Google Patents WO2016105555A1 - Portable airborne particle counting systems and methods It does not store any personal data.WO2016105555A1 - Portable airborne particle counting systems and methods The cookie is set by the GDPR Cookie Consent plugin and is used to store whether or not user has consented to the use of cookies. The cookie is used to store the user consent for the cookies in the category "Performance". This cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Other. The cookies is used to store the user consent for the cookies in the category "Necessary". The cookie is set by GDPR cookie consent to record the user consent for the cookies in the category "Functional". The cookie is used to store the user consent for the cookies in the category "Analytics". These cookies ensure basic functionalities and security features of the website, anonymously. Necessary cookies are absolutely essential for the website to function properly. Laboratory water sampling for purified water testing and water for injection (WFI).Parts/medical device cleanliness testing.Pharmaceutical parenteral monitoring to U.S., EP, JP and FDA standards.Alarm levels for pass/fail criteria to ensure quality control.Reduced operator error and increased process accuracy with recipes for repeat sample processing.Comprehensive software development documentation and full instrument qualification (IQ), operations qualification (OQ) and performance qualification (PQ) protocols.Precise sampling within 0.1 ml to produce repeatable results.Greater accuracy with 100% sample volume.Automated full calibration or routine verification functions.SamplerSight Pharma complies with FDA 21 CFR 11.Available with various custom report formats.Particle measurements reported per ml or per container values.Automated particle counter sensor calibration.Adapters for small volume injectables (SVI) and bag testing for intravenous (IV) solutions. The APSS-2000 system consists of an SLS-1000 syringe sampler, a LiQuilaz® E Series light obscuration spectrometer, and SamplerSight-Pharma software, allowing reports to meet 21 CFR 11 “Electronic Records and Signatures” rulings. Recipe functions allow the APSS 2000 to adapt to future regulatory changes. 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. Learn more from this expert demonstration. The entire system is validatable and 21CFR11 compliant. 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 APSS-2000 from Particle Measuring Systems is a fully contained syringe sampling liquid particle counting system. 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.
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