YBB 00272004-2015 Test for Insoluble Particulate Matter of Packaging Materials
This method is applicable to the determination of the size and quantity of insoluble particles in pharmaceutical rubber stoppers, infusion bottles, infusion bags, and plastic infusion containers. This method includes the light-blocking method and the microscopic counting method. Unless otherwise specified, the determination method generally first uses the light-blocking method; when the determination results of the light-blocking method do not meet the requirements, the microscopic counting method shall be used for re-examination, and the determination results of the microscopic counting method shall be used as the basis for judgment