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Intravenous plastic infusion containers and butyl rubber bottle plugs (III)

4.2.2 requirements for test solution


maximum allowable value





10ml sodium hydroxide solution

[C (NaOH) =0.01mol/l250ml]

10ml hydrochloric acid solution

[C (HCl) =0.01mol/l/250ml]

UV absorbance

enhance the lubricity of the catheter in the range of 23nm ~ 360nm; The weaving process makes the extremely thin catheter more resistant to tension and bending:

infusion container with nominal capacity ≤ 100ml 0.25

infusion container with nominal capacity ≤ 100ml 0.2

evaporation residue


reducing substance


ammonium ion


evaluation information of metal

Ba, Cr non intentional additives.And total migration compliance (only molded products), Cu, Pb


Sn for each metal, CD




heavy metals, calculated by pb2+


4.2.3 migration

requires container material composition and subcontracting.Layer, adhesive, adhesion promoter The migration amount of printing ink and other components into the infusion container should not cause pyrogen or toxic reactions

4.3 biological requirements

the standard stipulates that the anti microbial penetration often requires an experimental machine to carry out contraction tests, pyrogen, cytotoxicity, hemolysis, acute systemic toxicity, sensitization, intradermal stimulation and other requirements

5 main technical requirements of butyl rubber plug

5.1 sterilization resistance

it is required that the rubber plug should not lose its biological, chemical and physical properties under 121 ℃± 2 ℃ saturated steam for 30min

5.2 physical requirements

5.2.1 puncture and chip falling

the rubber stopper is often punctured by the injection needle or infusion bottle stopper puncture device in the normal use process, so it is clinically required that chip falling should not occur in the puncture process

5.2.2 puncture force

during normal use of rubber stopper, the puncture force should not be too large when using injection needle or infusion bottle stopper puncture device

5.2.3 the solubility of bottle stopper and container

this is an important index to maintain the efficacy of drugs. After the cork is covered on the bottle, it should undergo vacuum suction test to indicate whether there is leakage

5.2.4 self sealing

the rubber plug should have good sealing and no leakage during or after the puncture with injection needle or infusion bottle plug

5.2.5 particulate pollution limit

the particulate pollution limit shall be negotiated by the supplier and the demander. The particle pollution limit index is to assess the cleaning process of enterprises, and it is also a method to determine whether rubber plugs can be directly used in drug packaging

5.2.6 size and appearance

5.2.7 water content

for freeze-drying bottle closures, the manufacturer should recommend to the pharmaceutical factory the drying process to make the bottle closures reach the specified water limit

5.2.8 aging resistance

the minimum life of bottle stopper shall be determined by the manufacturer and the user through negotiation. The service life of the bottle stopper in contact with the drug belongs to the compatibility test conducted by the user. The aging resistance of bottle stopper depends on the storage environment and management. The storage guide and storage period test method of vulcanized rubber are specified in ISO 2230 "vulcanized rubber - storage guide" and gb/t "natural storage aging test method of vulcanized rubber" (refer to ISO 2230). These methods can be used by enterprises to determine the storage period of bottle stoppers

5.3 chemical requirements of dissolution solution

test items




class I: the turbidity does not exceed the standard suspension II

the suspension is the same as the Pharmacopoeia

class II: turbidity does not exceed standard suspension III


color class I and class II: chromaticity does not exceed standard solution Gy5



compared with the blank control solution, the difference of pH value is not more than 1.0


UV absorption

class I: 0.1

the UV spectrum measured on the elastic material leaching solution is mainly related to the type of accelerator in the elastic part formula or the existence of antioxidant. This test is applicable to all kinds of vulcanized rubber, usually measured with water immersion

class II: 0.2

reducing substance (easily oxidized)

class I: ≤ 3.0ml

c (Na2S2O3) =0.01mol/l

the extract of elastic parts may generally come from vulcanizing agents, accelerators and their reaction products. This kind of substance may include one or more of the following components: sulfur, thiuram, sulfurous amide, thiazole, dithiocarbamate organic amine mixture, phenolic resin and/or organic peroxide

class II: ≤ 7.0ml

c (Na2S2O3) =0.01mol/l

heavy metals

≤ 10 μ The metal oxides in gpb2+/10ml

leaching solution mainly come from the commonly used inorganic fillers and some vulcanization accelerators. These include determinable trace elements, but these trace metals are trace harmful substances in rubber ingredients, such as lead

soluble zinc (calculated by zn2+)

≤ 30 μ G/10ml

a small amount of zinc oxide is required in most rubber compositions to promote vulcanization and improve some physical properties. Therefore, zinc ions may be leached by water


≤ 20 μ Gnh4 +/10ml

traditional natural rubber formulas generally contain ammonium, which is usually produced by the presence of protein or ammonium in natural polyisoprene

nonvolatile matter

class I: ≤ 2.0mg

affected by the composition of rubber, the leaching solution of various rubber formulas may release different amounts of nonvolatile substances

class II: ≤ 4.0mg

volatile sulfide

≤ 50 μ Gna2s/20cm2

the traditional vulcanization method is to crosslink it with sulfur or sulfur-containing compounds. The rubber material produced by this vulcanization method can be soaked with water to extract volatile sulfides, especially when the pH value is acidic, it can form volatile sulfides


class I: ≤ 15 μ S/cm

when the elastic part is exposed to the water leaching medium, the elastic part can release substances that can increase the conductivity of the leaching medium

class II: ≤ 30 μ S/cm

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