The APSS-2000 system is an automated solution for measuring suspended particulate matter in liquids, designed to meet USP, EP, and JP regulatory standards. With its precision and compliance with FDA 21 CFR Part 11 requirements, it ensures optimal quality control for pharmaceutical and medical applications.
The APSS-2000, developed by Particle Measuring Systems, is a syringe sampling system designed to measure and count suspended particles in various liquids. This innovative system meets international regulatory standards, including USP, EP, and JP, ensuring full compliance for pharmaceutical and medical applications.
The APSS-2000 consists of three main components: an SLS-2000 syringe sampler, a LiQuilaz® II E Series light obscuration spectrometer, and SamplerSight Pharma software. The software allows for generating reports that comply with 21 CFR Part 11 regulations, ensuring optimal data traceability and integrity.
One of the key benefits of the APSS-2000 is its ability to process 100% of the sample volume, providing unmatched accuracy. The system can measure particles ranging from 1.5 to 125 µm in size, with a precise sample volume of 0.4 ml. This precision is crucial for achieving repeatable and reliable results, thereby reducing operational errors.
The SamplerSight Pharma software comes with advanced features, such as a Validation Information Notebook, which provides comprehensive documentation on software development and IQ, OQ, and PQ protocols. These features facilitate validation and regulatory compliance, which are essential in pharmaceutical and medical environments.
The APSS-2000 is also designed to be user-friendly, with easy-to-use drop-down menus and advanced security features, such as Active Directory password management. These characteristics ensure system integrity and minimize the risk of human errors.
In terms of applications, the APSS-2000 is ideal for monitoring pharmaceutical parenteral products, medical device cleanliness testing, laboratory water sampling, and testing Water for Injection (WFI) and Purified Water (PW). It can also be used for filter efficiency testing, providing a versatile solution for various quality control needs.
The APSS-2000 is a comprehensive and advanced system for measuring suspended particles, offering precision, regulatory compliance, and user-friendliness. It is designed to meet the strictest requirements of the pharmaceutical and medical industries, ensuring optimal quality control.
Logistics
Remma and its partners provide you with serviced and configured equipment tailored to your needs. Receive your product at your facility with standard or express delivery, and an installation option, all through a single point of contact.
Warranty
Our 12/24-month warranty ensures the safety and reliability of your medical equipment throughout its lifespan.
Flexible Financing
Settle your medical equipment in up to 36 installments with our financing service or pay after delivery with Remma Facility.
