As the FDA continues to introduce more stringent drug aseptic standards, the biggest challenge for drug manufacturers is to use packaging production equipment that can both save money and meet standards. In addition, with the development of drug delivery systems and the increasing popularity of unit-dose independent packaging, the integrated packaging technology of blow-fill-seal (BFS) has also been used during the aseptic filling of liquid medicines. The more widely used. Patrick Breisen, senior program manager at Cardinal Health Sterile Technologies, said: "With the continuous innovation of conveyors, plastic packages with higher flexibility can more easily communicate with these conveyors. In addition, consumers have also requested us to provide more containers that can be used with different delivery devices."
The process of blowing-filling-sealing integration not only provides greater flexibility for packaging design, but also reduces the risk of product contamination. In addition, it is more economical than traditional aseptic production processes. Chuck Reid, director of sales at Weiler Engineering, said: "The integrated bottle blowing-filling-sealing packaging machine has achieved a multi-step operation on one device and therefore has reduced operating costs and increased Aseptic insurance factor, as well as increased packaging design flexibility and other advantages."
BFS Technology Effectively Assures Sterilization During Production
In the section "Blowing-filling-seal aseptic packaging technology" in the book "Aseptic Pharmaceutical Manufacturing, Interpharm Publishers (July 1987; Out-of-print)", Cardinal is aseptic and healthy. The technology company's Frank Leo defines the blow-fill-seal technology as “using related technologies, equipment and processes to complete the forming of containers, filling of liquid medicines, and finally sealing of filled containers. All these The processes are all performed in a sterile manner at one time. Between the two processes, the product cannot be exposed to bacteria."
A clear advantage of the entire process over traditional packaging methods is that it reduces the number of parts required to assemble the package. Jeff Price, Technical Development Director of Vital Pharmaceuticals Ltd., said: "With the development of blow-fill-seal packaging, you can produce a one-piece, sterile container with a built-in safety seal. By contrast, typical traditional aseptic packaging requires at least three parts: vials, caps, and safety closures, where each part needs to be metered and strictly sterilized before filling.â€
Frank Harmon, vice president and general manager of Cardinal Health Aseptic Technologies, agreed that the blow-fill-seal technology is more economical than traditional packaging methods. He also stated that another great advantage of this packaging technology is that it is considered to be a more advanced aseptic technique, and therefore, the sterility of the blow-fill-seal technology is better than that of conventional aseptic filling. The insurance factor is greater. Because in the traditional packaging form, the containers and closures are sterilized separately and then combined together, which increases the possibility of contamination. Blow-fill-seal, an integrated packaging method, eliminates the need to transfer containers from one place to another.
Ank Henke, general manager of Rommelag explained: "The BFS technology allows the blow-fill-seal process to be completed on a fully automatic machine without manual intervention. It eliminates the need to remove any parts for high-temperature sterilization and eliminates the hassle of repeatedly loading and unloading parts, as well as cleaning and disinfecting all the channels that are in direct contact with the product, anywhere, anytime (CIP and SIP, in-situ cleaning). And in-situ sterilization. In addition, our equipment is equipped with an operator-free automatic configuration program in each category.†Modular machines help separate the machine's filling from technical components, the latter including hydraulics. Devices, pumps, valves, etc., further reduce the chance of particulate generation. And in the process of machine adjustment, there is no need for any manual disinfection, and if necessary, it can be handled by operating a remote visual system. Therefore, the operator does not need to put on dust-proof clothes and does not need to enter the clean room to adjust the equipment.
BFS technology is widely used
Blow-fill-seal integration technology is commonly used in ophthalmic and respiratory medicines, and sometimes in gastrointestinal and dental medicines, as well as in surgical medicine.
According to Harmon, BFS technology is more suitable for thermal drugs, he said: “We are now producing several highly heat-sensitive biological products, using the blowing-filling-sealing technology. Has a high stability and successful analysis results.†He also thought: “In the production process, the bottle cooling and molding process is almost completed at the same time, the product's temperature is only slightly increased at the beginning of the filling, But not enough to affect the quality of drugs."
Since BFS technology is more suitable for unit dose packaging, as more and more companies begin to use disposable packaging, BFS technology has also been more and more widely used.
Steve Tiltz, Executive Director of Marketing Department of Unicep Packaging Co., Ltd., believes: “Because of the increase in demand for unit-dose packaging, the application of integrated blowing-filling-sealing technology is also increasing, and the increase in demand is mostly due to In the past, multi-dose packaging was used, and now it is switched to a unit-dose packaging pharmaceutical company."
Unicep offers two types of blow-fill-seal integrated packaging: MicroDose and Twist-Tip bottles. These packages are produced using improved blow-fill-seal packaging equipment. As Tiertz explained: “In our production process, the sealing step is always performed after the container is formed and the filling is completed, and the heat sealing device is placed in a suitable position to seal the top of the container. "Unicep's packaging operation is performed at a low temperature, combined with multiple filling systems, making it easy to fill volatile and viscous products. The device limits the heating temperature, reduces the exposure time, and reduces the impact of the entire process on the product. Although the entire process is sterile, many of the company's customers also perform secondary sterilization using gamma rays and lasers.
According to Tiltz: "In general, many micro-dose products use long, tapered dispensing tips. Many pharmaceutical product laboratories are using micro-dose packaging for viscous products, with absorbability. The adhesive container wraps the surgical drug. The prefilled pipette consists of a spherical tube with a stretched neck for the exact application.†Craig, CEO, Business Development Woods said: “We think it's perfectly fine to use a pre-filled pipette to hold the viscous liquid. Then, the pipette is placed in a nitrogen-filled bag and finally packaged into the paper. Box."
Seeking new sealing technology
Carmena’s Harmon said: “There is an innovative technology in the blowing-filling-sealing packaging technology, which is to embed sterile packaging accessories in packaging containers to make it a multi-functional container. The top of the eye drop bottle or any similar accessory can be produced and disinfected on-line, and then the sterilized small parts are sent to the blow-fill-seal integrated production line for sterilized assembly during the production process. ."
Reid of Wheeler Engineering Co., Ltd. suggested: "When the company considers the integrated bottle blowing, filling and sealing technology, the first consideration is to confirm whether the packaging containers for the product and the resin material match. The next step is to choose the right one. Bottle type, bottle type mainly for transport. For example: you can choose small bottles, or needles with a unit dose. If used in respiratory therapy, you need to use a vertical seal to add a sprayer to the package."
Experts also believe that the integrated blow-fill-seal operation process is an excellent choice for many aseptic packaging products because of its flexibility, sterility advantages, and low cost.
Source: Industry Packaging Solutions