YBB 00372003-2015 PDF in English
YBB 00372003-2015 (YBB00372003-2015) PDF English
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Name of Chinese Standard | Status |
| YBB 00372003-2015 | English | 155 |
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Aluminium-plastics Combination Caps for Antibiotics Bottles
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Standards related to (historical): YBB 00372003-2015
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YBB 00372003-2015: PDF in English YBB 00372003-2015
YBB
Aluminium-plastics Combination Caps for Antibiotics
Bottles
Aluminium-plastics Combination Caps for Antibiotics
Bottles
This Standard applies to unsterilized aluminium-plastics combination caps for
antibiotics bottles.
[Appearance] Take an appropriate amount of this product and make a visual inspection
in a bright place with natural light. They should be clean and free of lubricant residue,
burrs, damage and injection molding flash. Plastic parts should be completely integrated
with aluminum parts.
[Mechanical properties of aluminum parts materials] * The tensile strength should
be 100~180 N/mm2. Elongation shall not be less than 2.0%.
Tensile strength refers to the maximum tensile load endured by the initial unit cross-
section during the tensile test until fracture. Elongation refers to the ratio of the increase
in distance between the marking lines to the initial gauge length when the specimen
breaks during the tensile test, expressed as a percentage.
Take an appropriate amount of aluminum sheets from the same batch number. Use a
tool with a width (b) of 12.5 mm, an original gauge length (L0) of 50 mm, a parallel
length (Lc) of 75 mm, and a transition arc radius (r) of at least 20 mm to cut the specimen
as shown in Figure 1. Test on tensile apparatus. The test speed is 10 mm/min±2 mm/min.
The specimen should be placed at a temperature of 23±2°C and a relative humidity of
50%±5% for more than 4 h. Conduct the test under these conditions.
Figure 4 -- Diagram of the tearing force test device for ZD or OD aluminum tear
sheet
[Opening quality] Based on the opening force test, remove the appropriate amount of
this product from the plastic parts. Perform visual observation. Openings in aluminum
parts should not be damaged.
[Compatibility] Take an appropriate amount of this product and cover it on a suitable
bottle containing water with the marked capacity (add a rubber stopper). Cap with
capping device. It should be matched appropriately.
[Sterilization resistant] Take appropriate amount of this product. Cap it on a suitable
bottle containing water with the marked capacity (add a rubber stopper). Cap with
capping device. After capping, place in steam sterilizer, at 121°C±2°C for 30 min,
including 130°C±2°C for 5 min. After sterilization, the plastic parts of the bottle cap
can withstand a steam sterilization temperature of 130°C without deformation or
discoloration. There should not be any noticeable changes in the surface of the
aluminum parts. The bottle cap should be free from breakage and abnormal deformation.
[Coating firmness] Take an appropriate amount of this product (the outer surface is
coated). After steam sterilization at 121℃±2℃ for 30 min, including 130℃±2℃ for 5
min, remove the plastic parts. Wipe the surface with absorbent cotton soaked in 80%
ethanol solution for 30 s. Then wipe the surface with absorbent cotton soaked in 70%
isopropyl alcohol solution for 30 s. The coating should be free of any wear.
Attachment 1 -- Inspection rules
1. Product inspection is divided into full inspection and partial inspection.
2. When any of the following situations occurs, a full inspection shall be carried out in
accordance with the requirements of the standard.
(1) Product registration.
(2) Reproduction after a major quality incident occurs on the product.
(3) Supervise random inspections.
(4) Resumption of production after the product is discontinued.
3. After product approval and registration, enterprises that produce and use
pharmaceutical packaging materials can conduct inspections for items other than "*" in
accordance with the requirements of the standard, provided there are no changes in the
origin of raw materials, additives, production processes, etc.
4. Inspection of appearance, convex edge, opening force, opening quality, compatibility,
sterilization resistance and coating fastness shall be carried out according to "Sampling
procedures for inspection by attributes -- Part 1: Sampling schemes indexed by
acceptance quality limit (AQL) for lot-by-lot inspection" (GB/T 2828.1-2012).
Inspection items, inspection levels and acceptance quality limits are shown in Table 2.
NOTE: Items with “*” must be inspected at least once every six months.
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Source: Above contents are excerpted from the PDF -- translated/reviewed by: www.chinesestandard.net / Wayne Zheng et al.
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