Medical Device Link.

FILLING EQUIPMENT

Packaging lines often only run as fast as their fillers can fill. Product viscosity determines filling speed, as does the need to minimize cross-contamination and spillage during dispensing. As companies review their packaging lines for their Overall Equipment Effectiveness (OEE), they will be considering filler capability in terms of speed, productivity, and availability. But what if they have reached maximum speeds with their existing equipment? Are their filling lines operating as effectively as they possibly can?

Fillers could be modified to penetrate Penetrex just as this lab unit does.

The Andwin Corp. (Woodland Hills, CA) is working on ways to expedite filling while reducing cross-contamination and spillage. “When you are filling faster than the rate at which air escapes from the container, you will have maximized your equipment’s capacity to fill,” explains Dr. Abner Levy, president of The Andwin Corp. “You end up sacrificing line speed to control a multitude of factors.”

Levy adds that controlling the amount of bioburden or dust that enters bottles on filling lines can be the “number-one dilemma” for some operators. “It’s expensive to maintain a sterile cleanroom, so the highest level of control is often used only for injectable products,” he says.

Dispensing control has been a goal of Levy’s for some time. With 22 patents, Andwin has been supplying collection products for blood, urine, DNA, and umbilical cord blood as well as transportation kits for years. “We have seen the efforts clinical labs must make to control spillage in automated environments when sampling urine, for instance. Cross-contamination is a key concern,” he says, “as is the potential for spillage in automated lines.”

Penetrex is available in standard 33-, 28-, 24-, and 20-mm bottle openings.

Thirty years ago, Levy set out to devise a solution. His ideas and designs evolved into a new repenetrable, resealable membrane cap-and-plug bottle closure called Penetrex. The product adds a polymer-based membrane to the core of standard bottle plugs often used with oral syringes. The core can be penetrated repeatedly, and its self-sealing design helps prevent spillage, evaporation, and contamination, Levy adds.

Andwin can help companies convert their packaging lines to fill Penetrex-plugged bottles. “The point-of-contact with the bottle or vial may require minor modifications. Converting lines to the Penetrex system is simple,” says Levy. Hoods or splash guards typically used in filling turrets or carousels could be eliminated. Andwin can help engineers with the conversion. Cooperative expense sharing may be possible, depending upon product volumes.

Levy believes process improvements shown in labs could help industrial fillers.

Andwin is offering standard bottle plugs already outfitted with the Penetrex membrane. While the currently chosen core material has been used for an FDA-approved product, says Levy, other materials are available to suit any type of liquid.

Levy believes that Penetrex could change the economics of industrial liquid filling. “Adding Penetrex closures to containers could speed up filling processes by 50−60%,” he says. Citing improvements in clinical lab automation, Levy says that Penetrex has eliminated steps in the specimen sampling process. “There is no need to recap containers after sampling,” he says. He acknowledges that industrial filling needs are different; however, he expects Penetrex’s ability to control product waste and contamination to have profound benefits in terms of speed and product quality.

Penetrex is even designed to minimize waste during product use, adds Levy. It also limits access to the product and adds another layer of protection for consumers and pharmacists.

In addition, “We tested Penetrex with moms and got a great response. They found it easy to use and economical,” Levy reports.