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LAL

review

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 Test-ing 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 endo-toxin 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 soft-ware 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 2010.

Maribeth Donovan Janke, Ph.D. Segment Manager Endotoxin Detection

For years, users have come to expect excel- lence from the WinKQCL™ software from Lonza. As operating systems and databases are enhanced and the needs of our custom-ers expand, our WinKQCL™ software too has changed. Table 1 briefly lists the resulting evolution of the WinKQCL™ software.

In April 2009, WinKQCL™ 4 Endotoxin Detec-tion 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 4.0.2 was released.

The WinKQCL™ 4 software meets 21 CFR Part 11 technical requirements for electronic re-cords and signature, audit trails and database archiving. It fully supports all of the quantita-tive 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 Qualifi-cation, 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. WinKQCL™ 4 Endotoxin Detection and Analysis Software

Table 1

Evolution of the WinKQCLTM 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

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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 pow-erful 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 re-sults table and plot can help managers make intelligent decisions with the click of a mouse.

The WinKQCL™ 4 software has been inter-nationalized 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 4.0.2 of the WinKQCL™ software is compatible with currently available oper-ating 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:

Windows® NT SP6 X

Windows® 2000 SP4 Professional X

Windows® XP Pro SP3 (32-bit) X X X X

Windows Server® 2003 R2 SP1, SP2 (32 & 64-bit) X X X X Windows Vista® Business SP1 (32 & 64-bit) X X X Windows Vista® Enterprise SP1 (32 & 64-bit) X X X

Windows Server® 2008 SP1 (32 & 64-bit) X X X

Windows Server® 2008 R2 SP1 (32 & 64-bit) * X

Windows® 7 Professional (32 & 64-bit) * X

Windows® 7 Ultimate (32 & 64-bit) * X

Windows® 7 Enterprise (32 & 64-bit) X

Windows® 95, 98, Me, NT, 2000 Home and Starter Editions of Windows® Linux® / Apple® OS

SQL Server® 2000 SP2 (32-bit) X

SQL Server® 2000 SP3a & SP4 (32-bit) X

SQL Server® 2005 SP2 & SP3 (32-bit) X X X

SQL Server® 2005 SP2 & SP3 (64-bit) X

SQL Server® 2008 (32-bit) X

SQL Server® 2008 (64-bit) X

Oracle®

WinKQCLTM Versions: 2.0 3.1 4.0 4.0.1 4.0.2

Operating System Compatibility**

Database Compatibility**

X = officially validated; * = tested

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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 4.0.2 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 sup-port from those vendors, we must move our software and support to the industry stan-dard 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 email support for previous versions is limited.

In addition, supporting products such as in-stallation CDs, licenses, user manuals, Quali-fication manuals, and Validation packages for the older versions of the WinKQCL™ software are no longer produced.

New versions of the WinKQCL™ software in-clude 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 4.0.2 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 Micro-soft Corporation. For version 4.0.2, Windows® XP should be upgraded to Service Pack 3 prior to installing the WinKQCL™ software.

WinKQCL™ 4, developed by Lonza’s endotoxin detection software development team, deliv-ers an open and flexible, multi-language user interface, powerful, interactive trending tools, and seamless and secure database manage-ment. It is an enterprise solution that fits all application sizes from standalone to global networks. Our Account Managers, Field Ser-vice Engineers and Scientific Support person-nel 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 experienc-ing a 6% invalid assay rate in kinetic chro-mogenic LAL testing. Invalid assays could not be traced to any single factor or combi-nation of factors based on numerous analy-ses and managerial conversations. No cor-relation 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 cur-rent version but also data generated with previous versions of the WinKQCL™ soft-ware. 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

de-termine that the rate of invalid assays was increasing due to an out of calibration pipet-tor 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 prod-uct and desires a seamless transition from one site to the next. In an effort to main-tain 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 func-tionality. The integrated trending module can be used to help support Out of

Specifi-cation (OOS) investigations that may arise during the transition. In addition, upgrad-ing 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 re-search and development and production facilities in different locations requires en-dotoxin 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 Eng-lish, but some feel more comfortable com-municating 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 ef-fortlessly about data analyses with English-speaking colleagues.

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Description Old Part Number New Part Number

Endotoxin Challenge Vials™ N187 00192568

E. coli Endotoxin O55:B5 N185 00193783

by Holly Kabrick, Associate Product Manager

Endotoxin, if introduced into the blood-stream, 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 de-struction of pyrogens such as endotoxin. Although several depyrogenation methods exist, a widely practiced means of destruc-tion is heating, particularly for glassware and other non-heat-labile materials. Endotoxin

in-dicators 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 effective-ness of the heating cycle. Depyrogenation is achieved if there is at least a 3-log reduction of endotoxin units in the baked vials as com-pared 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 in-dicators should not contain fillers. Examples of fillers cited in the monograph include lac-tose, albumin and polyethylene glycol (PEG).

In response to the now official USP mono-graph, in May 2010, Lonza launched two new products for depyrogenation studies: Endo-toxin Challenge Vials™ and E. coli EndoEndo-toxin

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 regard-ing the change in part number.

The E. coli Endotoxin O55:B5 product (p/n

00193783) is a high potency endotoxin commonly used to prepare endotoxin indi-cators. The Endotoxin Challenge Vials™ (p/n 00192568) are ready-to-use endotoxin in-dicators. 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.

New Products for

Depyrogenation

Studies

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In August 2008, we began posting kit Cer-tificates of Analysis (COA) on our Endotoxin Detection homepage. You may have saved www.lonza.com/coa as one of your “Favor-ites” so that you can go directly to the page and find the links for COAs.

If you have used www.lonza.com/coa 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 prod-uct type, scrolling to find the kit lot number and clicking the link, we have created a sim-pler search function.

To find the COA for your Lonza endotoxin de-tection kit, you simply need the catalog and lot numbers printed on the kit box label. For accessory items, you will need similar infor-mation. 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 sav-ing to your computer.

We hope you find this new search function on www.lonza.com/coa more user-friendly than our previous system. If you have any trou-ble getting a COA, please contact your local Scientific Support team.

New COA Search

Function

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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 over-all compliance, inspired a robust informatics platform for the life sciences industry. The MODA™ solution automates the manual, paper-based QC Micro tasks for environmen-tal monitoring, utility testing and product testing. It also provides integration with commonly used instrumentation and media found in the manufacturing facilities includ-ing 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

repository. This, coupled with on-demand reporting and analytical tools, provides our clients with features and flexibility not avail-able with a paper-based system.

There are three components of the MODA™ solution. The MODA-EM™ software for paper-less Environmental Monitoring automates your QC Micro data collection and manage-ment (EM, utility and product testing). The MODA-VIP™ Visual Intelligence Portal provides improved insight into your manufacturing op-eration with views of test results overlaid on your facility maps. The MODA-FDC™ Field Data Capture software lets you quickly collect, la-bel (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 sys-tems (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 bind-ers which is a challenge to quickly navigate during an audit. For Corrective and Preventa-tive Action (CAPA) purposes, building a set of trend reports may require more than eight weeks to prepare. By the time a trend of activ-ity 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 per-form meaningful preventative actions. The MODA™ solution ties together automated scheduling, workflows, mobile data acquisi-tion, device integraacquisi-tion, and advanced ana-lytics. 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 ben-efits throughout the QC organization. QC tech-nicians can quickly and accurately collect data in critical areas. Lab managers should see an increase in efficiency in processes for scheduling, managing and tracking. Supervi-sors who require immediate, detailed and ac-MODA-EM™ Software

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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 ex-ecutive management team can assess over-all 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 in-dustry. 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 pro-vides for improved decision making, regula-tory compliance and productivity. Our suc-cess 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

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Lonza Walkersville, Inc. 8830 Biggs Ford Road Walkersville, MD 21793

North America

Customer Service: 800 638 8174 (toll free) Scientific Support: 800 521 0390 (toll free) scientific.support@lonza.com

Online Ordering: www.lonza.com Europe

Customer Service: +32 87 321 611 Scientific Support: +32 87 321 611 scientific.support.eu@lonza.com Online Ordering: www.lonza.com

International

Contact your local Lonza Distributor

Customer Service: +1 301 898 7025, ext. 2400 Fax: +301 845 8291

scientific.support@lonza.com International Offices

Australia + 61 3 9550 0883 Austria 0800 201 538 (toll free) Belgium + 32 87 321 611 Brazil + 55 11 2069 8800 Denmark 45 43 56 74 00 France 0800 91 19 81 (toll free) Germany 0800 182 52 87 (toll free) India + 91 22 4342 4000 Ireland 1800 654 253 (toll free) Italy + 39 0363 45710 Japan + 81 3 5566 0612 Norway + 45 43 56 74 00 Poland + 48 781 120 300 Singapore + 65 6521 4379 Spain + 34 902 531 366 Sweden 020 140 4410 (toll free) Switzerland 0800 83 86 20 (toll free) The Netherlands 0800 022 4525 (toll free) United Kingdom 0808 234 97 88 (toll free)

Lonza Walkersville, Inc. Walkersville, MD 21793

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-2010-1 12/10

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