Plastic soft bag infusion packaging technology research
Release time：2016/5/7 11:07:51 Click times：1379
Transfusion is refers to by a large dose of intravenous drip enter the body fluids, is one of the clinical commonly used five agents, it provides patients with the required water, electrolyte and nutrients, also can be used as a drug intravenous drug delivery carrier. Since of the ninth five-year plan, the infusion production got a steady and healthy development of our country, the output from 1.38 billion bottles in 1995 (bag) growth in 2001 to 2.91 billion bottles (bag), the average annual growth of 16.1%, infusion of market capacity up to 3.5 billion bottles of 2003 (bag). At present, the infusion production using the packaging forms are: glass bottles, plastic bottles and plastic soft bag packaging, the plastic soft bag packaging is divided into PVC (polyvinyl chloride) bags and non PVC soft bag packaging.
1, the glass bottle infusion packaging technology
Glass bottled infusion has long been the main form of infusion packaging in our country, at present our country still use a glass bottle packaging 95% infusion. Glass bottled infusion as infusion of traditional packaging form, mainly has the following advantages:
1) the transparency of glass bottles is good, is advantageous to the infusion of insoluble particles detection.
2) glass bottles good thermal stability, be helpful for transfusion used in the process of production of high temperature sterilization in addition to bacteria, guarantee the quality of infusion.
3) has a good chemical inertness, barrier property and impermeability, ensure the quality stability of drug storage period.
But infusion using glass bottle packaging this technique has certain defects, mainly include:
1) transportation inconvenience, use limited geographical scope. Glass bottle high brittleness, easy because of the violent vibration and impact fracture, so the glass bottle infusion is not suitable for long-distance transportation, limit the geographic scope of the application.
2) technology is complex, the production efficiency is low. Infusion using glass bottle packaging, compared with other infusion packaging technology, the production process increases the stopper, the isolation membrane and glass bottles washing this several complex working procedures, process route is longer, production cycle is relatively longer, so the production efficiency is low.
3) high production cost. Due to the complexity of process route, equipment, covers an area of more wide, equipment investment cost and housing construction cost is higher, and in the process of handling of packaging containers and materials need to cost a lot of water, so the production cost is higher.
4) clinical use, unsafe. Medical staff when using glass bottle infusion syringe, want to prick stopper already, again want to wear out polyester film, inevitably introduces insoluble particles in infusion, transfusion insoluble particles can block the body in the microcirculation, and even cause bleeding platelet solubility < 2 >; In addition, clinical application, in order to make the infusion process can go smoothly, ventilation pipe to be inserted to the solution into the air, producing pressure differential, infusion in a state of full open at this moment, the dust in the air and microbes may enter the infusion bottle and pollution, lead to serious transfusion reaction.
Glass due to the heavy quality, high brittleness, easily damaged, inconvenient to carry and transport, therefore, in the 1960 s, with plastic containers as appeared on the international container of infusion, the end of the glass bottle infusion packaging technology the situation of unify the whole country.
2, plastic bottles, infusion packaging technology
Plastic bottle infusion packaging technology, mainly based on polypropylene (PP) and polyethylene (PE) as the material of packaging container. Our country is in 1984 by tianjin otsuka pharmaceutical company first introduced polypropylene gum bottle packaging production technology, to produce the first bottle PP bottled infusion in our country. The advantage of plastic bottle infusion packaging technology is:
1) light weight, the bottle weight is only 1/5 of the glass bottle weight, and not easily damaged, is advantageous to the long-distance transportation.
2) plastic chemical stability, good barrier property and the compatibility with drug, is advantageous to the long-term preservation of liquid.
3) advanced technology, high production efficiency. In the production of plastic bottles infusion, bottle blowing and filling in the same production area, even on the same machine, bottle with sterile air purge, even without washing directly to filling, eliminating the glass bottled infusion complex washing process, shorten the production cycle, improve production efficiency.
Although plastic bottle packaging technology overcomes the glass bottle packaging technology, not easy to transport and production efficiency is low, but must see plastic bottled infusion there are still some problems:
1) in clinical application, transfusion safety problems, plastic bottled infusion and glass bottled infusion, belong to the open way of transfusion, still needs to be inserted into the air in the process of using needles, set up air channel, to make the infusion drip smoothly, microorganism and particles in the air is still can be introduced into infusion needle through the air, causing damage to the human body.
Transparency than 2) plastic bottles, which is unfavorable for infusion clarity.
3) plastic inferior to the thermal stability of glass bottles, PP plastic bottles is not good low temperature resistance,
Encounter cold brittle, craze, PE plastic bottles is not high temperature resistant, sterilization cannot achieve the FDA when required by the 121 ℃.
3, plastic soft bag infusion packaging technology
In order to solve the problem of safety in bottled transfusion clinical application, plastic soft bag infusion packaging technology arises at the historic moment. Using this kind of packing technology infusion, can realize the fully enclosed infusion, clinical use because of the soft bag since the contractility, without having to form air circuit, using the outside atmospheric pressure extrusion would have forced medicine liquid drop out, avoid the open style infusion security hidden danger, to improve the safety of the transfusion. Plastic soft bag infusion packaging technology, according to the soft bag material into PVC soft bag packaging technology and non PVC soft bag packaging technology.
3.1 PVC soft bag infusion packaging technology
PVC soft bag packaging technology, compared with infusion glass bottles, plastic packaging technology, has the following advantages:
1) using PVC soft bag packaging, small volume, light weight, is lighter than the quality of the plastic bottles, save the storage space of hospitals and manufacturers, is more advantageous to transport and carry, it overcomes the glass bottled infusion quality heavy, big volume and easy broken inconvenient transportation and carrying, and bottle container need more storage space of faults.
2) PVC soft bag has the characteristics of compressive strength, the breaking force strong, easy to transport and emergency space-time putting-in-service proactively, this is a soft bag packaging an important characteristics of different from bottled infusion.
3) better transparency, is inferior to glass bottle, but better than the plastic bottles, do not affect the clarity check, can overcome the disadvantages of plastic bottles infusion clarity is poor.
4) realized the totally enclosed infusion method, clinical use, overcome the bottled infusion of secondary pollution problem, improve the security of the infusion.
5) simple process, high efficiency and low cost. PVC bag infusion bag making, filling and sealing process is in 10000 control environment (filling and sealing at the local level 100) under laminar flow protection in bag making, filling and sealing machine, bag making directly without cleaning after filling, compared with the glass bottle packaging technology, dispense with complex adhesive, polyester film, glass cleaning process. Greatly shorten the production technology, production efficiency was improved. At the same time, save a lot of washing water and land production plant area (in the production of glass bottled infusion glass bottles of storage, clean workshop, rubber plug storage, clean workshop, etc.), and PVC material price is low, fluids, production costs are reduced.
Although PVC soft bag infusion packaging technology exist above a lot of advantage, but there is still a fatal weakness, limit the promotion of PVC soft bag packaging technology:
1) PVC soft bag for wet steam, water, air barrier property of the poor and vulnerable to water, wet steam, and air permeability, is not conducive to long-term storage of liquids.
2) PVC soft bag for some drugs such as: oil soluble vitamin, insulin, different yamanashi nitrate ester, chlorpromazine, etc., there is a certain adsorption, reduce the effectiveness of drugs.
3) PVC soft bag dissolution content more, 2 ~ 5 microns on the number of insoluble particles than other packaging container, may cause vascular embolization, vein inflammation and allergic reactions.
4) a potential hazard to human health and the environment, PVC soft bag added during the production of plasticizers phthalates (DHEP), although can make PVC flexible packaging become soft and elastic. But the study found that this kind of material is a kind of carcinogen, which can dissolve from infusion, damage to health of patients. PVC soft bag infusion as disposable products, produce harmful gases, the dioxin pollution when burned in the disposal after the atmosphere, have a great harm to the environment. In view of this national drug testing bureau has made it clear that stopped approving new PVC soft bag infusion packaging manufacturers.
3.2 the PVC soft bag infusion packaging technology
The above three kinds of infusion packaging technology although each has advantages, but also have some shortcomings, so whether there is a new kind of infusion packaging technology, the advantages of both the 3 kinds of packaging technology, and without its defects? This is the European and American developed country in the 90 s developed the PVC soft bag packaging technology. In Japan, the infusion of non PVC soft bag packaging has accounted for 60% of the whole transfusion market.
Non PVC soft bag packaging technology has experienced two stages, one is in the 1980 s and 90 s of the polyolefin composite film packaging technology, soft bag by a mix of different membrane materials processing, usually for 3 ~ 5 layers. Polyolefin composite film light weight, high transparency, good for water, moisture, air barrier property, good heat resistance, chemical stability and drug compatibility, is a kind of ideal packaging material, but because in the process of preparation of composite membrane, used adhesive between the layers of film, is not conducive to the stability of the membrane material, the potential impact on the stability of the solution existence at the same time, so the application of this technology in the infusion production by a certain degree of influence; Second, in recent years to improve the technology of polyolefin multilayer co-extrusion film packaging technology, the technology used in the process of making soft bag multilayer polyolefin material melt crosslinking extrusion at the same time, don't need to add adhesive, eliminates the glue on the bad influence of membrane material, the stability of the liquid.
At present more popular polyolefin multilayer co-extrusion film is three layers structure commonly. Commonly used polyolefin multilayer co-extrusion film have 2 class, one kind is the inner, middle, adopts the polypropylene blended with different proportion of elastic material, non-toxic, inertia and good heat sealing, outer as high mechanical strength of the polypropylene or polyester material; The second category is the inner USES polypropylene with styrene ethylene butene styrene copolymer (SEBS) hybrid materials, middle-level using SEBS, outer with polypropylene materials.
Polyolefin multilayer co-extrusion film soft bag, bag making process does not use adhesive, plasticizer, and membrane material without dissolution, not to drop crumbs, for the soft bag infusion provides the guarantee for safe use of membrane material is easy to heat sealing, flexibility good impact resistance, temperature tolerance range, having high temperature resistant to sterilization under 121 ℃, and resistance to low temperature 40 ℃ (-); High transparency, good clarity; Good chemical inertness, drug compatibility is suitable for packaging of various fluids; Excluding chloride post-processing is harmless to the environment; Production process is simple, high degree of automation; Clinical transfusion soft bag can completely autogenous shrinkage, realize the fully enclosed infusion, avoids the infusion of secondary pollution, transfusion safety is high. Currently the only shortage is membrane material price is higher, and special bag making, filling and sealing equipment is imported more, prices high, so the production cost is higher than other packaging technology. But the good news is that the recent domestic hunan qianshan mountain company has developed has reached the international level of similar equipment, price is 1/3 of the imports, as domestic continuous digestion and absorption of the technology, the cost of production also will continue to decline.
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