Pharma&Biotech

Automating QC micro processes
with MODA™ platform improves efficiency,ease of compliance and costs for Lonza

MODA™ solution case studyIssue«	… clearly strengthened
our Bioscience division’s
capabilities with comprehensive automated,
quality informatics tomeet the critical needsof regulated quality
control environments. »Lukas Utiger, Head of Lonza Biosciences

Paper-based quality control microbiology (QC micro) processes were labor-intensive,
time-consuming, error-prone, and expensive.

Solution
MODA™ mobile data acquisition platform for automated, paperless, QC processes

Return on investment
Significant improvements in QC efficiencies, ease of regulatory compliance, cost reductions
and employee utilization–– Reduced time to perform environmental monitoring by 4 hours per-person, per-shift–– Reduced required QC staff from 11 to 8 FTE’s through attrition and reassignment–– Reduced analysis of sampling data and trending from weeks to seconds–– Eliminated miscellaneous costs such as for binders, autoclaving and off-site paper storage–– Improved regulatory compliance efficiencies with validated system and fullaudit trail traceability

Pharma&Biotech
Automating QC micro processes
with MODA™ platform

Lonza Group Ltd
Lonza (www.lonza.com) is one of the world’s leading suppliers to thepharmaceutical, healthcare, and life science industries. Its products andservices span its customers’ needs from research to final product manufacture. Lonza is headquartered in Basel, Switzerland and is listed on theSIX Swiss Exchange. In 2010, the company had sales of CHF 2.680 billion.

Executive summary
The Walkersville, Maryland facility was challenged with the typical paperbased quality control microbiology (QC micro) processes:–– Autoclaving particle-generating paper–– Capturing sampling data on paper–– Reconciling data to correct for numerous omissions and errors–– Re-entering data manually into a MS® Access® database–– Creating trend reports manually in MS® Excel® – limiting scope
and timely insights into trends–– Storing volumes of paper documentation – increasing the timeand complexity of FDA audits–– Requiring microbiology analysts to devote half their time tonon-QC micro activities«	The MODA™ platform provided acomplete solution for QC micro withmobile computing technology
and advanced visualization tools.
It enabled paperless and timely
collection of data at sampling
points, automated workflow
processes, and provided dataanalysis and trending in seconds
instead of weeks. »John Semon, Associate Director, QC Testing Services, Lonza WalkersvilleAs part of a company-wide Lean Six Sigma initiative to eliminate waste andreduce lead times, Lonza Walkersville beta-tested MODA-EM™, an environmental monitoring software for paperless QC micro data collection and management, in three of the site’s clean rooms. After using MODA-EM™ for a year,results were so impressive that system implementation was expanded toall 13 clean room suites at the Walkersville site. The software was upgradedwith more than a hundred recommendations from Lonza’s analysts, andutility monitoring (for water loops) was added, further increasing ROI. Inaddition to MODA-EM™, the MODA™ platform today also includes MODA-VIP™,
a Visual Intelligence Portal to improve insight into sampling data, and MODA
FDC™, a mobile computing capability using tablet PCs and other devices forField Data Capture of sampling data in clean rooms.
The MODA™ solution solved Lonza Walkersville’s micro QC issues in numerous ways with:–– Clean room-compatible computer equipment interfaced tolaboratory equipment (air particulate counters)–– Real-time, one-step, electronic capture of sampling data,
eliminating paper forms and redundant data entry–– Significant reduction in data errors and elimination of omissions
through mandatory, self-checking, data-entry fields–– Generation of trending reports in real time with a wide varietyof report formats–– Flora trending by person, site, room, facility, etc.
–– Client-specific reporting for contract manufacturing–– Automatic assurance that sampling is performed with only
calibrated equipment and non-expired materials and media“The MODA™ platform provided a complete solution for QC micro with mobile
computing technology and advanced visualization tools. It enabled paperless and timely collection of data at sampling points, automated workflow
processes, and provided data analysis and trending in seconds instead ofweeks,” said John Semon, Associate Director, QC Testing Services, Lonza
Walkersville.
Susan Harrison, Senior Manager, QC Microbiology, Lonza Walkersville,
added: “The system’s value proposition of ‘More Science, Less Paper’
manifested in higher process efficiency, ease of regulatory compliance,
significant cost reductions, and better use of employees, increasing theirjob satisfaction.”
After three years of working with the MODA™ platform, Lonza began expanding the system across its plants globally and acquired the emerging
company, MODA Technology Partners. “Based on our first-hand experience,
we recognized how the MODA™ technology would benefit our customers andpartners in life sciences industries, as well as other types of companies withregulated manufacturing, such as food processing,” said Lukas Utiger, Headof Lonza Biosciences. “The acquisition clearly strengthened our Bioscience
division’s capabilities with comprehensive, automated, quality informatics
to meet the critical needs of regulated quality control environments.”

Objectives
Reduce the time and resources required
for micro QC processes

Solution
MODA™ mobile data acquisition platform

Lonza became an early adopter of MODA™ technology through the effortsof microbiology analysts like Jeremy Tanner. “We faced multiple issues
with the paper-based system just as other QC microbiology labs do,” said
Tanner. “From planning and scheduling, through collecting and processing
samples, to entering data into a database and spreadsheets for analysis
and trending, our QC process involved more than 30 steps, and 20 ofthem were manual tasks. Typing information from paper forms took up
half my day. We then spent an excessive amount of time generating trend
graphs in Micorsoft® Excel® that were not very insightful. And when wecompleted trend charts, we had to compare them back to the paperwork
for verification because our process could not be validated.”

The MODA™ platform provided Lonza with software and cleanroom compatible hardware that automated the capture and entry of sampling data
directly into a computer system at the points of sampling. The platform
includes PC tablet computers and associated equipment, such as carts,
thermal barcode printers and barcode scanners. All the equipment is easily sanitized with familiar pharmaceutical cleaning agents such as bleachand sporicidal agents to keep from adding contaminates to the clean room
environment. The MODA-EM™ software also allows for data entry from othercomputing devices such as fixed workstations and qualified laptops inthe controlled areas.

More than 100 QA and manufacturing people are involved in capturing
sampling data at Lonza Walkersville. Because of the volume of work andthe number of end users, data correction delayed the review and approval of data.

«	The system’s value proposition of‘More Science, Less Paper’ manifested inhigher process efficiency, ease ofregulatory compliance, significant cost
reductions, and better use of employees,increasing their job satisfaction. »Susan Harrison, Senior Manager, QC Microbiology, Lonza Walkersville

The MODA™ system integrates directly with the air particulate countersused at Lonza. The information is pulled directly into the MODA™ platform
and sent to a server – eliminating the need for hours of manual data entry
during sampling. The system also provides more than 25 out-of-the-box
reports for trending as well as the VIP module for viewing results in any
way Lonza chooses to investigate the data. The automated reporting andquick, flexible analysis capabilities provide insight into issues that Lonza
would not have been able to find with its paper-based processes.
A typical automated sampling process at Lonza now involves:–– A person entering a clean room with the MODA™ mobile computing
environment on a cart–– Searching the system for the room/site the person is in–– Identifying the samples in the room to be collected–– Printing barcode labels for the samples requiring media(plates, bottles, vials, swabs, etc.)–– Using the MODA™ platform to operate particle counters in capture ofnon-viable particle count data, which is directly fed to a databaseThe result is one data-entry step, no transcription and immediate accessto the sample information. For the entire micro QC process at Lonza, theMODA™ solution eliminated all 20 manual steps, including the backend
work associated with data monitoring and trending.

www.lonza.com
www.lonza.com/moda

Return on investment
Improved efficiency, ease of compliance,costs and employee utilization
By removing paper from the process, Lonza was able to increase the number of samples it could take and manage – increasing QC capacity. Easeof regulatory compliance improved from a higher quality process – due tothe elimination of manual errors and omissions, the addition of a validated
system compliant with FDA 21 CFR Part 11, and capabilities to perform data
trending in ways not previously possible with a paper system.

Regulatory compliance
The MODA™ platform provided a validated system with electronic signatures
for complete process traceability and audit trail. Users can only accessportions of the system needed to complete their job function. Instant turnaround of trend reports also improves compliance efficiencies. Reports
can be generated as soon as sampling results are in the system, whichallows for rapid response to any possible contamination events.

USALonza Walkersville, Inc.
Walkersville, MD 21793“The system’s ease of use also simplifies compliance audits,” said Tanner. “QA staff can access MODA™ software from their computer and show
exactly the information an auditor requests. Our MODA™ capability has
dramatically shortened audit times, impressed auditors.
Microsoft and Excel are trademarks of Microsoft.

User adoption
In addition to microbiology analysts, more than 100 QC and manufacturingpersonnel across age groups and varying educational backgrounds use
the MODA™ system. “User adoption was quick and very high,” said Tanner.
“As people started using the system, they saw the value. When we ask
employees if they would like to go back to the paper system, most say
absolutely not.”For the QC analysts like Tanner, who were trained for science, more time
can be spent on analyzing information and making decisions so thatclean rooms, water and utility systems, raw materials and Lonza’s end
products can meet the highest standards of microbial control. “All employees involved with QC micro processes now complete more meaningful,value-added tasks,” said Harrison. “This not only helps the company, buteveryone’s job satisfaction as well.”Unless otherwise noted, all trademarks herein are the marksof the Lonza Group or its affiliates.
The information contained herein is believed to be correctand corresponds to the latest state of scientific and technicalknowledge. However, no warranty is made, either expressedor implied, regarding its accuracy or the results to be obtained
from the use of such information and no warranty is expressedor implied concerning the use of these products. The buyer
assumes all risks of use and/or handling. Some products may
not be available in all markets or for every type of application. Any user must make his own determination and satisfy
himself that the products supplied by Lonza Group Ltd andthe information and recommendations given by Lonza GroupLtd are (i) suitable for intended process or purpose, (ii) incompliance with environmental, health and safety regulations, and (iii) will not infringe any third party’s intellectual
property rights. No statement is intended or should be construed as a recommendation to infringe any existing patent.
© Copyright 2011, Lonza Walkersville, Inc. All rights reserved.
FL-CaseStudyMODA 06/11

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