Certification/Mensuration/Inspection 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.

Copley Inhaler Testing Equipment

MSP Corporation is the authorized exclusive U.S. Distributor for the Copley Scientific line of inhaler testing supplies.  Copley Scientific is the world's leading supplier of inhaler testing equipment, specifically designed to meet the requirements of the United States Pharmacopeia (USP) and the European Pharmacopoeia (Ph. Eur.).

The extensive range of products and services is designed to meet all the routine R&D and QC inhaler testing requirements for:

• Metered-Dose Inhalers (MDIs or pMDIs)
• Dry Powder Inhalers (DPIs)
• Nebulisers (and Aqueous Droplet Inhalers)
• Nasal Sprays and Aerosols

The products, software and services offered cover the following catagories:

• Delivered Dose Uniformity
• Delivered Dose Uniformity over Entire Contents
• Aerodynamic Particle Sizing by Cascade Impaction
• Critical (Sonic) Flow Control and Measurement
• System Suitability Testing
• Data Analysis
• Labor-Saving Devices
• Calibration, Maintenance and Impactor Stage Mensuration Services IQ/OQ Documentation

Copley's extensive catalog is available through MSP Corporation.

The new Copley NGI Cooler, available from MSP in North America, is a practical, easy to use system that improves the accuracy and reproducibility of inhaler product testing for solution-based devices such as nebulizers.

New pharmacopoeia monographs for nebulizer testing recommend using the Next Generation  Impactor (NGI) for droplet size analysis. They also highlight the issue of evaporative loss, which may result in artificially low particle size measurements. The new system’s rapid cooling action and ability to maintain stable temperatures throughout the test help avoid this problem.

Cascade impaction measures aerodynamic particle or droplet size, a key parameter for all inhaled products that ensures product consistency and broadly indicates deposition behavior within the respiratory system. For devices such as nebulizers, which deliver the active ingredient as an aerosolized solution, evaporation during testing, caused by impactor related heat transfer, is an issue. Loss of solvent reduces droplet size, producing artificially low particle size measurements and compromising accurate characterization of the device. Cooling the impactor to approximately 5 ºC is one of the most common ways around this problem.

The NGI cooler comfortably accommodates the NGI, either closed or open, allowing testing in a temperature controlled environment. Rapid cooling ensures that test temperatures, user adjustable to as low as 3 ºC, are reached in less than 5 minutes; temperature stability is to within +/-1.5 ºC. Large front and rear opening doors allow for easy access, with special access ports for the externally mounted device and pump tubing.

SPECIFICATIONS:

• Digital control of chamber temperature to between 3°C and ambient (typically 5°C to  8°C)
• Chamber designed to comfortably accommodate NGI in open or closed position
• Temperature stability ± 1.5°C
• Maximum ambient conditions to achieve maximum cooling = 32°C
• Time to reach minimum temperature from ambient <= 5 minutes
• Front and rear loading hinged door for easy access to chamber
• Hinged flap in front and rear doors for tubing access to chamber
• Side access port to allow external nebulizer connection to induction port
• Quiet operation
• Built-in strip light for high visibility inside chamber
• Automatic defrost allows continuous operation with no loss of chamber temperature
• Laboratory bench mounted (free-standing)
• Double glazed panels ensure high energy efficiency (max power consumption = 600W)
• Dimensions: 1000 mm (w) x 500 mm (D) x 575 mm

M150-M / M150-R-U / M150-U /M160 Marple-Miller Impactor (MMI™)

The MARPLE-MILLER IMPACTOR (MMI™) is a five-stage impactor with collection cups instead of the conventional collection plates. Originally designed for mass size distribution by chemical analysis of inhalable pharmaceutical aerosols, the MMI has also found a variety of non-pharmaceutical uses including size distribution analysis of oil mist, and soot particles from crankcase blowby of diesel engines. Cut-size diameters are 10, 5, 2.5, 1.25, and 0.625 µm. Easily removable collection cups allow direct weighing of collected particles or droplets. Solvent can be added to the collection cups for sample extraction and subsequent chemical analysis.  The Model 150 is designed for 30LPM and the Model 160 is designed for 60LPM.  (Model 150 is shown for purposes of illustration.)

M170 Next Generation Impactor

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 Impactor (NGI), was launched in 2000.

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.

M180 Flow Resistance Monitor Station

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.

M185 Fast Screening Impactor

MSP has developed a new fast-screening impactor for R&D and QbD applications of inhaler testing. Based on proven Next Generation Impactor (NGI) technology, the new Model 185 Fast Screening Impactor (FSI) is an easy to use, versatile instrument that enables the user to quickly, accurately and reliably determine the fine particle dose (FPD) of MDIs, DPIs and nasal aerosols and sprays. Its main features are:

• You decide the flow rate (28.3 L/min to 100 L/min)
• You decide the cut you want (4.7, 5.0, 10 micron; or custom)

The FSI uses a two-stage separation process: Large, non-inhalable boluses are impinged into a liquid trap, which is followed by a fine-cut impaction stage. This provides unparalleled accuracy, high capacity, low internal losses and low carry-over. No additional pre-separator is required, even for high-dose products. The FPD is collected within an external filter holder, with quick-release latches for rapid removal of the filter holder for gravimetric or chemical analysis.

The varied cut point and flow rate options are possible thanks to the special, inexpensive inserts that have been designed for the FSI. Inserts are available in any of the cut point and flow rate combinations indicated above, or custom; and additional inserts may be purchased separately at any time.

M4500 Andersen Sample Recovery System

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.

M4505 Induction Port Rinser

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.

M4510 PreSeparator Rinser

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.

M4515 Gentle Rocker

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.

M4520 NGI Assistant

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.

M4550 NGI Sample Recovery System

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 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 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.

Flow Cyto Prep

The FlowCytoPrep™ is a revolutionary new instrument that automates the tediously laborious and time consuming steps of manual sampling, sample preparation and sample injection in flow cytometry. When interfaced with a flow cytometer, it allows for truly automated flow cytometer operation including sampling, washing, fixing, staining, diluting and injecting. It allows for highly accurate, reproducible and detailed analysis of cell populations without the
need for direct operator intervention. It is ideal for sample handling and bioreactor monitoring without the need for extensive operator training.

The FlowCytoPrep™ combines the latest advances in automation,fluid handling technology and digital electronics to provide one of the most advanced and user-friendly turn-key devices ever developed to make truly automated flow cytometry possible. The FlowCytoPrep™ is a compact bench-top instrument that is easy to transport and set up in the laboratory or in the field. It is a must-have instrument for any biotechnology laboratory using flow cytometry for cell and cell culture studies.

FEATURES - Allows for truly automated flow cytometry operation including:

• Automated, sterile cell sampling from the cultivation vessel.
• Patented micro-reactor for automated cell washing, fixing, staining and dilution steps.
• Seamlessly interfaces with existing commercially available flow cytometers.
• Automated sample preparation.
• Multiplexed operation for increased sampling frequency.
• User-selectable sample preparation protocols.
• Configured for automated protocol optimization.
• Powerful, on-board computer.
• Easy-to-use software for system control.

APPLICATIONS

• Cell concentration and cell viability determination.
• DNA, cell cycle and size distribution analysis.
• Apoptosis measurements.
• Immunofluorescence staining.
• Expanding range of new protocols.
• Monitoring and controlling bioreactors to increase process productivity.
• Environmental monitoring.
• Quality control.