FAQ - Conteo de partículas en producción farmacéutica y ciencias de la vida

Pregunta
I am trying to find copies of guidelines from the FDA or related documents about what the safe cutoffs are for IV solutions etc. I am an in vitro biochemist. I have been using a nephelometer to determine solubility of some compounds but I have some concerns about how accurate this approach will be.

Respuesta

There is one specific document that you need to read, USP <788>. The current version of USP is 30, it is released annually and is combined with the NF (United States Pharmacopoeia & National Formulary). Test 788 refers to particulate matter in injectables (this includes all injectables, SVP & LVP), the first part is that it must be free from all visible particles, these are deemed to be those that are above 100 um, and then set limits are imposed for sub visible particles, 10 & 25 um in size. We have an application note on our website that will point you in the right direction regarding numbers.

The above requires that a particle counter is used to enumerate the values here; however, if your product is an emulsion, suspension or similar then it can be tested using a microscope method. We have also seen issues where relatively viscous solutions (protein rich) also require filtration due to unsuitability issues.

Particle Measuring Systems offers a service where we can baseline your solutions using our laboratory here in Boulder.

Contact us if you need more information or have questions.