IV bag manufacturing process

IV bag manufacturing, PolyPropylene films that package your health

Flexible bags have become the primary packaging of choice for a wide range of injectable pharmaceutical products. Ready to administer or to reconstitute, these drugs require sterile containers that are efficient, reliable, and secure due to their intravenously administration and are therefore mainly used in hospitals. Manufactured since their first appearance in the 1970s, flexible infusion bags are today mostly made from PolyPropylene based materials.
The design of the pouches requires solid expertise; thus, the role of the raw material is essential. The films must not only be inert and compatible with the active ingredient and its excipient, but they must also provide protection with barrier properties while complying with international pharmacopoeias. PolyPropylene films developed by Polycine, have the lowest sorption potential, extremely low bioburden, and have the lowest extractables and leachables. Qualities that characterize our Advanced PolyPropylene and PolyEthylene film series!

Polycine also offers multilayer co-extruded films in tubular form, or according to the request, cut on each side to obtain a double film before being wound on the reel. A choice depending on the design and volume of the bag to be manufactured. The film manufacturing process is carried out in a controlled class 10.000 environment, using medical grade raw materials free of any toxic substances. The films are thus perfectly adapted for the design of bags used for the packaging of antibiotics, painkillers, or the preparation of cytotoxic drugs in hospitals.

Flexible primary packaging, a complex manufacturing process that requires high-quality films

From a technical point of view,our film series are compatible with a wide variety of industrial tools for the manufacturing of flexible containers. Starting from the smallest volumes to large bags used for Dialysis The process of removing excess water, solutes, and toxins from the blood in people whose kidneys can no longer perform these functions naturally. This is also referred to as renal replacement therapy. , as well as process bags used in bioproduction. They are also perfectly suited for Form Fill Seal ( FFS Form Fill Seal
A process of bagforming "F" where the goods are also filled "F" into the container and sealed "S" afterwards in a fully automated machine. It's the most widely used process for the production of infusion […] ) machines, a turnkey solution that allows the manufacturing of the bag, its filling and sealing in a closed sterile chamber of the machine.

During the manufacturing cycle of a bag, the film undergoes different stages, which can differ depending on the complexity of the bag, or bag design. First the printing of the bag is done via a hot stamp transfer film ( APF Advance Print Foil
Hot stamping/printing film is a foil used in printing the labels on IV bags by transferring ink to a surface at high temperatures. ), thermotransfer foil or inkjet. Then, comes the separation of the film layers where the tubes are inserted and welded, followed by the contour-welding of the bag design. Each bag is then separated individually and subsequently robotically, or manually placed into the filling stations where each infusion bag is then filled through filling tubes. Ports are then inserted.

The welding of the bag’s body and the tubes is the step that requires expertise and careful attention since the quality of the welding can affect the tightness of the container. The procedure known as thermal welding consists of heating the film, previously cut according to the required format, to its melting temperature. It seals the bag hermetically, but it can also form internal seals to produce double or multi chamber bags. This is an alternative to separately pack unstable products, such as antibiotics that need to be reconstituted just before administration to the patient.

Concerning the quantity of the inserted tube(s), the amount is dependent on the final product. For example, ready-to-administer ( RTA Ready to Administer Drugs
Pre-packaged and ready for immediate administration without additional preparation. ) drugs are more often packaged in single-container bags with a single tube and connector for administration. Drugs requiring preparation, such as total parenteral nutrition, will be packaged in two-tube bags, where the second tube is allowing the injection of a product (reconstituted or not) into the bag.
Thus, films, tubes and connectors form a completely closed system where each element is compatible to ensure the integrity and the purity of intravenous drugs until their use. “