Upgrades In Blow-Fill-Seal Technology

Vendors are improving machine capacity and driving out costs with the addition of servos.
Marketplace trends are creating opportunities for cost-effective blow-fill-seal (BFS) technology. In newer applications, BFS containers provide a convenient means of delivery for drugs and diagnostic test kits used in the home, and precise, handy administration of OTCs.
As applications have extended to areas such as vaccines and biologics, unit-dose ampoules and bottles have gained increasing favor as non-breakable formats that provide sterility assurance to the point of use.
Generic drugs have embraced the cost advantages of BFS. Companies have explored new materials and resins for the packaging of biologics, as the versatile technology expands beyond its traditional respiratory and ophthalmic categories.
Increased regulatory emphasis on advanced aseptic processing for products that cannot be terminally sterilized is fostering more interest in BFS technology, says Chuck Reed, director, sales & marketing, Weiler Engineering (www.weilerengineering.com).
“Most large molecule drugs exhibit some heat sensitivity, which means they must be packaged aseptically. The growth of both biosimilar and generic drug substances is rapidly increasing. There is also an increased awareness of the impact of drug shortages for critical therapies, which is adding to the interest in BFS for multiple facility locations,” Reed says.
BFS’s efficiency has always been a selling point as containers are typically aseptically molded, filled, and sealed in one step on one machine. Recent advances in machines’ technology have further improved performance and overall equipment effectiveness (OEE).
ALL-ELECTRIC MACHINE
Weiler Engineering this year launched the all-electric ASEP-TECH Model 628 blow-fill-seal unit in which all machine motions are servo-controlled. Changeover is simplified as operators reference recipes on the HMI for parameter set up.
“Campaign strategies for different products and formats are now becoming more common especially for contract manufacturers. Companies are looking for easier tooling changeover to reduce downtime,” Reed says.
With a fully servo controlled system, maintenance procedures are simplified, and noise levels reduced.
All-electric control of the machine settings enables more functions to be remotely accessed for operational adjustments, Reed says.
Servo-controlled fill towers—with a patented electronic time and pressure fill system—in combination with a Siemens PLC control platform, support faster production rates, Reed says.
In addition, eliminating hydraulic functions reduces particulate generation, making the machine particularly suitable for parenteral applications. “Parenteral products must be 100% inspected for particulate contamination per regulation. All-electric functions help reduce any particulate contamination thereby providing an extra level of product protection,” he adds.
rommelag (www.rommelag.com) featured an electrically driven machine with the introduction in the 1980s of the 4010M Bottelpack BFS machine. In the rotary-style design, as many as 15 molds rotate vertically in a continuous chain as the uncut parison continuously feeds to the rotating molds, In the 4010M, servo drives control functions including the mold chain and fill system, with a small hydraulic unit used for mold closing, says Tim Kram, general manager, rommelag USA.
In 2002, rommelag introduced new machine designs with all motors servo driven. In the Bottelpack BFS model series servos control functions including mold opening and closing, parison wall thickness, extruder lifting, dosing system movement, deflashing, high voltage leak detectors, and secondary container handling systems, Kram says.
“We did this to increase both the machine capacity and the controllability. The servo controller offers higher precision at higher speeds. They also take the guess work out of tuning; the system is fully controlled from the HMI and it records all changes that are made,” Kram says.
Rommelag in 2012 offered full servo options for replacing hydraulic systems on earlier generation Bottelpack BFS machines.
MONITORING PRODUCT TEMPERATURES
For bio tech and vaccine applications, rommelag has developed the Cool BFS systems. The systems use temperature sensors at various points from the product holding tank through to final packaging to verify product temperatures.
“BFS machine inner temperature characteristics have been estimated with modeling software in the past. With our Cool BFS systems we have quantified the temperature the product sees at each step in the BFS process and are able to accurately predict the resulting effect on the product,” Kram says.
Unicep (www.unicep.com) has made advances in its proprietary in-line modified BFS technology used in non-sterile packaging of liquid, gel, cream, and lotion products, OTC drugs, medical device diagnostic products, dietary supplements, and animal health.
“We continue to develop our proprietary BFS technologies for both high and low volume applications. With our low-to-medium volume technologies, we are driving out overall costs and supporting a wider range of fluid viscosities, thus removing barriers so that more products can gain the benefits of unit dose BFS,” says Paul Knight, vice president of sales and
engineering.
“With our mid-to-high volume technology development, we are reducing fixed tooling costs so that we can offer customers innovative package designs while getting the cost and functional benefits of unit dose BFS,” Knight adds.
Unicep within the last year has launched two new container design innovations. The DualDose keeps
two product components separate until point of use. The user bends an outer tube to snap an inside vial for mixing the two components then dispenses
by twisting off the top of the outer tube.
And most recently Unicep debuted the SwabDose a single-dose applicator in which the product is inserted and ready to dispense. The user snaps open the container to access the product saturated on the tip of a swab. 
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