Plastic intravenous fluid containers

FIGURE 2.7 A plastic intravenous fluid container contains 1000 ml. 

Moorhatch, R, and Ciou, W. L. (1974), Interactions between drugs and plastic intravenous fluid bags. II. Leaching of chemicals from bags containing various solvent media, Am. J. Hosp. Pharm., 31,149-152. 

Diazepam in intravenous fluid containers and administration sets exhibited a loss during storage due to adsorption onto and absorption into plastics [11,12],... 

The rapid movement in the global phthalates market away from using plasticisers 2-ethylhexanol (2-EH) and diethylhexyl phthalate (DEHP) in favour of alternative products was underscored recently when BASF revealed plans to close its 2-EH and DEHP plants in Germany. The restructuring in Europe will have no effect on BASF s plasticiser portfolio in Nafta and Asia, however, where the company will continue to offer 2-EH and DEHP. About 70% of the plasticiser maiket volume is phthalates, and plasticisers make up about 60% of the plastic additives maiket. PVC accounts for 80-90% of global plasticiser consumption. In October 2003, California added DEHP to the state s list of more than 750 chemicals known to cause birth defects or reproductive harm. Previous studies had shown that the chemical can leach from plastic bags that contain intravenous fluids, blood, tube feedings or other medical treatment, and thereby enter the bodies of patients. 

PP is often combined with PE to achieve desirable properties from both compounds. Commonly selected for its strength, resiliency, and gas/water impermeability, PP commonly constitutes closures and seals. Bags for packaging intravenous fluids are often manufactured from PP stock. Although not commonly utilized in the U.S.A., PP can also be used as a moisture barrier as one layer of a blister pack film. As with all plastics, though, manufacturers of PP should assure users that no additives leach out of the PP resin into the pharmaceutical preparation and quality testing specifications are contained in the USPp ... 

Plastic containers are also widely used for packaging parenteral products, such as intravenous (IV) infusion fluid containers, irrigation fluid containers, prefilled disposable syringes, and some administration sets. Polymeric containers have an added advantage of low breakage and are preferred when the SVP product is a highly toxic material such as oncolytic drugs. Typical polymeric... 

Blow-fill technology is an aseptic process whereby the container is formed from thermoplastic granules, filled with sterile solution and sealed, all within one automatic operation. The bulk solution should have a low bioburden and is delivered to the machine through a filling system that has been previously sanitized and steam sterilized in situ. Concern has been expressed that the machine itself may generate particles. The plastic granules are composed usually of polyethylene, polypropylene or one of their copolymers and are heat extruded at 200°C into a tube. The two halves of a mould close around this tube and seal the base. The required quantity of sterile fluid is filled into the container, which is then sealed. Products packed in this way include intravenous solutions, and small volume parenteral, ophthalmic and nebulizer solutions. The... 

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