LabAutomation 2006 - SLAS

TP25
Joseph Kofman
Pfizer
San Diego, California
joseph.kofman@pfizer.com
LabAutomation2006
Co-Author
Todd Baumgartner
Embracing the Unattainable: Creating an Integrated Electronic Environment for
Analytical Laboratories
Even a superficial review of working practices within analytical laboratories across the pharmaceutical industry reveals key areas within
the workflow that have unmet needs with respect to integrated informatics systems. Despite tremendous efforts to move towards a
“paperless” environment, current systems within analytical laboratories typically provide autonomous support in relation to other analytical
processes. Knowledge is successfully captured and accumulated, but not shared effectively. The development and implementation of a
complete “chain of custody” solution for laboratory data and information is needed to fully meet the compliance requirements of 21 CFR
Part 11, provide extended productivity improvements, and reduce the support and maintenance costs of multiple redundant systems.
There has been work in integrating different solutions (e.g. CDS and LIMS); however the strategy for a complete system has not been
defined. A critical aspect of the Analytical Laboratory Integrated Solution (ALIS) is that each of the systems is linked through touch points
(common interfaces), and all laboratory data is acquired and stored electronically by specialty applications, but is accessible for data
mining through all associated applications. A prototype of ALIS was built based on a strategic process map and focused on integration
and information exchange between independent applications. The integrated solution was designed so that information flow within the
analytical laboratory was improved or at least maintained. The benefits gained from this integrated system are far greater than if the
components were implemented independently.
TP26
Saikalyan Kotha
Flow Sciences
Leland, North Carolina
skotha@flowsciences.com
Co-Author(s)
Ray Ryan
Douglas B. Walters, KCP Inc.
Ventilated Robotic Enclosures for Product and Personal Protection in
High-Throughput Laboratories
Today’s potent material handling laboratories have changed significantly. Synthesis-based R&D has moved into the new millennium and
been supplemented with processes using sophisticated computer and high throughput robotic technology. The laboratory use of novel
compounds of unknown potency is rapidly expanding, and requires flexible task-specific containment solutions to minimize environmental
impact, protect operators, and optimize process efficiency. While many laboratory operations can only be safely performed in large
traditional chemical hoods, or biological safety cabinets limitations often arise because containment is not always effective, the hood design
is not task-specific and is not designed for high through put equipment, relocation is difficult, and purchase, installation and operation
is expensive. Hence, in many cases unique process-specific containment solutions must be developed to provide safe, adaptable and
energy efficient enclosures in the rapidly changing laboratory environment. This presentation describes several custom designed vented
enclosures developed for pharmaceutical and medical research.
This project encompassed three distinct phases critical to the project’s successful completion.
The definition of specific robotic equipment such as, liquid handling, incubators, and powder handling equipment. Optimizing designs with
computational fluid dynamics (CFD) to maximize containment and energy efficiency, and to resolve ergonomic issues and provide easy
operator access to the enclosed equipment. Commissioning of enclosures with on-site testing to ensure effective containment. This project
emphasizes the importance of task-specific containment solutions for use with high-through put and robotic equipment
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