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The Laboratory Robotics
Interest Group Mid Atlantic Chapter |
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The Laboratory Robotics Interest GroupSeptember 2000 MeetingAnalytical ApplicationsDate: Tuesday, September 26, 2000
Agenda: On the menu:
Presentation: A technical
discussion for archiving chromatography data system files and reports as part of a 21CFR Part 11 compliance strategy Analytical laboratories have many challenges to face these days. 21CFR Part
11 has required laboratories to start archiving their raw data files to maintain
processability for future FDA inspections. If requested during an
Presentation: Opening the Door to a
Paperless Laboratory The pharmaceutical industry is rapidly transitioning to flexible, multi-site global organizations operating under demanding regulations. Effective information management provides a foundation for high productivity, rapid response, and regulatory compliance. The industry can no longer rely on today's combination of paper and electronic records. VelQuest's ePMC?(electronic Process Management and Compliance) System provides a "paperless" electronic platform that facilitates compliance with GLPs and cGMPs, including 21CFR Part 11, and is complimentary to LIMS and chromatography data acquisition systems. The ePMC?System enables primary data capture at the source creating valid electronic records, and linking these records to the procedures for which the data was created.
Presentation: New Advances in
Fiber Optic Dissolution Testing An in-situ fiber optic dissolution system has been developed for the analysis of dissolution profiles. The system utilizes 12 immersion probes to acquire UV spectra during a dissolution test. Each probe is placed inside a dissolution vessel and remains in the vessel for the duration of the test. Each probe is then coupled to a spectrometer by means of a fiber-optic light guide. Twelve PDA spectrometers are utilized to collect an absorbance spectrum from each probe, at set time intervals, during the dissolution test. After setup, the system runs without analyst intervention for up to 72 hours. All results are automatically calculated, and secured in real time. Topics to be covered include:
Presentation: Strategies for High
Throughput HPLC Method Development To Support Combinatorial Chemistry When analyzing combinatorial chemistry library compounds by HPLC in support of drug discovery, the HPLC sample throughput and the average cost-per compound quickly become important issues due to the large numbers of compounds analyzed. This is particularly true for encoded combinatorial libraries prepared by split-pool and direct divide synthesis. To address these issues, high throughput HPLC methods are needed. This presentation describes the strategies used to develop fast, generic high throughput HPLC methods. Our approach to decrease the typical HPLC run time and solvent consumption involves decreasing column length and diameter, reducing gradient time, and increasing column flow. Overall, the HPLC run time and solvent consumption were reduced by 60-65%. Reductions in column length and increases in flow usually result in a loss in efficiency, and it is this loss that ultimately limits the method's resolving power. To achieve reductions in run time and mobile phase consumption, while maintaining resolution, other parameters, such as particle size, temperature effects, column types, scaling the flow rate, and scaling the gradient time were also studied and discussed in this presentation.
Poster: Automated Moisture System Our laboratory's, (Nabisco Research's Analytical Chemistry), major responsibility is testing food products in various stages of development and stored under various conditions to determine shelf life. Moisture content is one of the primary chemical parameters measured. There are a wide variety of methods for the determination of moisture in food and the method selected depends on the type of food being analyzed. The technique we selected to automate is for the determination of moisture based on oven drying. The method employs a convection vacuum oven. Our most common matrix, cookies and crackers are run at 70' C under vacuum <50mm Hg (6.7kPa), for 18 hours. The weight change in the sample is reported as moisture loss. This technique was an ideal candidate for complete automation since we analyze over 5,000 samples a year. Also the method has well defined and simple steps, allowing for easy implementation as an automated analytical process. The majority of products run by this technique are cookies and crackers, which are pourable and require little manipulation.
Poster: AMINO ACID ANALYSIS OF
PEPTIDES USING ANION-EXCHANGE CHROMATOGRAPHY WITH INTEGRATED AMPEROMETRIC
DETECTION AAA-Direct?is a powerful new technique for amino acid analysis using integrated amperometric detection and a highly selective anion-exchange column. This technique enables the direct detection of virtually all amino acids without pre- or post-column derivatization and without compromising sensitivity. The AminoPac?PA-10 anion exchange column was designed to separate amino acids with baseline resolution. Acid-hydrolyzed peptides (100 picomoles per injection) are directly analyzed for amino acids without concern for derivatization efficiency. In this paper, methods for preparing protein or peptide samples for hydrolysis and subsequent amino acid analysis by AAA-Direct are presented. This method is subject to different interferences than observed with pre- or post-column derivatization techniques. Therefore, sources of potential interference including common laboratory equipment and reagents were investigated, and methods to eliminate these have been developed. Techniques available to desalt proteins and peptides, and common hydrolyzing reagents were investigated for their suitability with AAA-Direct. Peptides were hydrolyzed in 6N hydrochloric acid or 50:50 (v/v) propionic/ hydrochloric acid, and then evaporated to dryness, reconstituted in water and directly injected. Peptides were also hydrolyzed in 4N methanesulfonic acid (MSA) and diluted for direct injection. High recoveries of tryptophan (W) were observed using MSA hydrolysis.
Poster: HIGH-THROUGHPUT
CHROMATOGRAPHIC DATA ANALYSIS USING CLIENT/SERVER BASED CHROMATOGRAPHY SOFTWARE
AND A PROPRIETARY VISUAL BASIC APPLICATION MODULE In order to determine the aqueous solubility of small organic molecules, an HPLC procedure has been developed that is capable of analyzing hundreds of injections of chemically diverse compounds daily on one instrument. Assay results consist of aqueous solubility in the range of 1-200 然, purity (relative peak area at the detection wavelength), and UV-VIS spectrum of the compound. We faced two great challenges during assay development: 1) Information about the molecular structure of compounds to be analyzed in this assay is routinely not disclosed by Cerep's customers; 2) Sequence programming and data analysis could easily become rate-limiting for productivity when several hundred injections are performed every day. Point 1) was successfully addressed by developing an ultrafast universal HPLC method (total run time: 3 min per injection) with wide-bandwidth PDA detection. The enhanced workflow of Dionex' Chromeleon software and a Visual Basic application in Excel developed at Cerep have made it possible for the assay operator to prepare, program, inject, analyze, and audit chromatographic results of up to 200 compounds or 400 injections daily. At the same time, chromatographic data are archived, results are electronically submitted for QC-approval, and client reports are repared.
Directions (on-line directions): The Raritan Valley Community College campus lies at the crossroads of Central New
Jersey, with Routes 22, 202 and 206 and Interstates 287 and 78 just minutes away. The
College is situated on the north side of Route 28 in North Branch. From INTERSTATE 287 SOUTH - (From Morristown Area): Take Interstate 287 SOUTH to Interstate 78 WEST. Proceed on 78 WEST for approx. 3 miles to Exit 26 (Lamington/North Branch). At light make a left onto Lamington Road. Proceed on Lamington Road til it ends (approx. 3 miles). At STOP sign make a left onto Route 28 EAST. Entrance to the College will be on your left approx. 1/8 of a mile. From GARDEN STATE PARKWAY SOUTH - (From North Jersey): Take Exit 142 for Interstate 78 WEST. Proceed on 78 WEST for approx. 26 miles to Exit 26 (Lamington/North Branch). At light make a left onto Lamington Road. Proceed on Lamington Road til it ends (approx. 3 miles). At STOP sign make a left onto Route 28 EAST. Entrance to the College will be on your left approx. 1/8 of a mile.
FROM THE SOUTH From INTERSTATE 287 NORTH - (From Edison Area): Take Interstate 287 NORTH to the Route 22 WEST exit. After approx. 7 miles (just before the 5th light), exit onto Orr Drive. At the end of Orr Drive make a left at the STOP sign. Make first right into the College. From GARDEN STATE PARKWAY NORTH - (From the Shore area): Take Exit 127 to Interstate 287 NORTH. Proceed on 287 NORTH to the Route 22 WEST exit. After approx. 7 miles (just before the 5th light), exit onto Orr Drive. At the end of Orr Drive make a left at the STOP sign. Make first right into the College. From ROUTE 206 NORTH - (From Princeton Area): Take Route 206 NORTH to the Somerville Circle. At the Somerville Circle exit onto Route 28 WEST. Proceed on Route 28 WEST for approx. 4 miles. Entrance to the College will be on your right.
FROM THE EAST From INTERSTATE 78 WEST - (From Newark Area): Take Interstate 78 WEST. Proceed on 78 WEST and get off at Exit 26 (Lamington/North Branch). At light make a left onto Lamington Road. Take Lamington Road til it ends (approx. 3 miles). At STOP sign make a left onto Route 28 EAST. Entrance to College will be on your left approx. 1/8 of a mile.
FROM THE WEST From INTERSTATE 78 EAST - (From Clinton Area): Take Interstate 78 EAST to Exit 26 (Lamington/North Branch). Turn right at light onto Lamington Road. Proceed on Lamington Road til it ends (approx. 3 miles). At STOP sign make a left onto Route 28 EAST. Entrance to the College will be on your left approx. 1/8 of a mile.
FROM OTHER AREAS From NEW JERSEY TURNPIKE - Take the New Jersey Turnpike to Exit 10. After toll, bear left, exit onto Interstate 287 NORTH. Proceed on 287 NORTH to the Route 22 WEST exit. After approx. 7 miles (just before the 5th light), exit onto Orr Drive. At the end of Orr Drive make a left at the STOP sign. Make first right into the College. From ROUTE 31 NORTH - Take Route 31 NORTH to Route 202 NORTH. Stay on Route 202 NORTH for approx. 10 miles til you come to the Somerville Circle. At the Somerville Circle exit onto Route 28 WEST. Proceed on Rt 28 WEST for approx. 4 miles. Entrance to the College will be on your right. From PENNSYLVANIA TURNPIKE - Take either Route 78 East, or Route 22 East to Route 78 East. Follow directions above "FROM THE WEST" (From Clinton Area).
FROM THE PARKING LOT (see map of campus) Follow signs to parking lot #2.
Area Hotels
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