Description
PAMAS USP – Software for Pharmaceutical Particle Analysis
PAMAS USP is advanced software developed for the analysis and evaluation of particle measurements in pharmaceutical liquids. The software is used together with the PAMAS SVSS particle counter for the analysis of parenteral drugs, infusion solutions, ophthalmic liquids and oral solutions in accordance with applicable pharmaceutical standards.
For liquids with higher viscosity, the PAMAS SBSS system is used.
The software is designed to comply with the requirements of 21 CFR Part 11 and supports evaluation according to international pharmacopoeia standards such as:
USP (United States Pharmacopeia)
EP (European Pharmacopoeia)
BP (British Pharmacopoeia)
JP (Japanese Pharmacopoeia)
The measurement reports contain all sample parameters as well as a clear numerical and graphical presentation of the results. The software also automatically evaluates the measurement data according to the selected pharmaceutical standard, simplifying quality control and documentation.
PAMAS USP also makes it possible to create and use customised internal test procedures for specific quality requirements. Automatic data backups can be configured to a predetermined storage location for increased data security and traceability.
For validation purposes, both a complete software validation package and support for IQ/OQ validation (Installation Qualification and Operational Qualification) are available.
Benefits
21 CFR Part 11-compliant software
Support for USP, EP, BP and JP
Automatic evaluation according to pharmaceutical standards
Numerical and graphical presentation of results
Option to create customised test procedures
Automatic data backup
Validation package including IQ/OQ available
Please contact us for more information about PAMAS USP and compatible particle counting systems for pharmaceutical applications.
