YBB 00242004-2015: Combinational Closures of PP for Plastic Infusion Containers(with ring-pull)

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Scope

the rubber liners and inner closures; hang the containers upside down; hang weights of 0.3
kg to the puncture device. The puncture device shall be retained for 4 h before being pulled
out and the punctured part shall have no leakage.
Leakproofness of Drug Injection Point Take 10 samples above mentioned to mount
respectively to the matched plastic infusion containers; seal the containers after injecting the
marked volume of infusion water; use an injection needle to puncture vertically for 3 times at
three different points of the drug injection point of combinational closures; after pulling out
the injection needle, place the plastic infusion containers between two parallel plates; apply
an internal pressure of 20 kPa; hold for 15 s. The drug inject point shall have no leakage.
[Bacterial Endotoxin] Take an appropriate amount of combinational closures; mix in
accordance with the proportion of adding to each sample 50 ml of bacterial endotoxin test
water; shake for 1 min; use the moist heat sterilization method to heat to 121°C ± 2°C; hold
for 30 min; cool to room temperature as test solution; conduct measurement by law (General
Rule 1143 of Part 4 of Chinese Pharmacopoeia 2015). The amount of endotoxin in each 1
ml of test solution shall not be greater than 0.25 EU.
[Storage] The inner packing shall be sealed with LDPE pouches for pharmaceutical
packaging and stored in a clean, ventilated place.
Annex – Inspection Rules
1.Product inspection is divided into full inspection and partial inspection.
2.In case of any of the following circumstances, a complete inspection shall be conducted
as required by standards.
(1) Product registration;
(2) Resumption of production after a major quality accident of product.
3.In case of any of the following circumstances, the inspection for the items except “**” shall
be conducted as required by standards.
(1) Inspection by attributes for supervision;
(2) Resumption of production after a production halt.
4.After the approval registration of product, the inspection for the items except “*” and “**”
may be conducted as required by standards, provided that there is no change in the place
of origin of materials, additives, production process or other aspects of the manufacturer
and user of pharmaceutical packaging materials.

Basic Data

Standard ID	YBB 00242004-2015 (YBB00242004-2015)
Description (Translated English)	Combinational Closures of PP for Plastic Infusion Containers(with ring-pull)
Sector / Industry	Medical and Pharmaceutical Packaging Industry Standard
Classification of Chinese Standard	C08
Word Count Estimation	4,499
Date of Issue	2015-08-11
Date of Implementation	2015-12-01
Older Standard (superseded by this standard)	YBB 0024-2004
Regulation (derived from)	China Food and Drug Administration Announcement 2015 No.164
Issuing agency(ies)	China Food and Drug Inspection Institute