LabAutomation 2006 - SLAS

MP89
Frank Wallrafen
Dr. Herterich & Consultants GmbH
Saarbrucken, Germany
frank.wallrafen@DHC-GMBH.COM
Where Laboratory Technologies Emerge and Merge
LIMS – Equipment Binding in Consideration of the Regulatory Requirements Depending
on the 21 CFR Part 11
In the 21 CFR 11 there are requirements stated for validating (computer) systems/defaults for electronic records and electronic signatures.
This is a large demand in the issue of the equipment interfacing with laboratory information management system (LIMS). This means a
LIMS has to meet all GxP requirements by providing user identification, auditing, sample tracking and so on. Another point of view is the
business benefits. (e.g. on-line calculations,automatic check of expiry ...) This means the LIMS must ensure a unique sample tracking and
positive sample identification in the interrelationship with the instrument connection.
The equipment binding is very complex and various. These show two different problems. The different types of devices and the not defined
standards during the data supply. The connection possibilities between the LIMS and the equipment are determined by the equipment
parameters and feasibility. Depending upon kind of the equipment the following interfaces are available
• Serial link
• File Importer - validated “black box” interface
• Programming - method to handle a bi-directional binding between the equipment and the LIMS .
The aim is to get results, part 11 compliant, from instruments into the LIMS with as little user interaction as possible to reduce error-proneness.
And that is the problem, to find a possibility to reach this target. One Method is to put a pc next each instrument. The other possibility is to use
RS232 over TCP/IP. One example is the “”scanner balance job””. With this solution you are able to be compliant to the 21CFR11.
MP90
Lois Tack
PerkinElmer Life & Analytical Sciences
Downers Grove, Illinois
lois.tack@perkinelmer.com
Co-Author(s)
Earl Ritzline
Daniel Nippes
Indian River Regional Crime Laboratory
Pat Rostron
Jeremy Sanders
PerkinElmer Life and Analytical Sciences
Robotic QPCR Setup for Small Batches of Forensic Casework Samples Using
ABI Quantifiler ® Human and Y Male DNA Quantification Kits as Part of a Complete
Automation Scheme
Automated DNA sample processing of forensic samples from crime scenes is challenging due to the limited sample numbers and DNA
amounts. Accurate DNA quantification is critical to successful DNA normalization and forensic STR-based genotyping. Because crime
scene samples are from diverse biological substrates and display broad concentration ranges, precise quantification is vital. Frequently,
there is insufficient DNA for more than one profile attempt. The advantages of real time quantitative PCR (QPCR) are sensitivity and linearity.
For QPCR using ABI Quantifiler ® Human and Y Male DNA Quantification Kits, the reactions resemble STR amplification conditions and can
reveal the presence of PCR inhibitors. The Y-specific kit allows differential detection of male and female DNA components in mixed samples
from rape cases.
We describe validation of a rapid automated QPCR assay using ABI Quantifiler ® Kits for small batch crime scene DNA samples. A
MultiPROBE ® II 4-Tip PCR Setup Forensic Workstation from PerkinElmer LAS was used with the Low Volume Dispense Option to carry out
analyses including QPCR setup, normalization and STR PCR setup. A WinPREP ® protocol was developed for QPCR setup using both total
human and Y-specific DNA kits. The workstation reformatted purified DNA from tubes and prepared serial dilutions of DNA standards from
both kits in the same 96-well plate. Purified DNA was prepared from dried blood, sperm and saliva on cloth cuttings in batches of 12-24
samples. An ABI Prism ® 7000 Sequence Detection System was used to detect and quantify the amplified DNA reactions.
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