Originally Published PMPN January 2006
Bottles and Closures
New Openings in Bottles and Closures
by David Vaczek, Senior Editor
Drug firms are working with suppliers and talking with end-users in their search for convenient and safe bottle and closure solutions.
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| Comar has applied its Helical Lock system to glass and plastic vials for maintaining seal integrity after sterilization. |
Closures have not lacked for innovation as industry has pursued the elusive goal of developing convenient yet child-resistant (CR) closure and bottle solutions. Many consumers, however, remain frustrated with CR closures, though they have grown familiar with push-and-turn or squeeze-and-turn designs.
As an aging population becomes less tolerant of unfriendly packaging, some drug firms are talking with customers and working with suppliers to develop solutions that users can truly appreciate. Companies that want customers to have a positive experience with their product have not relied solely upon senior-friendly CR testing standards.
“There is a growing sensitivity among pharmaceutical companies that just meeting the Consumer Product Safety Commission (CPSC) protocol may not be enough to make their customers happy. A product isn’t necessarily friendly [when it meets the CPSC standard], particularly to those with arthritis or other physical challenges,” says William Shankland, vice president, business development, Rexam Closures and Containers (Evansville, ID). “Companies are focusing on the consumer experience and on minimizing inconvenience.”
Responding to consumer feedback, McNeil Consumer Healthcare developed the EZ-Open cap, a non-CR closure specifically targeted to customers with arthritis. The design on bottles of Tylenol Arthritis Pain (acetaminophen) extended-relief caplets features a fat cap with large serrations for gripping. McNeil also employs new push-and-turn style closures on other Tylenol Arthritis Pain SKUs. The EZ-Open and the push-and-turn designs have gained ease-of-use commendations from the Arthritis Foundation. Companies with a family of product in different sizes are allowed to put out one noncomplying non-CR package, providing that the SKU is not the most popular item in the group. The package must be labeled as intended for households without small children, according to the Poison Prevention Packaging Act.
“Companies have come out with non-CR packages that became their most popular item. In those cases, they have had to convert it to a CR package and make their non-CR package another size,” says an industry consultant.
O-I (Owens Illinois; Toledo, OH) is another manufacturer that has sought feedback from the Arthritis Foundation, where packaging that shows significant improvements in accessibility and ease-of use is identified through a formal test protocol. “We have emphasized making our CR performance meet the needs of the arthritic community,” says Roger Smith, director of global technology and innovation for O-I Healthcare Packaging Inc.
Induction Sealing Dwells on New Cap Challenges Induction sealing has gained wide use in the drug industry since 1982, when FDA began requiring tamper-evident packaging for most OTC drugs. Besides providing tamper evidence, hermetic foil seals also prevent moisture and oxygen transmission and eliminate leakage. For addressing tamper evidence, FDA mandated that container mouth inner seals “must be torn or broken to open the container and remove the product. The seal cannot be removed and reapplied without leaving visible evidence of entry. Seals applied by heat induction to plastic containers appear to offer a higher degree of tamper resistance than those that depend on an adhesive to create the bond.”
Today, air-cooled induction sealers have replaced their cumbersome water-cooled predecessors. The Unifoiler waterless induction sealer by Pillar Technologies (Hartland, WI) takes up one-third the space of water-cooled equipment. One pharmaceutical customer is replacing 11 water-cooled lines with Unifoiler sealers and may be adding six new lines, says Cheryl Miller, induction sealer marketing and sales, Pillar Technologies. “Their equipment was only two years old. Waterless sealers are rapidly replacing the older-style, water-cooled systems. Only extremely unique applications still have a need for the water-cooled machines. We have eliminated filters, hoses, pumps, radiators, flow switches, water, and in some cases, a mess,” she says. Bill Zito, induction sealer vice president sales for Enercon Industries (Menomonee Falls, WI) says he’s not surprised when companies make the switch to a waterless sealer. “Enercon pioneered air-cooled technology more than a decade ago. In the last five years, many companies have switched over to our line of Super Seal air-cooled cap sealers.” Different cap and bottle configurations often require different induction sealing methods. The approach used is dictated by the location, during cap application, of the foil in relation to the top of the cap, and to the lip of the container. Many two-piece cap-in-cap systems typically require tunnel-style induction coils, because the foil is too far away from the top of the cap to be effectively heated by a flat-coil configuration. “The foil may be as much as 1¼4 to 2¼3 of an inch below the top of the cap. With a flat coil, the electromagnetic field that heats the foil dissipates,” says Zito. Tunnel styles support high-speed capping when package sizes are uniform. For contract packagers sealing a range of cap sizes, “all-in-one coils” may be called for. Both Enercon Industries’ All-in-One sealing head and Pillar Technologies’ Universal flat coil support sizes from 20 to 120 mm. The sealing heads have some capabilities to seal child-resistant (CR) caps. “We don’t have to automatically jump customers into a tunnel coil,” says Pillar’s Miller. “With child-resistant and click-lock closures, the foil is located a little further down from the top of the cap. People think they need a tunnel coil for this. Our Universal coil provides greater power on the top end for sealing these systems,” she says. Zito says that Enercon has done a great deal of statistical analysis supported by field and laboratory data that shows it is possible to have some success sealing a CR container with a flat coil. “Packagers do need to understand that the geometry of the CR bottle and the physics of the induction process makes a tunnel sealing head more efficient, allowing the user to seal faster and use a smaller power supply,” he says.
New one-piece cap-and-bottle configurations are also challenging induction sealer manufacturers to adapt their equipment for successful sealing. The advent of air-cooled induction technology has propelled the use of induction sealers as an alternative to conduction sealing, where seals are applied before capping. Enercon is working with several pharmaceutical companies that are considering converting from a two-piece cap to a child-resistant, single-piece senior-friendly cap. The company has developed a pressure belt induction sealer for these types of applications. The pressure belt is required in this instance because the cap in the push-and-turn package raises up after it is screwed on, putting the foil at a distance from the lip of the bottle, says Zito. “In order to get a good induction seal, the foil needs to be in contact with the lip of the container. This is easy to do with a standard cap. The application torque applies enough pressure to seal the container. This new closure is torqued on like a standard cap, but once engaged, it locks on and lifts up,” Zito says. The pressure belt maintains contact with the cap throughout the sealing process, forcing the cap to hold the seal in place. The pressure belt eliminates the necessity of getting the correct application torque. And, there is no need for a second retorquing step after the caps have been seated. “Those companies are planning to replace our standard induction sealers with our new pressure belt solution. Once these packages are introduced, we expect to see a lot more people going to one-piece caps. They are less expensive, and you are eliminating the need for retorquing,” says Zito. Pillar Technologies is offering an induction seal detection system that is more cost effective and features easier setup and alignment than previous models. Features include a relay encoder working with multiple optical sensors that signals faulty bottle/cap combinations. The device warns the operator of any containers that are missing liners. A pneumatic reject mechanism is available to kick defective containers off the line. The device detects loose or crooked caps or mis-seated containers and shuts down the line if a bottle becomes stalled under the induction coil. Many of Enercon’s pharmaceutical customers use its integrated detection/ inspection and rejection systems, however the industry is still searching for a way to achieve 100% seal verification. Says Zito, “There is no way you can measure the quality of the seal, or tell if the bottle is completely sealed, when the cap is on the bottle.” Pharmaceutical firms looking to achieve 100% seal verification may be able to benefit from recent induction advancements developed for other industries. These new capless sealing systems that apply the seal prior to capping are attracting interest. Mechanically, they operate similarly to conduction sealing machines in that the seal is applied onto the container and then held in place during sealing. Induction, however, is a much easier technology to work with. Platen management and monitoring as well as temperature ramp up and cool down times are avoided. And induction requires one-tenth the power of conduction, where platens are typically heated to 400°F, says Zito. “Induction sealing is much safer and more efficient. The induction heating head is cool, and you are applying much less pressure. We can also apply a silicon rubber pad on the sealing element to make up for any irregularities in the container. Then you can perform a water bath or retort process to test the seal before the cap goes on,” he says. For capless sealing, companies can easily retrofit existing conduction systems with Enercon’s induction power supply unit and sealing heads. And they can employ seal and container handling techniques already being used, in indexing, rotary, and pressure-belt configurations. Zito says that a capless induction system is significantly less costly than conduction. But companies might spend more for cap-less induction than they would for on-cap induction. The capless solution induction equipment is about five times the cost of Enercon’s induction technology for sealing capped containers. Zito said the technology is under test with a number of customers. “Forty percent of our inquiries at the Pack Expo Las Vegas show were about capless sealing,” he says. Although new closure systems and the desire to ensure that seals are completely sealed are spurring the industry to investigate new foil seal solutions, traditional cap and bottle induction sealing has remained the industry-preferred method for many major pharmaceutical manufacturers, because of its cost and ease of use. |
“Senior panels can generally accomplish opening and reclosing senior-friendly bottles. [But] we try to go beyond the CPSC requirements, and we have learned a great deal more about how to make packages easy to open and resecure. We tend to target the Arthritis Foundation’s criteria, which puts more of an emphasis on mobility and joint testing and on redundancy of opening,” he says.
Companies may be digging deeper to find out what their customers want. But making closures that meet both senior-friendly and CR needs remains the ultimate challenge. “You are not designing only for seniors. Among the 100 million people with arthritis, many are younger people with rheumatoid arthritis, with children in the home,” Smith points out.
CPSC’s test protocol puts an emphasis on ensuring that CR designs remain functional in use, since consumers tend to reapply them incorrectly or intentionally leave them unassembled if frustrated with them. After packaging is opened by adults and appears to be resecured, it is then given to a panel of children. The number of children in excess of 10% who succeed in opening the package counts as failures to resecure by adults.
O-I’s 1-Clic vial and closure reversible packaging system gives consumers and pharmacists a choice in the type of closure they will use. Several major retail pharmacy chains have transferred to the 1-Clic for prescription drug vials, says Smith. The one-piece system—which earned an Arthritis Foundation ease-of-use commendation— features an audible click when locked in place. The child-resistant position requires a tab to be held down and turned. In non-CR mode, closure threads are screwed into container threads. “Pharmacies typically have to offer a CR package, unless the customer requests a non-CR package. They have to carry two closures. The 1-Clic provides a very crowded pharmacy with one fewer item to stock,” says Smith.
ONE-PIECE DESIGNS
Some of the new CR closure designs are appearing in one-piece cap-and-bottle systems that offer the advantage of lower cost versus two-piece solutions. One-piece systems use less resin, requiring less tooling and cap assembly costs. The success of one-piece systems has caused manufacturers of two-piece systems to drop their prices in some cases, say suppliers.
“As customers look to drive cost out of the value chain in the packaging of solid-dose products, they are evaluating alternatives to current two-piece child-resistant closures,” says Jerry Miles, director of marketing, Alcan Global Pharmaceutical Packaging, Plastics America (Montreal). Alcan has been working with Rexam’s North America Closure division to develop complete packaging systems using one-piece closure designs.
Comar Inc. (Buena, NJ) has improved its Helical-Lock push-and-turn CR senior-friendly closure. “The system functions the same as the original, but we have increased the performance, making it easier to put on and remove,” says David Mansera, technical operations manager.
O-I will release early this year a one-piece push-and turn spring-lock design, says Smith. “The distinct advantage of one-piece systems over two-piece systems is that one-piece systems are not dependent on the application torque to be effective. The general public has been indoctrinated into pushing and turning when they see a CR closure, so the spring-lock design will give the customer something they know,” Smith says. “Once educated on nontorque-dependent closures, such as squeeze-and-turn closures, or our 1-Clic, consumers will prefer to use them. They like the audible click you get with a squeeze-and-turn closure,” he adds.
Rexam has provided a low-torque solution in a one-piece system with its Squeeze-Lok Low Profile squeeze-and-turn closure, where locking can be seen, heard, and felt. In push-and-turn designs, it offers closures with a positive off-drive function that requires less force to engage the CR mechanism, says Shankland.
Bouchons MAC Closures Inc. (Waterloo, QC) offers an alternative to push-and-turn and squeeze-and-turn CR caps with its flip-top cap and containers. They have gained use with RX, OTC, and health and beauty products because of their ease of use and attractive design, says Stephanie Roux.
The senior-friendly CR snap-on caps open with an audible pop when squeezed on the side. They include the FTCR19100 24 mm for liquids, the FTCR 19000 38 mm for tablets, and the FICR MACpack 38 mm for small counts, traveling, and trial sizes. “All industries that use CR closures have been extremely receptive to our new line. The nutraceutical industry is starting to consider CR caps as a value-added solution. They have not wanted to consider push-and-turn caps because older customers find them harder to use,” Roux says.
While safety and convenience are key issues in bottles and closures, other imperatives are driving design. “Alcan Global Pharmaceutical Packaging as a whole has been looking at where we can support our customers in their efforts to thwart counterfeiting and ensure product authenticity. The key is to understand what the customer is hiring the package to do. Customers are hiring packaging for assistance in compliance, brand recognition, and product integrity,” Miles says.
CAPS WITH CHIPS
Rexam Closures is exploring using RFID tags and taggants for brand protection and anticounterfeiting. Working with Tagsys (Doylestown, PA), the company is developing child-resistance closures with stock RFID tags. “We are in the conceptual stage, putting together prototypes for testing by our clients,” says Shankland.
In the past year O-I has set up a lab to test alternatives for mechanically attaching tags to closures and containers and for embedding the chips into the caps and containers during molding. The company will run a pilot with a major pharmaceutical manufacturer in the first quarter, says Smith.
Tags can be made more tamper resistant when they are attached inside caps or are placed “in the melt stream of the parison” for incorporation into caps and containers. Misreads that occur with tags affixed to labels can also be minimized.
“When tags are placed in labels, if the labels are not oriented or are touching, reads are compromised. When we have been attaching or embedding the chips, we have found it makes them much more forgiving to orientation.”
And cap and container tagging allows packagers to maintain line speeds and addresses the accountability issues that arise when tags are precoded. “Most of our customers want to label and program the chip after the fill, so they don’t have to match the bottle to the appropriate chip number. When you are precoding, you have to get the right label to the right line, at the right time. With the chip embedded in the container, you avoid the need for an extra piece of equipment for orienting the labels, which slows in-line label coding. We precheck the chip to make sure it is activated before fill. The write antenna can be placed in an optimized position where it takes up virtually no space, and you can program the tag at normal line speeds,” says Smith.
INNOVATIONS
In bottle materials, companies report continuing interest in glass-replacement materials for vials. Alcan and O-I offer plastic alternatives such as COC (cyclic olefin copolymer).
Companies are also testing Aclon (PCTFE) as a layer in blow-molded containers. Aclon was launched this year by Honeywell Speciality Films (Morristown, NJ) as a clear, high-barrier material for use in multilayer containers. O-I has tested Aclon as a possible alternative layer material in its proprietary MLX injection blow molded containers. “We have tested incorporating Aclon as one of the material choices,” says Smith.
The Healthcare Packaging Group, a division of O. Berk Co./Kols Containers (Union, NJ), is offering thick-wall HDPE pharmaceutical rounds in three sizes for products requiring moisture and light protection. The containers are more than twice as thick as standard bottles, with a minimum wall thickness of 0.050 in., says Steven Nussbaum, director of marketing.
O. Berk’s Desiccant Basket fits into standard stock containers and resides completely within the bottle. The basket supports easy retrieval of a desiccant from drug packaging for products requiring reconstitution or for use with pills capsules and tablets. “The desiccant basket has been sold to a company that places a powder in a bottle and then the pharmacist or customer must add a liquid to the powder. Without the basket, the desiccant would sink to the bottom, where it would be difficult to remove or might be ingested by the patient,” says Nussbaum.
Talisman Technologies LLC (Plainview, NY) has developed a bottle cap closure that dispenses only one dose at a time. The One Dose Pill Dispenser provides what the company calls “unit dosing with a bottle.” When the bottle is turned upside down, a mechanism ensures that only a single pill (or dosage, which may be two pills) is dispensed. The closure can be added to existing bottles and containers or incorporated into new designs. According to Shaan Khan, founder and coCEO, the precise dosing is hygienic and eliminates the chance of contaminating the remaining doses. A push-in-and-up tab as well as a turn-upside-down-and-spin motion makes the design child resistant and senior friendly, says Khan. He reports that drug firms are launching tests of injection-molded prototypes.
As they listen more closely to their customers, manufacturers are working with suppliers to surmount design hurdles and devise custom solutions for cap and bottle systems. Comar has put its Helical Lock system to a new use in response to a customer’s problem with closure back-off when screw-thread vials are sterilized.
“In standard screw thread systems, the pressure that is applied to the liner is released in sterilization, and the seal integrity is jeopardized. We developed a Helical Lock closure system for glass or plastic vials that resolves this problem. We now think this solution will perhaps have wider application in the marketplace,” says Manera.
“We often work with pharmaceutical companies on specific design questions they have,” adds Tom Collins, Comar’s vice president, sales and marketing. “Companies today are more likely to say, ‘I’ve got this problem, can you tell me how to solve it,’ rather than say ‘do you have a closure that fits this requirement,’” he says.
Copyright ©2006 Pharmaceutical & Medical Packaging News
