonly used instrumentation and media found in the manufacturing facilities including production and laboratory areas. This includes integration with Lonza s WinKQCL software platform for endotoxin testing. The MODA platform enables automated access to quality data through a single information MODA-EM Software repository. This, coupled with on-demand reporting and analytical tools, provides our clients with features and flexibility not available with a paper-based system. There are three components of the MODA solution. The MODA-EM software for paperless Environmental Monitoring automates your QC Micro data collection and management (EM, utility and product testing). The MODA-VIP Visual Intelligence Portal provides improved insight into your manufacturing operation with views of test results overlaid on your facility maps. The MODA-FDC Field Data Capture software lets you quickly collect, label (barcode) and track test samples for EM, utilities and products at the point of sample within all critical areas. The MODA solution can be integrated with your laboratory information management systems (LIMS) to bridge the communication gap between quality assurance and production. Address Paper-based QC Micro Challenges Common manual paper-based process steps still burden most QC Micro programs: paper scheduling, marker labeling of sample media, manual reconciliation, paper log book entry, and manual notification of deviations. Test results are stored in shelves of paper binders which is a challenge to quickly navigate during an audit. For Corrective and Preventative Action (CAPA) purposes, building a set of trend reports may require more than eight weeks to prepare. By the time a trend of activity is developed and recognized, the condition causing the trend is likely to have changed. This makes it difficult to support corrective action activities and nearly impossible to perform meaningful preventative actions. The MODA solution ties together automated scheduling, workflows, mobile data acquisition, device integration, and advanced analytics. The MODA solution removes manual, paper-based tasks, saving time and money while helping to improve compliance. Benefits to the QC Organization With the MODA solutions, QC organizations can automate data collection from devices and people, eliminating redundant data entry and transcription errors. They can increase worker efficiency and enforce regulatory compliance. Supervisors can make sound product quality and release decisions with comprehensive analysis and reporting and quickly advance Green initiatives. The MODA solution is equipped with the hardware, software and implementation services required to get you into production quickly, allowing your time and resources to be directed toward higher value initiatives and paths to operational excellence. The MODA solution delivers measurable benefits throughout the QC organization. QC technicians can quickly and accurately collect data in critical areas. Lab managers should see an increase in efficiency in processes for scheduling, managing and tracking. Supervisors who require immediate, detailed and ac- LALreview 6

7 curate reporting on the production area will be enabled to make sound product release decisions, conduct effective investigations and provide quick response to audits. The executive management team can assess overall program effectiveness with the availability of longer term trend reports. More science. Less paper. With its MODA product line, Lonza delivers on its vision of a comprehensive, automated informatics platform for quality control and quality assurance for the life sciences industry. The MODA platform enhances our customers ability to manage risk, improve efficiencies and help ensure final product quality. As a user of the MODA product at our Walkersville manufacturing facility, Lonza has direct experience with the value it provides for improved decision making, regulatory compliance and productivity. Our success at Walkersville is now being replicated across all Lonza manufacturing sites as part of a global rollout of the solution. The MODA implementation at our Singapore plant was recently completed and other Lonza sites in Europe and North America are soon to follow. We look forward to helping our clients and peers achieve similar success as we move toward the common goal of improved quality control and safer products. your (LIMS) to quality MODA-VIP Software MODA-FDC Platform 7 LALreview

8 Lonza Walkersville, Inc Biggs Ford Road Walkersville, MD Contact Information North America Customer Service: (toll free) Scientific Support: (toll free) Online Ordering: Europe Customer Service: Scientific Support: Online Ordering: International Contact your local Lonza Distributor Customer Service: , ext Fax: International Offices Australia Austria (toll free) Belgium Brazil Denmark France (toll free) Germany (toll free) India Ireland (toll free) Italy Japan Norway Poland Singapore Spain Sweden (toll free) Switzerland (toll free) The Netherlands (toll free) United Kingdom (toll free) Lonza Walkersville, Inc. Walkersville, MD Tecan and Freedom EVOware are trademarks of Tecan Group Ltd. Windows, Windows Vista, Windows Server, and SQL Server are trademarks of Microsoft Corporation. Linux is a trademark of Linus Torvalds. Apple is a trademark of Apple, Inc. Oracle is a trademark of Oracle Corporation. ELx808 is a trademark of BioTek Instruments, Inc. Unless otherwise noted, all trademarks herein are marks of the Lonza Group or its affilitates. The information contained herein is believed to be correct and corresponds to the latest state of scientific and technical knowledge. However, no warranty is made, either expressed or implied, regarding its accuracy or the results to be obtained from the use of such information and no warranty is expressed or implied concerning the use of these products. The buyer assumes all risks of use and/or handling. No statement is intended or should be construed as a recommendation to infringe any existing patent. Copyright 2010, Lonza Walkersville, Inc. All rights reserved. A-LAL /10 8 LALreview