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Complying with USP 729 / 788-1788 Regulatory Requirements

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Sizes and counts suspended particulate matter in a wide range of liquids, including parenterals, to meet all current U.S., European and Japanese Pharmacopoeia standards.

When it comes to quality control for liquid drug manufacturers, it’s important to meet regulations while minimizing waste. The APSS-2000 Liquid Particle Counter sizes and counts suspended particulate matter in a wide range of liquids, including parenterals, to meet all current U.S., European and Japanese Pharmacopoeia standards.

Along with USP 788 and USP 789 for particles in liquids, the APSS-2000 Particle Counter has recipe functions that allow it to adapt to future regulatory changes, and its small sample volume minimizes the waste of expensive product.

The APSS-2000 Liquid Particle Counter includes: an SLS-1000 Syringe Sampler, a LiQuilaz® eSeries Light Obscuration Spectrometer and SamplerSight Pharma Software, allowing reports to meet 21 CFR 11 regulations for electronic records and signatures.

SamplerSight Pharma Software allows operators to manage sampling requirements for batch-based operations and provides 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.

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Liquid Particle Counter USP 788 with software
Sampler Sight Pharma
Sampler Sight Pharma
Liquid Particle Counter USP 788 with software
Sampler Sight Pharma
Sampler Sight Pharma

The APSS-2000 Liquid Particle Counter for USP 788 is a fully contained syringe sampling liquid particle counting system. It provides user flexibility from the many liquid sampling configurations to the comprehensive Sampler Sight software that allows the user to collect, analyze and report data from one simple platform. The software is validatable and 21CFR11 compliant. Learn more from this expert demonstration. Contact us for a quick quote.

Features

  • Sizing capability from 1.5 to 125μm
  • Sample volumes from 0.1ml to 1L
  • Adapters for small volume injectible (SVI), large volume injectable (LVI) and bag testing for intravenous (IV) solutions
  • Automated sensor calibration
  • Particle measurements reported per ml or per container values
  • Available with various custom report formats
  • SamplerSight Pharma complies with FDA 21 CFR 11
  • Automated full calibration or routine verification functions

Benefits

  • 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

Applications

  • Pharmaceutical parenteral monitoring to U.S., EP, JP and FDA standards
  • Parts/medical device cleanliness testing
  • Laboratory water sampling for purified water testing and water for injection (WFI)
  • Filter efficiency testing

Supporting Materials

Application Notes & Brochures

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FAQs

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SamplerSight Pharma (SSP) stores the sample data in the Microsoft® SQL Server Database container. The database can either be installed on a local machine or networked with a remote SQL instance (the data will be then somewhere in the company network). The SQL Database is typically located under: C:\Program Files\MicrosoftSQLServer\MSSQL10_50.SQLEXPRESS\MSSQL\DATA when using the local machine data storage setup.Data retrieval is a dedicated functionality of the SamplerSight Software. Data can be recalled or filtered using several “tags”. Examples of these tags include the date/time, or other specific information included in the sample report prior to sampling (batch number, lot, etc.)The SQL Express database (included in the software package) is limited to 10 GB of data storage, easily allowing use of the APSS-2000 for several years. The best approach for one method may not be valid for all in terms of database usage. From a dataintegrity point of view, the SQL database does not have any risk of data loss due to quantity or age, provided that a periodical backup is performed. One advantage of using a unique database is the capability to easily recall old data without changing the database used. However, if recalling old data is not required, a yearly replacement database could be the desired solution.Sensors should be aligned during calibration at PMS. However, this may not be necessary if DC light and verifications and daily checks are within the specified tolerances.The instrument resolution is calculated by using the Electronic method, which is the most complicated method but most accurate in terms of results. Additional details about how the software performs the calculation can be given upon request.

Available Accessories

  • Pharmaceutical Calibration Kit

    Verify your particle counter works in advance of taking a sample with the Pharmaceutical Calibration Kit for extinction sensors. Contains one size/count standard at 15µm and seven NIST-traceable particle size standards: 2, 5, 10, 15, 20, 25 and 30µm. Available in packs of six.

  • Sample Extender Tubing

    Pack of 10 extension tubes with male and female Luer fittings on opposite ends for sampling from IV bags or containers larger than 6″ tall. Specs: 18-gauge, 2.7″ long.

  • Spare Syringe (1ml-25ml)

    Spare syringe for revision D and higher LS-200 and revision C and higher LS-50 samplers.

  • IV Bag Holder

    Requiring no additional bench space, this two-horn IV bag holder clamps directly to the sample stage post to hold 1L IV bags next to the sampler for quick, easy particle testing. Includes a 10-pack of 20″ sample tube extensions and a six-pack of coring needles to pierce the IV bag’s septum for accurate particle data.

  • Magnetic Stirrer with Cable

    Magnetic stirrer with cable for mixing samples during syringe sampling.

Still have Questions?

Our customer support is ready to answer your questions or get a quote ready for you.

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