endotoxin testing a comprehensive training course · 7 pharma&biotech endotoxin testing – a...

Pharma&Biotech

Endotoxin TestingA Comprehensive Training Course

Endotoxin Testing Methodologies and Regulatory Requirements

Pharma&Biotech

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Course OverviewLonza’s Endotoxin Detection Training Courses are structured around a well integrated combination of lectures dealing with test methodologies and regulatory requirements coupled with practical demonstrations and hands on practical exercises where delegates gain experience with a variety of Endotoxin detection test methods, understanding of assay characteristics and approaches to problem solving.

The training courses are designed on a daily modular basis so that delegates may select the level and content relevant to their learning needs.

In each of the courses, Lonza fosters an open and informal environment where questions and discussion are actively encouraged. The number of delegates for each day course is deliberately restricted to ensure a posi-tive interactive learning environment. Each delegate will have a chance to state their objectives at the beginning of the course and these will be reviewed at the end of the day. A signed training certificate is presented to each delegate upon successful completion of each day course.

As part of our continuing commitment to our customers, Lonza can also offer custom designed Endotoxin Detection Training Courses on site at your company (for a minimum of 4 delegates). The custom courses can include some or all of the standard course content and can include practical demonstration and hands on problem solving sessions.

Introduction to Endotoxin Testing Training

– This course is designed to provide new users with the basic tools to conduct Endotoxin testing within the laboratory and includes practical demonstrations of a variety of detection methods.

Advanced Endotoxin Testing Training

– We know how important reliable product quality is for your day-to-day research. In this course, we therefore use the highest quality standards in the industry so you can rely on the performance of our products, now and in the future.

Practical Endotoxin Testing

– This course is designed for delegates who wish to gain direct prac-tical experience to develop or improve their skills with Endotoxin assays. This course is a full day of practical training including prod-uct validation and troubleshooting using the delegate’s chosen detection method.

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Introduction to Endotoxin Testing Training Course

History and Overview

An initial overview is given of the history of fever and injectable drugs, including the basic research that established the structure and function of the Endotoxin molecule. The discovery and development of the rabbit pyrogen test and LAL Endotoxin detection methods are also discussed in this section.

Methods

All the current Endotoxin detection methods are covered in detail includ-ing the most recent development and the probable future of Endotoxin testing, an assay based on recombinant technology and no longer reliant on bleeding the horseshoe crab as a source of raw material. Background, advantages and disadvantages and practical application of each test method are examined.

Practical Demonstration

Practical demonstrations of the following methods using Lonza products: – Gel Clot using PYROGENT™ Ultra Liquid Standard Gel Clot Kit for use

in semi-quantitative gel clot testing – Kinetic Turbidimetric or Chromogenic (tailored to the delegates’ par-

ticular interests) using PYROGENT™-5000 or Kinetic-QCL™ Complete Reagent Kits and WinKQCL™ Endotoxin Detection Software for use with plate readers

– Recombinant Factor C using PyroGene™ Endotoxin Detection Method using fluorescent technology and WinKQCL™ Endotoxin Detection Software

The practical demonstration session is intended to give delegates an overview of the methods and an insight into the practicalities of running a test. Time will be allowed for questions. For hands on practical training, please see our Practical Endotoxin Testing Training Session.

Understanding the Data Report

As software systems become more sophisticated both in terms of func-tionality and to meet regulatory requirements, the information present-ed in assay reports becomes more complex. It is important that there is a good understanding of how the information provided on the assay report is generated and how to interpret unexpected results. This ses-

sion will take delegates step by step through a WinKQCL™ Assay Report explaining the significance of each piece of information and how it can be used to control Endotoxin testing in the laboratory.

Endotoxin Testing and Regulatory Requirements

Regulatory requirements are a constantly changing field and our course material is updated to reflect the most recently issued documentation and existing or draft requirements or initiatives from the main regula-tory bodies.

This session provides delegates with vital information on: – Who are the regulatory authorities, what documents are relevant,

what are the requirements, and what guidance they provide – How to comply with the requirements for product independent and

product dependant validation – Calculating MVD and using dilution to overcome assay interference – Practicalities of routine product release testing – Medical device testing

Common Assay Issues

Validation of the laboratory, equipment, technician, reagents, and prod-ucts for Endotoxin test methods should mean that a robust method is employed. Due to the physical characteristics of Bacterial Endotoxin and the biological origin of most reagents currently available, variability within the test is inevitable. Common issues such as variable PPC recov-ery, Endotoxin and %CV results as well as blank reactions are discussed in this section with hints and tips for avoidance.

Pharma&BiotechEndotoxin Testing – A Comprehensive Training Course

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Advanced Endotoxin Testing Training CourseThe Advanced Endotoxin Testing Training Course is intended to give new and experienced users a deeper insight into Endotoxin testing. In order for delegates to gain the most from the advanced day course, we would recommend that delegates have either previously attended an Endotoxin Detection Training Course, have attended our beginner’s day course or have been conducting Endotoxin testing in their labora-tory for some time.

Water Testing

Water can be a most vital component in the manufacture of a therapeutic drug or medical device to make, maintain and validate. The importance of adequate water testing routines and the regulatory documents impact-ing this are discussed including validation and revalidation protocols. Each water system will be designed specific to the manufacturing site and final products to be produced. However most will have similar basic components. It is important to understand where Endotoxin contami-nation can occur, which water samples to take and where from, which containers to use and the sampling routine procedures to ensure you have good monitoring of the water quality. Trending of water testing results is critical to show good process control.

The Mathematics of Kinetic LAL Testing and Assay Variability

This section of the advanced training course is included in response to delegate requests. The Bacterial Endotoxin test is a test of bioactivity and is not a clearly defined chemical test; as such, variability within the test is inevitably higher than for a simple ELISA or protein assay. Understanding the causes of variability and being able to differentiate between inherent and user introduced variability is an important part of assay control in the QC laboratory.

This section explains: – How limits were set for PPC recovery – How to choose which PPC concentration to use – How log-log transformation of the standard curve affects variation – How the sensitivity range of kinetic assays were determined – The effect on variance as the sample Endotoxin value increases – Standard curve regression methods (linear/polynomial)

Raw Material Testing

Whilst there is no official regulatory requirement to test raw material for Bacterial Endotoxin, the regulatory focus on process control testing is certainly increasing. Auditors now expect raw material to be tested prior to manufacturing of final product and the results become part of final product batch records. Adequate testing of raw material helps to build quality into a final product and can prevent costly mistakes such as adulteration of final product by a contaminated raw material. It is often difficult to assign Endotoxin limits or sampling protocols for raw material. This section provides guidance and suggestions on how to set appropriate limits.

Overcoming Assay Interference

The Introduction to Endotoxin Testing Training Course covers MVD calcu-lations and the use of dilution to overcome assay interference. However, there are some products whose characteristics mean simple dilution may not overcome interference. There are several alternative sample pretreatment methods which can be considered and are discussed in this section.

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Depyrogenation

What happens if your product, water or raw material is contaminated with Bacterial Endotoxin? For established products on the market, the manufacturing process should be robust enough to limit the chance of gross contamination, but when you are designing a new production process, Endotoxin removal steps should be considered. Some products such as those which are made in bacterial cell systems will by their very nature contain high Bacterial Endotoxin levels. This section discusses Endotoxin inactivation and removal methods that can be employed.

Clinical Implications of Endotoxin

This section looks more closely at the structure and function of Bacterial Endotoxin in the clinical situation. Delegates will gain a good understand-ing of the development of sepsis and septic shock from the clinical to the molecular level.

The Making of LAL

The horseshoe crab is a living fossil. Discover how the crab is sourced, bled, tagged, and returned to its natural environment. Let us take you through the production process from raw lysate through QC testing and the vialing of the final product. This section will also describe how the new recombinant Endotoxin detection reagent system is made. This section helps provide insight into differences in lysate formulations and how they impact product testing.

OOS/OOT

What happens when you get an unexpected result? This could be a poor PPC recovery, a higher than expected Endotoxin load, a poor %CV, an issue with the standard curve parameters, or a simple blank reaction/contamination. This section will discuss why it is important to conduct well planned OOS/OOT investigations, when they should be conducted and with whom to discuss the results. The section also contains a case study as a helpful guide to how a good OOS/OOT investigation can prevent future assay or product batch failures.

Glucans

The LAL assay methods are subject to false positive reaction in the pres-ence of LAL-reactive material, usually glucan-like in character. This sec-tion explains what glucans are, where they are found and what to do if you suspect your Endotoxin positive results may in fact be glucan contamination. The clinical relevance of glucan contamination of your product is also discussed.

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Pharma&BiotechEndotoxin Testing – A Comprehensive Training Course

The Practical Training Day is designed to pro-vide training on a flexible basis for a small group of delegates to learn more about the practical application of the Endotoxin detec-tion method of their choice.

Delegates will learn a variety of useful practi-cal skills that will help develop and improve their ability to run Endotoxin assays and obtain accurate and reproducible results. The course is deliberately informal to aid open discussion and learning. A work book is provided to guide the delegate through the assay procedures and work exercises and a signed training certificate will be given upon successful com-pletion of the course.

Particular attention is paid to helping delegates become comfortable with the assay, how to deal with difficult products and how to trouble-shoot in the event of unexpected results.

In order to ensure individual attention, each practical course is limited to a maximum of 6 delegates. If you are interested in our prac-tical course, but the scheduled courses are full, please do log your interest with your local Product Specialist who will contact you when new dates are being scheduled.

Supporting Theory for the Practical Course

– Which method to choose? – Validation from a practical stand point in-

cluding an outline of equipment IOPQ – Collection and review of information need-

ed before starting assays for reagent and product validation

Reagent Validation – The Initial Qualification Test (also known

as Confirmation of Lysate Sensitivity Test or Confirmation of Linearity Test). This test is often used to train and validate techni-cians prior to conducting routine or valida-tion testing. A brief outline of the test and the requirements is presented prior to the practical work and each delegate is given the chance to conduct this assay.

Product Screening (also known as Inhibition Enhancement Testing)

– Each delegate will be given at least one product, for which they will calculate the Endotoxin limit, MVD and PFC for the prod-uct and set-up and run a screening assay to determine suitable dilution(s) where the product least interferes with the assay. The assay results for each delegate’s product will be discussed as well as the practical use of product pretreatment methods used where simple dilution is not adequate to overcome assay interference.

Product Validation – Validation of the product given is conducted

by testing 3 samples from 3 different lots of the product at the dilution determined in the product screening assay. This assay shows assay reproducibility.

Try Another Method – Time permitting, the delegates are given

the option to try another Endotoxin de-tection method testing a pre-validated product.

Advanced Endotoxin Testing Training Course

The course will include the following sections:

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Alan Baines

Alan Baines is currently the Head of Strategic Projects for Lonza BioScience. An Honours graduate in Pharmacology from Leeds University, he has over 35 years of experience in Endotoxin testing since the LAL test was first introduced to the UK in the mid 1970’s. Alan founded Lonza’s UK operation in 1992, was appointed European Director for the whole of the European life science business in 1998 and subsequently became the director for the European Endotoxin Detection Strategic Business Unit, which was formed in 2001. In early 2004, Alan assumed overall global responsibilities for the endotoxin detection business unit before being promoted in 2012 to the role of Head of Strategic Projects for Lonza Bioscience. Alan presents regularly at PDA and PMF forums and training courses in both the USA and Europe and is the author of the chapter „Routine Testing“ in „The Bacterial Endotoxins Test; A Practical Guide“, published by the PDA in 2011.

David Guy

David Guy is the European Director of Sales for Testing Solutions within Lonza Bioscience. Based in the UK, David has over 20 years’ experience in Endotoxin testing starting as a Product Specialist 1992 and being heavily involved with the introduction of kinetic endotoxin testing systems to the UK between 1992 and 1998. David managed the UK business between 1998 and 2001, progressing to become the LAL Business Development Manager for Europe until 2004 when he was promoted to European Director for Lonza’s newly formed Endotoxin Detection business unit. During this time, David has given many training

courses for endotoxin testing in the UK and across Europe. An expert in the computing and instrumentation side of endotoxin testing systems, David has been involved in the developmental processes for robotic testing platforms, a number of versions of Lonza’s WinKQCL™ software.Prior to working within endotoxin testing, David was involved in the sales and support of cell culture bioreactor systems and flow cytometry systems.

Simon Jackson

Professor Simon Jackson, BSc PhD, is Professor of Environment and Human Health and Director of the Centre for Research in Translational Biomedicine at Plymouth University. Simon has over twenty years experience in Endotoxin research and in particular the innate immune response to Endotoxin and its role in sepsis. He has produced over 190 peer-reviewed publications, book chapters and numerous presentations at international scientific and medical research conferences. Simon is also an advisor and reviewer for research councils, research charities, science and medical journals, acts as a consultant to several organisations and is on the editorial board of the journal Innate Immunity. Throughout a distinguished research career, Simon has been closely involved with the measurement of Endotoxin in both basic research and applied clinical and environmental settings and has been responsible for setting up and monitoring systems for plasma Endotoxin in a number of clinical trials of anti-endotoxin and anti-sepsis therapies. Previous posts include Director of Biomedical Research at the University of the West of England, Bristol, Research Director, Medical Microbiology, Cardiff University School of Medicine and

visiting scientist, Dartmouth Medical School, New Hampshire, USA.

Ruth Noé

Ruth Noé (BSc (Hons) Medical Microbiology, Leeds University 1994), is the UK & Ireland Sales Manager for Testing Solutions within Lonza Bioscience Products division of Lonza. Ruth has been with Lonza since 2001, first as a Product Specialist (north UK) and since 2004 as Sales Manager. Ruth’s role includes sales, support, technical advising, troubleshooting, validation, equipment installation and maintenance, training, service document control, safety representation and line management. Previous to her employ with Lonza, Ruth was a Biotechnology Business Development Manager for 3 years with a CRO working with customers to design their preclinical product biosafety testing protocols (including adventitious virus, bacterial and endotoxin detection test methods). Ruth has also spent time in research laboratories testing blood and bone marrow samples using various molecular biological techniques and in routine virology laboratories in the public health sector.

Speakers

The Lonza Endotoxin Detection Training Course was designed by the following experts:

Lonza Walkersville, Inc. – Walkersville, MD 21793

Unless otherwise noted, all trademarks herein are marks of the Lonza Group or its affiliates. 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 2012, Lonza Walkersville, Inc. All rights reserved. BR-LAL-UK-1 07/12 RT-BR011

Contact InformationNorth AmericaCustomer Service: 800 638 8174 (toll free)[email protected] Support: 800 521 0390 (toll free)[email protected]

EuropeCustomer Service: +32 87 321 [email protected] Support: +32 87 321 [email protected]

InternationalContact your local Lonza distributorCustomer Service: +1 301 898 7025Fax: +1 301 845 [email protected]

International OfficesAustralia + 61 3 9550 0883Austria 0800 201 538 (toll free)Belgium + 32 87 321 611Brazil + 55 11 2069 8800Denmark 808 83 159 (toll free)France 0800 91 19 81 (toll free)Germany 0800 182 52 87 (toll free)India +91 40 4123 4000Ireland 1 800 654 253 (toll free)Italy 0800 789 888 (toll free)Japan + 81 3 6264 0660Norway 800 16 557 (toll free) Poland + 48 781 120 300Singapore + 65 6521 4379Spain 900 963 298 (toll free)Sweden 020 790 220 (toll free)Switzerland 0800 83 86 20 (toll free)The Netherlands 0800 022 4525 (toll free)United Kingdom 0808 234 97 88 (toll free)

www.lonza.comwww.lonza.com/lalseminar

Pharma&Biotech

The Kinetic-QCL™ Kinetic Chromogenic Assay is a quantitative, kinetic assay for the detection of Gram-negative bacterial endotoxin. A sample is mixed with the reconstituted LAL reagent in a 96-well plate, placed in the incubating absorbance plate reader, and automatically monitored over time for the appearance of a yellow color.

In the presence of endotoxin, the lysate will begin to cleave the chromogenic substrate causing the solution to become yellow. The time required for the change is inversely proportional to the amount of endotoxin present. The concentration in unknown samples can be calculated from a standard curve

Due to the basis of the enzyme reaction, the Kinetic-QCL™ Assay is less impacted by inhibitory products that may interfere with the clotting mechanism in Turbidimetric and Gel Clot assays. This feature, along with the sensitivity range of 0.005 to 50 EU/ml, makes this assay optimal for biological products such as vaccines and antibiotics.

Using our extensive experience and practical expertise with endotoxin detection and its regulatory requirements, Lonza has developed an integrated system to support quantitative endotoxin detection. Each system component has been validated and can be verified. This all leads to reliable, reproducible and accurate quantitative results.

Kinetic-QCL™ LAL Assay Make Critical Decisions with Confidence:Quantitative Endotoxin Results

For Endotoxin Detection






© Copyright 2012, Lonza Walkersville, Inc. All rights reserved. FL-KineticAssay 05/12 RT-TS003

www.lonza.com/pharmabiotechwww.lonza.com/lal

Each quantitative system incorporates three elements:

– Kinetic-QCL™ Kinetic Chromogenic LAL Assays

– WinKQCL™ Endotoxin Detection and Analysis Software

– ELx808™ Absorbance Plate Reader

These elements integrate seamlessly to meet your testing requirements, providing actionable results that allow you to be confident in your critical decisions.

The Kinetic-QCL™ Kinetic Chromogenic Assay kits contain co-lyophilized lysate/substrate and matched control standard endotoxin (Part No. 50-560U contains LAL Reagent Water). Bulk kit configurations are available; bulk kinetic chromogenic LAL and matched control standard endotoxin are packaged separately but should be ordered together. These bulk configurations are made to order, and therefore, require a lead time. Please contact Customer Service for more information.

Kinetic-QCL™ LAL Assay

Source LAL

Data quantitative

Type kinetic chromogenic

Format 96-well plates, incubated

Standards usually 3-5 points run in duplicate

Negative controls LAL Reagent Water in duplicate

Assay controls one set of spiked samples in duplicate per sample

Range 0.005 EU/ml – 50 EU/ml

Assay time approximately 1 hour

Temperature 37°C + 1°C

Detection wavelength

405 nm

Ordering Information

Cat. No. Description Size/Quantity

50-650U Kinetic-QCL™ Kinetic Chromogenic LAL Assay 192 tests/kit

50-650NV Kinetic-QCL™ Kinetic Chromogenic LAL Assay 2,040 tests/kit

50-650H Kinetic-QCL™ Kinetic Chromogenic LAL Assay 2,400 tests/kit

K50-643U Kinetic-QCL™ Bulk Kinetic Chromogenic LAL Assay 2,400 tests

E50-643L Bulk Endotoxin Kinetic Chromogenic LAL 25 vials

25-335 Standard Kinetic System (ELx808™ Reader, data station with printer, WinKQCL™ Software, SND Plate)

system

25-515 (EU) Standard Kinetic System (ELx808™ Reader, data station with printer, WinKQCL™ Software)

system

25-315 ELx808™ Reader device

25-501 WinKQCL™ Software Package –

25-502 WinKQCL™ Workgroup License Agreement –

25-503 WinKQCL™ Reader License Agreement –

25-504 WinKQCL™ Qualification Manual –

25-505 WinKQCL™ Validation Package –

25-342 Stepped Neutral Density Plate plate

W50-100 LAL Reagent Water, <0.005 EU / ml 100 ml

W50-1000 LAL Reagent Water, <0.005 EU / ml 1,000 ml



Pharma&Biotech

The PyroGene™ Recombinant Factor C Assay is the evolution of endotoxin detection testing. Lonza scientists have developed a recombinant form of Factor C, the first component in the horseshoe crab clotting cascade activated by endotoxin. Recombinant Factor C (rFC) is activated by endotoxin binding, and the active enzyme then cleaves a synthetic substrate, resulting in the generation of a fluorescent signal.

The reaction is run in a 96-well microplate and is measured at time zero and after a one-hour incubation in a fluorescent microplate reader using excitation/emission wavelengths of 380/440 nm. The log net fluorescence is proportional to the log endotoxin concentration and is linear in the 0.005-5.0 EU/ml range.

PyroGene™ Recombinant Factor C AssayEvaluation Program in Your Own Lab


Endotoxin Testing is Evolving – Don’t Be Left Behind






© Copyright 2012, Lonza Walkersville, Inc. All rights reserved. FL-PyrogeneEval 05/12 RT-TS005

www.lonza.com/pharmabiotechwww.lonza.com/pyrogeneeval

Advantages of the PyroGene™ rFC Assay – Endotoxin specific, recombinant technology eliminates false-positive glucan reactions – Predictable, reliable lot-to-lot assay performance – Sustainable resource – no animal utilization – Endpoint fluorescent assay, comparable to other quantitative LAL methods – 510(K) submissions have been approved by the FDA using PyroGene™ rFC Assay as a final

release test – Comprehensive FDA Master File

Evaluation Program DetailsLonza will provide the following material to cover a one month evaluation period:

Quantity Description Cat. No.

3 PyroGene™ rFC Kit 50-658U

3 Reagent Reservoirs 25-364

2 Dilution Tubes N207

9 96-well Plates 25-340

3 Racks of 20-200 µl pipette tips 25-415

3 Racks of 100-1000 µl pipette tips 25-417

Lonza will also provide an FLx800™ Reader (part no. 25-344) as a loaner for a one month period. Lonza will install the WinKQCL™ Software (part no. 25-501) under a limited license to the evaluator.The evaluator is required to sign an evaluation agreement prior to Lonza providing the above materials and the placement of the reader and software.

Lonza and the PyroGene™ rFC Assay are leading the way through the evolution of endotoxin detection.

Pharma&Biotech

The PYROGENT™-5000 Assay is a quantitative, kinetic assay for the detection of Gram-negative bacterial endotoxin. A sample is mixed with the reconstituted LAL reagent in a 96-well plate, placed in the incubating absorbance plate reader, and automatically monitored over time for the appearance of turbidity.

In the presence of endotoxin, the lysate will begin to gel causing the solution to become cloudy or turbid. The time required for the change is inversely proportional to the amount of endotoxin present. The concentration in unknown samples can be calculated from a standard curve.

The PYROGENT™-5000 Assay is perfect for laboratories needing to process large numbers of samples. It is ideal for water samples, large volume parenterals and water rinse from medical devices.

Using our extensive experience and technical expertise with endotoxin detection and its regulatory requirements, Lonza has developed an integrated system to support quantitative endotoxin detection. Each system component has been validated and can be verified. This all leads to reliable, reproducible and accurate quantitative results.

PYROGENT™-5000 LAL Assay Reliable Quantitative Endotoxin Results: Helping Ensure Product Quality







© Copyright 2012, Lonza Walkersville, Inc. All rights reserved. FL-PyrogentAssay 05/12 RT-TS004

www.lonza.com/pharmabiotechwww.lonza.com/lal

Each quantitative system incorporates three elements:

– PYROGENT™-5000 Kinetic Turbidimetric LAL Assays

– WinKQCL™ Endotoxin Detection and Analysis Software

– ELx808™ Absorbance Plate Reader

These elements integrate seamlessly to meet your testing requirements providing information that allows you to be confident in making critical decisions.

PYROGENT™-5000 kits contain turbidimetric lysate, reconstitution buffer for the lysate and matched control standard endotoxin. Bulk kit configurations are available; bulk turbidimetric LAL, reconstitution buffer and matched control standard endotoxin are packaged separately but should be ordered together. These bulk configurations are made to order and therefore require a lead time. Please contact Customer Service for more information.

PYROGENT™-5000 LAL Assay

Source LAL

Data quantitative

Type kinetic turbidimetric

Format 96-well plates, incubated

Standards usually 3-5 points run in duplicate

Negative controls LAL Reagent Water in duplicate

Assay controls one set of spiked samples in duplicate per sample

Range 0.01 EU / ml – 100 EU / ml

Assay time approximately 1 hour

Temperature 37°C ±1°C

Detection wavelength

340 nm


Cat. No. Description Size/Quantity

N383 PYROGENT™-5000 Kinetic Turbidimetric LAL Assay 100 tests/kit

N384 PYROGENT™-5000 Kinetic Turbidimetric LAL Assay 200 tests/kit

N588 PYROGENT™-5000 Kinetic Turbidimetric LAL Assay 2,250 tests/kit

N688 PYROGENT™-5000 Kinetic Turbidimetric LAL Assay 4,500 tests/kit

T-50-300L PYROGENT™-5000 Bulk Kinetic Turbidimetric LAL Assay 1,250 tests

T50-300U PYROGENT™-5000 Bulk Kinetic Turbidimetric LAL Assay 5,000 tests

T50-600L PYROGENT™-5000 Bulk Kinetic Turbidimetric LAL Assay 2,500 tests

T50-600U PYROGENT™-5000 Bulk Kinetic Turbidimetric LAL Assay 10,000 tests

B50-300L Reconstitution buffer for T50-300L 25 vials

B-50-300U Reconstitution buffer for T50-300U 100 vials

B50-600L Reconstitution buffer for T50-600L 25 vials

B50-600U Reconstitution buffer for T50-600U 100 vials

25-335 Standard Kinetic System (ELx808™ Reader, data station with printer, WinKQCL™ Software, SND Plate)

system

25-515 (EU) Standard Kinetic System (ELx808™ Reader, data station with printer, WinKQCL™ Software)

system

25-315 ELx808™ Reader device

25-501 WinKQCL™ Software Package –

25-502 WinKQCL™ Workgroup Agreement –

25-503 WinKQCL™ Reader License Agreement –

25-504 WinKQCL™ Qualification Manual –

250505 WinKQCL™ Validation Package –

25-342 Stepped Neutral Density Plate plate


W50-1000 LAL Reagent Water, <0.005 EU / ml 1,000 ml



– Extended reader integration - Integration of Molecular Devices® SpectraMax®, Gemini™ and VersaMax™ readers; BioTek™ ELx808™, Eon™, FLx800™ and Synergy™ 2 readers; and the Tecan® Sunrise™ reader offering users more choices and flexibility in microplate readers

– Kinetic SmartStop™ monitoring - To address split pair and other reaction conditions

– Enterprise level IT features - Including wide area network support, ability to work across time zones, application virtualization, Active Directory® integration and data segregation by lab

– Multi-language user interface - English, French, German, Italian, Japanese, Spanish, Portuguese, Simplified Chinese and Traditional Chinese

– Extended user convenience - Customizable endotoxin test reports and enhanced edit assay features

New Version 5 Featuring:

Pharma&Biotech

WinKQCL™ 5 Software We Analyze Endotoxin Data Every Day


Contact your Lonza representative for more information or visit www.lonza.com/winkqcl.

www.lonza.com/pharmabiotechwww.lonza.com/winkqcl

The WinKQCL™ 5 Endotoxin Detection and Analysis Software offers a fully integrated solution for your quantitative endotoxin detection testing, data management and reporting needs. The software meets 21 CFR Part 11 technical requirements for electronic records and signatures, audit trails and database archiving.

It can be installed as a simple standalone system, or it can interface with multiple robots and readers in multiple labs around the world, all storing data in a single database. Reader

validation tests can be run from the WinKQCL™ Software and stored in the same database. The built-in database backup and maintenance scheduler makes it easy to maintain the system.

The user-friendly and flexible Template Manager allows you to customize plate layout with a click of a mouse using the SpeedFill™ and Drag n’ Drop features. The interactive and enhanced trending tools provide actionable results on demand, helping you easily detect drift and enabling you to make proactive decisions.





Active Directory is a trademark of Microsoft Corporation.Molecular Devices, SpectraMax, Gemini and VersaMax are trademarks of Molecular Devices, LLC.BioTek, ELx808, Eon, FLx800 and Synergy are trademarks of BioTek Instruments, Inc. Tecan and Sunrise are trademarks of Tecan Group Ltd.


© Copyright 2012, Lonza Walkersville, Inc. All rights reserved. FL-25-501 07/12 RT-TS007


Cat. No. Name Description

25-501 WinKQCL™ 5 Software Package Disc, workgroup license, reader license

25-502 WinKQCL™ 5 Workgroup License Additional workgroup license

25-503 WinKQCL™ 5 Reader License Additional reader license

25-504 WinKQCL™ 5 Qualification Manual IOPQ manual for software and readers

25-505 WinKQCL™ 5 Validation Package Disc containing software validation documentation

endotoxin testing a comprehensive training course · 7 pharma&biotech endotoxin testing – a...

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