Industry News May 2006

Revolutionary Bill™ Dissolution Data System™ (DDS™) Brings Digital Technology to the Dissolution Lab

Chatsworth, CA � April 13, 2006�Hanson Research Corp. (USA), the pioneer in dissolution technology, is pleased to present Bill™, a new Dissolution Data System™ (DDS™) for corporate-wide LIMS interfacing and single-point administration and control of instruments, protocols, users, security, and data. Developed in an exclusive partnership with Labtronics, Inc. (Canada), Bill creates a seamless digital link between Hanson's world-class dissolution testing instruments and Labtronics' LimsLink™, the industry's leading LIMS integration solution.

“Bill DDS will maximize the performance of the entire dissolution process, ” comments Roy Hanson, Chairman and CEO of Hanson Research and son of company founder Bill Hanson, in honor of whom Bill DDS was named. “Our instruments are LIMS-ready, and now dissolution labs will enjoy full access to the power of Labtronics' LimsLink.”

Robert Pavlis, President of Labtronics Inc., adds, “Using the embedded power of LimsLink, Bill DDS will give the dissolution lab the ability to connect directly to any LIMS, giving everyone from lab managers to top executives a total digital solution for data management.”

Hanson and Labtronics invite you to explore the features and benefits of Bill DDS via a free, educational Web Cast on June 15, 2006. An additional Web Cast will be held in September 2006. For more information, please contact Hanson Research at sdubin@hansonresearch.com

Hanson-Erweka


Pre-Mixed SGF (pH 1.2) Without Enzyme

Fort Collins, CO, April 26, 2006�CHATA Biosystems offers pre-mixed Simulated Gastric Fluid (pH 1.2) without enzyme. The buffer solution, commonly used in pharmaceutical dissolution applications, comes conveniently packaged in CHATA's disposable 100-L CHEM+NECT™ flexible bag technology. The sterile bag, placed inside a 30-gallon fiber drum, is equipped with a quick-connect delivery system that can be easily connected directly to an automated dissolution system or can be dispensed into a carboy with an available pump accessory from CHATA. The pre-packaged media greatly reduces preparation time and cost while improving laboratory consistency.

CHATA adheres to stringent cGMP manufacturing standards, documented in a 13-page batch record. All expiration dates on commercially available CHATA buffers are backed by at least 12 months of “in-use” stability studies. The SGF buffer solution is made with ACS grade salts and high purity water that exceeds the requirements for both ASTM Type IA Water and USP Purified Water. CHATA solutions are further validated to meet the demands of today's pharmaceutical companies. This validation process includes pH certification, UV scan, and sterility testing according to USP <71>. Every product comes with a lot-specific Certificate of Analysis that offers actual test results on the prepackaged media.

For 6 years, CHATA has manufactured a wide range of prepackaged reagents for today's leading pharmaceutical companies, specializing in commercial and custom manufactured solutions.

For more information, please contact:
Customer Service
CHATA Biosystems
877-246-2428
customerservice@chatasolutions.com
www.chatasolutions.com


SA 500: A New Concept in Dissolution DAD Technology...

Pharma Test Introduces A Powerful Diode Array Spectrophotometer for Dissolution Applications

Limitations of classical UV / VIS measurement technology
Up to now, most automated dissolution instrument systems used spectrophotometers that could only be operated in traditional single-wavelength (or possibly in multiple wavelength) mode. Scanning is possible but slow due to the monochromator operation, which is required to provide the selected wavelengths from the built in light source. This slowly moving grating provides the usual trade off found in scanning instruments between speed and resolution. The faster the scan, the lower the resolution; the greater the resolution required, and the slower you have to scan; based on this limitation, single wavelength operation was a trade-off for simpler measurement capabilities with monochromator-based technology.

Shortage of valuable information
The resulting data that is collected around single wavelengths gives absolutely no information as to signal drift with time due to possible pH change of the dissolution medium. Neither does it give any indication as to the stability of the measured active moieties with time, which may be important for dissolution studies of slow- or modified- release products.

Now you can collect more valuable information and fast!
This is completely changed with the introduction of the SA 500 DAD spectrometer. As it has a diode-array design, there are no moving parts between the light source and the sample. The incident radiation passes through the sample and the spectrum is analysed directly by the DAD polychromator. This means that the detector can now handle a broad range of wavelengths and can resolve adsorption details over a whole scanned spectrum, in this case, from 190 to 1020 nm.

Speed and Stability
Scans over the entire spectral range can be completed in 12 ms. The spectral range is also important. Stability and low noise operation at the low end (<200 nm) is critical for the new ASTM E387 rules for stray light measurement using KCl solutions at 198 nm.

UV Cell Changer for Single or Multiple Bath Operation
The SA500 also offers a 16-way cell changer as standard for single or multiple dissolution bath operation. Use the standard 10 x 10 mm cells for normal operation (for cells with preferred path lengths of 0.1�10 mm).
The SA500 can also be equipped with an 8-cell holder for 20-mm path length cells, which is unique and offers operation and measurement at lower analyte concentrations. This could be the difference between staying with validated UV measurement technology or switching to HPLC and having to revalidate methodology.

Control Software for General and Dissolution Applications
Use the supplied TidasDAQ control software to use the SA500 as a normal DAD UV / VIS instrument for discrete samples for the following applications:

Use the WINDISS32 Software Program for fully compliant 21 CFR part 11 dissolution applications. Use the SA500 with a single bath or with two baths. This Dissolution Software is flexible enough to allow the control of almost any bath and commonly available pump type in combination with the SA500 as part of a closed loop “on-line” or hybrid “on- and off-line” system.

IQ, OQ, PQ Requirements
As with all other Pharma Test products, each instrument is delivered with full IQ, OQ paperwork, as well as an instrument log book, free of charge.
Our technically qualified staff are able to supply local PQ support and perform System Suitability Tests using USP Calibrator Tablets.

Further Information:
For full specifications and further downloads, visit: www.pharma-test.com


Pharma Test Introduces A New Instrument to Monitor Suppository Softening: a Key Indicator of Stability. The SPT-6 Suppository Penetration Test Apparatus

Whereas the disintegration point of a suppository is relatively straightforward (place in a water bath at 37 �C and if it doesn' t melt, then it may not be used for patient application: use our PTS3E instrument for this test), the determination of suppository stability was, up to now, a more complicated job. Some suppositories may dry out, harden, or even shrivel up, but the USP has indicated that excessive softening is a major indication of suppository instability. This would also be indicated by oil staining on packaging.

Pharma Test now offer a test for the direct automatic measurement of softening time of suppositories on the PTZ AUTO EZ instrument series in accordance with the new monograph EP 2.9.22.

The SPT-6 is attached to a standard PTZ AUTO EZ instrument so that the softening time for each individual test station (6) is automatically recorded, stored, and used for batch comparison at a later date (using the PTZ32 software suite).

If a QC application only is needed, where individual softening times are not required, then the SPT-6 may also be used in conjunction with the PTZS single-station manual Disintegration Tester.

Further Information:
For full specifications and further downloads, visit: www.pharma-test.com


Distek, Inc., Obtains CE/ETL Certification for the VIP 4400 In-Situ Dissolution Vessel Washer and 3100 Series Bathless Disintegrator

North Brunswick, NJ, March 3, 2006�Distek, Inc., having worked with an independent testing company, obtained CE/ETL certification for the VIP 4400 and 3100 Series of bathless disintegrators.

Gerry Brinker, President and founder of Distek, Inc. says “The addition of the CE/ETL certification to our instruments ensures the global reach of Distek and our products.”

Distek is a leading manufacturer of pharmaceutical testing instruments that provide solutions for dissolution, disintegration, friability, and hardness testing.


Pharm Alliance Group Announces New Dissolution Tester

The Pharma Alliance Group announces the introduction of its VR12 dissolution tester.The new 12-vessel dissolution tester has been designed with the same features inherent in their existing line of dissolution testers. Its 12 vessels work harmoniously and efficiently to double the output of your laboratory operations while lowering the overall equipment validation and maintenance costs.Whether you require to run the same compound with different concentrations or different compounds of the same concentration, the VR12 will provide your laboratory with unprecedented versatility and efficiency by running either of these scenarios simultaneously. The VR12 is also available in a 14-vessel configuration. The instrument is suitable for USP Apparatus 1, 2, 5, and 6, but includes USP Apparatus 1 and 2 as standard equipment. Soon the unit will also be available with its own extensive package of dissolution software for environments demanding the highest level of automation.

Contact us or visit our website and begin experiencing immediate productivity and efficiency increases to your laboratory dissolution operations.


28319 West Industry Drive
Valencia, CA 91355
Tel.661.294.7955 Ext 202
Fax.661.793.6502

Visit us at www.pharma-alliance.net


Analytical Solutions, Inc. ASI has moved. Our new address is:

Site Address:
2300 Englert Drive, Suite F
Durham, NC 27713
Telephone:919.549.9700
Fax:919.990.8534

Please visit our Web site for information and directions: www.asi-rtp.com


A New Contract Testing Laboratory: Quality Compliance Laboratories (QCL)

Outsourcing of analytical testing is growing larger at an ever increasing pace.The trend is understandable if one considers the cost involved in maintaining manpower and equipment currency in a large pharmaceutical laboratory or the start up costs if your business is new or the number of virtual companies looking for laboratory services.

This article introduces and launches Quality Compliance Laboratories (QCL) as an option for those looking for a fully GMP compliant contract testing laboratory. Located in Toronto, Canada with over 10, 000 square feet of state of the art facilities and equipment, we are open for business and prepared to offer our clients the best in terms of service and compliance.The laboratory has obtained its establishment license from Health Canada (HPFB), is registered with the United States Food and Drug Administration (FDA) and has successfully undergone a number of client GMP audits.

In today's cost and service driven economy, clients are continually searching for service providers who are committed to delivering the quality they demand and must have with a quick turn around time and at an affordable cost.These items have often been considered to be, to a certain extent, mutually exclusive but, not at QCL!

We are in the unique position of having an exclusive agreement with the Academy of Applied Pharmaceutical Sciences (AAPS) to provide us with a continuing supply of degree level analysts specifically trained in pharmaceutical analysis by industry experts.This ensures that we can readily adjust our staffing requirements to meet even the most demanding of project volumes and maintain our committed turn around times.

All of our analysts have University degrees, have received specific pharmaceutical training from AAPS and have undergone our internal training program prior to testing a client' s materials or products. This ensures both the high quality of work and level of compliance expected from QCL.

Finally, our cost structure is quotation based and very competitive with provisions for both RUSH and EMERGENCY services. Both status require commencement of work immediately upon receipt of a properly documented sample with rush status samples worked upon in regular working hours whereas emergency status samples are worked upon constantly, around the clock, until completed. In addition to competitive rates, QCL offers a graduated discount schedule for multiple sample assays so that we pass along the benefits of bunching the same type analysis together.

If you would like to know a little more about us, please visit us at www.qctest.com or contact us, toll free, at 1-877- 305-0998 and learn what we can do for you.