CN102126694B

CN102126694B - Method for eliminating deformation of polypropylene transfusion bottle

Info

Publication number: CN102126694B
Application number: CN2010106109599A
Authority: CN
Inventors: 刘懿鑫; 肖宇; 高国辉
Original assignee: KUNMING NANJIANG PHARMACEUTICAL CO Ltd
Current assignee: Sichuan Kelun Pharmaceutical Co Ltd
Priority date: 2010-12-29
Filing date: 2010-12-29
Publication date: 2012-11-14
Anticipated expiration: 2030-12-29
Also published as: CN102126694A

Abstract

The invention relates to the field of medical appliances, in particular to a method for eliminating the deformation of a polypropylene transfusion bottle. The method is characterized by comprising the following steps of: lowering the temperature of a liquid medicament to 25-30 DEG C during dispensation in a preparation procedure; welding a cover by adopting a non-exhausting way in a filling procedure; maintaining pressure under the pressure of between 0.26 MPa and 0.28 MPa when the temperature is raised to 80 DEG C in a sterilizing procedure; maintaining pressure by using the pressure coefficient of between 0.26 MPa and 0.28 MPa at a heat preserving stage in the sterilizing procedure; maintaining pressure at 80 DEG C under the pressure of between 0.26 MPa and 0.28 MPa at a cooling stage in the sterilizing procedure, for exhausting; and lowering the temperature below 50 DEG C in the sterilizing procedure for discharging. In the invention, the characteristics of a polypropylene material are utilized, solution preparation, filling and sterilizing processes are improved, and low-temperature filling is adopted, so that the contraction of the bottle caused by over-high temperature of the liquid medicament is prevented; and the external pressure resistance of the bottle is improved to prevent the bottle from being deformed, and the problem of deformation of the polypropylene transfusion bottle, which is produced in a high-altitude region, in a low-altitude region is solved.

Description

A kind of method that solves the distortion of polypropylene infusion bottle

Technical field

The present invention relates to medical instruments field, specifically a kind of method that solves the infusion bottle distortion.

Background technology

At present infusion bottle mainly adopts polypropylene material, is PP that PP is a kind of hemicrystalline High molecular material, and it will be harder than PE and higher fusing point is arranged, because crystallinity is higher; The surperficial rigidity of this material and anti-cut characteristic are fine, because crystallization, the shrinkage percentage of PP is quite high, is generally 1.8 ~ 2.5%; Reason is between the molecule of High molecular material certain slit is arranged, and this gap size and material structure, temperature have much relations, as long as but the slit is arranged; Temperature rises, and the material molecule heat motion is all on the rise, and molecular potential is also increasing; So the material volume is increasing, after the opposite cooling, the material volume has the trend of dwindling.The height above sea level Xi Gaodong of China is low; The PP of high altitude region production infusion bottle to the region of no relief of low height above sea level can produce the phenomenon of shrinkage distortion; Cause certain influence to use; Also let the people produce the problematic illusion of infusion bottle quality easily, thereby the PP infusion bottle that needs to solve highlands production produce distortion this " blemish in an otherwise perfect thing " to low height above sea level region of no relief.

Summary of the invention

The object of the present invention is to provide a kind of method that solves the distortion of polypropylene infusion bottle,, prevent the purpose of PP plastic bottle in low height above sea level region of no relief body shrinkage distortion thereby reach through improving the technology in the PP infusion bottle liquid medicine filling.

The invention discloses a kind of method that solves the distortion of polypropylene infusion bottle, it is characterized in that may further comprise the steps:

Drop to normal temperature (25-30 ℃) to fluid temperature when 1), preparation process makes up a prescription;

2), can operation is covered operation in weldering and is adopted not exhaust mode;

Adopt the pressurize of 0.24-0.28Mpa pressure when 3), sterilization process is warmed up to 80 ℃;

4), sterilization process carries out pressurize at holding stage with the pressure coefficient of 0.24-0.28Mpa;

5), sterilization process is in temperature-fall period exhaust during with 0.24-0.28Mpa pressurize to 80 ℃;

6), sterilization process cools to below 50 ℃ and offers for sale.

We know that with the rising of physical features, the earth reduces the gravitation of atmospheric envelope gas molecule gradually at the earth's surface, and the density of air molecule reduces; The temperature of atmosphere also reduces simultaneously.So at the earth's surface, with the increase of physical features height, atmospheric numerical value reduces gradually.In 2km, atmospheric value can be similar to thinks that linearity reduces with the increase of geography height; Beyond 2km, atmospheric value reduces gradually slow with the increase of geography height.So there is introduction in the past in the junior physics teaching material: in height above sea level 2 kms, can think 12 meters of every risings approx, barometric pressure reduces by 1 mm Hg.So the difference of pressure that product must bear to the low altitude area is necessary for 0.02Mpa (being equivalent to 2000 meters diff-Hs).

In common process, the fluid temperature when making up a prescription generally is controlled at more than 45 ℃, and the temperature that pours into the soup of plastic bottle can exceed much than ambient temperature; And can seal closure is tight immediately after the liquid medicine filling, spilling when avoiding liquid medicine filling or overflow bottleneck, the internal volume of general bottle has more more than 10% than the required volume that pours into liquid at least; That is to say; Retain the air more than 10% on the soup behind the hot filling in the bottle, this part temperature that retains air is the same with soup, when after after a while; When bottle inner liquid medicine and air are reduced to ambient temperature; Will cause negative pressure because of the liquefaction of expanding with heat and contract with cold with liquid Shanghai Automobile Factory in the bottle, when negative pressure surpasses bottle wall intensity, will cause the plastic bottle wall to cave in, be out of shape; In the present invention, just fluid temperature is dropped to normal temperature (25-30 ℃) when preparation process makes up a prescription, make the temperature of soup consistent, thereby avoided because of causing negative pressure because of the liquefaction of expanding with heat and contract with cold with liquid Shanghai Automobile Factory in the bottle with ambient temperature.

In sterilization process, flow process is water filling-intensification-insulated sterilizing-cooling-pressure release-drainage procedure.Pressure raise along with temperature build-up when sterilization heated up in common process; (general temperature is 115 ℃) pressure becomes constant voltage 0.22Mpa when reaching sterilizing state; (time is 30min) keeps the 0.22Mpa pressure sterilization always in sterilization process; Pressure reduces along with the reduction of temperature during cooling, and sterilization finishes when in-cabinet temperature is cooled to design temperature (55 ± 5 ℃).Like this product that comes out of sterilization in the highlands the rare problem on deformation that exists, but than almost all distortion of low altitude area.

In the present invention, soup came to life when sterilization was warmed up to 80 ℃, and pressure of the inside of a bottle begins to increase; Bottle outwards expands; For guaranteeing that bottle type and actv. guarantee that pressure must increase bigger pressure in the bottle in sterilization chamber, consider on the sterilization cabinet design bearing pressure to be limited to 0.3Mpa, sterilize near the upper limit with upward pressure as adopting 0.29Mpa; Security risk is bigger, so select 0.24-0.28Mpa to carry out the pressurize sterilization.

Cooled to before 80 ℃ in sterilization, bottle inner liquid medicine temperature is still higher, and pressure of the inside of a bottle is still bigger; Bottle outwards expands; After offeing for sale,, cool to 80 ℃, make sterilization back product bottle type more attractive in appearance so we take 0.24-0.28Mpa pressure to carry out pressurize because of its contractibility makes the product distortion.

The temperature that offers for sale height causes soup and Inside Air Temperature higher, and the bottle contractibility is bigger, when reducing to ambient temperature, will cause negative pressure because of the liquefaction of expanding with heat and contract with cold with liquid Shanghai Automobile Factory in the bottle.When negative pressure surpasses bottle wall intensity, will cause the plastic bottle wall to cave in, be out of shape.Reducing to offers for sale below 50 ℃ can make bottle interior temperature and ambient temperature be consistent, and prevents a bottle interior negative pressure distortion.

The present invention utilizes the characteristic of polypropylene material, when dosing, can and sterilization, improves pressure of the inside of a bottle, the invention has the advantages that through the improvement to dosing, can and sterilization process, adopts cold-aseptic filling, prevents to cause bottle to shrink because of fluid temperature is too high; Begin to adopt the pressurize of 0.24-028Mpa constant voltage for 80 ℃ in the sterilization intensification to cooling to 80 ℃ always; Prevent that bottle from change the polypropylene vial shrinkage percentage because of the variation of external temperature; Thereby influence the plumpness of bottle; Improve the critical external compressive resistance ability of bottle, guarantee that bottle shape is indeformable, solved the polypropylene infusion bottle produced at high altitude region problem in the low altitude area distortion.

The specific embodiment

The can of embodiment 1:500ml sodium chloride injection

(1) the liquid drug temperature is 28 ℃;

(2) adopt 115 ℃ of sterilising temps, sterilization 30 minutes, pressure coefficient 5.5 (0.26Mpa) to sterilize; Sterilization heated up since 00: 47;, sterilising temp begins to carry out pressurize when reaching 80 ℃ with 0.26Mpa pressure; Pressurize always went out when cooling to 50 ℃ to 80 ℃ of beginnings of sterilization cooling pressure release in 02: 55;

(3) the back product that offers for sale is full, and the bottle type is more attractive in appearance, and pressure of the inside of a bottle improves the critical external compressive resistance ability of bottle through detecting between 0.010-0.015Mpa pressure, guarantees that bottle shape is indeformable.

The can of embodiment 2:100ml5% glucose injection;

(1) the liquid drug temperature is 30 ℃;

(2) adopt 115 ℃ of sterilising temps, sterilization 30 minutes, pressure coefficient 4.8 (0.24Mpa) to sterilize; Sterilization heated up since 06: 24;, sterilising temp begins to carry out pressurize when reaching 80 ℃ with 0.24Mpa pressure; Pressurize was always offerd for sale when cooling to 50 ℃ to 80 ℃ of beginnings of sterilization cooling pressure release in 07: 54;

Claims

1. A kind of method that solves the distortion of polypropylene infusion bottle comprises soup preparation, liquid drug, sterilization process, it is characterized in that specific as follows:

Drop to 25-30 ℃ to fluid temperature when 1), preparation process makes up a prescription;

2), can operation is covered operation in weldering and is adopted not exhaust mode;

Adopt the pressurize of 0.24-0.28Mpa pressure when 3), sterilization process is warmed up to 80 ℃;

4), sterilization process carries out pressurize at holding stage with the pressure of 0.24-0.28Mpa;

5), sterilization process is in temperature-fall period exhaust during with 0.24-0.28Mpa pressurize to 80 ℃;

6), sterilization process cools to below 50 ℃ and offers for sale.