PARTICULATE CONTAMINATION CONTROL SPECIFICATIONS AND PROCEDURES TO IMPLEMENT PARENTERAL FLUIDS PREPARATION

摘要

The fundamental standard for control of particulate material in both large and small parenteral injections is "PARTICLE MATTER IN INJECTIONS", USP 23 <788>. This document states the maximum quantities of particles of specific sizes that can be present in parenteral liquids, as well as the equipment and procedures that can be used to characterize these levels. Although <788> specifies instrument performance requirements, there are other specifications which have been developed by worldwide voluntary standards organizations such as ASTM, CEN, JIS, VDI, and ISO which provide useful information on specifications, calibration, and operational procedures. These documents can be useful in reducing time and effort in establishing acceptability of the instruments and procedures used to characterize acceptable products. Specifications for production methodology, for production area control, and for performance and operation of measurement systems are provided. Sources for pertinent documents are provided.