Parameter for assessing parenteral cleanliness based on particle-size distributions.

A new parameter for assessing the particulate matter content of large-volume parenteral solutions was developed and tested. Some problems and shortcomings associated with previously proposed standards are discussed, together with the potential advantages of employing the proposed parameter. Cleanliness factors were compared with another parameter and were less susceptible to changes resulting from the method of measurement utilized and the premeasurement conditions encountered by the solution. The use of these cleanliness factors in conjunction with an automatic particle counter is proposed as a worthwhile supplement to the USP-NF standard for monitoring the quality of large-volume parenteral solutions.