Catalog excerpts
Automated Parenteral Sampling System Sizes and counts suspended particulate matter in a wide range of liquids to meet regulation standards BENEFITS The APSS-2000 syringe sampling system sizes and counts suspended particulate matter in a wide range of liquids and meets or exceeds all current USP, EP, and JP requirements. Recipe functions allow the APSS-2000 to adapt to future regulatory changes. The APSS-2000 system consists of an SLS-2000 syringe sampler, a LiQuilaz® II E Series light obscuration spectrometer, and SamplerSight Pharma software, allowing reports to meet 21 CFR Part 11 regulations. Defect Reduction • 100% sample volume for greater accuracy • A precise sample volume within 0.4 ml is achieved with the syringe sampler, producing repeatable results • SamplerSight Pharma software comes with a Validation Information Notebook, providing comprehensive software development documentation and full IQ, OQ, and PQ protocols • SamplerSight Pharma complies with FDA 21 CFR 11 User-Friendly • Reduce operator error and ensure process accuracy with recipes for repeat sample processing to USP, EP, or JP standards • Automated particle counter calibration wizard for full calibration or routine verification • Alarm levels for pass/fail criteria ensure quality control • Automated backup scheduling ensures enhanced data integrity Comprehensive System • Easy-to-use pull-down menus • Active Directory security password maintains system integrity • Particle measurements are reported per ml or per container values • Small sample volume minimizes waste of expensive product • Various custom report formats are available • Electronic report approval Particle size capability from 1.5 to 125 µm Fifteen user-selectable sizing channels Meets and exceeds all USP, EP and JP requirements Sample volumes from 0.4 ml to 1 liter Adapters for SVI and IV bag testing Automated sensor calibration Plug and play ultrasonic bath and magnetic stirrer options available A P P L I C AT I O N S • Pharmaceutical parenteral monitoring to USP, EP, JP and FDA • • • • standards Parts/medical device cleanliness testing Laboratory water sampling Water for Injection (WFI) and Pu
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Automated Parenteral Sampling System Liquid Sensor Size Range Size Channels Flow Rates Volume Sampled Maximum Concentration Sample Temperature Zero-count Level Capillary Size Maximum Pressure Maximum Sample Viscosity Laser Source Laser diode Wetted Surface Materials 1 Fused Silica, Black Quartz, Teflon, Kel-F®, Kalrez® Greater than 90% accuracy (less than 10% coincidence loss) at maximum recommended concentration. Liquid Sampler Syringe Size Sampling Mode Minimum Sample Volume Wetted Surface Materials Glass, Teflon 17.1 x 9 x 15 in (43.4 x 22.9 x 38.1 cm) Including particle counter Weight…
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The APSS 2000 liquid particle counting system sizes and counts particles in liquids, including parenterals. This solution meets all US, European and Japanese pharmacopoeia standards, including USP 788.
The APSS 2000 helps you meet regulations, such as USP 788, while using only a small sample size, which helps you minimise waste of expensive product.
While it is currently programmed for USP 788, the APSS-2000 Parenteral Particle Counter has recipe functions that allow it to adapt to future regulatory changes, helping you save money in the long-term while meeting requirements.
More than just a particle counter, the APSS-2000 System includes:
- An SLS-1000 syringe sampler
- LiQuilaz®eSeries light obscuration spectrometer
- SamplerSight Pharma Software, allowing reports to meet 21 Code of Federal Regulations (CFR) 11 regulations for electronic records and signatures.
SamplerSight Pharma Software enables you to manage sampling requirements for batch-based operations while providing a comprehensive view of the batch information with histogram, time plot and tabular data presented in an easy-to-use format that is easily reported.
SamplerSight Pharma features a validatable, user-friendly, Windows-based software with context-sensitive help.
Key features include:
- Sizing capability from 1.5μm to 125μm
- Sample volumes from 0.2ml to 1l
- Adapters for small volume injectibles (SVI) and bag testing for intravenous (IV) solutions
- Automated particle counter sensor calibration
- Particle measurements reported per ml or per container values
- Available with various custom report formats
- SamplerSight Pharma complies with US Food and Drug Administration (FDA) 21 CFR 11
- Automated full calibration or routine verification functions
Key benefits include:
- Greater accuracy with 100% sample volume
- Precise sampling within 0.1ml to produce repeatable results
- Comprehensive software development documentation and full instrument qualification (IQ), operations qualification (OQ) and performance qualification (PQ) protocols
- Reduced operator error and increased process accuracy with recipes for repeat sample processing
- Alarm levels for pass/fail criteria to ensure quality control
Key applications include:
- Pharmaceutical parenteral monitoring to US, European Pharmacopoeia (EP), Japan Pharmacopoeia (JP) and FDA standards
- Parts/medical device cleanliness testing
- Laboratory water sampling for purified water testing and water for injection (WFI)
- Filter efficiency testing
The APSS-2000 Liquid Particle Counter for USP 788 measures and counts suspended particle matter in a variety of liquids, particularly parenteral, to satisfy all current US, European and Japanese Pharmacopoeia requirements. It is critical to follow requirements while limiting waste when it relates to particle monitoring quality control for liquid medication producers.
The APSS-2000 Particle Counter features recipe functions to help it adjust to future policy measures, as well as USP 788 for particles in liquids, and its tiny sample capacity reduces the waste of valuable products.
The APSS-2000 Liquid Particle Counter, part of Particle Measuring Systems (PMS) comprehensive liquid particle counter series, contains an SLS-1000 Syringe Sampler, SamplerSight Pharma Software, and a LiQuilaz® eSeries Light Obscuration Spectrometer, which allows reports to fulfill 21 CFR 11 standards for electronic records and signatures.
SamplerSight Pharma Software enables operators to handle sample needs for batch-based procedures and gives a perfect overview of batch information, including a histogram, tabular data and time plot, all displayed in an easy-to-use manner that can be simply reported. SamplerSight Pharma has a Windows-based program that is validatable and user-friendly, with context-sensitive support.
The APSS-2000 Liquid Particle Counter for USP 788 is an entirely enclosed liquid particle counting instrument for syringe sampling.
From the several liquid sampling setups to the extensive Sampler Sight software, which allows the user to gather, examine and export data from a single platform, it gives the user flexibility. The software is 21CFR11 compatible and validatable. The below video tutorial reveals more.
APSS-2000 Syringe Sampler — Liquid Particle Counter Demo
Video Credit: Particle Measuring Systems
Features
- Sample sizes range from 0.2 mL to 1 L
- Various custom report formats are available
- Bag testing for intravenous (IV) solutions and adapters for small volume injectibles (SVI)
- Full calibration or regular verification functions that are automated
- Particle counts in liquids are given per mL or container values
- Capacity for particle size ranging from 1.5–125 µm
- Sensor calibration for a liquid particle counter that is automated
- FDA 21 CFR Part 11 is followed by SamplerSight Pharma
Benefits
- To get reliable findings, precise sampling within 0.1 ml is used
- To provide quality control, alarm levels for pass/fail criteria is available
- Complete Instrument Qualification (IQ), operations qualification (OQ), and performance qualification (PQ) procedures are all included in the software development documents
- With a 100% sample volume, accuracy is improved
- Recipes for repeat sample processing reduced operator error and improved process accuracy
Applications
- Cleaning of parts and medical devices
- USP 788, EP, JP and FDA guidelines for pharmaceutical parenteral particle monitoring
- Testing the effectiveness of filters
- Water samples were taken at the laboratory for purified water testing and water for injection (WFI)
Available Accessories
Pharmaceutical Calibration Kit
With the Pharmaceutical Calibration Kit for Extinction Sensors, users can make sure that the particle counter is working before taking a sample. One size/count standard at 15 µm is included, as well as seven NIST-traceable particle size standards at 2, 5, 10, 15, 20, 25, and 30 µm. Packs of six are available.
Image Credit: Particle Measuring Systems
Sample Extender Tubing
Pack of ten extension tubes featuring male and female Luer fittings on opposite ends for sampling from IV bags or containers taller than 6′′ tall. 18-gauge, 2.7′′ length.
Image Credit: Particle Measuring Systems
Spare Syringe (1 ml-25 ml)
Spare syringe for LS-200 revisions D and above, as well as LS-50 revisions C and above.
Image Credit: Particle Measuring Systems
IV Bag Holder
This two-horn IV bag holder clips directly to the sample stage post to store 1 L IV bags adjacent to the sampler for rapid, uncomplicated particle detection, with no additional bench space required. A ten-pack of 20′′ sample tube extensions is included, as well as a six-pack of coring needles to penetrate the IV bag’s septum for precise particle data.
Image Credit: Particle Measuring Systems
Magnetic Stirrer with Cable
In syringe sampling, a magnetic stirrer with a cable is used to stir samples.
Image Credit: Particle Measuring Systems