Providing Tomorrow's Advanced Detection Technologies Today

THE IDEX SYSTEM FOR

PROCESS ANALYTICAL TECHNOLOGY (PAT) APPLICATIONS

ID Detection Systems is offering advanced Raman based laser instruments for use in real time analysis of pharmaceutical process streams. A number of pharmaceutical processors are excited about use of our system as a noninvasive in-line process analyzer complementing their Process Analytical Technology (PAT) program.

The IDEX-1000

PAT is rapidly gaining acceptance throughout the industry as a process for designing, analyzing and controlling pharmaceutical and chemical manufacturing through timely measurements (during processing) of raw and in-process materials. This approach addresses final product quality upstream thereby saving time and considerable expense. Our IDEX analyzers are perfectly suited for real time in-line analysis 24/7. What sets us apart is our advanced low cost laser and spectrometer technology permitting high quality and resolution for a fraction of the cost of other process analyzers.

The IDEX Field-1000

“PAT permits manufacturers to refocus on improving the process of making drug products more efficiently and with less variability. PAT allows companies to focus and determine what variables are most critical to the final desired product and where controls should be inserted into the process. …………Detecting errors or process deviations and correcting them while the product is being made is more cost effective...” (Pharmaceutical Processing, March 2006)

IDEX Sensor Applications

(Examples)

Pharma Manufacturing:

• Four barrels of white powder just came into the loading dock, how do I quickly test whether it is material X? (Incoming raw material ID)

• The wet-lab may take one hour to analyze this compound, how can I quickly find out what it is?

• Production says there is 1% active in this tablet, how can I test it quickly? (Quality Control)

R&D Application:

• How do I distinguish between the two isomers of the same material?

• We already have a mid-IR/FTIR instrument, I just need a complementary technique.

• We need fingerprinting capability, we need to study surfaces, we need to characterize materials.

Process Application:

• I need to continuously monitor this reaction and know when to stop adding ingredients.

• I need to monitor six different reactions simultaneously, and need to plot real time charts.

• I need to communicate data with our main computer, LIMS.

Spectrum of a commercial Tylenol tablet

Spectra acquired on IDEX - 1000 (resolution 10cm-1 and IDEX – 1000 HR (resolution 6cm-1) systems

Advantages to use of Raman based IDEX System

Cost: The IDEX system is a fraction of the cost of other comparable systems.

Time: The IDEX provides real time in-line measurements every 5-10 seconds around the clock.

Product Quality: Instead of HPLC end of the line batch analysis, higher sampling frequency with automated testing has been shown to result in higher certainty of product quality along with expedited batch release.