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注射剤（非経口投与剤）の不溶性微粒子試験に最適な、JP/USP/EPの規格基準に対応した液中パーティクルカウンター

APSS-2000　光遮へい型パーティクルカウンター

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するパーティクルカウンターです。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、シリンジユニット のSLS-1000、光遮へい型パーティクルカウンターの LiQuilaz® E20P/15Pと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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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.