The hottest intravenous plastic infusion container

2022-08-21
  • Detail

Intravenous plastic infusion container and butyl rubber bottle stopper (II)

2.3 production mode

- three in one (three in one) of forming, filling and sealing, and the container is directly produced by the pharmaceutical factory

- produced by a professional container manufacturer

3. Introduction to butyl rubber bottle stopper

3.1 raw rubber

currently depends on imports

supplier: Exxon and Bayer

halogenation form: mainly divided into chlorination and bromination

3.2 main processing process

ingredients (raw rubber + compounding agent) → mixing → parking → forming → vulcanization → flushing → cleaning → silicification → packaging → (can be used directly)

3.3 production status

3.3.1 production plant

currently starts relatively late, has a production history of less than 10 years, and has more than 10 enterprises, The output generally ranges from hundreds of millions of systems automatically exiting the calibration state to only a billion. Due to the influence of production, drug price and other factors, many drugs (especially large infusion) are still using natural rubber. The State Drug Administration plans to phase out natural rubber stoppers step by step, and stipulates that butyl rubber bottle stoppers must be used for some drugs at this stage

3.3.2 variety and specification

butyl rubber stopper is mainly suitable for pharmaceutical packaging in long-term contact with injections. At present, the types of domestic production include:

- antibiotic bottle stopper: the output accounts for the majority

- large infusion bottle stopper: small output

- freeze drying injection bottle stopper: the output accounts for a certain proportion

- freeze drying infusion bottle stopper: the output is very small

- simple piston and gasket for insulin injection and other drugs: the output is very small

glue will only be recorded when necessary. The development strategy is to develop varieties and reduce specifications

3.3.3 product formula

in order to meet the packaging needs of various agents, butyl rubber plugs should develop a variety of formulas

foreign enterprises have developed thousands of formulas. At present, the number of formulas of domestic enterprises is too small to meet the needs of various drugs

suggestion: the formula of the enterprise should be monitored, such as considering establishing a formula filing system

4. The main technical requirements of plastic infusion containers

4.1 physical requirements

4.1.1 adaptability of production process

mainly refers to the sterilization resistance. After the infusion containers undergo the corresponding filling, sealing and sterilization processes, It should meet the following physical requirements specified in the product standard (temperature adaptability, pressure resistance, impermeability, fall resistance, water vapor penetration, insertion port, injection point, infusion device retention and puncture point impermeability, suspension device)

4.1.2 the three properties of temperature adaptability, pressure resistance and impermeability

are three evaluation indexes under a test process, which stipulates the anti compression permeability of the container loaded with liquid medicine after the temperature (low temperature and high temperature) that may be experienced (actually may be experienced) during storage and transportation. Containers marked with "fear of freezing" are not subject to low-temperature treatment

4.1.3 fall resistance

the infusion container shall not break when it falls on a hard, rigid and smooth surface at a certain height at (23 ± 3) ℃

4.1.4 transparency

the transparency requirement of infusion containers is to facilitate the inspection of particles in infusion

take the turbidity standard stock solution in accordance with appendix IX B of the Pharmacopoeia of the people's Republic of China, add pure water and dilute it 100 times to obtain the suspension. Fill the suspension into an empty infusion container to the nominal capacity, and fill the other empty infusion container with pure water to the nominal capacity. Then compare it with pure water on a black background and detect it visually. The detection shall be carried out under the condition that the upper and lower parts of the infusion container form an angle of 90 ° with the observation axis, and the infusion container is illuminated with an incandescent lamp with an illumination of 0 LX to 10000 LX, which makes the built-in impossible. The light source should directly irradiate the infusion container to avoid irradiating the eyes of the test personnel. If the turbidity of the test suspension is easy to be observed, the test is considered to be qualified

4.1.5 water vapor penetration

it is required that the water vapor penetration of the full container within the validity period shall not exceed 5%. The mass loss of the container filled with water shall not exceed 0.2% when it is placed at 65% ± 5% relative humidity and 20 ℃ for 14 days. Equivalent to a quality loss of no more than 5% within one year

4.1.6 particle pollution

particle pollution is to assess the cleanliness of the container. During the test, the container filled with clean water should be sterilized, and then the particle content should be tested. The measured particles have two sources, one is caused by pollution, and the other is caused by material falling off. Standard 3. Restart. Before the second start, it is stipulated that:

diameter is greater than or equal to 2.0 μ M particles should not be more than 200/ml

nominal capacity internal diameter ≥ 5.0 μ The particles of M should not be more than 20/ml, and there is no visible foreign matter

test method:

particle counting is tested with instruments, and visible foreign bodies are tested with the clarity test method specified in the Pharmacopoeia

4.1.7 outer cover

it is required that the puncture area should have an outer cover to prevent pollution. The "outer cover" in the definition is a broad concept, which can also seal the whole container. This type can also improve the water vapor permeability by ensuring the cleanness of the insertion port. In foreign countries, there are outer bags with vacuum packaging

4.1.8 the insertion port (connected with the infusion set) requires that the insertion point should be penetrated by the plastic puncture device specified in GB8368. When testing with the specified method, the puncture force shall not exceed 100N at the puncture speed of 500mm/min

4.1.9 infusion set retention and puncture point impermeability

this performance refers to that after the insertion port is inserted into the puncture device of the infusion set, the puncture device is not easy to fall off and does not leak

when testing with the specified method, there should be no liquid leakage at the insertion point, and the puncture device of the infusion set should not slide out of the insertion point

4.1.10 injection point (for injecting liquid medicine into the container)

it is required that the injection point has good sealing (no leakage after puncture)

4.1.11 suspension device

the suspension device of the container shall have sufficient strength. It is specified that a 7n tensile force shall be applied to the infusion container (after filling) of 250ml or less for 60min; For infusion containers larger than 250ml (after liquid filling), apply a tensile force of 15N for 60min, and the suspension device shall not break

4.1.12 other

standards also stipulate container identification and appearance requirements

4.2 chemical requirements and test methods

4.2.1 requirements for original containers or sheets

requirements

maximum value

burning residue

polyolefin

0.5mg/g

polyvinyl chloride containing plasticizer

1mg/g

metals: Ba, CD, Cr, Pb, Sn

3mg/kg of each metal

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