First, the characteristics of multi-cavity bag
Multi-cavity bag technology is very advanced for the current packaging industry, with the following characteristics:
1, drug safety
By opening the virtual welding between the chamber, the multi-chamber bag technology realizes the preparation in a closed environment, completely eliminates the possible microbial contamination and dispensing errors in the preparation, and prevents hospital infection. At the same time, the environment is low, and there is no need for a special sterile dispensing room when dispensing drugs.
2, fast operation
There is no need to use pumps, syringes, pipelines and other auxiliary facilities, which can greatly shorten the mixing time of medicine, and highly reflect the rationality of drug use.
3. Environmental Protection
The bag body material is non-PVC film, does not contain phthalate esters such as DEHP[diethylhexyl phthalate] and other plasticizers, reduce the environmental pollution of medical waste.
4. Energy saving
It can reduce the storage space of drugs in circulation and medical units.
5. Emergency needs
Especially suitable for rescue, disaster relief, emergency, field rescue, war and other characteristics.
Second, the type and formula of non-PVC multi-cavity bag infusion packaging film
1, packaging film type
From the packaging drug state can be divided into liquid liquid and powder liquid two types, these two types have different requirements for the virtual welding heat bonding strength of packaging film; From the solubility of packaging drugs can be divided into two types of fat soluble and aqueous solution, the two types have a great difference in the selection of packaging film inner layer materials; The sensitivity and hygroscopicity of packaged drugs to oxygen can be divided into low barrier and high barrier, and these two types have great differences in water and gas barrier.
2, packaging film structure and formula
At present, there are two common structures, the first type is the United States Xiyuer company products as the representative of the five-layer structure, its main composition is: modified ethylene-propylene copolymer/polyethylene/polyethylene/ethylene methyl methacrylate polymer/ester copolymer, the five-layer thickness ratio is: 15%/5%/65%/5%/10%, the inner layer is a blend of polypropylene copolymer and elastomer SEBS(styrene-ethylene-butylene styrene block copolymer, styrene-ethylene-butene-styrene block copolymer). By adjusting the content of ethylene monomer in the copolymer and the proportion of elastomer SEBS, the range of heat sealing window was changed to achieve real welding and virtual welding, and the cooking resistance was better. In the middle, polyethylene is used to improve the softness of the film. The outer layer of ester copolymer has good heat resistance and printing coloration.
The second type is a three-layer structure represented by German Polisini Company and Baxter Company products, which is mainly composed of: PP, PE, PB copolymer and SEBS mixture /PP, PE copolymer and SEBS mixture /PP and SEBS mixture, the ratio of three layers is: 15%/70%/15%, the inner layer is a mixture of polypropylene terpolymer and SEBS, by adjusting the content of ethylene butene monomer in the terpolymer and the proportion of SEBS to change the range of heat sealing window, achieve real welding and virtual welding, and excellent cooking resistance and water resistance; The middle layer is polypropylene binary copolymer blended with SEBS to increase the softness, toughness and low temperature resistance of the film. The outer layer is homopolymer polypropylene blended with SEBS to provide heat resistance and printability. The three layers of materials are added with a certain proportion of SEBS(styrene-ethylene-butene-styrene) to improve the softness and reduce the crystallinity of the entire film, so as to avoid the temperature of the film during cooking, which will cause the increase of crystallinity and affect the transparency, hardness and brittleness.
The inner layer of the above two formulations is non-polar polymer, which is not suitable for high-frequency welding. The melt crystallization of the inner layer material during high temperature hot pressing leads to high liquid leakage rate of the finished product bag, and the poor gas resistance of the two films is not suitable for direct packaging of oxygen sensitive drugs such as fat milk and amino acids. Expensive high barrier outer bag film needs to be vacuumed for packaging. The quality of drugs is unstable and the application range is narrow.
To this end, Hubei Hengtai Rubber & Plastics Co., LTD., after research and development, launched a new five-layer structure, its main components are: EVA/ COC(cyclic olefin copolymer)/ polyethylene/vinyl acrylate polymer/ester copolymer. The inner layer EVA is copolymerized by ethylene and vinyl acetate. It does not require any plasticizers and stabilizers to be added during processing. At the same time, its excellent flexibility, low temperature resistance, aging resistance, heat sealing and other aspects are better than PVC. EVA is a polar polymer, which can be realized by hot pressing and high frequency welding to achieve real welding and virtual welding, which can reduce the leakage rate of finished bags, especially suitable for packaging fat soluble drugs; The secondary inner layer is COC instead of traditional polyolefin. COC material has no unsaturated double bond, triple bond or aromatic ring structure, so COC material has better heat resistance and oxidation resistance characteristics, and its thermal cracking temperature can be higher than 400℃. In addition, COC materials use non-toxic monomers as raw materials (cycloolefin monomers), and the polymer purity is extremely high, with transparent, very low water permeability, no cytotoxin, no induced organism mutation, no stimulation, in line with FDA standards and other characteristics, thus greatly improving the film barrier, temperature resistance and safety, to solve the barrier problem of ordinary packaging film.
3. Production process
At present, the non-PVC multi-cavity bag infusion packaging film used in China is produced by blow molding method, and there are two main categories: one is the five-layer co-extrusion blowing air cooling process represented by Xiyuer; The other is the three-layer co-extruded blowdown water cooling process represented by the German Polysini company.
As far as is known in the world, only Germany Fresenius Company and Baxter Company in the United States use the rolling method to produce non-PVC multi-cavity bag infusion packaging film, and mainly to their own pharmaceutical factory supporting, small output is not external supply.
The other five-layer structure formula contains low melting point polymers such as polyethylene and ethylene-vinyl acetate copolymer. In order to meet the sterilization requirements of high temperature (115 ~ 121℃, 12 ~ 30min) in infusion production, it must be cross-linked by electron beam radiation to improve the temperature resistance of the packaging film. The electron beam also radiates the packaging film for sterilization, which is more suitable for packaging aseptic powder.
Four, the main production equipment
1, five layer co-extrusion film production equipment (Canada Byton company manufacturing)
Extrusion system: five extruders (inner and outer screw φ45mm, secondary inner and outer screw φ40mm, intermediate layer screw φ75mm), five layers of co-extruded plane superposition die head.
Up-blowing foam forming system: double lip air ring, inner bubble cooling (IBC), outer bubble cooling, bubble diameter control device, first traction device.
Rotary winder: 360. Rotary traction device, second and third traction device, tension control device, surface and center winding device.
Radiation crosslinking device: Linear electron accelerator (0.8Mev, 50mA)
2, three-layer co-extruded film production equipment (Guangdong Jinming Plastic Equipment Co., LTD.)
Extrusion system: three extruders (inner and outer screw φ45mm, middle layer screw φ75mm), three layers of co-extruded bevel superposition die head.
Downblown bubble forming system: single lip air ring, bubble stabilizing device, cooling sizing water ring, herringbone plate, first traction device, collecting tank.
Rotary winder: 360. Rotary traction device, second and third traction device, tension control device, surface and center winding device.