Procedural Software Particle Counting in compliance with USP 787
With a special accessory for small sample volumes, the particle counting systems Pamas SVSS and Pamas SBSS can now be upgraded, so as to meet the regulations of the USP 787 pharmacopoeia for Subvisible Particulate Matter in Therapeutic Protein Injections.
The Pamas product range offers two devices that are specially designed for pharmaceutical applications: the Pamas SVSS for the analysis of low viscous liquids and the Pamas SBSS for high viscous samples. With these specially equipped particle analysing systems, it can be easily verified if the pharmacopoeia are being respected. The Pamas USP pharmaceutical procedural software programme provides standardised measuring reports in compliance with the pharmacopoeia USP, EP, BP, JP and IPC. So the user can see at one glance whether the analysed sample meets the requirements of the selected standard. The software can also be used to validate particle counters.
The laboratory instruments SVSS and SBSS are now compatible to the pharmacopoeia USP 787 (Subvisible Particulate Matter in Therapeutic Protein Injections). Up to now, it had only been possible to fulfill the pharmaceutical standards 788 (Particulate Matter in Injections) and 789 (Particulate Matter in Ophthalmic Solutions). Since the company has developed accessories for small sample volumes, the instruments can also fulfil the additional pharmacopoeia USP 787. The software monitors whether the requirements of the USP 787 standard are fulfilled.