Medical Device Link.

NEWS

One good design can flow into another. Comar (Buena, NJ) demonstrated such design evolution during its recent “Lunch and Learn” seminar series, which kicked off in March in Del Mar, CA. The maker of drug-delivery technologies explained how some of their designs have evolved into others in order to meet customer needs.

“Many companies fear the term custom design. They worry about cost and time to market,” said Guy Worth, regional sales manager for Comar. “But they often need some rework of an existing approach.

‘This component would be good if only it had no rubber grommet . . . had another chamber . . . had better seal integrity,’ customers say. What is needed is to take off-the-shelf designs and tweak them to an application. Product design is an evolutionary field. One idea leads to another.”

For instance, Worth pointed to the use of syringes for delivering oral medicines to children. “The rubber grommet typically used in a syringe could be a choking hazard in an oral syringe, and the rubber could interact with the product,” he explained. “Companies came to us asking for a better dosing product than the dropper, and we were already aware of some of the concerns about a traditional oral syringe, so we put our product development team and materials testing lab to work.”

Originally headed by David A. Manera, now technical consulting manager, Comar’s engineering team started experimenting with a unique two-piece syringe with a flexible gland-type seal typically used in the hydraulics industry. Other two-piece designs on the market force the barrel to stretch around the plunger, creating variations in the force to actuate, given the manufacturing tolerances of the two components,” said Manera. Comar’s Oral Syringe Dispenser, which utilizes a gland-type seal, features a plunger injection molded with an additional sheath-like mechanism around its shoulder that flares out slightly for a tight seal inside the syringe. Comar says that the design enables smooth, easy, and accurate dosing throughout the tolerance ranges. (Manera’s name is on the patent, as is the case with several of Comar’s designs.) The required plunging force is smooth and consistent. Even viscous products with the consistency of peanut butter can be dispensed. Evolving from Comar’s design is an adapter that snaps into the neck of a bottle for a clean transfer of liquid to the syringe. A dual-chamber bottle followed to suit two-part protein-based products that cannot be mixed until the point of use, and then came a brand-new slim, unit-dose dual-chamber vial.

Manera then explained the firm’s Harmony system, launched in 1998. The mainly plastic vial-and-closure combination can help users condense a multiple-step lyophilization process into just two steps, with the second step, sealing, taking place in the lyophilization chamber. Flexible tangs that hold the snap-on vial closure in place required special patented rotating molds for manufacture. These tangs contribute to Harmony’s advanced seal integrity and consistency on the amount of ice sublimed during the lyophilization process, which Manera said is better than that of the typical vial/stopper/crimped aluminum cap. Comar worked with Chase Logeman to make “simple modifications” for the filling and capping process.

No company has adopted the Harmony system yet, mainly because of the costs of requalifying and revalidating a completely new package and material, said Manera. Comar’s hope is to remarket it now to new biotech firms with proteins needing barriers higher than the industry standard.

Developing the Harmony system led Comar to tackle another closure-related challenge—“loss of seal integrity because of closure back off during autoclave conditions,” explained Manera. Its patented Helical Lock system was designed to prevent fully torqued closures from opening slightly (backing off) after autoclaving. Horizontal lugs hold the seal in a compression mode. The design then evolved toward solid-oral dose bottles for child-resistant, senior-friendly closures given its one-piece, short-rotation design with an internal sealing mechanism.

Worth and Manera then talked about Comar’s multiple-step design service, which enables companies to hire Comar for just design assistance and prototype or for complete product development.

Comar then took its Lunch and Learn series on the road—next stop, San Francisco, and then across the United States to New Jersey.