Skip to product information
1 of 3

PayPal, credit cards. Download editable-PDF and invoice in 1 second!

YBB 00332004-2015 English PDF (YBB00332004-2015)

YBB 00332004-2015 English PDF (YBB00332004-2015)

Regular price $110.00 USD
Regular price Sale price $110.00 USD
Sale Sold out
Shipping calculated at checkout.
Quotation: In 1-minute, 24-hr self-service. Click here YBB 00332004-2015 to get it for Purchase Approval, Bank TT...

YBB 00332004-2015: 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.
YBB 00332004-2015
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE 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 0.5??m 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

View full details