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YBB 00402003-2015 PDF in English


YBB 00402003-2015 (YBB00402003-2015) PDF English
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YBB 00402003-2015English120 Add to Cart 0-9 seconds. Auto-delivery. Aluminium-plastics Combination Caps for Infusion Bottles Valid

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YBB 00402003-2015: PDF in English

YBB 00402003-2015
YBB
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
Aluminum-Plastics Combination Caps
for Infusion Bottles
Aluminum-Plastics Combination Caps
for Infusion Bottles
This Standard is applicable to the aluminum-plastics combination caps for non-
sterilized glass infusion bottles.
【Appearance】take an appropriate amount of this product; directly visually examine
in a bright place with natural light. It shall be clean, free of residual lubricant, burrs,
damage, and injection flash. The plastic parts shall be fully integrated with the
aluminum parts.
【Mechanical properties of the aluminum part materials】* the tensile strength shall
be 100~180N/mm2; elongation shall be no less than 2.0%.
Tensile strength refers to the maximum tensile load on the initial cross-section per unit
in the tensile test until the test specimen is broken. Elongation refers to the ratio of the
increase in the distance between graticules to the initial graticule (expressed in
percentage), in the tensile test, when the specimen is broken.
Take an appropriate amount of aluminum sheet with the same batch number; use the
tool with width (b) of 12.5mm, original gauge (L0) of 50mm, parallel length (Lc) of 75mm,
transition arc radius (r) of at least 20mm to cut the specimen as shown in Figure 1.
Conduct the test on the tensile device; the test speed is 10mm/min ± 2mm/min. The
specimen shall stand for 4h above at the temperature of 23°C±2°C, and relative
humidity of 50%±5%; and test shall be performed under the above conditions.
Figure 1 -- Specimen Diagram for Mechanical Property Test
Elongation shall be calculated as per the following formula:
Where:
Figure 3 – Opening Force Diagram Figure 4 – Type-ZD Aluminum Part Tear-Sheet
Tearing Force Test Device
【Opening quality】take an appropriate amount of this product through the opening
force test, and removing the plastic parts; visually examine; the opening position on
the aluminum part shall be free of damage.
【Conformability】take an appropriate amount of this product; cover it onto the bottle
filled with nominal capacity of water (add rubber stopper); seal with capping-machine;
it shall match properly.
【Resistance to sterilization】take an appropriate amount of this product; cover it
onto the bottle filled with nominal capacity of water (add rubber stopper); seal with
capping-machine; after that place into the steam sterilizer; maintain for 30min at
121°C±2°C, including maintaining for 5min at 130°C±2°C. After sterilization, the plastic
part of the bottle cap can withstand 130°C steam sterilizing temperature without
deformation or discoloring; the surface of the aluminum part shall be free of any
obvious changes. The bottle cap shall be free of breaking or abnormal deformation.
【Coating fastness】(applicable to the aluminum cap with coating on the outside
surface) take an appropriate amount of this product; maintain for 30min at 121°C±2°C,
including steam sterilizing for 5min at 130°C±2°C; remove the plastic part; wipe the
surface with absorbent cotton dipped in 80% ethanol solution for 30s; then wipe the
surface with absorbent cotton dipped in 70% isopropanol solution for 30s. The coating
shall be free of any abrasion.
Annex I -- Inspection Rules
1. The product inspection is divided into full inspection and partial inspection.
2. In any of the following cases, a full inspection shall be carried out in accordance with
the requirements of the standard.
......
Source: Above contents are excerpted from the PDF -- translated/reviewed by: www.chinesestandard.net / Wayne Zheng et al.