nate anderson automation engineer pdl biopharma · 5 copyright © 2007 osisoft, inc. all rights...
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Copyright © 2007 OSIsoft, Inc. All rights reserved.
RtReports at PDL BioPharma
Nate Anderson Automation Engineer PDL BioPharma
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Copyright © 2007 OSIsoft, Inc. All rights reserved.
Agenda
l PDL BioPharma l Business Challenge
u Drivers
l Solution u OSIsoft components used u Reports –Batch, Building Monitoring Systems, Utilities
l Benefits l Future Plans
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Copyright © 2007 OSIsoft, Inc. All rights reserved.
PDL BioPharma
l Leader in the discovery, development, manufacturing and marketing of innovative therapies for serious or lifethreatening illnesses
l Emphasis in areas of u Acute cardiac care u Autoimmune diseases u Inflammatory conditions u Cancer
l Manufacturing facility – Brooklyn Park, Minnesota l Headquarters – Fremont, California
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Protein Design Labs
l Roots in Antibody humanization technology l License technology to biotech and pharmaceutical partners l Market biopharmaceutical products for the hospital setting u Cardene® I.V. for the shortterm treatment of hypertension u Retavase® for acute myocardial infarction u IV Busulfex® (Black Box Warning) for conditioning prior to a bone
marrow transplant . l Leading clinical programs include
u Nuvion® (visilizumab) , in development for intravenous steroid refractor ulcerative colitis
u Ularitide in development for acute decompensated heart failure.
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Copyright © 2007 OSIsoft, Inc. All rights reserved.
Business Challenge
l New facility was planned for construction u Groundbreaking Oct 2002 u First run May 2005
l Electronic reports wanted u PI was specified as the data historian u RtReports compliance was a brand new OSISoft product, with a
release in line with the timing for the plant startup
l Based on previous experience, wanted to avoid custom components and go with off the shelf software u Another site had a data historian with some custom components
that couldn’t be validated
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Copyright © 2007 OSIsoft, Inc. All rights reserved.
Business Drivers
u GMP documentation. u Avoid installing chart recorders § Needed electronic signatures and permanent access to data
u Batch system reporting § Needed to be able to integrate data from batch execution system and generate reports that reflected what the processing equipment was actually doing
u Batch release time § PDL’s target:
– New product: 30 days to release for final filling. – Existing products: 15 days to release for final filling.
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Copyright © 2007 OSIsoft, Inc. All rights reserved.
OSIsoft Components Used
l PI Server l RtReports l RtWebparts l 200 ProcessBook and PI DataLink licenses l COM Connectors l MCN Health Monitor l OPC Interface l PI Batch Interface l PI ACE l RtAlerts l Enterprise Agreement
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Copyright © 2007 OSIsoft, Inc. All rights reserved.
Enterprise Agreement
l Motivations for Enterprise Agreement u Network Operations Center § Maximum uptime is important § Remote monitoring
u Unlimited Tag Count
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Solution
l Implemented RtReports version 2.2 l Worked with Rovisys
u Integrator with extensive PI system experience u Installed RtReports u Created initial master templates and subsequent templates
l System ownership transferred to PDL BioPharma for tech support and issue resolution
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Copyright © 2007 OSIsoft, Inc. All rights reserved.
Solution
l Generated 3 report classes, each with a master template. u Batch u Building monitoring systems u Stand alone utilities
l All reports within a class have the same look and feel u Same header u Similar trends u Same cover page
l Went back to system teams for individual template development u Minor fine tuning to the report for the each piece of equipment/functional
area.
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Batch Reports l 17 Batch reports
u Production recipe – two week duration u CIP, SIP, Downstream purification, Media prep, Buffer prep
l Developed a batch report skeleton, summarizes batch events l Rockwell Software RSBatch is the batch execution system
u .EVT file interface § Operations, phases, procedures, recipe parameters, phase states, recipe version information
u Rockwell database for alarms and factory talk events u Shared equipment was difficult to account for in our batch implementation.
l Verifications, comment sections, overall signoffs l Reports contain GMP information used by, managers and supervisors
in the Manufacturing Quality departments
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Copyright © 2007 OSIsoft, Inc. All rights reserved.
Batch Report
l Iterative Report structure allows for recipe modifications without changing or revalidating report u Recipe changes are picked up by the data anf format engine rules and iterative report structure
u In our old system, when the control system was modified, the custom coding didn’t update the report automatically.
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Copyright © 2007 OSIsoft, Inc. All rights reserved.
Building Monitoring / Automation
l 10 Building monitoring reports u Incubators, refrigerators, stability rooms, cold rooms, warehouse,
waste treatment l Basic chart recorder replacement
u Monitoring environmental conditions, pressure, humidity, temperature
l Equipment owner signs off on reports u QC, Manufacturing, Materials, Safety
l Alarms u Queries look at alarm states, pull low and hi alarm points. u Trends created for alarm events u Red colored text if value is outside the acceptable limit
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Copyright © 2007 OSIsoft, Inc. All rights reserved.
Stand Alone Utilities Reports
l 7 reports u Autoclave, tote washers, clean steam generators u Small set of reports accounts for 80% of the system activity
l Equipment classes were utilized l Manufacturing owns the reports
u Individual areas sign off on their own reports u Autoclave reports generated for each cycle § 3 autoclaves run up to 5 cycles per day
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Copyright © 2007 OSIsoft, Inc. All rights reserved.
BAS/BMS log report
l Newest reports u Added after initial implementation
l Reporting off SQL database l First timebased reports for site l Using RtReports instead of Crystal reports
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Copyright © 2007 OSIsoft, Inc. All rights reserved.
Benefits
l One system used and validated for reporting u Batch, workflow, signatures, time series, relational data u Only need to publish a report template Not validate another system (i.e.
Crystal or SQL) l GMP impact
u User can log in and do a weekly check on 20 or 30 important entries, not 5000 entries
u Less likely to overlook important details u Time savings
l Electronic reporting u Reduction in the workflow around paper documents. Don’t need to have
assistants file documents, then move to different storage locations for long term storage
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Challenges
l Issue: Stability issues in version 3.0 l Resolution: Software improved in version 3.1
l Issue: Initial reports longer than 30 minutes to generate l Resolution:
u Worked with the integrator to do benchmark testing u modified some stored procedures , switched interfaces to store
data associated with very expensive queries in PI. u Report generation time is less than 2 minutes
l Issue: RTReports migration (migrating system from 1 server to another for testing) is difficult
l Resolution: Solved in RtReports Version 3.2 (server name removed from templates)
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Copyright © 2007 OSIsoft, Inc. All rights reserved.
Challenges
l Issue: Problem backing up security l Resolution: Solved in current release
l Issue: Managing security groups and people as local groups has been difficult
l Resolution: Solved with the security work that is going on in PI Server 3.5 and Analysis Framework 2.0
l Issue: Problem with cookie size and the number of security groups users are in (every report has its own security group for approving, commenting and verifying)
l Resolution: Solved in current release
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Challenges
l Issue: A module is put into PI Module Database every time a report is viewed from the generator (problem with large amounts of autolog data generated)
l Resolution: Solved in version 3.2 – moving the storage of report properties from the PI Module Database to PI Annotations
l Issue: Time based reports were not available at startup (needed for BMS reports) l Resolution:
u Reports created as batch reports (daily, weekly, monthly) u Reports will be migrated to time based reports when version 3.2 is released
§ Looking at what PIANO will do for autogeneration, time based reports will provide more ease of use for operators
l Issue: RtReports provides more reporting and less analysis tools for tweaking of data
l Resolution: Datalink for Excel Services to be used
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Conclusion
l Issues will come up with any project, but working together with OSIsoft, we have been able to resolve them. u PDL BioPharma can focus on the manufacturing and business issues
u OSIsoft can focus on the software issues
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Future Plans
l Batch Reports u To provide more value to plant operators, more process information with
trends and diagnostics is being added to the initial GMP reports u Proposed for 2008, utilize RtReports with RTPortal for more access to
plant floor operations by incorporating: § SAP tie ins (plant maintenance), equipment conditions, calibration data, LIMS
l PI Notifications to be installed u Currently a PI Notifications beta customer u Already contracted with integrator to migrate RtAlerts rules to PI
Notifications l RtReports 3.2 to be installed at release
u Time based u Report parameters
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