Medical Device Link.

BAGS AND POUCHES

Pharmaceutical bulk bags from Beacon Converters can be customized with a range of materials, ranging from ultra-high-barrier versions to breathable ones.

Pouch and bag technology has continuously evolved in response to customer-specific requirements and vendor-driven innovation aimed at performance improvement and cost reduction. Converters have enhanced bag ruggedness, improved material barrier and sealing properties, and increased bag performance during sterilization.

“Many of our new products are developed with a customer need identified. We have an arsenal of materials and a tremendous amount of pouch and bag manufacturing flexibility,” says Edward Haedt, director of marketing, Perfecseal Inc. (Oshkosh, WI).

Perfecseal recently produced a high-barrier foil pouch with a small clear internal window for viewing a component packaged inside a compartment of the pouch. For pharmaceutical and diagnostic markets, the company is developing capability for complex, high-precision pouch sealing.

“This relates to potentially complex multicompartment sealing and applications where the pouch size must conform to tight tolerances. Pouches could require print positioning to conform to complex sealing patterns within the pouch. This becomes challenging with very small pouches that contain a lot of labeling information,” says Haedt.

“With a small billboard for the print on a small pouch, our customers like to take printing as close to the edge of the pouch as possible,” he adds.

Perfecseal has developed a hot-bar surface-treatment technology that addresses overheating when sealing film to film. “Traditionally, hot-bar sealers require films with a heat-resistant outer layer to prevent the film from melting on the bar. This can cause distorted seals and sometimes even open seals. Laminates containing an outer biaxially oriented film such as BOPET or BOPA are typically used to prevent sticking.

“With the new technology that we have developed for our pouch lines, we can seal monolayer polyethylene films and coextruded peelable polyethylene films used in chevron and corner-peel pouches. These nonlaminated films tend to be somewhat less costly and can often be more than adequate for an application,” Haedt says.

Alcan Packaging Medical Flexibles (Chicago) uses the Ultimate Header Film (UHF) G1 series of laminates in its Ultimate Header bags. Bags are featured with a peel-seal film and uncoated Tyvek header, in Kwikbreathe bag styles for the packaging of sterile medical kits and gowns.

The multilayer film provides puncture, tear, and impact resistance, while reducing costs by eliminating nylon in the laminate. “The header bag with the G1-series films has taken off since we launched it last year. Some people are comfortable with coated Tyvek, but many of our customers are looking to reduce the amount of Tyvek because of the cost. They want to knock down sterilization time as cycle times become more rigorous,” says Jesse Blake, bag and pouch marketing manager.

Beacon Converters Inc. (Saddle Brook, NJ) is working with A34T, a new peelable structure combining Tyvek and foil. “We developed this product to meet the needs of customers that were looking for high gas barrier and high physical barrier combined,” says Alison Tyler, technical director for Beacon Converters. “We have seen applications with this product that range from abrasion and moisture resistance requirements to cryogenic products. Because the structure is made with Tyvek, the gamma resistance is higher than that of nylon foil structures. Tyvek is also very dimensionally stable and is resistant to stretch, which is important when coupled with foil that has very limited ability to stretch.”

Beacon Converter’s A34T offers the strength properties of Tyvek married with the barrier properties of foil to provide a unique combination of barriers.

SPEEDING STERILIZATION

“The more robust and breathable the bag, the more vacuum you can use to flush out the residual gas to complete the sterilization process faster. The uncoated Tyvek provides two to three times the breathability of coated Tyvek,” Blake says.

“We have improved the film’s clarity and made it stronger, so you can downgauge a 4- to 5-ml bag to a 3- or 4-ml one,” he adds.

The bag minimizes Tyvek material by using a narrow 3- or 4-in. header strip or Tyvek in a barbell configuration. The peelable film is the product contact layer to which the Tyvek header is sealed. The peelable film is die-cut for breathability.

The peelable film with the Tyvek header is peeled from an interior UHF film layer. The interior UHF layer in the bag’s body is die-cut for product access.

“The user peels off the Tyvek window part and then removes the product through the die-cut in the bag. The Tyvek and peelable film window stay with the bag. We are peeling one film away from another, so there is no potential for Tyvek fiber tear,” Blake says.

Blake says that Alcan is testing a desiccant foil that provides an active packaging solution for products such as drug-coated devices. “We have header-style pouches using the laminate in stability at the moment. The desiccant addresses any moisture that is left after the pouch is EtO sterilized and sealed.”

Perfecseal has added printing capacity required for the packaging of combination drug/device products in EtO-sterilized Tyvek header pouches. “These are foil-laminate pouches that provide excellent barrier to moisture, oxygen, and light. The packaging requires a lot of labeling. If the package is small, printing on one side is not sufficient. We are supporting these applications with two-side registered printing.”

BAGS ON A ROLL

Stewart Baker, vice president, sales, Advanced Poly-Packaging Inc. (Akron, OH), says that automatic bagging solutions are suitable for device makers with higher volume and fast turnaround output requirements. The company has launched a focus on the medical device field with new pouch and automatic bagging machine solutions. “Companies start to look at automation when they are doing in excess of 2500 bags per shift or per day. Our Model T-1000M automatic bagger allows bagging at speeds of up to 20 times faster than hand bagging,” says Baker.

“For some companies, turnaround time is an issue, where they might need to produce 10,000 bags in a day or two. Other customers are using automatic baggers to reduce the number of employees dedicated to bag filling,” he says.

Advanced Poly-Packaging has modified the Model T-1000M to run preopened Tyvek bags on a roll. The firm converts pouches that are perforated and preopened with the polyester side slit. To handle the Tyvek pouch sealing with the T-1000M, the seal bar’s thickness was increased from 1¼8 in to 3¼8 in. A new controller maintains sealing temperatures ±3Þ for consistent, validatable sealing, says Baker.

With the T-1000M, the bag is blown open when the perforation on the Tyvek side is detected after the bag is indexed into position. A manual switch cycles the bag after product insertion. The bag drops after sealing and separation.

“As the bag is held for sealing, we reverse the bag above it to put tension on the film at the perforation. The tear-off bar tears the perforation at the same time the bag is being sealed,” says Baker.

Advanced Poly-Packaging’s Model T-375 tabletop bagger and printer launched this year addresses the requirements of labeling accuracy in pharmaceutical bagging. Bag feeding, printing, and sealing are done in one step, with a patented next-bag-out printing system.

After a PC captures data scanned from a pill bottle presented by the operator, the unit prints and feeds one bag for filling, “so there is no chance of putting the wrong product into the wrong bag,” says Baker.

ACCURATE LABELING

For accurate bag filling and printing, Automated Packaging Systems (Streetsboro, OH) launched in 2006 the Autobag AB 180 OneStep and AB 255 OneStep baggers. With the imprinter located above the bag loading position, each bag is printed just before it is indexed for loading. The OneStep units are suitable for pharmacy fulfillment applications and accurate bagging and printing in short-run medical device and kit packaging, at speeds up to 30 bags per minute.

Tim Groff, director of marketing, says the OneStep packaging systems are optimized for flexibility, with an operator-friendly AutoTouch Control Screen, onboard diagnostics, and easy integration with shipping and customer databases.

The company recently introduced support for the DeviceNet protocol and Ethernet communications, in response to customer requirements for packaging system integration and high-speed communication of related information.

DeviceNet supports OEMs, integrators, and package system engineers that are integrating flexible packaging solutions with Automated Packaging Systems’ baggers. Ethernet provides high-volume, high-speed data transfer to process controllers and computer databases.

“Companies are looking for the ability to manage information at the machine level, and for information on bagger performance. Ethernet enhances overall production capabilities by communicating machine performance characteristics through local area networks to production systems,” says Groff.

“Fully automated pharmacy fulfillment operations need to communicate high volumes of critical data to process controllers, computers, and databases. They need to know where the product, documentation, and bags are at all times in the cycle. Coding, bagging, and shipping information are directly linked to a control or computer system to ensure that the right drug and right documentation go to the right person at the right time,” says Groff.

Automated Packaging converts its Autobag preopened perforated bags on a roll for running on its automatic and semiautomatic bagging systems. Bags on a roll also provide convenient bag handling and dispensing for firms using manual sealers.

Groff says medical device firms have adopted the SPrint Side Pouch Bagging system that uses SidePouch bags for kit packaging. With this system, single or multiple operators can load products into master packs at speeds up to 120 bags per minute.

Groff says customers are testing bags made from various unique coextruded films that the company offers for medical device applications that require extreme high barrier and rugged performance.

Uncoated Tyvek header strips on Alcan Packaging’s Ultimate Header bags minimize Tyvek material and promote faster sterilization cycle times.

SPECIAL DELIVERY

To meet one customer’s requirement for cost-effective packaging of multiple sizes, LPS Industries (Moonachie, NJ) provided 400-ft rolls of polyester/foil/polyethylene tubes. “This is the first request of this kind we have seen. Instead of ordering our minimum of 5000 bags for five different sizes, the customer is cutting off the tube to the desired length and sealing both ends,” says Jack Cunneen, vice president of sales.

Point-of-care diagnostic test use has proliferated in doctors’ offices and in the home. They require barrier pouch materials and, if the product is not unit-of-use, a recloseable feature. “The packaging of instant-assay diagnostic kits is a huge growth market for us. Once the chemistry is imparted to the device, it must be kept extremely dry. Our Vapor-Loc aluminum laminate pouches provide moisture and oxygen protection. Top-Loc zippers are used where repeated access is required,” says Cunneen.

“After the bag is sealed, you have a hermetically sealed bag with a potential shelf life of up to two years. When you open the bag to access the zipper, the device is no longer hermetically protected, but the bag will retard degradation of the product,” he says.

LPS has developed a solution for printing serialized bar codes onto pouches, mainly in response to requirements from agriculture chemical customers. “There does not seem to be a pressing demand for serialized codes from our medical customers. Demand arose from the agriculture sector, when ammonium nitrate was used to construct the bomb used in the Oklahoma City bombing,” Cunneen says.

Beacon Converters customizes bulk bags for pharmaceutical customers looking for a solution to transporting large quantities of pharmaceutical products and materials. “In some cases, we make an ultra-high-barrier bag with barriers to light and moisture,” says Tyler. “This is a typical requirement in the pharmaceutical industry to protect active compounds. In other cases we provide breathable barriers for large-scale gas sterilization of components for injectable drugs that must be kept particle free.”