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IONSCAN®-LS

THE ULTRA-FAST ALTERNATIVE TO HPLC

 

Adapted from an article originally published 09/05/2005 in
www.in-pharmatechnologist.com

This case reported on a way to streamline pharmaceutical cleaning validation tests prior to initiating a new batch. It was developed by Smiths Detection and the Dober Group.

The two companies collaborated to develop a method for detecting Dober's Chematic pharmaceutical cleaning agents with Smiths' IONSCAN®-LS system. This analytical method allows drug manufacturers to ensure their equipment is free from cleaning agent residuals to nanogram levels with unprecedented speed and accuracy.

Traditionally, pharmaceutical manufacturers employ high-performance liquid chromatography (HPLC) for cleaning validation. But due to the long setup and analysis times, this analytical method often requires one to two days of downtime before processing equipment can be certified for cleanliness.

In contrast, the IONSCAN®-LS system makes use of ion mobility spectrometry (IMS), a fast, simple analytical method for detecting low levels of organic compounds. The IONSCAN®-LS provides reliable test results in 45-90 seconds.  Cost per sample is low and the equipment requires minimal training to use.

Dober's detergents cover the spectrum of acidic, alkaline and neutral-based cleaning agents for a diverse set of pharmaceutical manufacturing applications. The analytical method developed by Smiths focuses on one of the families of surfactants used in Dober's cleaning agents providing customers with quantitative data about the ‘last to leave' constituent, thereby demonstrating removal of the cleaning agent.

The IONSCAN-LS method for the detection of Dober's Chematic detergents is an example of how the technology has become invaluable to pharmaceutical companies trying to reduce their downtime associated with cleaning and cleaning validation, while safeguarding the quality of the products that they produce.  IONSCAN-LS can reduce downtime by more than 75 percent over conventional methods so the financial implications are significant.

For labs interested in evaluating this technology, in partnership with Smiths Detection, Betatek will develop a method for detecting a compound or agent critical to a particular lab cleaning validation process and calibrate the IONSCAN®-LS machine. 

With the machine in place on a trial basis the lab can fully evaluate the technology in three dimensions: economics, adaptability to current practice and efficacy.

We are pleased to be working with Smiths Detection to introduce the IONSCAN®-LS as an alternative to HPLC for the validation of cleaning verification to the Canadian Pharmaceutical sector. Our sector is looking for an analysis method that can provide the same sensitivity and repeatability as HPLC while requiring little or no sample preparation and shorter analysis time. IONSCAN®-LS is the proven answer.

We have a simple philosophy as a supplier of instrumentation. The lab equipment we bring to our customers must have a strong economic justification, can be readily adapted to current practice and has a high level of efficacy. In the case of the IONSCAN®-LS by Smiths Detection all three aspects are strongly present.

IONSCAN®-LS solution provides data real time. That speed translates into incredible savings in time and money transferring production equipment from one product to another. It also reduces costs by reducing the time and skills required as well as the need for disposing of solvent waste. There is much money to be saved using the new technology. We know that it will become the industry standard.

Betatek seeks to add value to projects evaluating the adoption of a new technology through methods development. With the Smiths Detection technical staff, we provide calibration and methods development for two compounds along with the initial training. Building upon the initial experience, other methods can then be developed by the client staff further accelerating the adoption of the technology. Additionally, there is a less obvious but important benefit that results from the use of the IONSCAN®-LS. Skilled professionals are now free to use HPLC for higher level science. 

The article we have posted below speaks eloquently to the efficacy of the technology. Cleaning between manufacturing runs represents a challenge.  IMS offers an ultra fast alternative to HPLC for cleaning validation. Because of this speed samples are run quickly and analysis results are obtained within seconds, IMS parameters can be modified quickly and optimization reached fasted that in HPLC.

 

Cleaning verification is one of the critical processes in pharmaceutical manufacturing. Equipment contamination can come from any of the materials that have been in contact with the equipment surfaces, including active pharmaceutical ingredients (APIs) from previous runs and cleaning agents. It is critical to avoid carryover of trace amounts of either active or other materials from one batch to another to avoid adulteration of the product.

 

For that reason, equipment used in pharmaceutical manufacturing must be cleaned before each use, and the cleaning procedure used must be in accordance with good manufacturing practices (GMPs). Before cleaning validation, cleaning verification procedures describing specific sampling and associated analytical methods are used to demonstrate the efficacy of the cleaning procedure.

 

Volumes of information have been written on cleaning verification in print and online, and many universities offer courses dedicated to this topic. FDA has standards (for example, 21 CFR Part 211.67) and associated guidances detailing requirements and offering interpretations for cleaning verification. Companies spend significant resources developing and validating the analytical methods required for cleaning verification. The analytical method must be specific, sensitive, accurate, and precise, and, to be cost-effective, it must be fast. Along with these requirements, the analytical method should be easy-to-use and it must be compliant with 21 CFR Part 11, FDA’s regulation for electronic data collection.

 

By: Kent Payne, Wayne Fawber, Jose Faria, Joey Buaron, Reno DeBono, and Azhar Mahmood

 

Source: Smiths Detection

 

Click here to download this comprehensive article.

The need to verify cleaning between manufacturing runs presents a special challenge to the analytical chemist. These articles describe the principal of ion mobile spectrometry and its performance compared to HPLC for the analysis of cleaning validation samples.  See:

http://www.sensir.com/Smiths/InLabSystems/IonScan/Spectroscopy05.pdf   http://www.sensir.com/smiths/inlabsystems/IonScan/AAPSNovelFeb05.pdf  http://www.forumsci.co.il/newsletters/GSKLimitTestPharmEurope.pdf

Key terms from the article:

API - active pharmaceutical ingredients

GMP - good manufacturing practices

Cleaning verification procedures

Validation and analytical methods for cleaning verification

SOP - standard operating procedures

TOC - total organic carbon

HPLC - high performance liquid chromatography

"IMS offers an ultra fast alternative to HPLC for the validation of cleaning verification methods "

Accelerated methods development 

 

 

Ion Mobility Spectrometry (IMS) is an analysis method which measures the mobility of ions in the gas phase. The IONSCAN® systems by Smith Detection and represented in Canada by Betatek Inc., measure the drift time of ions at high temperatures (typically 110 - 250 C) through clean, dry ambient air at atmospheric pressure. Sample analysis begins with thermal desorption to vaporize samples followed by a soft chemical ionization process. The ions are then gated into a drift tube and their drift times monitored. The drift time of the ions is characteristic of the size/charge ratio and cross-sectional area of the ion. To a first order approximation this is related to mass.

IMS couples extremely good sensitivity with fast operating speed and operating simplicity. The technique detects concentrations in the picogram-to-nanogram range. There is little or no sample preparation and the analytical response usually occurs within fifteen seconds. Untrained operators become skillful with the instrument in a matter of a few hours.

The most prevalent application in pharmaceutical sector is cleaning validation. Other applications under evaluation include dissolution testing, content uniformity testing, residual solvent screening, and raw material identification.

 

Specifications
•  Technology: Ion Mobility Spectrometry (IMS)
•  Sample collection: solid and liquids
•  Sensitivity: picogram to nanogram
•  MW range: 15 - 1000 AMU
•  Analysis time: 6 -20 seconds
•  Size: 15.5 x 13.5 x 13 (in)
               40 x 34 x 32 (cm)
•  Weight: 47 lbs. (22 kg)
•  Input voltage:  95 - 265 VAC
                         50 - 400 Hz (autoswitching)
•  21CFR Part 11 compliant software
•  IQ/OQ/PQ available
•  Optional Autosampler available

With the IONSCAN®-LS attached to a computer, you can use the IM software to collect, store and print data, including plasmagrams. Instrument parameters can also be changed with the IM Software. If the detection of a substance is made, it’s name is displayed on the color LCD with it’s relative strength. Through the use of soft keys, the user can scroll to view the plasmagram of a detection, inspect the status of the instrument and more.

Many pharmaceutical manufacturers are looking for an analysis method that can provide the same sensitivity and repeatability as HPLC while requiring little or no sample preparation and shorter analysis time. The current standard analysis method is to use high performance liquid chromatography (HPLC). HPLC sample preparation and analysis can take many hours, while results from the IMS technology are available in minutes.  This translates into incredible savings in time and money transferring your production equipment from one product to another. The IONSCAN®-LS solution provides data real time.  It also reduces costs by reducing the time and skills required as well as the need for disposing of solvent waste.

The IONSCAN®-LS is represented in Canada by Betatek Inc.

For complete specs go to:
http://trace.smithsdetection.com/documents/LifeSciences/IonScan_LS.pdf

 

 

"It really tells the story of our business. Our intent was to clearly communicate that we are really there for our customers. We feel strongly that we sell and support the best instrumentation. We have a superior track record for delivering superior support through installation, validation, implementation, method development, and ongoing service and support. Our team has an extraordinary experience base. We have built a reputation for superior customer service upon which our success in the market place is based."

                                                Steve Goldenberg, President Betatek Inc.

In Canada Smiths Detection offers through Betatek Inc. announces its new high throughput IONSCAN®-LS trace detection instrument designed to provide chemists with a new tool for identification and quantification of trace compounds, excipients and wash down detergents. The instrument is designed and manufactured at their facility in Mississauga.

The IONSCAN-LS is a new Ion Mobility Spectrometer specifically designed for pharmaceutical and chemical laboratory environments. The IONSCAN-LS utilizes the same technology as other Smiths Detection systems deployed throughout the world for security applications in the detection of illicit drugs and explosives. The IONSCAN-LS selectively ionizes organic compounds and separates them according to their unique "time of flight". Solid or liquid samples can be easily introduced, with little or no sample preparation. The analysis is fast and simple and typically completed within 6 to 20 seconds with the results being displayed on the color screen. Method development is quick and new target analyses can be programmed into the instrument within minutes. Calibration is performed automatically. The IONSCAN-LS is sensitive and capable of detecting picogram to nanogram levels of most chemicals. The IONSCAN-LS lets you analyze samples easier, faster and less expensively than other instruments available today.

IONSCAN® systems have been installed in over forty pharmaceutical manufacturers throughout the world.

The IONSCAN®-LS is represented in Canada by Betatek Inc the pharmaceutical and life sciences sectors.

Smiths Detection is part of the global technology business Smiths Group. It offers advanced integrated security solutions for customers in commercial and military markets worldwide and is a leading technology developer and manufacturer of sensors that detect and identify explosives, chemical and biological agents, weapons, and contraband. Its advanced technology security solutions also include Smiths Heimann x-ray imaging systems, millimetre-wave technology and a specialist software supply business for the management of large sensor and video surveillance networks. Separate business units focus on related products for the life sciences, and food manufacturing industries.

Betatek offers a wide range of containment technologies as described on: http://www.betatekinc.com/ContainmentTechnology.html. For a video on Flow Science's solutions visit: http://www.flowsciences.com/videos/anachem512k.php.

 

 

The IONSCAN-LS is a new Ion Mobility Spectrometer specifically designed for pharmaceutical and chemical laboratory environments. The IONSCAN-LS utilizes the same technology as other Smiths Detection systems deployed throughout the world for security applications in the detection of illicit drugs and explosives. The IONSCAN-LS selectively ionizes organic compounds and separates them according to their unique "time of flight". Solid or liquid samples can be easily introduced, with little or no sample preparation. The analysis is fast and simple and typically completed within 6 to 20 seconds with the results being displayed on the color screen. Method development is quick and new target analyses can be programmed into the instrument within minutes. Calibration is performed automatically. The IONSCAN-LS is sensitive and capable of detecting picogram to nanogram levels of most chemicals. The IONSCAN-LS lets you analyze samples easier, faster and less expensively than other instruments available today.

IONSCAN® systems are the word's leading trace explosives detector and are currently installed at more than 130 airports in the USA and many airports throughout the world.

Beratek markets and supports this fine product in Canada.

To view the animation:

1. Click below on the paperclip icon 

1 Attachments 

2. On the next page, click on IMS Workshop animation.ppt 

3. Click yes to allow the presentation to open.

4. Click on the icon on the bottom right corner of the slide (above the words SMITH IMS OPERATON400B.exe) to activate the demo.

 

 

We are an alliance partner of Flow Sciences, Inc. 

 

Flow Sciences' mission is to provide containment systems for laboratory, pilot plant and manufacturing areas. The products are designed to protect operators from exposure to hazardous particulates and vapors while performing delicate operations.

 

Flow Sciences, Inc. is focused on achieving the following goals for all of its enclosures:

maximized containment

ergonomic ease of use

high performance standards

minimal energy consumption

design flexibility

 

The Flow Sciences' team, with over thirty years experience in laboratory containment, is committed to finding containment solutions that meet your needs

See: http://www.flowsciences.com/alliances.php

Betatek Inc. is a Canadian distributor of laboratory equipment and instrumentation used primarily by industrial manufacturers. Our core areas of expertise include equipment used for Pharmaceutical, Food, and Chemical testing as well as Plant Growth, Environmental, Biotechnology areas of research.  Betatek Inc. products and services:
Balances 
Environmental Chambers
Indicators 
Laboratory Equipment 
Test and Measurement Instrumentation 
Testers

Listing on: http://www.labcanada.com/IntDirectory/webdir.asp

Betatek Inc.www.betatekinc.com  
Betatek Inc. is a Canadian distributor of high quality laboratory instrumentation and equipment used by Pharmaceutical, Biotechnology, Food, Government and University Research Laboratories.