By Marie Redding
The heat-sealing process for packaging sterile medical devices must be validated to comply with FDA regulations. Heat-sealer machine manufacturers are offering different types of equipment options and systems that can help ensure seals are in compliance. While high-end options can add a substantial amount to a machine’s price tag, a number of lower-priced options are also available. Some tools are built right into the machine.
Is Time A Factor?
The extra options available for heat sealers are designed to help medical device manufacturers perform a thorough validation of the heat-sealing process—and sometimes being able to do this in the least amount of time is the goal.
“Everyone is looking for ways to reduce the amount of time it takes to validate and package a product,” says Thomas Misik, vice president, sales, Belco Packaging Systems (Monrovia, CA).
John Lewitt, vice president of sales, Emplex Bag Sealing Solutions, a division of PlexPack (Toronto), feels differently. He says that none of his customers ever ask for ways to make the validation process faster. “Most of the people I meet in the medical field are looking for ways to make things better, more efficient...and more complex, not quicker or simpler,” explains Lewitt.
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Charlie Webb, president, Van der Stähl Scientific (Redlands, CA) points out that there has always been an ongoing struggle between production and quality departments at many medical device firms. He says that when production teams win out with a rush-to-market mentality, quality teams are left to pick up the pieces after a packaging failure that may prompt a recall.
“As developers of packaging equipment, we have a duty to be sensitive to the packaging validation process as well as the business side. We cannot forget that medical device manufacturers are businesses with a customer-driven production pace,” says Webb. “At the end of the day, we can never forget the critical nature of sterility. The quality department must have final say on ship dates.”
Jeff Quinto, general manager, PackworldUSA (Nazareth, PA) says, “The more you do to increase quality control, the more you are helping to prevent costly rejects,” he says.
Webb agrees. “There’s nothing that will cause a device company more wasted time than having to deal with a recall. The more verification systems you can have in place to try to prevent mistakes from happening, the more efficient the sealing process will be,” he adds.
Quinto and a few other experts feel there’s really no way to ‘streamline’ the validation process because extra tools that are designed to help with quality control, which are added to machinery, must be validated—adding yet another step to the process.
Dustin Hanson, Fargo Automation (Fargo, ND), feels slightly differently. “Tools that can take the human factor out of the equation will help streamline the heat sealing process; there are several options available to help medical device manufacturers do this,” he says. “The advances in automated heat sealers, specifically robotic, are making this possible.”
John Abraham, president, AtlasVac Machine (Cincinnati), adds: “Time is always a factor. Packaging engineers are usually brought into a project late, and the timeline is always blown before the project gets to their phase.” Agreeing with Hanson, Abraham says any piece of equipment that will enable an engineer to validate a new package design or process with certainty—and more quickly—is priceless. “The last thing a package engineer wants is a call from management concerning a ‘late launch’ of a new device, jeopardizing cash flow or profits,” he says. “Validating correctly the first time will help prevent this.”
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In-Process Inspection and Testing
Van der Stähl Scientific says its machinery helps to ensure quality control by utilizing a “forced compliance system.” The supplier’s patented MS-451-PV, for instance, has a built-in peel tester and visual inspection system.
“This system moves package testing to the cleanroom,” says Webb. The system works by forcing a worker to perform the required test, and if the seal strength is not at the Pass/Fail threshold that Quality has set, the machine will not continue to operate until a quality manager evaluates possible failure causation and enters a four-digit passcode. “It is like having a 24-hour quality control robot in your cleanroom,” he says.
Van der Stähl also offers several different systems designed to help quality teams manage compliance, such as stand-alone visual inspection machines. The VIU system gives operators a repeatable standard, using a set light source, light angle, and magnification. Van der Stähl’s visual test is a quick way to see whether there are seal failures occurring in the heat-sealing process.
“Operators can quickly look at a seal for clues that the seal is creeping out of status. All of the inspections data such as date, time, lot number, and pass/fail information are recorded on the unit; the data can be purged later for quality data archiving,” explains Webb.
More Monitoring Tools
Several other suppliers are offering ways to enforce a greater level of quality control on heat sealed packages. “Over the years we have sold different types of data-acquisition systems that monitor the whole sealing process. As this technology has improved, we are now able to truly monitor the sealing process in real time—at a fraction of what it used to cost,” says Lewitt, of Emplex Bag Sealing Solutions. “I have one customer monitoring multiple machines from one central computer.”
“Monitoring the process as closely as possible will help prevent costly mistakes,” Lewitt adds.
When tools are built right into a machine, it can be more efficient than having to use external equipment, according to Robert van Gilse, director of marketing and business development for Tegrant Corp., Alloyd Brands (DeKalb, IL). “The types of equipment our customers have been asking for include marking systems and vision systems, such as cameras and computers that verify that a package is in place,” says van Gilse.
There are a number of useful digital features available on heat sealers. These can be used to control and monitor the seal parameters during the sealing and validating processes.
All Packaging Machinery (Ronkonkoma, NY) manufactures fully validatable high-speed band sealers with digital controls that are intended to be easy to read, which helps during the validation process. “Having digitally controlled closed-loop controls on the sealer ensures repeatable parameters for the time [speed], temperature, and pressure, allowing you to easily duplicate a validatable seal,” says Dan Wood, president, All Packaging Machinery. “These features have always been incorporated into the design of our medical sealers from the beginning, as we understand the demanding processes of medical device
manufacturers,” Wood continues.
Digital speed controls help make the sealing process more efficient. Emplex Bag Sealing Solutions offers a wide range of machinery, and recently updated its entire line of validatable band sealers. “In doing so, we switched to a digital speed controller that allows the operator to punch in an exact speed. In the past, they were only able to monitor the speed digitally,” explains Lewitt.
Heat sealers that ease format changes are essential when working with high volumes of medical kits, according to Hanson of Fargo Automation. The company offers a variety of different form-fill-seal machines used for these types of kits. A different product configuration is reloaded often, for each type of kit. “Many of our customers have to change tooling as often as 3 times a day,” says Hanson.
Fargo Automation’s changeover process consists of stopping production of the current tooling configuration, and pressing a button to begin an automatic system “clean out.” When the quick-change option is used, each tooling piece is either held in place with a toolless clamp or fixture or by an auto-release pneumatic lock for larger pieces.
RFID technology can facilitate the tool-change process by enabling a machine to automatically recognize the tool that has been loaded. “By using RFID, the pneumatic locks will relock automatically when the correct tooling is in place,” says Hanson. “As an added feature, all of our tooling is color-coded to provide a quick visual check of the tooling to make sure it’s all correct,” he says.
“We’re definitely seeing an increased demand in the use of RFID technology,” says van Gilse, of Alloyd Brands. “By ensuring the machine is set correctly, mistakes are prevented during validation. The correct pressure, dwell time and temperature settings, which have already been validated for that tool, will automatically be set,” says van Gilse.
The Efficiency of A Bluetooth Scanner
Belco Packaging Systems offers its customers a bluetooth bar code handheld scanner, designed to help reduce the amount of paperwork necessary to complete the validation process for heat sealong a package. (The paperwork is part of documenting the sequence of events used to produce effective seals that maintain sterility, in order to be compliant with ISO 11607. This standard specifies the validation requirements for the forming, sealing, and assembly process for the packaging of terminally sterilized medical devices.)
The scanner reads the customer’s work order and automatically populates the correct process parameters into the controller. “This speeds up data input and eliminates the risk of operator error. It provides extra assurance that no mistakes have been made,” explains Belco Packaging’s Misik.
When considering whether a feature, such as Belco Packaging’s scanner, is worth the price tag, consider the fact that it can help avoid potential problems. “A slight mistake could potentially turn into a huge issue,” says Misik.
Fargo Automation also offers a hand held bar code scanner, which is used at the human machine interface. As a precaution, the system is designed to only start when new Work Order (WO) router information is entered. (In this case, a WO is a sheet of paper that contains human readable information and a bar code. The bar code holds the information with the product being run, and its corresponding lot and date codes, as well as bar codes for any product being run.)
“Our customers had complained about operators having to manually type in the human-readable information because they were seeing several mistakes being made. This scanner takes away the human error factor,” says Hanson.
Once the code is loaded, Fargo Automation’s system automatically looks for and recognizes the new codes for each type of medical device or package. “If the lot and date code is being printed, the printer will automatically be updated as well, via an integrated network. Next, a reader confirms that the printer is functioning correctly,” explains Hanson.
Temperature Control Options
When temperatures fall outside the validated temperature ranges, seal integrity is threatened. Specific machines have various features designed to control the temperature in different ways, but all have the same goal of ensuring seal repeatability.
“Delivering perfect heat seals every time starts with precision temperature controls. Our entire line of medical heat sealers employ the advanced TOSS Technology,” says Quinto. “TOSS Technology eliminates all the inherent inconsistencies found with thermocouple controls. It monitors and controls the change in resistance of the heat seal band at a rate of 60 times per second, providing precise temperature control throughout the entire sealing cycle along with flawless repeatability.”
Multivac Inc. (Kansas City, MO) manufactures vacuum chamber systems (C400 TC and C500 TC) that have constantly heated seal bars with thermo controls, so temperatures can be held with a close tolerance. An industrial PC (IPC) system is used to control the temperature and hold it in a very tight range. Its unique control panel is a password-protected touch screen, built right into the machine. “Our touch screen system is user-friendly and intuitive. The IPC-HMI allows recipes to be saved by product and quickly recalled by operators,” says Bill Williams, product manager, compact packaging systems group.
The screen is password protected, and actual parameters can be adjusted within a predefined range (seal time, temperature, pressure, and chamber pressure), as established during the validation process.
“The selection of recipe can also be driven by RFID technology embedded within the quick change pouch positioning device of the chamber machine. Add our printer and handheld scanning device and you are well on your way to 21CFR Part 11 compliance,” says Williams. The supplier first launched this IPC system in 2007, but now it’s available across Multivac’s range of medical packaging machines.
A Reliable Heater
Medical device companies can also avoid costly machine downtime, revalidations, and stocking spare parts by choosing a heat-sealer with a documented history of reliability, according to CeraTek Sencorp (Hyannis, MA).
The heater is a critical component of a sealing machine. “We haven’t had to sell a replacement tray sealer heater because of a failure in the field since the inception of our MD-Series sealers in 1995,” says Lynne Barton, product specialist, CeraTek Sencorp. Instead of a cartridge-style heater, CeraTek Sencorp uses a custom-designed blanket-style heater in its line of medical device tray sealers, ensuring a uniform heat profile across the entire heated platen. “This eliminates issues with temperature distribution, tool layout, and detecting heater burnout, typically experienced in machines that utilize cartridge-style heaters,” she adds.
The Advantages of a Larger Seal Bed
A machine with a large seal bed area is necessary when packaging larger medical devices, but it can also be a useful time-saver, says Tegrant Corp.’s van Gilse. Tegrant Corp/Alloyd Brands launched a medical device tray sealer last year called the Aergo 2 Max. The machine has a very large seal bed area, measuring 20 × 28 in.
Belco Packaging Systems offers two machines with a large seal bed area. One measures 30 × 25 in. and another is 40 × 30 in.
“A large seal bed can make most jobs more efficient because inner and outer parts of the package will usually fit on the same tray,” says van Gilse. Tegrant Corp.’s sealer will fit both one inner and one outer part of a large package, or multiple inners and outers of smaller packages on its seal bed. “We just did a job where we sealed 8 packages of each part per tray—so we were able to seal 16 parts simultaneously.”
The Importance of Equivalency
Sometimes a medical device manufacturer will own duplicate machines. Knowing whether or not multiple machines are equivalent can be a very useful time saver should the sterility in your cleanroom become compromised, says Misik of Belco Packaging. The supplier has been manufacturing machinery to this documented specification for its customers. “If something were to happen to the cleanroom and operations need to be shut down, the tooling can be moved to a different cleanroom that contains an equivalent,” says Misik. “A full qualification process won’t have to be repeated on the same package again and production can continue after a miniprocess qualification, saving a lot of time,” he says.
Calibrating heat sealers once a year is usually standard procedure for many companies, according to PlexPack’s Lewitt. “This ensures that any multiple machines are operating at the same parameters as when originally validated,” he explains.