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YBB 00332004-2015: Test for Fragmentation of Injection Closures
YBB 00332004-2015
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
Test for Fragmentation of Injection Closures
Test for Fragmentation of Injection Closures
This method is applicable to the test for fragmentation of injection closures.
The puncture fragment refers to the number of visible fragments generated by the
penetrator penetrating through the rubber stopper or liner in the puncture test,
observed without the help of a magnifying tool; it is calculated by the number of
fragments.
Method I
Applicable scope: used for the rubber stopper of the injection with suitable specification.
This method aims to determine the relative trend of the puncture fragments by
puncturing the rubber stopper or freeze-dried rubber stopper for different injection
solutions. The results are affected by various factors, such as optimization process of
the rubber stopper, the types of the capping device, sealing resistance, the size and
sharpness of the penetrator, the amount of lubricant on the penetrator, and the
operator’s vision.
Based on the above reasons, in order to obtain the comparable results, it is necessary
to control the above factors that affect the results. For this reason, the rubber stopper
to be tested must be performed synchronically-compared test with the rubber stopper
having a known number of puncture fragments.
If the results of the rubber stopper having a known number of puncture fragments are
consistent with the previously known results (i.e. the test results are the same or one-
particle different from the know number of puncture fragments), then the test results of
the tested rubber stopper shall be judged to be valid.
Apparatus: injection bottle: it is matched with the rubber stopper to be tested; with the
capacity of 50mL above (including 50mL), 20 pieces (including the control test).
Aluminum cover or aluminum-plastic combination cover: they are matched with the
rubber stoppers to be tested; 20 pieces.
Manual-capping machine: it is matched with the rubber stopper to be tested; 1 set.
Suction filter.
Metal penetrator: stainless steel (1Cr18Ni9Ti) long needle; see Figure 1 for the
specification and dimension; 1 set.
fragments through a microscope.
Use the same method to calculate the rubber stoppers with the known number of
fragments.
Expression of results: separately record the total number of visible fragments (i.e.
the total number of fragments per 10 needles) of the two rows of injection bottles. If
the results of the rubber stoppers with known number of puncture fragments are
consistent with the previous known results, then the results obtained by the rubber
stopper to be tested shall be judged to be valid. Otherwise, it is invalid. In the puncture
process, if more than 2 (including 2) rubber stoppers are pushed into the bottle during
the puncture; then such item is judged to be unqualified. If one out of 10 rubber
stoppers are pushed into the bottle, another 10 rubber stoppers shall be taken for
retesting, during which no rubber stopper is allowed to be pushed into the bottle.
Method II
Applicable scope: used for the rubber stopper of the injection with suitable specification.
The medical rubber stopper is usually used in conjunction with an injection needle.
When the injection needle is used to penetrate the rubber stopper on the injection
bottle, the rubber stopper may generate fragments, the quantity and size of which shall
affect the quality of the drug in the bottle, so strict control of it is required.
Unless otherwise specified, the “Direct Method” is generally used for testing.
(1) Direction method
Apparatus: injection bottle: it is matched with the rubber stopper to be tested; with the
capacity of 50mL below, there are 12 pieces.
Aluminum cover or aluminum-plastic combination cover: they are matched with the
rubber stoppers to be tested; there are 12 pieces.
Manual-capping machine: it is matched with the rubber stopper to be tested; there is 1
set.
Suction filter: equipped with 0.5µm filtering membrane.
Syringe: syringe with 1mL scale; it is matched with injection needle.
Injection needle: (conforming to GB 15811-2011); outer diameter of 0.8mm; bevel
angle is L-shaped (long); the bevel angle of needle is 12°±2°. Before use, wipe with
acetone or methyl-isobutyl ketone; there are 12 pieces.
Determination: firstly, pre-treat the rubber stopper: estimate the total surface area A
(cm2) of the 12 pieces of rubber stopper to be tested; place the rubber stoppers into