Erweka Introduces a New Degasser and Media Pre-Heating Tank

Erweka Mediprep 120

The new bench-top degasser from Erweka offers pre-heating, degassing, and dosing of dissolution media. Dispensed volumes from 250 to 1000 mL can be chosen in steps of 50 mL with an accuracy better than ±1%. The media is dispensed by weight using the new load cell. A nominal degassing time of 1 min 30 sec for 1000 mL of heated media means a six-station test can be prepared in less than 10 min from cold media storage.

Degassing is better than 5.5 ppm. A printer is included for calibration and test results. Easy to use menus guide the user through each operation, making media preparation easier and quicker than ever. No waiting for media tanks to heat up. Media changes are quick via the flush routine.

Erweka Media Pre-Heating Tank MT66, MT120, MT160 (for connection to Mediprep 120)

For your media storage, Erweka offers tanks made of polypropylene or stainless steel (66 L, 120 L, or 160 L�other sizes on request). The tanks pre-heat the media and can be moved around the laboratory on 3" diameter casters. Media is heated by means of the integrated 1.500-Watt (at 230 V) electronic heater. Temperature is adjustable between 10 and 50 °C, temperature displayed.

For more information, please contact sales@erweka.com. Website: www.erweka.com

COVIDIEN LAUNCHES MALLINCKRODT BAKER'S J.T. BAKER® DILUT-IT™ DISSOLUTION MEDIA CONCENTRATES

New Range of Concentrates Reduces Dissolution Media Preparation Time by up to 75 percent

Phillipsburg, NJ. (Nov.12, 2007) � Covidien Ltd. (NYSE: COV, BSX: COV) today announced the launch of its Mallinckrodt Baker J.T.Baker DILUT-IT dissolution media concentrates. This new brand of pre-mixed concentrates reduces the time needed to prepare dissolution media by up to 75 percent, while also significantly cutting costs and increasing flexibility for customers. DILUT-IT dissolution media concentrates also improve the quality and consistency of the media produced, ultimately reducing costly rework and simplifying the task of regulatory compliance for technicians in Research and Development (R&D) and Quality Control (QC) laboratories.

Designed to improve operational efficiencies during dissolution testing, J.T.Baker DILUT-IT dissolution media concentrates simply require the addition of purified water for use, with no need to weigh and mix chemicals. By eliminating weighing and mixing variables, J.T.Baker dissolution media concentrates greatly increase reproducibility, thereby reducing operator error, rework, and waste. For chemists, these improved processes deliver significant cost savings for every liter of dissolution media produced, compared with manually preparing media in-house, and also drive productivity by enabling more samples to be tested.

"The J.T.Baker DILUT-IT dissolution product line is a clear example of Mallinckrodt Baker's continued efforts to provide the laboratory testing industry with high-quality, cost-efficient products and solutions that increase productivity," said Russell Thorpe, Global Marketing Director � Laboratory Products. "The time savings and efficiency that our concentrates bring enable lab technicians to focus on their primary objectives of performing dissolution testing, instead of the ancillary task of mixing media concentrates."

J.T.Baker DILUT-IT dissolution media concentrates are designed to deliver the quality and consistency for which J.T.Baker products are known. Manufactured with raw materials in accordance with USP guidelines and under validated processes in Mallinckrodt Baker's ISO-certified facilities, these dissolution media concentrates are packaged to stringent fill tolerances of ±0.5 percent of target volume. This ensures lot-to-lot consistency and reproducible results, while making certain that each batch is measured against published product specifications.

Mallinckrodt Baker offers a range of convenient packaging configurations for overall ease of use, minimization of storage capacity, and reduction of costs associated with shipping heavy bulk components. Currently, concentrates are available to produce 6-L, 25-L, and 50-L batch sizes of dissolution media. Varied package sizes also provide flexibility according to customer testing requirements. In addition, J.T.Baker DILUT-IT dissolution media are packaged in high-density polyethylene (HDPE) bottles for enhanced safety.

Mallinckrodt Baker is an industry leader in analytical testing, with a long history of providing the scientific community with high-quality products and innovations. The introduction of DILUT-IT dissolution media complements the existing line of high-quality products available from Mallinckrodt Baker in Beaker to Bulk™ packaging.

For product specifications and technical information, visit www.mallbaker.com/dissolution

ABOUT MALLINCKRODT BAKER, INC.

Mallinckrodt Baker, Inc., is a manufacturer of high-purity chemicals and related products and services sold under two well-known and respected brand names, J.T. Baker® and Mallinckrodt® Laboratory Chemicals. These products are widely used in research and quality control laboratories, microelectronics, environmental testing laboratories and universities, and for manufacturing in the pharmaceutical, biotechnology, and other industrial markets. Based in Phillipsburg, New Jersey, Mallinckrodt Baker, Inc., is part of Covidien, formerly Tyco Healthcare.

All trademarks are owned by Mallinckrodt Baker, Inc., unless otherwise noted. Mallinckrodt® is a trademark of Mallinckrodt Inc. COVIDIEN and COVIDIEN with Logo are trademarks of Covidien AG or its affiliate. © 2007 Covidien AG or its affiliate. All rights reserved.

Varian, Inc. offers new Mechanical Qualification (MQ) Service

Cary, N.C., Varian, Inc. � Varian, Inc., announces the addition of Mechanical Qualification (MQ) services to our line of analytical instrument qualification services. Varian can assist dissolution laboratories who choose to implement a mechanical qualification of USP dissolution Apparatus 1 and 2 in conjunction with, or as an alternative to, the traditional USP Performance Verification Test.

In October 2007 the FDA issued draft guidance supporting the mechanical qualification of dissolution apparatus using the Center for Drug Evaluation and Research (CDER) procedure document on mechanical qualification.1 The FDA also supports other mechanical qualification procedures such as the ASTM E 2503-07 standard developed by the American Society for Testing and Materials.2 Both procedures verify the mechanical integrity of dissolution apparatus as intended by the manufacturer and as required by the user environment. The Varian MQ procedure incorporates the technical requirements of these standards through precise measurement of the physical parameters that are critical in the setup and operation of USP dissolution Apparatus 1 and 2.

As a leader in dissolution science, Varian offers both MQ and PQ qualification guides and services to help ensure compliance and enhance the productivity of the FDA-regulated dissolution laboratories.

The Varian MQ procedure provides instructions on how to measure each of the critical mechanical parameters and document the results according to current Good Manufacturing Practice (cGMP) standards. The qualification procedures also include documentation of the personnel who are approved to perform and review this procedure, equipment information, and the calibrated instruments and materials used to complete the qualification.

The critical physical parameters measured as part of the Varian MQ procedure include paddle and basket shaft wobble and verticality, depth, rotational speed (rpm), vessel centering and verticality, and vessel temperature conformance. The Varian MQ also documents parameters such as vibration, vessel, shaft and basket condition, and vessel plate level. Varian field service chemists use calibrated instruments to measure physical parameters with the Varian QAII C Dissolution Systems Suitability Station and the Varian VK 5010 Centerline Height Measurement System. Both the QAII C and VK 5010 are portable, allowing the user to move between dissolution apparatus in a typical laboratory. These systems are equipped with electronic sensors to measure both paddles and baskets within vessels on most brands of dissolution apparatus. Digital measurements reduce the likelihood of human error arising from the use of manual gauges.

Varian continues to offer the VK Verified line of vessels, paddles, shafts, and baskets, which are accompanied by a Certificate of Conformance (COC) as suggested by the FDA and ASTM mechanical qualification procedures. The COC documents the measured dimensions of each component used in the dissolution apparatus and verifies that the dimensions are within stated tolerances. Absence of these verification certificates can result in tedious, time-consuming measurements using highly intricate and expensive tools. At Varian, we utilize calibrated measuring tools and equipment to ensure hemisphericity, circularity, and cylindricity of the dissolution vessel. Varian also has personnel who are highly trained and experienced in verifying and documenting that your dissolution equipment meets the strictest mechanical specifications.

Due to high demand and customer requirements, Varian will continue to offer the Performance Qualification (PQ) service and guides to carry out the USP Performance Verification Test with Prednisone and Salicylic Acid tablets. The Varian PQ service also includes the verification of the critical physical parameters of the dissolution apparatus (e.g., rotational speed, wobble, centering, height, level, vibration, and temperature).

For additional details about the Varian Mechanical Qualification (MQ) or the Performance Qualification (PQ) procedures, please contact our Dissolution Hotline at 1-888-826-5351 or email us at dissolution.hotline@varianinc.com

For more information on the complete line of industry-leading dissolution systems offered by Varian, please visit www.varianinc.com

Pharma Test Announces PTWS 310 Series: First Dissolution Testers to Incorporate Environmental Vibration Suppression

Pharma Test Apparatebau GmbH now offers a modern dissolution tester designed to improve performance in the matter of vibration. Improvements come from the quality of construction and detailed research aimed at making a better dissolution instrument that is prepared for potential changes to the Operational Qualification.

The first issue is the safety of the heating system, and with Pharma Test units, there is a safety sensor as well as a control sensor. The second issue is the accessibility and construction of the heating elements, which coincidentally contain the circulation pump (Figure 1). It is conveniently accessed via a small drawer unit without having to disturb the positioning of the bath itself. It also contains a safety sensor after the heating element as well as a safety over-temperature switch and a thermal fuse, items missing in several current designs. The built-in vibration suppression is illustrated in Figure 2.

The pump is suspended on a sprung platform to eliminate virtually all potential vibration from the pumped heating system. The water bath is also set up for vibration damping. This design accounts for the impact of environmental vibration sources. The vibration damping is clearly shown in Figure 2. You will note that the first line of defense against environmental vibration is the installation of metal-encapsulated rubber feet. This mechanically "decouples" the dissolution tester from the work bench and also allows for easy leveling of the dissolution tester prior to installation. The second line of defense is the installation of unique, specialized polymeric vibration dampers (Vibroban ™) that isolate the water bath from the rest of the dissolution tester. This effectively provides a second decoupling mechanism to eliminate almost all vibration from the working environment. The effects of this system in the face of external environmental vibration sources can be seen in Figure 3. The results clearly show the huge influence of vibration while doing a Prednisone dissolution test.

Issues such as vibration, both intrinsic and environmental, may have different effects depending on the instrument design. It has been illustrated on more than one occasion that "thinking outside the box" and implementing some critical features based on intensive R&D offers a multi-directional approach to eliminating factors that are detrimental to the whole dissolution process. In this way, users are offered an unrivalled degree of security in the dissolution process that meets not only current requirements but also proposed norms that are currently under discussion.

Reference
1. Burmicz, J. Mechanical versus Chemical Calibration Debate. Dissolution Technol. 2007, 14 (2), 10.
2. Pharma Test Application Note: An Investigation into vibration effects in Dissolution Tests, Tika et al, March 2007

For further information, please contact us:

Pharma Test Apparatebau GmbH Siemensstrasse 5 D-63512 Hainburg Germany

Tel: +49-6182-9532-600 Fax:+49-6182-9532-650 Email: info@pharma-test.de Web: www.pharma-test.com

Global Launch of the SOTAX OPT-DISS™ UV Fiber Optic Dissolution System with Integrated WinSOTAX™ Advanced Dissolution Software

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The SOTAX Group, worldwide market leader in automated dissolution innovation, in partnership with Leap Technologies, leader in Fiber Optic UV for In Situ Dissolution Analysis, is announcing the release of the SOTAX OPT-DISS™ UVFO system.

This Fiber Optic UV dissolution testing system is completely integrated with seamless control by WinSOTAX Advanced dissolution software. Used in R&D and QC for over 10 years, WinSOTAX software, which is 21 CFR part 11 compliant, controls the entire range of all SOTAX semi and fully automated on-line dissolution systems. The SOTAX OPT-DISS™ system includes the SOTAX AT 7smart dissolution bath, a standard in terms of reliability and reproducibility, manufactured to include our unique Auto-Compliance features such as auto-vessel centering and auto-height adjustment. In the SOTAX OPT-DISS™ UVFO system, the AT 7smart now provides an open architecture that allows for a unique and safe fiber optic probe handling/removing capacity. The ARCH™ Probe, because of its unique low disturbance open design, prevents excipient buildup and bubble entrapment and provides consistent low path length measurements. The improved ARCH™ Probe design is more robust than previous probes, thereby eliminating solarization effects and minimizing potential hydrodynamic effects that larger probes create in the dissolution vessel. With its amazing ability to scan six vessels simultaneously every five seconds, the SOTAX OPT-DISS™ is the ideal solution for in situ measurements when testing ER, SR, MR, IR, and flash-release forms. Today, SOTAX and Leap Technologies combine their best unique design features in one dissolution system, the SOTAX OPT-DISS™ with integrated WinSotax Dissolution Software Control.

Contact your local SOTAX office to arrange for your in-lab demonstration!

LOGAN INSTRUMENTS CORP. ANNOUCES NEW HIRES

Logan Instruments Corporation of Somerset, NJ, a leading manufacturer of instrumentation for the pharmaceutical industry, is pleased to announce the immediate appointment of a new sales and marketing team for North America.

Joining the company in key management roles are Stuart N. Bates, Director of Sales and Business Development, and Mark Sackler, Director of Sales and Marketing. Mr. Sackler and Mr. Bates will share sales management responsibilities in North America and will assume other important roles. Mr. Bates will handle responsibilities for training and service globally, while Mr. Sackler will assume the primary marketing responsibilities.

We are very excited to simultaneously bring on two individuals with such extensive capabilities and experience in our industry. This marks the start of a new era of growth for Logan Instruments," said Dr. Luke Lee, President and founder of Logan Instruments.

Mr. Bates is a trained chemist with ten years of pharmaceutical industry experience including seven years in dissolution sales. He has served as product manager for Delphian Technology and sales manager for Sotax USA.

Mr. Sackler brings a 30-year career in sales and marketing communications. His past major roles include sales manager of Delphian Technology and pION INC, both instrumentation companies, as well as President of SMG Publishing Inc. and Vice President of Marketing for Medical Tribune Group, both medical publishers.

In other personnel moves, Logan named Cook Technical Solutions LLC and MLS Analytical as Central and Midwest regions sales representatives, respectively.

About Logan Instruments:

Logan Instruments' products have been used for nearly two decades by top pharmaceutical companies on five continents. Since its founding in 1990 by Dr. Luke Lee, it has grown into a worldwide leader in the design, manufacture, and distribution of products for dissolution, diffusion, and physical testing of pharmaceutical dosage forms. Its innovative products range from basic, manual systems to fully automated instrumentation for USP Apparatus 1, 2, 3, and 7 dissolution and Franz Cell diffusion. Contact: Dr. Luke Lee 732-302-9888.