Reading Scientific Services (RSSL Pharma) has completed the refurbishment of its microscopy laboratory, adding a dedicated room in which to carry out analysis and counting of sub-visible particles
The new Sub-visibles Room is isolated from the rest of the laboratory, having only the specialist equipment used for detecting and counting sub-visibles in parenteral solutions.
The same resource can also be used for looking at particulates shed by implants such as stents and prosthetics, and for looking at sub-visible particles in aerosols.
USP 788 and EP 2.9.19 set out limits on the numbers of sub-visible particles (>=10um and >=25um) that are acceptable in injectables, whereas USP 789 defines limits for ophthalmic solutions.
However, sub-visible particles can also occur in other products and RSSL Pharma says it is able to develop validated methods to monitor the presence/absence of sub-visible particles in products not covered by any pharmacopoeia.
Investment in the new Sub-visibles room has also been accompanied by investment in a new image archiving system.
Although used primarily with the light and scanning electron microscopes within the department, it is also used to archive and document images acquired with remote devices.
The new, networked system provides improved security, traceability, search and retrieval of product and foreign body images produced for RSSL's many clients, mainly in the pharmaceutical, healthcare and food sectors.
