New materials, machinery, and providers offer users more support.
By Daphne Allen
The Asep-Tech Model 660 blow-fill-seal machine from Weiler Engineering Inc. is designed to produce sterile containers ranging in size from 200 to 1000 ml.
Blow-fill-seal (BFS) packaging has eased drug delivery in some of the most critical of health emergencies, such as with inhaled therapies. It has also streamlined the application of sterile rinses and topical treatments. And it has made certain oral solutions convenient for immediate consumption. These uses have made blow-fill-seal a proven winner in a few drug categories.
The technology’s standard format, though—a flexible unit-dose vial usually made from low-density polyethylene—may have slowed its reach beyond these applications. However, increasing material options and technology improvements along with more suppliers vying for market share are giving potential users expanded opportunities.
Even if blow-fill-seal technology use weren’t stretching beyond traditional uses, the niche is slated for growth. Robert B. Gettis, corporate development for Vital Pharma (Riviera Beach, FL), says that his firm is seeing a growing demand for the use of sterile, unit-dose packaging in the area of ophthalmic and respiratory therapy. “With the aging population, companies are spending more research dollars on sight and breathing drugs, which are suited for blow-fill-seal unit dosing,” he says. “For eye care, more attention is being given to drop size to provide accurate dosing of strong medication. Many of the drugs being developed today are given in low doses, so if the prescription calls for one or two drops per eye, the volume of the drop itself may be critical. We can design the orifice of the blow-fill-seal containers to deliver a precise volume.”
Gettis adds that in respiratory care, “drug companies recognize the acceptance of inhalation therapy and the value of nebulizing drug products for both children and the elderly.”
|See Sidebar: More Science to the Art of Blow-Fill-Seal|
Rommelag continues to provide its bottelpack blow-fill-seal machines to companies in traditional industries such as ophthalmics and inhalation and IV products, says Tim Kram, general manager of Rommelag USA Inc. (Evergreen, CO). However, the company has “recently had machines move into the oral unit-dose and aseptically filled preservative-free cosmetic unit-dose products markets,” he reports. “Blow-fill-seal will see new applications within the oral unit dose, injectable parenteral market (especially oxygen-sensitive products), and vaccines markets.”
The increasing prevalence of combination products may also fuel demand, says Chuck Reed, sales manager for the Americas for Weiler Engineering (Elgin, IL), the manufacturer of Asep-Tech blow-fill-seal equipment.
Weiler Engineering's Asep-Tech Model 660 places a sterile, multientry insert or a tip and cap insert into the container prior to final sealing.
MORE THAN JUST LDPE
Technology providers are working to increase material options. “We have introduced coextruded blow-fill-seal capability to our customers,” says Kram. “With this technology, our customers are now able to custom design their containers with multiple resin materials.” Barrier materials are now possible, he says. “Coextrusion technology will allow some customers to lower their production costs because secondary overwrapping will not be necessary. The product’s required barrier properties will be built into the blow-fill-seal container wall.”
Reed from Weiler says that “the introduction of new resins will continue to drive the movement from glass to BFS. New flexible resins with increased temperature capability for autoclaving are now available.” Weiler has just introduced Asep-Tech Model 660 for high-output production of large-volume parenterals. The machine is designed to produce 250- to 1000-ml bottles in a range of geometries and resins, Reed says.
Other newly used materials may improve product appearance. “Higher-clarity plastic resins are being requested by customers who want better container presentation to the end consumer,” says Kram. “Monolayer PET containers allow us to produce high-clarity transparent containers with an attractive appearance.”
Availability of economical raw materials for blow-fill-seal packaging can be a challenge, says Jake Love, director, business development, for Asept Pak (Malone, NY), a new company preparing to begin blow-fill-seal packaging production in 2007. “Considering that the raw material used in production—plastic resins—are themselves hydrocarbon based, we will likely have to address alternative raw materials—soybeans? More immediately, for example, economical mining, [such as] recycling and redistribution of used plastics from the market back into the manufacturing cycle, may become an imperative to the viability of BFS technology.”
More combination products and the introduction of new resins will continue to drive the movement from glass to BFS, claims Weiler Engineering, which offers the Asep-Tech Model 660.
Users aren’t just looking for new materials, says Kram. His firm has seen “an increase in the variety of closure designs in the past years,” he says. “This shows that more end-users are adapting blow-fill-seal to their products. One of the greatest strengths of blow-fill-seal technology is its ability to create a wide variety of container and closure shapes and sizes.”
Reed says that “insertion technology will become more important as users seek new delivery methods for breakthrough drugs. This technology, pioneered by Weiler, places a sterile, multientry insert—typically for injectable products—or a tip-and-cap insert—for precise drop control typically for ophthalmic products—into the container prior to final sealing, all under Class 100 conditions within the BFS machine.”
Reed says that to meet accelerating market conditions, BFS machines have gotten faster, with increased capability. “An increased emphasis on flexibility of machine design to permit rapid changeover among product mixes will help drive the future of BFS,” says Reed. In addition, “more emphasis will be placed on line integration with ancillary equipment, such as vision systems for in-line/in-process inspection and post-BFS processes.” He adds that “older machines have come under increasing challenge, due in part to the changing regulatory environment, but also due to technological advances with a myriad of electronic devices designed to enhance production efficiency and reliability.”
Kram sees such requests from users. “Our customers are asking for higher-capacity/lower-operation-cost machines.” To meet this need, Rommelag introduced servo drive technology to its bottelpack blow-fill-seal machine line. “This improvement replaced the conventional hydraulic drives used on some of our machines,” says Kram. “The result was increased machine efficiency, accuracy, and speed.” Further, “new high-speed machines were developed to improve production speed and lower production cost per piece.” Rommelag currently has seven base machine models to cover varying production requirements.
Weiler has developed a pick-and-place deflashing system for its Asep-Tech Model 660 to capture individual containers or packs at the point-of-flash removal, allowing easy orientation in virtually any dimension.
Design development time may be shrinking. American Plastic Technologies Inc. (APT; Schiller Park, IL) reports that it has developed techniques to make blow molds for any kind of bottle, container, or medical device in two weeks. “We can machine blow molds in aluminum bronze, aluminum 7075, or beryllium copper by using high speed CNC and CAD/CAM systems,” says Rao K. Murukurthy, CEO. “We will also sample the molds before shipping and can send [users] bottle samples and validation reports along with the mold.” APT can also blow mold the containers.
APT has also reportedly developed a low-cost blow-fill-seal machine. “We have designed this machine for the production of small-volume parenterals. It can produce 0.5- to 30-ml containers at a rate of 2400 to 3600 per hour,” says Murukurthy. The largest container this machine can blow-fill-seal is 500 ml, at a rate of 500 per hour.
The market entry of new (or returning) players may also demonstrate the technology’s evolution.
Asept Pak has completed engineering studies, undertaken the complete renovation of an 18,000-sq-ft facility, and acquired and initiated installation of four Rommelag blow-fill-seal machines. “We are proceeding with Phase I plans to commence production in early 2007 in a totally modernized plant, housing the initial four new sterile production suites, administration, QA/QC staff, lab, materials inventory, and product storage/ shipping,” says Love. “Phase II will implement plans for expansion of production and warehousing facilities on available property.”
Healthstar has announced that after a five-year absence from the market, it has resumed supplying used blow-fill-seal equipment. It originally began helping existing equipment owners remarket idle equipment in 1986.
“Since our return to the marketplace, we have completed two major projects,” explains Bill Grabowski. “The first project was the purchase and resale for a major IV products supplier in Mexico of five large-volume blow-fill-seal machines. The second was the purchase and remarketing of five high-speed vial machines employed for inhalation therapy products for a U.S. manufacturer. Healthstar was able to place this equipment with five different users throughout the United States and India.” To support these new blow-fill-seal users, Healthstar provides molds and machinery.