Quality standard for aluminum caps for injection bottles

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Quality standard for aluminum caps for injection bottles

Quality standard for aluminum caps for injection bottles


At present, a wide range of medical injections in clinical medicine, such as penicillin vial, Large infusion bottle, antibiotic bottle and so on, all use aluminum cap. The quality of aluminum cap affects the medication safety of patients. Therefore, the quality control of aluminum cap for injection bottle is particularly critical.


YBB00082005-2015 aluminum caps for injection bottles are a part of Chinese pharmacopoeia (2015 edition). The standards specify the quality of aluminum caps for injection bottles:


[appearance] take the right amount of this product, in the natural light bright place, face up to visual inspection, should be clean, no residual lubricant, burr, damage.


[mechanical properties of aluminum parts] The tensile strength of the material shall be 130-180n /mm and the elongation shall not be less than 2%.


[flange] take an appropriate amount of this product and measure with vernier caliper, accurate to 0.1mm, flange should not be more than 3%.


[opening force] Opening force of type B (two Bridges) and type C (three Bridges) aluminum cover: 25N < type B tear piece < 60N, 46N < type C tear piece < 76N; Tearing force of type D (tearing type) aluminum cover: 30N < bridge breaking force < 50N; 5N < total open force < 25N.


[thickness] the thickness shall be determined by the buyer and the seller through negotiation within the given range, and the thickness and tolerance shall not exceed ±0.022mm.


[sterilization resistance] take an appropriate amount of this product, rinse it with water and bake it in an oven at 180℃ for 1 hour. The surface should remain unchanged, and the surface layer should be free from uplift and detachment.


[compatibility] after baking at 180℃ for 1 hour, cover the appropriate amount of this product on the bottle containing the nominal capacity of water (add the rubber plug), and use the sealing device to seal the product. It should be properly matched, and no fracture or abnormal deformation is allowed.


[coating firmness] take an appropriate amount of this product (suitable for aluminum cover with coating on the outer surface), bake for 1 hour at 180℃, wipe the surface with absorbent cotton soaked with 80% (V/V) ethanol solution for 30 seconds, then wipe the surface with absorbent cotton soaked with 70% (V/V) isopropanol solution for 30 seconds, the coating should not have any wear.



Consequences of unqualified aluminum caps for injection bottles:


    1. The aluminum cover is not tightly packed, resulting in the extrusion collision in transportation and storage, which will affect the sealing of the products.

    2. The tearing process is very laborious or the rupture occurs when the whole cover is half torn, which means that the whole cover cannot be torn off, causing inconvenience in use.

    3. Appropriate opening force is conducive to the operation of medical staff.