Aseptic filling BFS technology

As the FDA continues to raise the level of sterility, pharmaceutical manufacturers are faced with the challenge of “how to meet the requirements and find the most economical packaging solution”. The challenges faced by pharmaceutical companies have promoted the development of blow-fill-seal technology and equipment, making it an important method for the aseptic filling of pharmaceutical solutions. In fact, the blow-fill-seal three-in-one technology integrates the three steps of blow-molding of containers, aseptic filling of liquids, and container sealing into a single process to complete the aseptic packaging process. The entire production process guarantees sterility and combines all major production steps. As far as the bottelpack device itself is concerned, it is like a small factory.
Small-capacity injection ampoules using Ruhr's mouth Cost savings

For single-dose liquid packaging, the choice of blow-fill-seal technology is the best way to save money.

First of all, single-dose containers produced by the blow-fill-seal triple-in-one technology, especially polypropylene (PP) bottles used in hospitals, can replace glass bottles, thereby maximally avoiding product packaging damage and ensuring Safe medication.

Second, with the same specification of containers, the production cost of using the blow-fill-seal technology is significantly lower than the production cost of glass bottles. Using a piece of equipment to replace three machines, including fillers, stoppers, and capping machines, can save a considerable portion of costs. Moreover, the traditional aseptic filling requires a lot of manpower, and the fully automatic blow-fill-seal triple-in-one device saves on excessive labor costs, and at the same time can avoid the operator's interference with aseptic production. High sterility level protection.

Wide application

Today, in the pharmaceutical industry and the entrusted packaging industry, a wide range of products are being packaged using blow-fill-seal technology and equipment, and plastic raw material varieties that can be used for blowing-filling-sealing three-in-one equipment More and more. Of course, not all liquid products are suitable for filling with blow-fill-seal tripler devices. Volatile and viscous are two limiting factors. So far, most of the blow-filling- Sealing three-in-one equipment can only use polyethylene PE and polypropylene PP materials.

Rommelag Romgege recently introduced a BFS tripler with multi-layer co-extrusion technology to produce multilayer containers with barrier layers for superior performance. This opened up a new situation for drug packaging. The BFS blow-fill-seal three-in-one device can package high-viscosity syrups, such as syrups, ophthalmic ointments, and gynecological ointments, as well as vitamins or supplements. Alcohol's "active" product.

Increase in demand

With the technological innovation and market development, the demand for aseptic production is constantly increasing. At the same time, a single-dose container also exhibits many advantages: it is convenient and practical, does not require long-term preservation, and has a potential market for numerous applications in nasal medicine, contact lenses, and ophthalmic care. At the same time, the use of single-dose containers can also prevent the occurrence of infectious diseases in hospitals.

At present, 85% of the single-dose containers produced by the BFS blow-fill-seal triple-instrument are used for drug packaging. Eric Goupil, CEO of Unither of Amiens (France), stated: "For physiological fluids, the demand for consumers will increase by 15% to 20% if they are packaged in aseptic single-dose containers." To occupy the growing market In 2002, Unither acquired the pulp mill of Sanofi-Synthelabo in Coutances, France. The purpose of this acquisition is to be able to put the BFS blow-fill-seal triple-in-one equipment into production in 2004, increase production capacity, and enhance the ability to compete with world-class competitors. To this end, Unither invested 20 million euros in the renovation of the Coutances plant. In addition to the company's six other high-speed single-dose BFS blow-fill-seal triples, Unither announced that its nine-unit capacity has reached an annual production of 1 billion units. This record made it surpass the German holopack company and became the leader in France and throughout Europe.
Blowing-filling-sealing integrated machine

Small volume injection ampoule bottle using Ruhr mouth

At present, no matter whether it is a large-volume injection drug solution or a small-volume injection drug solution, whether it is a multi-dose ophthalmic drug or a single-dose ophthalmic drug, or an inhaled drug, these products are widely used in plastic packaging containers.

The plastic packaging container meets the various factors that pharmaceutical products need to consider when selecting packaging materials, such as quickness and convenience in operation and use, potential risks, avoidance of injuries, and safe and environmentally-friendly disposal of waste, which also lead to plastics. The reason why packaging containers are widely used.

Rommelag's newest ampoule plastic packaging form - Luer's small-volume injection ampoule ampule, which uses BFS technology for aseptic production and is suitable for packaging all small volume injections. Before we introduce it, let's take a look at the production process of traditional glass ampoules:

The typical glass ampule production process is as follows:

Printing and Labeling of Empty Glass Ampoule Bottles/Cleaning and Sterilization of Empty Glass Ampoules/Aseptic Filling and Closure with Ampoule Fillers/Sterilization of Sterilizers/Blue Dye Leak Detection/Check/Packing and The above methods have obvious differences. The process of using the BFS blow-fill-seal three-in-one method to produce plastic ampoules is very simple: under aseptic conditions, plastic particles are molded in the mold and filled with liquid. seal. The ampoule container is then leak tested, checked, sterilized, and packaged.

Simply put, the main advantages of plastic ampoules are:

* No liquid needle extraction * Fingers will not be cut or stabbed * There is no glass, bacteria or plastic granules in the liquid * No damage to the container during operation * Convenient storage and transportation * Safe and pollution-free waste disposal

Ruthenium with Luer can bring obvious benefits to users. The head of the ampoule can be twisted off quickly, making the opening of the ampoule more convenient. Thanks to the unique ampoule/syringe connection system, needleless direct withdrawal of the drug solution can be performed using only the standard Luer taper syringe or a syringe with a Luer lock ring. Needle-free liquid extraction can eliminate the danger brought by the sharp needle tip. At the same time, the ampoule will completely collapse, ensuring that there is no residual liquid in the bottle. Another important feature is that the ampoule can be safely placed on the syringe before use, and the medical staff can easily identify different drugs to facilitate the safe management of the drug. (Finish)

Source: International Pharmaceutical Processing and Packaging