Five links of PVC bag infusion production

Point out the five links of PVC bag infusion production

due to the particularity of PVC (polyvinyl chloride) bag infusion in packaging materials, production process, storage methods, etc., its production is slightly neglected or lax, which will directly affect the quality of finished infusion products. According to years of practice, the production of PVC bag infusion should focus on the following five key links

■ one of the key links: select the bag body

PVC bag is made of non-toxic PVC plastic particles through high-temperature plasticization and heat sealing in a 100000 level clean environment. It is a clean and reliable packaging container for filling and infusion. Due to the differences in raw material sources, instruments and equipment, bag making process and technology among PVC bag manufacturers, the quality is also different. Therefore, PVC bag manufacturers with a certain production scale, perfect after-sales service and good social reputation must be selected

the quality of PVC bags is an important factor affecting the quality of infusion. PVC bags should have beautiful appearance, good gloss, uniform thickness of the bag body, small weight difference, high sealing degree of the bag body, and the pyrogen and particles in the bag should meet the standard. In addition, since the plasticizer and other impurities contained in the dissolved matter of the filled PVC bag have an impact on the pH value of the infusion after disinfection and sterilization, the PVC bag product with the least impact on the pH value of the infusion should be selected

domestic PVC infusion bags have single head pipe type, double head pipe type and multi head pipe type. The single head tubular bag has only one tube, which is inconvenient for clinical application and dosing. There are many tubes in the multi head tubular bag, so it is easy to enter particles and pollute the bag body during bag making and bonding. Because one tube of the double headed tube type bag is used for filling and infusion, and the other tube is used for clinical dosing and infusion, it is both beautiful and applicable. At the same time, PVC bags with heat sealing process for bag body and pipe shall be selected. The PVC bag with bonding process is easy to cause infusion leakage due to the weak bonding position, which affects the infusion quality and clinical medication safety

because the labels of PVC bag infusion are directly printed on the bag body, the labels of products of different varieties and specifications should be distinguished by different colors as far as possible, and the label instructions should be complete. The infusion name, specification, content, function and use, usage and dosage, precautions, storage conditions, batch number, validity, approval number, production unit and other items should be complete, with clear handwriting and good printing quality, The handwriting has no residual smell and is not easy to fall off

■ key link 2: infusion filling

the filling equipment of PVC bag infusion is roughly divided into liquid flow system and weighing and quantitative filling system. No matter which filling system is used, a certain amount (about 100ml) of liquid should be discarded at each filling nozzle before filling, so as to prevent particles from being brought into the filling pipe due to uncleanness. Practice has proved that when the residual air in the bag is greater than 5% of the capacity of the infusion bag, obvious expansion deformation or bag explosion may occur. Therefore, in the filling process, it is necessary to control the filling volume of infusion, completely exhaust the residual air in the infusion bag, heat seal the bag tube in time, and mark the initially filled infusion for the inspection of finished products

when heat sealing the infusion bag, the tube tail should be clamped and no liquid should flow out. Adjust the heat sealing temperature and time of the heat sealer to avoid the failure of sealing the infusion bag pipe during heat sealing or the leakage of liquid at the pipe head caused by melting during heat sealing. Always check the heat sealing performance of the heat sealer to make it in a good normal working state, and do a good job of moisture-proof and corrosion-proof maintenance

■ the third key link: disinfection and sterilization

before disinfection, infusion bags should be placed on the laminate of the disinfection rack in an orderly manner in rows, the tubes on the bag body should be unified in one direction, the printed label side of the bag body should be all upward, there should not be too much overlap between bags, and there should be a certain gap between the two laminates. It is necessary to reduce the mutual extrusion between the bag bodies and avoid affecting the disinfection and sterilization effect due to the blocked flow of high-pressure steam and uneven heating of infusion on the laminate

the most important link in the production process is to correctly select the temperature and pressure of disinfection and sterilization of PVC bag infusion. In domestic reports, hot press sterilization at 103 ℃ ~ 110 ℃ is generally used. When the author used 0.12 (± 0.01) MPa at 103 ℃ for 45 minutes, the bag burst rate was less than 1%, and the infusion was negative after sterility test and pyrogen test

moisture has a certain penetration effect on heated PVC bags. If the infusion bag is sprayed for too long after disinfection and sterilization, the surface temperature of the infusion bag will drop too much, which is not conducive to the evaporation of permeated water, resulting in the whitening of the bag body, the decrease of clarity, and it is not easy to recover. After groping, the author controlled the spraying time of infusion bag within two minutes, and achieved satisfactory results

■ key link 4: finished product inspection

during finished product inspection, samples should be taken from the upper, middle and lower layers respectively according to the position of the laminate of the disinfection frame, and the infusion at the four corners of the lower layer is the focus of sampling inspection. The infusion marked at the initial filling is a must. Practice shows that in the same batch of infusion, the number of bacterial endotoxin and particles of the initially filled infusion is often slightly higher than that of the later filled infusion, which may be related to the pollution of the infusion transmission pipeline. Therefore, it is necessary to strengthen the cleaning treatment of infusion pipelines. In addition to selecting high-quality stainless steel pipes or silicone pipes as infusion transmission pipelines, practical quality control measures should also be formulated

the inspection method of clarity of PVC bag infusion is similar to that of glass bottle infusion, except that the illumination of lamp inspection box should be twice that of glass bottle infusion, that is, 2000 ~ 3000 liters. In practical work, it is difficult to check the clarity due to the interference of bag body and label, but the light inspection must not be avoided

■ key link 5: storage

in the stored PVC bag infusion, liquid leakage and even mildew are occasionally found, which is mainly caused by the loose adhesion between the bag body and the pipe of individual infusion bags, or the pipe cannot be sealed or even melted when filling infusion. In order to effectively solve the problems of permeability, water permeability and liquid leakage mildew of PVC bag infusion, it is necessary to put plastic outer packaging on the outer sleeve of the infusion bag. Plastic bags with high density and low water permeability should be selected for the plastic outer packaging of infusion bags, and the effect of vacuum packaging is better. When mildew spots are found on the external surface of the bag, the outer packaging should be removed immediately, and the outer packaging should be carried out after wiping with an effective disinfectant in time (1% chlorhexidine alcohol solution is better). A layer of packaged rigid plastic baskets for infusion. 3. System solutions: provide a set of spray free material system solutions, including mold design, process design, dynamic load impact, impact pressure test, etc., which are completely driven by this national policy: (1) structural design: Moldflow engineers provide the optimization scheme of product structure. The number of layers should not be too high, the infusion baskets should not be too full, and the top plastic baskets should be covered. The air in the storage room should be circulated, and the correct use method of the ring stiffness tester and the appropriate temperature and humidity for the normal protection of the equipment should be maintained. In order to ensure the quality of PVC bag infusion and the safety of clinical medication, it is necessary to conduct a comprehensive sampling inspection again after the finished product is stored for 3 months

source: China Medical News