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注射剤などの不溶性微粒子試験に最適な、薬局方に適合した光遮へい型液中微粒子自動測定システム

APSS-2000 光遮へい型微粒子自動測定システム

APSS-2000は、液体サンプル中に含まれる不溶性微粒子の粒径および粒子数を光遮へい方式により測定し、結果分析、レポート生成、印刷までを自動的に連続実行する液中微粒子測定システムです。日本薬局方/JPおよび米国薬局方/USP、欧州薬局方/EPに準じた、注射剤（非経口投与剤）の不溶性微粒子試験に最適です。 APSS-2000は、シリンジサンプラー のSLS-1000、光遮へい型パーティクルカウンターの LiQuilaz® E20P/15PとWindows® 10で動作するSamplerSight Pharmaソフトウェアで構成され ており、21 CFR Part 11（電子記録・電子署名に関する規制）に対応しています。

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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 video demonstration. Contact us for a quick quote.

　

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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 FilesMicrosoftSQLServerMSSQL10_50.SQLEXPRESSMSSQLDATA 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.

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  • 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.