Jun 21, 2021 | Blog, CeraTek, Medical Pouch Sealer
The Different Types of Medical Pouch Sealers
Medical pouches are sealed in different ways, depending on the type of pouch material being used, the sealing temperatures needed, and other factors. The four most common types of medical grade heat sealers are: constant heat, impulse heat, rotary band, and form fill seal (F/F/S).
Constant heat sealers
A constant heat sealer is typically a “jaw type” sealer, with seal dies that repeatedly open and close, sealing one pouch at a time. A constant heat sealer has a heater embedded into its aluminum sealing die. The operator turns the machine on and selects the appropriate recipe. After a short period of time (approx. 10 minutes), the die is heated to the set temperature and the heat is evenly distributed across the sealing die, and the die will remain at this temperature until the sealer is turned off or a different temperature is selected. Because the die is heated to one temperature and it remains at that temperature until either the set point is changed or the machine is powered OFF, constant heat sealers are the easiest heat sealers to validate. They also provide the most stable, repeatable sealing process and require less ongoing maintenance than other types of sealers.
For these reasons, constant heat technology is the preference of most medical device manufacturers. Typically, constant heat technology is used to seal the three sides of the pouch when it is made —and so, it is the technology that will provide the best, most compatible seal across the final, or fourth, side of the pouch.
Impulse heat sealers
Like constant heat sealers, impulse heat sealers are usually also “jaw type” sealers; however, the heating element of an impulse heat sealer is a very thin wire that can heat up and cool down quickly. As a result, after an “impulse” of heat is generated, the die rapidly reaches temperature and then cools down, all while under pressure. The operator can keep the die closed as the heating element cools and the pouch material drops below the melt point to a temperature that allows the pouch to be removed from the sealer and handled without worries about it being tacky or damaging the seal.
Impulse heat sealers are typically used for either the high temperature sealing or welding of mono-layer materials. They are not preferred when sealing pouches made from multi-layer materials because when the temperature fluctuates between heating and cooling every cycle, it is difficult to maintain accurate process control.
The most common method for monitoring the fluctuating seal temperature on impulse heat sealer is with a thermocouple, which measures the temperature and sends that signal back to the temperature controller. Impulse sealers require very fine thermocouples because the finer the thermocouple, the faster the response. (which means they are likely to need frequent replacement). Note: Every time maintenance is required on a medical grade heat sealer to replace a critical component that is part of either the temperature delivery, pressure delivery, or the time delivery system, the sealer needs to be re-qualified.
Rotary band or continuous band heat sealers
A rotary band or continuous band heat sealer is not a “jaw type” sealer that seals one pouch at a time. Instead, a continuous band or rotary band heat sealer uses opposing bands to carry pouches through the heat sealing process. The operator feeds the leading edge of the pouch into the sealer, where it is captured by the bands and pulled through to the section where heat is applied. The heat brings the materials to the melt point and welds them together, and then the bands continues to pull the pouch through the sealer to an unheated section where cooling occurs. The cooled pouch then emerges from the other end of the machine.
The advantage of a continuous band or a rotary band heat sealer is throughput. It offers significantly higher output compared with a jaw type heat sealer. In addition, a continuous band sealer is optimal when the two sides of the pouch are the same material (similar materials have the same thermal expansion rate and dissimilar materials can expand at different rates which can result in wrinkles in the seal). Rotary band sealers are also optimal for products that are light weight, flat, and lower profile. Rotary band sealers can operate in a horizontal or vertical orientation.
Interestingly, a continuous band or a rotary band heat sealer offers the benefits of both constant and impulse heat. The actual pouch sealing is done with constant heat, which is a very stable temperature, but then the pouch is pulled along to an area where there is no heat, enabling it to cool under pressure.
Form fill seal heat sealers (F/F/S)
A form/fill/seal machine does not use preformed pouches. Instead, it uses two rolls of material that come together in the middle of the machine to actually create the pouch around the product. The operator places the product, either manually by using automation, into the sealer and then the sealer uses a set of reciprocating dies to create a sealed pouch around it. Form/fill/seal machines can be horizontal of vertical.
Form fill seal machines are used for high throughput, high output requirements. In fact, they can usually run as high as 20 plus cycles a minute. However, tool change overs for form fill seal heat machines can be time-consuming because in these instances, seal dies and cutting mechanisms need to be replaced. By contrast, with a traditional impulse sealer, constant heat sealer, or rotary band sealer that uses a preformed pouch, there are no full-on changeovers, enabling operators to move easily and quickly from one type of pouch to another.
For any of these heat sealers to be used for medical pouch sealing, they should be ISO 11607-compliant. ISO 11607 is a guidance document that is used to define many different aspects of sterile packaging. For example, for a piece of sealing equipment to be ISO 11607-compliant, it must have the ability to verify and alarm temperature, pressure, and time.
Jun 9, 2021 | Blog, CeraTek, Medical Pouch Sealer
Medical Pouch Sealing
Medical pouch sealing is a process that is used within the medical device and life science industries for packaging medical products that require sterilization. The process involves two main components: a medical pouch and a medical grade heat sealer.
A medical pouch is a flexible package consisting of laminated or mono-layer flexible materials including but not limited to Tyvek®, coated foil, film, and coated paper. The pouch is created by bringing two webs of material together and sealing them on three sides, leaving the fourth side open. The product is inserted into the pouch and then it is heat sealed across the fourth and final side to create a sealed package in preparation for sterilization.
The heat sealer used in this process must be a medical grade sealing system that provides accurate and repeatable control over temperature, pressure and seal time. In addition, the system should include process alarms and features to prevent the operator from modifying the validated settings, and the heat sealer should be ISO 11607 compliant, cleanroom compliant and able to be validated and calibrated.
Because medical packaging is so critical for keeping medical and life science products free from contamination, medical pouches are considered part of the product delivery system. When a medical device manufacturer is designing a package, they qualify the package along with the product because the product is not considered usable unless it can arrive at its ultimate destination as a sterile product. So, the sterile barrier system is the package, and in most cases, the package is part of the product, because the product cannot be used without proper packaging.
Medical pouch sealing is used for a variety of items that need to be kept sterile
Manufacturers use medical pouches to package a wide range of high value products used in health care and the life sciences. For example, medical pouches are used to package single use disposable devices, such as catheter delivery systems. . In addition, medical pouches can be used for devices that ultimately become a permanent part of a patient’s anatomy, such as stents, the components used for hip replacements and the screws and rods that can be used to repair bone fractures. Medical pouches are also used for packaging certain surgical instruments, although in many of these cases, the instrument is cleaned/reprocessed, sterilized, and packaged more than once.
Typically, medical pouches are not used for lower value medical products, such as gauze or bandages. They are used mostly to package medium or high value, low volume medical products.
Mar 23, 2021 | News
SencorpWhite promotes Corey E. Calla to Chief Executive Officer. Calla will lead growth in SencorpWhite’s seven business units: White Systems, Sencorp Systems, Intek, Minerva Associates, CeraTek, Accu-Seal, and Customer Service.
HYANNIS, MASS. March 23, 2021 – SencorpWhite, the recognized global leader in high quality, end-to-end solutions for automated packaging, integrated intelligent storage solutions, and warehouse automation software, announced the promotion of Corey E. Calla to President & Chief Executive Officer of SencorpWhite. In conjunction with Calla’s appointment, Brian Urban, who has been with SencorpWhite for 26 years, will be transitioning into a senior advisory role on the company’s board. These leadership changes are effective immediately.
Prior to joining SencorpWhite in October 2018 as President of White Systems, a business unit of SencorpWhite, Calla gained 22 years of experience in the material handling industry at Intelligrated (purchased by Honeywell in 2016), FKI Logistex, and Pinnacle Automation. Under his vision and sales leadership, Intelligrated grew their service business by over 400%.
“We are excited to begin the next chapter at SencorpWhite and I am confident Corey will utilize his expertise and leadership capabilities to drive exceptional growth for SencorpWhite,” Brian Urban said. “His deep knowledge of sales, service, and software make him the perfect fit to lead us as we continue to expand our product lines and customer base.”
In 2 years as President of White Systems, Calla has significantly expanded the White Systems sales and marketing teams, oversaw the integration of our Intek and Minerva software teams, and recruited new leadership for SencorpWhite’s extensive field service team. Most notably, Calla and his team established a presence in the rapidly expanding e-commerce market and initiated large projects with key accounts in the distribution center and manufacturing space.
“I am enthusiastic about the future of our business and the incredible team we are building,” said Calla. “SencorpWhite is uniquely positioned to rapidly innovate and bring to market high-quality systems and solutions configured to unique market changes. I am truly excited to be leading the SencorpWhite team in this next chapter, focusing on customer satisfaction, innovation and acquisitions that drive total customer value in all our business segments.”
Feb 1, 2021 | News
SencorpWhite and Urania Engineering are pleased to announce the development of a strategic partnership that will link Urania’s innovative engineering solutions with SencorpWhite’s technical expertise and broad service capabilities in medical heat sealers.
www.sencorpwhite.com/rotary-band=heat-sealers
This collaboration solidifies SencorpWhite’s commitment to providing with high performance heat sealing systems. Rotary band heat sealers are ideal for medium to high volume applications, making it the application of choice in medical device and pharmaceutical packaging, as well as food and dry bulk products.
Urania Engineering, based in Hazelton, PA, has a proud history of American engineering and innovation that spans more than 40 years, and is the leading manufacturer of rotary band heat sealing equipment. The company’s PouchPro and Packaging Answer systems are synonymous with innovation and efficiency in the packaging industry. “We have been working closely with the SencorpWhite team and are confident that our relationship provides the potential for a long and mutually beneficial collaboration that provides increased value to our existing customer base and the expanding market for heat sealing and packaging equipment,” says Eric Curran, General Manager at Urania Engineering.
SencorpWhite, through its CeraTek and Accu-Seal sealing businesses, will provide greater market reach, enhanced technical support, and strengthened service capabilities. Drawing on its extensive industry knowledge and participation on ASTM and AAMI technical committees, CeraTek and Accu-Seal distinguish themselves by serving as a trusted partner to customers operating in FDA regulated industries like medical and food packaging.
“With this partnership, we have the ability to increase the breadth and reach of sealing markets and processes,” says Kent Hevenor, Vice President of Sealing Technologies. “With the expected on-shoring of medical device manufacturing, the Urania product is well suited for medium and high-volume applications.”
The combined strengths of SencorpWhite and Urania maximizes our innovative technologies for customers seeking solutions to meet the ever evolving packaging requirements for a variety of industries. Regardless of scope, the blending of technologies and technical expertise provides proven, cost-effective results.
You can view rotary band heat sealer technology at sencorpwhite.com/Urania and learn how SencorpWhite products improve your business with packaging technology and innovative system solutions, as well as industry-leading service.
About CeraTek and Accu-Seal: CeraTek and Accu-Seal are business units of SencorpWhite and offer the latest technology and trends in constant heat and impulse heat medical pouch sealers, vacuum chamber sealers, and custom machinery. SencorpWhite, founded in 1947 and headquartered in Massachusetts, is also comprised of White automated storage, Intek and Minerva software, and Sencorp thermoforming systems.
About Urania: Urania Engineering is an American-based manufacturing company using innovative technology and a modular approach to machine design aimed at satisfying the needs of evolving industries. The company uses an in-house operations approach, keeping all stages of the manufacturing process at their Northeast Pennsylvania facility.
Sep 12, 2019 | Blog, News
$960,000 will support student learning…
Capecodtoday.com recently wrote about Cape Cod Community College being awarded two grants totaling $960,000 providing support and technology for students studying in Science, Technology, Engineering, and Math (STEM).
The first grant, awarded to the College by the National Science Foundation (NSF), will fund over 50 scholarships to academically talented students with demonstrated financial need in the College’s Engineering, Computer Science, Mathematics, and Science programs.
Eligible students must be US citizens who qualify for FAFSA based financial aid, enrolled full-time in a STEM degree program with a GPA of at least 3.0 or higher, and have completed at least 6-credits prior to becoming a participant. This grant will focus on increasing access and entry for low-income, rural, and diverse students into STEM programs and well-paid, in-demand STEM careers.
The second grant, awarded to the College via the Massachusetts Workforce Skills Cabinet with support from the Baker Administration, provides $310,000 for classroom and laboratory technology upgrades in Engineering, Digital Manufacturing, Robotics, and Industrial Internet of Things (IIOT) training. These funds allow significant enhancements to the College’s Engineering, Computer Science, and Manufacturing toolsets and equipment.
The College collaborated with local high schools and area industry partners including Teledyne Marine Systems, SencorpWhite, Hydroid, and Onset Computer Corporation to develop the grant and to ensure continuity of technology.
“These grants, and the commitment they provide, will have tremendous impact for our students,” said John Cox, President of Cape Cod Community College. “We are seeing a STEM revolution happening in our region and beyond, and we are proud that our students, faculty, and staff are at the center of this movement. With more access to STEM degrees, upgraded technology, and a new Science and Engineering Center coming in 2022, Cape Cod Community College is positioned for the future of STEM education.”
Activities for the NSF grant will be led by Fredrick Bsharah, Department Chair and Associate Professor of Engineering for Cape Cod Community College, Bridget Burger, Director of Cape Cod Regional STEM Network, and Jill Neumayer DePiper, Senior Research Associate at the Education Development Center. Grant activities for the MassSkills award will be managed by Bsharah.
“Here on the Cape and Islands we have an opportunity to create a bright future for ourselves withscience and technology, and 4Cs is uniquely positioned to offer pathways to success for our students with high-quality STEM programs, made even more meaningful with grants like these,” said Burger. “We are immensely thankful for these two grants and for the support we’ve received from NSF and the Massachusetts Workforce Skills Cabinet to continue to enhance our STEM offerings and technology.”
For questions about the grants or how to apply for STEM scholarships, contact Fredrick Bsharah at fbsharah@capecod.edu or Bridget Burger at bburger@capecod.edu.
Nov 19, 2018 | Blog
Thanksgiving is just around the corner, and if you’re like me, you’ve probably grown somewhat accustomed to thinking about it as just one more in a string of over-commercialized events. Don’t get me wrong—I thoroughly enjoy the family time, the football and of course, the turkey, complete with stuffing and New England’s celebrated cranberry sauce. But if I’m being perfectly honest, it’s been a while since I’ve thought about the holiday’s true meaning.
All that changed earlier this month, when my eyes were opened by our outstanding SencorpWhite employees. Let me explain.
First of all, a few weeks ago, we held an all-employee luncheon in honor of Veterans Day, and I had the privilege, on behalf of all of us at SencorpWhite, to personally thank each and every employee who has served, or serves, in any branch of the United States armed forces and to present each one with a jacket, as a small token of our appreciation. Coincidentally, this luncheon was held on November 6, Election Day, which made it even more meaningful. As I told the group gathered that day, veterans have sacrificed to protect our right to vote—and for that, we are truly grateful.
This theme was underscored a few days later, when Noelle Forde, SencorpWhite’s HR manager, came into my office looking puzzled. “This has never happened before,” she said. “I have a request from one of our employees to buy everyone at SencorpWhite lunch.”
As it turns out, Doug Flook, one of our remote Field Service Technicians from Texas, had written to Noelle to say that because he was so thankful for the help and support he receives from SencorpWhite employees, he wanted to sponsor a “thank you lunch.” Oh, and by the way, Doug sent a check with the letter to cover the cost of lunch for everyone!
Now, I am not often at a loss for words, but in this instance, I didn’t know what to say. I asked Corey Calla, our newly appointed President of White, into my office, and the three of us began to discuss how we should handle Doug’s request.
We couldn’t possibly let an employee pay for everyone’s lunch—that just didn’t seem like the kind of precedent we wanted to set. But what other option did we have? I tried letting Doug know that I would personally match the money he sent, and then we could donate the total in Doug’s name to a charity of his choice. But Doug was adamant. “I want to thank everyone for what they do for me,” he said. In fact, here is exactly what Doug put in writing to all SencorpWhite employees:
A Co-Workers Words of Thanks
Greetings Friends and Co-Workers of SencorpWhite, I know each of us performs the duties to which we are all hired to do. That in and of itself creates a conducive atmosphere or environment in which to work in. However, SencorpWhite employees don’t stop there. The effects of such are evidenced in the pride of workmanship, customer satisfaction, and employee relations. The customers in my area are all satisfied with the “product” we provide. This satisfaction stems from the components of the whole. Thank you for the efforts each of you provide that makes my efforts less burdensome and more meaningful. To show appreciation I invite you to a pizza luncheon.
Thank ya’ll very much,
Doug Flook – Field Service TX
How could anyone say no to that?
I mentioned earlier that Corey Calla was in on the conversation about how to handle Doug’s request. During that discussion, he told us that his prior employer has an employee-sponsored fund that periodically provides a meaningful distribution to any employee who anonymously requests assistant in time of need. That sounded like a brilliant idea to me! Is there any better way to say “thanks” to our fellow employees than to start a fund that can help one in time of need?
I told our team that I would take the matching money I offered Doug and “seed” the start of the fund. Corey jumped in and said, “I’ll match you!” Then, Justin Edwards, our new CFO, quickly followed with, “I’ll match you, too!”
I am happy to report that we now have sufficient seed money to start our new fund and that we are finalizing the details so we can formally introduce it during SencorpWhite’s traditional “Week of Thanks.”
Any employee will be able to donate to this new fund, and as Corey explained, what started out as a similar small gesture at his former employer, has grown into a meaningful part of that company’s culture. I have no doubt that the same will happen at SencorpWhite, and to recognize and thank Doug Flook for reminding us about what it truly means to be thankful, we will name our new fund the “Flook Fund.”
Like I said in the beginning, this month has opened my eyes in new ways. Thank you, again, to all our veterans, and to Doug, Corey, Justin, and Noelle… and my best wishes to all of you for a joyous holiday!
