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YBB 00272004-2015: Test for insoluble particulate matter of packaging materials
YBB 00272004-2015
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
Test for Insoluble Particulate Matter of Packaging
Materials
Test for Insoluble Particulate Matter of Packaging
Materials
This standard applies to the determination of the size and number of insoluble
particles in pharmaceutical rubber stoppers, infusion bottles, infusion bags and
inner-caps of plastic infusion containers.
This method includes the photoresist method and the microscopic count
method. Unless specified otherwise, the method for determination is generally
the photoresist method; when the test results of the photoresist method do not
comply with the provisions, it shall use the microscopic count method for retest,
and use the test results of the microscopic count method as the judging criteria.
Method I -- The photoresist method
[Principle] When particles in liquid pass through a narrow and small testing
area, the incident light perpendicular to fluid direction weakens because of the
blockage of particulate matter; the signal output by the sensor becomes weaker;
such signal change is in direct ratio to the cross section of the particulate matter.
The photoresist method for the test of insoluble particulate matter is based on
this principle.
[General requirements for apparatus] The apparatus generally includes
three parts -- sampler, sensor and data processor. The measured particle size
range is 2 ~ 100 μm; the test particle concentration is 0 ~ 10 000 piece/mL.
[Test environment and testing] As specified in Chinese Pharmacopoeia 2015
Edition, Part 4, General Rule 0903.
[Calibration and verification of apparatus] As specified in Chinese
Pharmacopoeia 2015 Edition, Part 4, General Rule 0903.
[Method for determination]
(1) Pharmaceutical rubber stoppers: unless specified otherwise, take several
rubber stoppers to be tested (of a total surface area about 100 cm2); place into
a 250 mL conical flask; add an appropriate amount of particulate matter test
water (the ratio of the milliliters of particulate matter test water to the square
centimeters of the total area of rubber stoppers to be tested is 1:1); use
aluminum foil (or other appropriate sealing materials) to cover the opening of
the conical flask; place in the oscillator (rotating horizontally and circularly, in a
diameter of 12 mm ± 1 mm, at an oscillation frequency of 300 r/min ± 10 r/min)
for oscillating for 20 s. Carefully remove the aluminum foil (or other appropriate