Ruide Study

Currently, commonly used infusion flexible packaging materials are polyethylene (PE), polypropylene (PP), polyvinyl chloride (PVC) and ethylene-2-vinyl-acetate-copolymer (EVA).

This article focuses on the intricacies of PVC infusion bags in medical use.  With the combination of Ruide Tech team's experimental results and manufacturing experiences,  targeting on 1. drug adsorption, 2. migration of PVC residues, 3. ventilation and moisture permeability of PVC infusion bag, to describe the safety problem of PVC infusion bag, and put forward the corresponding improvement method accordingly.

1. Drug adsorption

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2. The transfer of harmful substances in PVC bags

PVC infusion bag is one kind of multi-component plastic material. In the molding process, in order to improve the properties of finished products or processing conditions, the manufacturer will normally use plasticizers, heat stabilizers and other additives. In addition, vinyl chloride is toxicity in a certain degree. Besides, PVC may have residual vinyl chloride monomer presence. Therefore, the study of the transfer of PVC infusion bag components is of great significance, which can guarantee the quality and safety of drugs.

2.1 The transfer of plasticizer

PVC is a hard material, in order to make it transparent and soft, the manufacturer will add plasticizer dioctyl phthalate (DEHP) in manufacturing processes. Polyvinyl chloride (PVC) with DEHP is widely used in the production of medical equipment, such as intravenous infusion bags, blood bags, peritoneal dialysis bags. DEHP is considered to be an environmental endocrine disrupting factor that is toxic to multiple systems in the body, especially in male newborn and adolescent. Some studies have confirmed that DEHP is carcinogenic, teratogenic.

DEHP is a fat-soluble liquid, it can not be covalently bonded to the PVC molecules. It is easy to precipitate from the plastic, and in the infusion process it will transfer to the liquid, and then enter the body with the liquid, cause some health problems, or bring new health risk to the patient. Some studies have shown that phthalate plasticizers can transfer from plasticized PVC medical devices and storage bags to stored liquid. Ruide Medical used to determine the release of DEHP after loading two different types of PVC infusion bags in different liquids (0.9% sodium chloride solution, different concentrations of ethanol solutions). The results showed that these two kinds of PVC infusion bags had a small amount of DEHP dissolved after filling 0.9% sodium chloride solution. These two kinds of PVC infusion bags were found with DEHP dissolved after filling different concentrations of ethanol, and with the increase of ethanol concentration, The amount of DEHP dissolved in the two kinds of PVC bags was 12.9μg / mL and 15.9μg / mL, respectively. Our team uses gas chromatography 2 mass spectrometry (GC2MS) method to identify PVC infusion bag with hot distilled water containing cetyl alcohol, plasticizer phthalic acid, and its derivatives; PVC infusion bag filled with 0.9% sodium chloride, 5% glucose sodium chloride, 5% glucose, 10% glucose, 0.25% metronidazole glucose and injection of water were detected diethyl phthalate, 22 acetyls benzoic acid, and other impurities. In addition, even in a neutral water environment, the plasticizer will dissolve after a period of time, the amount of elution goes with PH and temperature.

2.2 The transfer of PVC macromolecules

It was reported that during use of PVC infusion bag filled with paclitaxel 5% glucose, scientists found out that a lot of white flocculent aggregates appear in the liquid. As per related analysis and research, paclitaxel is an oil-soluble drug, in the production process using polyoxyethylene castor oil as the solvent. PVC can be dissolved in polyoxyethylene castor oil, resulting in an infusion of insoluble floc. Therefore, in order to avoid medical malpractice, the infusion of paclitaxel injection should avoid the use of PVC infusion bags and PVC infusion sets.

2.3 The transfer of other harmful substances

PVC is widely used during the production of infusion equipment, in order to prevent resin degradation, usually with calcium, zinc, barium and other elements of the stabilizer, the metal ions in the infusion process may transfer out, with the liquid or blood products into The human body, the impact on human health.

A small amount of vinyl chloride monomer that is left in the PVC resin or is decomposed by the resin during processing has been tested to be a carcinogen. The dissolution of vinyl chloride monomer in infusion bags has not been reported.

To solve the above problems, Ruide Medical developed non-DEHP PVC raw materials. This material can avoid DEHP precipitation, reduce security risk during application. In addition, Ruide Medical has very strict control of PVC raw materials. All PVC raw materials are sourced from world-class suppliers, and we have a strict system to take regular assessments of each batch of raw materials, to ensure the safety and reliability of raw materials.