Three-in-one blow-fill-seal technology for aseptic filling

As the FDA (Federal Food and Drug Administration) 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 three-in-one technology of blow-fill-seal combines 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." Rommelag Rowe Hubert Berrebi, trade manager at Muller, said, "The entire production process guarantees sterility and brings together all the major production steps. For the bottelpack itself, it is like a small factory."

saving cost

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. Mr. Berrebi said: “Rommelag ROHM has recently introduced a BFS triple device with multi-layer co-extrusion technology that can produce multi-layered containers with a barrier layer and has excellent performance.” This opened up new possibilities for drug packaging. Situation, using BFS blow-filling-sealing three-in-one device can pack high-viscosity syrupy liquids, such as syrups, eye ointments, gynecological ointments and other drugs, and "active" products containing vitamins or alcohol.

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.

Unither's single-dose packaging medicine production process

Unither of Amiens (France) is a model for single-dose production using the blow-fill-seal technology. In order to implement the blowing-filling-sealing three-in-one technology on a large scale in the future, the Unither of Amiens (France) company acquired the Sanofi-Synthelabo pulp mill in Coutances, France, in 2002. To this end, the company has invested 20 million euros for the renovation of the plant since April and added three blow-fill-seal high-speed machines for the treatment of ointments and asthma. . The following is a description of the packaging of vials for a physiological slurry using the blow-fill-seal three-in-one device of Unither.

Step 1: Configure the liquid

The first step in the entire production process is to configure the liquid to be filled: a physiological slurry, precisely the mixture of water and salt. This slurry will be packaged in single dose vials. In order to prepare and store this mixture of water and salt, Unither used three tanks, one for the production of the liquid and the other two for the storage of the liquid.

Step 2: Aseptic filling with blow-fill-seal tripler

This is the key to the entire production process. The process is to concentrate the blowing, filling and sealing of polyethylene PE vials in one operation. The entire process was completed under aseptic conditions, that is, in the 10,000-grade clean area. In order to achieve this goal, Unither chose the bottelpack 4010 rotary blow-fill-seal three-in-one device manufactured by Rommelag Rommel. The device is filled with 5 ml single-dose vials and the production speed can reach 21,000 bottles/hour.

Step 3: Rapid cutting and separation of containers

When the filled plastic containers are sent from the blowing-filling-sealing three-in-one device, each 20 containers are horizontally connected in a row. Each row is connected end to end in a vertical direction to form a plastic bottle and is continuously sent out. The three-in-one equipment, after entering the rapid separation system, is divided into ten rows of containers in each row and enters the conveyor belt behind. This process is called "rapid cut-off and separation."

Step 4: Leak test of the finished product

Afterwards, the rows of vials are conveyed by the conveyor belt and enter the leak detector. The leak detector detects whether or not there is a leak in the integrity of the leak detector.

Step 5: Labeling

At the end of the test, each vial was individually labeled and placed in a cardboard box. This concludes the entire production process.

Source: Export Goods Packaging