Product Guide. MSP Corporation Rice Creek Parkway, Suite 300. Shoreview, Minnesota 55126, U.S.A. Phone: Fax:

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1 Product Guide inhalertesting MSP Corporation 5910 Rice Creek Parkway, Suite 300 Shoreview, Minnesota 55126, U.S.A. Phone: Fax:

2 About This Guide If you are viewing an electronic copy of this guide, the green-colored links found below can be clicked upon (ctrl+click) to navigate directly to that section of the guide. If you are reviewing a printed copy, you can request an electronic copy by sending us an (sales@mspcorp.com) or downloading one directly from our web site Dose Content Uniformit ngi and Accessories ACI and Accessories FLOW CONTROL Labor Saving Equipment qualification Services About MSP MSP uses its expertise in nano/micro particles to design, develop, and manufacture scientific instruments and equipment for airborne particle sampling and measurement, pharmaceutical inhaler testing, and semiconductor applications. MSP is noted for its innovative products and the creative use of aerosols for industrial applications. MSP is also the authorized exclusive distributor of Copley Scientific inhaler testing products in North America. Dose COntent Uniformity DUSAs for MDIs The sampling apparatus for MDIs is manufactured according to pharmacopeial requirements based on the original design by Charles Thiel. It comes complete with two LDPE sealing caps, filter support cap and flow meter adapter. part number A-X A-X A-X Sampling Apparatus for MDIs (Delivered Dose) Base Plate for above DUSA (includes Small Clamp, Stand and Boss head) Pack of 500 Glass Fiber Filters (25 mm) A-X Set of LDPE Seals MDI DUSA Component Parts

3 Dose COntent Uniformity, cont d DUSAs for DPIs The sampling apparatus for DPIs is capable of sampling at a variety of flow rates up to 100 L/min. It features a quick-connect pressure sampling port and quick-release bayonet caps and adapters. It comes complete with two LDPE sealing caps, filter support cap and flow meter adapter. part number A-X A-X A-X A-X Sampling Apparatus for DPIs (Delivered Dose) Base Plate (includes Large Clamp, Stand and Boss head) Pack of 100 Glass Fiber Filters (47 mm) Set of LDPE Seals DPI DUSA Component Parts Waste Shot Collector The model WSC2 waste shot collector is a compact bench top vacuum filtration system designed to work in conjunction with the delivered dose apparatus. It is suitable for both MDI and DPI applications. To operate, the user simply places the inhaler in the mouthpiece of the waste shot collector and fires a shot in the normal fashion. part number A-X A-X A-X Waste Shot Collector WSC2 (includes 1 cartridge) Spare Filter Cartridge Flow Meter Adapter WSC2 Waste Shot Collector Breath Simulator The model BRS1000 breath simulator is a microprocessor controlled instrument specifically designed for the testing of inhaled drug products. It is most commonly used to make dose content uniformity determinations of nebulizers. The system allows the user to determine the rate of delivery and the total amount of active delivered. part number A-X A-X A-X A-X Breath Simulator Model BRS1000 Filter Holder and Adapter Mouthpiece Adapter for BRS1000 Pack of 100 Filters for the Breath Simulator Breath Simulator

4 Next Generation Pharmaceutical Impactor (NGI ) Design and Performance The effort involved in the operation of cascade impactors and the uncertainty in the particle size distribution results have long been a source of concern for those involved in the testing of pharmaceutical inhalers. For this reason, in 1997, a group of prominent pharmaceutical companies involved in the development and manufacture of inhalers asked MSP to develop a new impactor specifically designed for testing pharmaceutical inhalers using the very latest design theory. The result, the Next Generation Pharmaceutical Impactor (NGI), was launched in The NGI is a high-performance, precision, particle classifying cascade impactor designed for testing MDIs, DPIs, nebulizers and aerosol and nasal sprays. Calibrations to document the stage cut-off aerodynamic diameters at 15, 30, 60 and 100 L/min were conducted according to pharmaceutical standards. The NGI has seven stages plus a micro-orifice collector (MOC) and its main features include: Designed by and for the pharma industry Meets and exceeds all USP and EP specifications State of the art aerodynamic performance Operates at any flow rate between 15 and 100 L/min Particle size range covered: 0.24 to 11.7 microns (dependent on flow rate) 7 stages total with 5 stages always in the cut-off range between 0.54 and 6.12 microns Corrosion resistant construction Electrically conductive; unaffected by static Excellent accuracy, reproducibility and stage efficiency: all stages 500 < Re < 3000 Easy drug recovery with low inter-stage losses Comprised of just 3 main parts to lend itself to practical semi and full automation Monographs incorporated both into the USP and EP Today, its accuracy, ease of use and high productivity is making the NGI the new workhorse of the pharmaceutical industry. Next Generation Pharmaceutical Impactor (NGI) NGI (Open View) Showing Stages and Collection Cups NGI Universal Induction Port (UIP) Part number A-X Next Generation Pharmaceutical Impactor A-C NGI Universal Induction Port A-B NGI Pre-Separator A-X O-ring Kit for the NGI Seal-Body (Set of 18) A-D Cup Tray A-X Set of 6 Small Cups A-X Set of 2 Large Cups A-A Welded Cup Tray Manifold NGI Pre-Separator 4

5 Next Generation Pharmaceutical Impactor (NGI ) Accessories The NGI itself is comprised of just 3 main parts: Bottom Frame (which holds the cup tray containing the eight collection cups) Seal-body (which holds the o-rings and nozzle pieces) Lid (which contains the inter-stage passageways) This design allows for a wide range of accessories that can be incorporated into the impactor to help users solve their formulation-specific challenges. Most of these accessories come in the form of variations in the design of the collection cups. Among these are: Deep cups to bypass any stage or stages after stage 1 Special filter-holding cups to perform gravimetric particle size distribution determinations Exhaust cups to allow users to bypass any downstream portion of the impactor altogether Cups which hold sintered glass disks for collection through impingement Metal screen-holding cups to allow users to tailor their own impaction surfaces Cups with false lids for stage 1 to assist the user in minimizing losses Also, the NGI has been designed with a micro-orifice collector (MOC) which in most cases eliminates the need for a final filter. For formulations with a considerable mass fraction in the ultra-fine particle size range, however, internal and external filter holders are available to provide a means of collecting this fraction. Other accessories include fine-cut Pre-Separator inserts, adapters for using the NGI with glass expansion chambers (nasal spray and aerosol testing) and a special lid for making flow resistance measurements across each impactor stage. Bypass (Deep) Cup Exhaust Cup - Side View Sintered Glass Frit Cup Gravimetric Cup Exhaust Cup - Top View Large Cup with False Lid part number A-A Small Bypass (Deep) Cup A-C Small Collection Cup for Gravimetric Analysis A-A Small Exhaust Cup A-B Small Collection Cup with Sintered Glass Disk A-A Small Collection Cup with Metal Screen A-X Large Cup with False Lid for Stage A-A Internal Filter Holder A-A External Filter Holder A-X Pack of 100 Filters for the above A-X Fine-Cut Pre-Separator Inserts A-S Glass Expansion Chamber Adapter A-B Flow Resistance Measurement Lid Internal and External Filter Holders Fine-Cut Pre-Separator Inserts 5

6 ACI and Accessories Andersen-type Cascade Impactor (ACI) The original ACI was designed and manufactured according standards for the environmental air sampling industry, but the Copley Scientific ACIs offered by MSP for inhaler testing applications have been re-designed and manufactured to meet the exacting standards of the pharmaceutical industry. The ACI and all accessories are offered in superior grade stainless steel, aluminum or titanium and are manufactured according to the latest state-of-the-art machining technologies. All ACIs and accessories are also thoroughly inspected and certified to conform to all critical specifications listed in USP Section <601> and EP Section Aluminum, 316 SS and Titanium Andersen-type Impactors Model A-S Andersen-type Cascade Impactor (316SS) A-S USP Induction Port for the ACI (316SS) accessories A-S 28.3 L/min Pre-Separator for the ACI (316SS) A-S 60 L/min Pre-Separator for the ACI (316SS) A-S Conversion Kit for 60 L/min Operation (316SS) A-S Conversion Kit for 90 L/min Operation (316SS) A-X A-X A-D A-B A-A Quick Clamp for the ACI One-Piece 316SS USP Induction Port Special Inlet Cone for Use with the NGI UIP Special 28.3 L/min PS Lid for Use with the NGI UIP Special 60 L/min PS Lid for Use with the NGI UIP Pre-Separator, 60 L/min Conversion Kit and Collection Plates Quick Clamp for the ACI A-X Box of 100 Glass Fiber Filters (81 mm) Flow control Flow Control Accessories MSP offers pumps, flow meters and flow controllers specifically designed to accurately and reproducibly determine and control the strength, duration and flow stability of simulated inspirations for inhaler testing. Coupled with the model DFM2000 flow meter, the model TPK2000 flow controller automatically measures and calculates all critical set-up parameters: P1, P2, P3, P3/P2 ratio, flow rate, temperature, relative humidity, atmospheric pressure, along with the date, time, instrument serial numbers and calibration data. Model A-X A-X A-X Critical Flow Controller Model TPK2000, 110V Flow Meter Model DFM2000, 110V High Capacity Pump Model HCP5, 110V Model TPK2000 Flow Controller & Model DFM2000 Flow Meter 6

7 Labor Saving Equipment NGI Sample Recovery System (NSRS) The NSRS is a semi-automated sample recovery system that accepts the NGI components, dissolves the collected particles, and places one or more sets of samples into HPLCready vials for subsequent analysis. It improves the reproducibility and efficiency of the sample recovery methods employed during inhaler testing, increases R&D and QC laboratory throughput, and frees technical staff for other duties. The NSRS will recover the samples from the mouthpiece adapter, induction port, stages 1 through 7 and the MOC. The NSRS comes complete with appropriate safety features, on-site installation and training, full FAT/IQ/OQ documentation, and a 1-year warranty. Preventative maintenance and extended warranty service contracts are also available on request. NGI Sample Recovery System (NSRS) NGI Semi-Automation Modules The model 4520 NGI Assistant provides semi-automated sample processing for the NGI. The operator places up to three collection trays on the platform and the system then adds a precise volume of solvent to each cup and rocks each tray to dissolve the drug product in the added solvent. The NGI Assistant then proceeds to aspirate an aliquot of each of the dissolved samples and dispenses it into HPLC-ready vials for analysis. Also offered are the model 4505 Induction Port Rinser and the model 4510 Pre-Separator Rinser. After using the NGI Assistant to deliver the recovery solvent to up to three induction ports and pre-separators (or dispensing the recovery solvent manually), the systems dissolve the drug product through single axis (IP Rinser) and dual axis (PS Rinser) rotation. All three systems include an on-site installation and operational qualification, certificate of conformance and all needed accessories. NGI Assistant NGI Induction Port Rinser NGI Pre-Separator Rinser Manual Sample Recovery A significant number of procedures performed during inhaler testing are highly repetitive and their performance leads to bottlenecks which compromise overall laboratory operations and efficiency. Relatively simple and inexpensive sample recovery tools have been designed to alleviate such bottlenecks and to ensure that testing is carried out in a consistent, reproducible and controlled fashion. These tools can also help to reduce the unwanted effects of repetitive strain. The NGI Gentle Rocker and the Copley model SPU Sample Preparation Unit aid the analyst in recovering deposited samples from NGI cups and total dose tubes or induction ports, respectively. NGI Gentle Rocker SPU 1000 SPU Fixtures 7

8 Labor Saving Equipment, cont d Andersen Sample Recovery System (ASRS) The ASRS is a semi-automated sample recovery system that accepts the components of the ACI, dissolves the collected particles, and delivers one or more sets of samples to HPLC-ready vials for subsequent analysis. It improves the reproducibility and efficiency of the sample recovery methods employed during inhaler testing, increases R&D and QC laboratory throughputs, and frees technical staff for other duties. The ASRS will recover samples from any ACI configuration including the mouthpiece adapter, induction port, pre-separator, stages 0 through 7 and the filter. The ASRS comes complete with appropriate safety features, on-site installation and training, full FAT/IQ/OQ documentation, and a 1-year warranty. Preventative maintenance and extended warranty service contracts are also available on request. Andersen Sample Recovery System (ASRS) Qualification Services Qualification Services MSP provides qualification services for its entire inhaler testing product line, with particular expertise in providing impactor mensuration services. The stage mensuration offering includes a comprehensive visual condition assessment, leak test, nozzle protrusion inspection where applicable, and an optical inspection of every nozzle of every stage of the cascade impactor. MSP has led the industry in this field by combining both area-based and edge-contrast diameter measurements along with flow resistance to truly characterize an impactor s suitability for use. MSP also offers calibration services for leak testers, flow meters and flow controllers, and repair, preventative maintenance and re-qualification services for all of our labor saving equipment. Copyright 2008 MSP Corporation (MSP-PG20, Rev. A). The MSP Logo is a registered trademark of MSP Corporation. Next Generation Impactor (NGI) and other instrument names and acronyms are trademarks of MSP; all rights reserved. Copley Scientific Limited Colwick Quays Business Park Private Road No. 2, Colwick Nottingham NG4 2JY, United Kingdom Phone: +44 (0) Fax: +44 (0) sales@copleyscientific.co.uk MSP Corporation 5910 Rice Creek Parkway, Suite 300 Shoreview, Minnesota 55126, U. S. A. Phone: Fax: sales@mspcorp.com