New Practice for Reporting and Classifying Cleanliness with Respect to Particulate Matter in Pharmaceutical Processes
1. Scope
The proposal is for a standardized scheme for reporting and classifying the particulate cleanliness of pharmaceutical processes. The standard will address reporting of particle levels based upon processing unit (e.g. single-use assembly), surface area, or volume of the specified equipment. The standard will address the issues of containers versus flow-through processes (e.g. filtration). Also the standard will classify particles into the size-bins required by the pharmacopoeia: sub-visible and visible particles. Out of scope are the setting of particle level specifications, and specifying which particle measurement test method is applied.
Currently there are no standards which prescribe reporting and classification of the cleanliness of pharmaceutical processes with respect to particulate matter. The IEST standard for classifying surface cleanliness (and similarly ISO 14644-9) are inadequate to address special needs of pharmaceutical manufacturing. Especially the reporting of data from the application of USP <788> to the measurement of particles in process equipment is not standardized.
