BLOW-FILL-SEAL
Senior Editor
Blow-fill-seal manufacturers are adding capacity for respiratory and ophthalmic drug packaging, and growing applications such as oral products, in vitro test diluents, and vaccines.
Vital Pharma, which manufactures its own line of BFS machines, is upgrading its Riviera Beach, FL, facility with a series of “Best in Class” sterile processing suites to support anticipated BFS manufacturing growth through 2010, the company has announced.
For nonsterile BFS production, Unicep (Sandpoint, ID) is adding six high-speed BFS machines from Weiler Engineering to service new business and meet anticipated demand. The machines will be used in packaging feminine products, including an OTC product, that Unicep recently gained in a new account, says CEO John Snedden, DDS.
“We have seen extraordinary demand in the last 12 to 14 months, and anticipate 40% growth in the next year based on our recent contracts,” Snedden says. “Customers want the safety and convenience that single-use containers provide.”
The new machines will add 80 to 150 million units a year capacity, depending on unit size, for high-speed filling. Unicep also operates eight modified BFS units for handling smaller runs.
Unicep’s high-speed unit-dose packaging of diluents used in in vitro diagnostic test kits has been a growth area, as testing moves to doctors’ offices and home settings.
Rao Design International (Schiller Park, IL) has experienced sales growth in the BFS machines it manufactures and its turnkey services. The company is building larger, more-efficient models, for packaging products including liquid antibiotics and IV solutions, says Rao Murukurthy, CEO.
IV solution bottles are made on shuttle-style machines in which mold cavities alternately shift in from the left and right for filling from one common extruder in one cycle. A 10-cavity unit fills 10 half-liter IV bottles in a 15-second cycle. Other machines blow-fill-seal 50 cavities for single-cycle production of smaller bottles.
In customizing solutions to clients’ needs, Rao Design provides production system components, and research and development on product formulation, with BFS processing support services offered by its Asep-Pack division.
Along with the molds and machine hydraulics and electronics, the firm supplies and integrates batch-making tanks and boilers, sterilizers and fuel steam generators, and tower and piping systems. Cleanroom development services also are offered.
“At a client’s request, we have teams of personnel to perform their BFS operations,” Murukurthy says. “The client only has to worry about marketing, and maintaining quality standards and efficiency.”
BFS is an efficient alternative to glass for some applications, as the multiple steps and machines required for glass packaging are eliminated. The lightweight vials and bottles eliminate breakage issues in hospitals, and are easily handled by caregivers and patients.
“Blow-fill-seal is the most economical way to package a product; manufacturing, filling, and capping is performed in one step in a sterile environment,” says Murukurthy. “For virtually damage-proof [labeling], we can engrave a lot of information on the container in the mold.”
Many manufacturers of ophthalmic and respiratory products have moved from multidose bottles to unit-dose vials. Besides providing patients with sterility assurance and convenient dosing, unit doses can avoid the need for preservatives that might cause allergic reactions.
“The unit-dose segment of BFS has a lot of growth potential,” says Chuck Reed, director of sales and marketing, Weiler Engineering (Elgin, IL). He says the unit-dose bottle is easier for hospitals and home-care settings, and convenient in infant dosing, and the smaller carry-on package requirements on airlines.
Reed says Weiler has developed a system for welding caps onto large-volume IV solution bottles made of LDPE or polypropylene (PP). “This is a secondary piece of equipment designed to incorporate a multientry insert cap on top of the BFS container, after which the entire package is autoclaved.”
Because molds can be created for an array of sizes and shapes, packagers can use BFS for creating distinctive packaging such as for oral products.
Overseas markets are driving applications for oral applications, as well as injectibles. Herbal tonics and vitamins are often packaged in BFS formats in China and India, Reed says.
STANDOUT CONTAINERS
Supporting an energy drink manufacturer, Rao Design is supplying the BFS machinery, setting it up at a dedicated client facility, and running the production. The oral electrolytes are packaged in a canlike plastic container with a cone-shaped break-off top.
“For oral liquids, we can create a customized, potentially differentiated unit-dose convenience format,” says Michael Riley, VP business development, Catalent Pharma Solutions (Woodstock, IL).
Riley sees continuing strong demand for respiratory and ophthalmic packaging, along with potential for BFS in newer applications. Upgrading capacity at Catalent is a priority, Riley says.
“Customers are making specific requests for [newer] BFS solutions, and we are looking at new design formats and applications in certain nontraditional market areas,” Riley says. The contract packager has 38 aseptic BFS machines.
“Respiratory products such as albuterol and ipratropium are relatively simple solutions to formulate,” he adds. “We are seeing more demand for products such as emulsions and suspensions that are more complex to formulate and fill.”
Riley notes that besides the advantages of quality and sterility assurance and flexibility in container design, BFS provides processing efficiencies. Where a large number of doses must be produced in a short period of time, such as in vaccine production, BFS exceeds traditional fill-finish formats in processing efficiency and high output, he says. The automated contained process provides better sterility assurance.
Most BFS applications employ LDPE or HDPE, as cost-effective materials that create containers with a supple feel. PP is also used as a more rigid alternative, and companies have tested materials including PET.
A Rao Design client is buying three BFS machines for packaging IV solutions in PP. The customer favored a material that could be used with the steam autoclaving they were using in their glass packaging. “PP is a very stiff material in my opinion, but some customers like it because it can be steam sterilized at high temperatures,” Murukurthy says. “LDPE requires hot water autoclaving. PP provides excellent water-vapor barrier properties, [at lower] material costs.”
For providing barrier, “foil pouching is the most prevalent approach for most applications,” says Riley.
Multilayer extrusions have been used for products such as those with high sensitivity to oxygen and carbon dioxide. BFS machine manufacturer rommelag USA (Evergreen, CO) has catered to barrier needs with its bottlepack Co-Extrusion unit that handles up to a seven-layer parison.
Rao Design sources coextruders for integration with its BFS machines. Murukurthy notes that although coextrusions using EVOH for oxygen barrier have been favored for protein-based products, cost is an issue. “We package [IV-delivered] total nutritional products in LDPE. The container is then pouched in aluminum, we draw a vacuum, and seal it.”
“You will be seeing more of a push in the next five years for coextrusion,” says Snedden. “The application dictates whether you use a foil pouch or multilayer container. Pouches don’t solve all problems because, in some cases, you have to account for head space.”
Unicep deploys BFS machines that run in intermittent cycle, or staged filling and sealing, for packaging highly viscous liquids, and high-alcohol-content solutions. In this process, filling is slowed down to support the filling, or to keep high-alcohol-content product at cooler temperatures.
Snedden says customer queries about BFS packaging supporting sustainability initiatives are becoming more prevalent. BFS packaging offers cost-effective manufacturing, breakage resistance, and ease-of-use, however, vials and bottles are often viewed as less-friendly packaging from a “green” standpoint.
“There are very interesting trends in new materials,” Snedden says. “We are following trends in the development of biodegradable polyethylene derivatives. These would be exciting alternatives to the standard materials used in BFS packaging today.”
