BFS technology can aid keep sterility throughout the biologics producing procedure.
Blow-fill-seal (BFS) technology offers a number of benefits over various other aseptic strategies, such as versatility in product packaging style, the capability to make sure a high degree of sterility guarantee, and also keeping affordable (1 ). Furthermore, using BFS technology restricts human participation, which better enhances the degree of sterility guarantee by getting rid of a substantial contamination aspect from the procedure completely. The technology improves the capability to develop the container and also closure throughout the product packaging procedure, which enables an extra personalized style of the container. BFS technology can hence be utilized to fulfill details requirements and also enhance container ease-of-use (1 ). In order to discover more on the logistics, advantages, and also possible disadvantages of BFS technology, Drug Technology consulted with Waiken Wong, PhD, supervisor of advancement design at Woodstock Sterile Solutions, an Illinois-based company of sterilized advancement and also business services.
Advantages of BFS technology
PharmTech: Can you please describe what BFS product packaging technology is and also exactly how it relates to bio/pharmaceutical production?
Wong (Woodstock Sterile Solutions): Blow-fill-seal product packaging technology is a technique where the container is developed, full of item, and afterwards secured in a sterilized setting. What appears is a totally sterilized completed item. It’s an excellent discussion for lots of medicines, consisting of biopharmaceuticals. Sterility is crucial for biologics and also lots of various other medicines since it stops microbial pollutants in items.
PharmTech: What advantages does BFS product packaging technology deal, contrasted to typical glass vial production?
Wong (Woodstock Sterile Solutions): There is much much less human treatment when BFS product packaging [is employed], and also human beings are the greatest source of contamination. Contamination can have an adverse influence on microbial sterility. Since the BFS procedure takes place totally inside the cupboard of the equipment, there is long shot for outside contamination and also troubles with sterility. With BFS, the setting inside the cupboard of the equipment is continuously checked for sensible and also non-viable particle, and also there is a continuous, favorable stress shower of high-efficiency particle air (HEPA)- filteringed system air that covers the filling up area of the BFS equipment. With those controls in position, in addition to the automation of the BFS equipment, the driver does not need to remain in the space. It is created to operate its very own, with no human treatment. A fringe benefit is that there are less elements contrasted to glass vials, so you do not need to manage stoppers, kink tops, and also various other closures. There are no comparable cleansing actions to the ones glass vials require to undergo. There are additionally no comparable therapy actions to the ones glass vials require to undergo, such as depyrogenation. Raw material is utilized; it goes straight right into the BFS equipment and also is built straight. So, there are less elements, less action in the real production procedure, and also there is much much less human communication.
PharmTech: Can you describe chilly temperature level BFS and also its advantages contrasted to routine BFS?
Wong (Woodstock Sterile Solutions): Cold temperature level BFS calls for carrying out a mix of strategies completely in one production procedure to aid manage the quantity of warm that is conveyed onto a medicine item. Throughout the common BFS procedure, there is normally a fair bit of warm, since raw material is being thawed to make containers. The containers themselves additionally require to be cozy throughout the procedure to make sure that the containers can be secured closed in the last action. There exists warm, yet Woodstock Sterile Solutions has actually located means to manage that warm to make sure that biomolecules can make it through without any influence with the production procedure. With a cool BFS procedure, there are extra medication items that you can package, given that you do not need to bother with medicines that are thermally delicate. Numerous biomolecules are warm delicate, and also there are lots of healthy proteins that can denature or deteriorate with warm, so generally, the biopharma sector has actually steered clear of from BFS and also stuck to glass– a reliable alternative. Having this collection of producing actions broadens what is feasible for medication items in blow-fill-seal.
Executing BFS technology
PharmTech: What are some crucial factors to consider when carrying out BFS technology?
Wong (Woodstock Sterile Solutions): One vital factor to consider is recognizing the medication item’s compatibility/interactions with plastic. Prior to choosing BFS, there requires to be an understanding of exactly how the item engages with plastic– if there are worries concerning adsorption or absorption, for instance. In addition, plastic containers are absorptive in such a way that glass is not, and also it is crucial to recognize if that will certainly have an effect on the item throughout its life span. That being claimed, there are means to respond to permeation, whether it is water vapor vacating or oxygen moving in, in order to keep the high quality of the item within. Finally, although BFS can be utilized to fill up fluids that are extremely thick, if the item is much more ointment-like, after that it will certainly be hard to fill up utilizing BFS. That makes it tougher to press with the piping and also various other components of the system, yet the technology can manage a large range of thickness.
PharmTech: What are the disadvantages of utilizing BFS technology, if any type of?
Wong (Woodstock Sterile Solutions): The leaks in the structure pointed out earlier is one difficulty, as are the product communications I kept in mind. Additionally, there are obstacles with warm and also thermally delicate items, yet those can be resolved utilizing chilly BFS.
PharmTech: What are the regulative and also conformity factors to consider when utilizing BFS, if any type of?
Wong (Woodstock Sterile Solutions): FDA thinks about BFS as an innovative aseptic production strategy, identifying its capability to create sterilized medication items accurately while additionally guaranteeing a high degree of high quality for individuals. The sector is held to the very same requirements, as all medication product packaging modern technologies are, to make sure item security and also high quality.
S. Bondre, et al., ARPB 3 (4) 494– 499 (2013 ).
Regarding the writer
Alivia Leon is an assistant editor for Drug Technology, Drug Technology Europe, and also BioPharm International
Short article information
Vol. 46, No. 9
Pages: 37, 51
When describing this short article, please mention it as A. Leon, “Improving Sterility Utilizing Blow-Fill-Seal Technology,” Drug Technology 46 (9) 37, 51 (2022 ).