Technimark Expands Global Headquarters To Meet Growing Demand In Medical Market

Global plastic injection molding leader expanding medical manufacturing facilities in Asheboro, N.C. with acquisition of adjacent property to existing campus

ASHEBORO, N.C., (May 2, 2022) – Technimark, a global manufacturing provider for the healthcare, consumer packaging and specialty industrial markets, announced today that it will expand its operations in Asheboro, N.C., with the acquisition of a 204,000-square-foot medical facility. The space, equipped with Class 7 and Class 8 clean rooms, will specialize in medical manufacturing, including precision injection molding, value-added assembly, finished device assembly, contract manufacturing, and logistics operations.

Technimark is committed to expanding cleanroom facilities worldwide that satisfy its global customer base’s specific needs and requirements. This acquisition allows Technimark to expand its healthcare manufacturing footprint on its global headquarters campus. The new Asheboro facility brings Technimark’s global headquarters campus to 1.4 million square feet.

“We’re excited to significantly expand our medical manufacturing operations at our global headquarters in Asheboro, North Carolina,” said Kris Peavy, CCO & President of Healthcare. “Creating open capacity to meet our customers’ future manufacturing needs is a pillar of our organic growth strategy.”

More growth news is on the horizon in 2022 and 2023 for Technimark, including major expansions underway at Technimark facilities in Mexicali, Mexico, United Kingdom, Ireland, Germany, and China to support growth in all our core markets.

About Technimark

Technimark is a global manufacturing solutions provider for the healthcare, consumer packaging and specialty industrial markets. Technimark specializes in precision injection molding, value-added assembly and full supply chain services. Technimark provides clients with customized, end-to-end solutions based on technology and innovation that improve quality, reduce risk, lower costs and speed products to market. With facilities in the Ireland, United Kingdom, United States, Mexico, China and Germany, Technimark delivers high-quality products worldwide. As part of Technimark’s commitment to sustainable and responsible business practices, the company has embedded the Ten Principles of the United Nations Global Compact into strategies and operations, and committed to respecting human and labor rights, safeguarding the environment, and working against corruption in all its forms. For more information, visit technimark.com.

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Come see us at MD&M West 2022 – Booth # 2841

Your products. Our innovations. A perfect match.

Technimark Healthcare.
The perfect combination of innovation and experience.

Technimark Healthcare brings together decades of product innovation and a deep understanding of the healthcare market.

What does that mean for you?

You now have a manufacturing partner who can not only keep up with a changing medical and pharmaceutical landscape, but help you stay on top of the latest technological advances while maintaining the highest levels of quality.

Come see for yourself. Stop by while you’re in Anaheim, and let’s see what we can create when we put our heads together.

MD&M West 2022
Booth # 2841

April 12th-14th
Anaheim California

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Technimark Earns MedAccred Certification for El Paso Facility

Company currently pursuing new industry standard MedAccred certification for its other medical device facilities worldwide

ASHEBORO, N.C. (Jul, 6, 2021) – Technimark announced today that its production facility in El Paso, Texas, received its MedAccred certification from the Performance Review Institute. The facility, which is also ISO 13485:2016 certified and 21 CFR 820 compliant, specializes in medical contract manufacturing, including services such as custom injection molding, assembly and logistics operations for the medical device industry.

“Patient safety and quality are our highest priorities, and we are excited to partner with MedAccred to ensure our critical processes are best-in-class,” said Kris Peavy, president of Technimark’s Healthcare division. “The significant growth of our medical device business around the world, and specifically in our El Paso facility, made MedAccred certification a perfect fit. The accreditation helps us further demonstrate our expertise as a trustworthy and high-quality supplier in the medical device industry.  We’re currently pursuing accreditation at all of our medical facilities, and we expect them to be certified in the near future.”

The MedAccred certification program was developed by the Performance Review Institute, a non-for-profit organization that facilitates collaborative supply chain oversight programs, quality management systems approvals and professional development activities in industries that rely on high-quality, high-safety protocols. MedAccred is managed by the medical device OEMs, contract manufacturers and suppliers who collaborate to provide the sector with a trustworthy, evidence-based tool to ensure the suppliers’ processes and products meet the highest standards and improve product quality.

“Technimark is clearly committed to quality and improving patient safety by meeting the rigorous requirements set by technical experts in the medical device industry,” said Connie Conboy, director, MedAccred. “Technimark is a true leader in the medical device industry as demonstrated by their MedAccred Accreditation for Plastics Injection Molding at their El Paso, Texas facility.”

In describing the MedAccred certification process, the Performance Review Institute notes that preventing output deficiencies requires that critical processes and products be validated during manufacturing to prove that they are fit for purpose, satisfy regulatory requirements and reduce overall risk. The MedAccred certification does just this by:

  • Providing consistent, standardized critical process accreditation accepted by the Medical Device Industry resulting in fewer redundant onsite audits by multiple OEMs
  • Having Subject Matter Experts conduct in-depth critical process audits that are compliant and consistent with accepted industry/technical standards
  • Providing greater visibility of the supply chain to all levels and sub-tiers that provide critical processes, consistent with regulatory requirements (e.g., FDA, ISO 13485, MDD/MDR, etc.)
  • Improving the flow down of OEM requirements to sub-tier suppliers
  • Applying medical device industry-accepted and consistent technical requirements that yield process discipline, greater operational efficiency and continuous improvement resulting in higher quality and lower overall cost

Mr. Peavy explained that the audit is very thorough and drills into each individual process under review. “While MedAccred certification requires an ISO-certified quality management system, the process is not simply a QMS audit. Rather, it focuses on the key elements of the manufacturing process itself,” he said.

Audits are conducted by industry-approved and trained SME auditors on behalf of its subscribing OEM members using collaboratively created audit criteria. The accreditation is granted and accepted by the program’s subscribing OEM members. The audit criteria incorporate industry-accepted performance standards and manufacturer specifications that meet regulatory requirements.

“On behalf of Technimark and our clients, I want to thank the entire El Paso team for leading the way on this notable achievement,” Mr. Peavy said.


About Technimark

Technimark is a global manufacturing solutions provider for the healthcare, consumer packaging and specialty industrial market. Technimark specializes in precision injection molding, value-added assembly and full supply chain services. Technimark provides clients with customized, end-to-end solutions based on technology and innovation that improve quality, reduce risk, lower costs and speed products to market. With facilities in the United States, Mexico, United Kingdom, Ireland, Germany and China, Technimark delivers high-quality products worldwide. For more information, visit technimark.com.

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Technimark Will Manufacture and Package Innovative Nasal Swabs to Support Medical Community

Company partners with Rhinostics and P&G subsidiary iMFLUX to help increase access to advanced testing tools for COVID-19, influenza and other diseases

ASHEBORO, N.C. (April 26, 2021) – Technimark has partnered with Rhinostics and a P&G subsidiary, iMFLUX, to produce, package and distribute individually packaged medical-grade polypropylene nasal swabs to help healthcare professionals and researchers detect and diagnose potential infections such as COVID-19.

iMFLUX developed a novel fully injection-molded polypropylene nasal swab that P&G licensed to Rhinostics to bring to the clinical laboratory market. The novel swab allows for easy collection from the front of the nose and provides sample concentration of up to 30-fold over other swabs in viral transport media.

“Technimark is honored to join with other global leaders in healthcare innovation to address the increasing need for devices that can safely and accurately detect dangerous infections more quickly,” said Kris Peavy, president of Technimark’s Healthcare division. “Production of the medical-grade polypropylene nasal swabs will begin in April at Technimark’s headquarters in Asheboro. The swabs will be injection molded and packaged in an ISO Class 8 Cleanroom then sterilized prior to distribution.”

“We are proud to partner with Technimark, iMFLUX and P&G to bring new collection devices like the P&G nasal swab to clinical laboratory workflow,” said Cheri Walker, chief executive officer of Rhinostics. “Not only does the nasal swab production help to relieve supply chain bottlenecks, the new design and polypropylene materials allows for comfortable collection and sample concentration due to dry shipment and improved release of viral particles.”

Rhinostics plans to register the P&G polypropylene nasal swab as a Class I exempt medical device and will pursue Emergency Use Authorization for home collection with rPT-PCR testing, the gold standard for detection of SARS-CoV-2 infection.

“We are proud to see the P&G-developed nasal swab come to market through the efforts of Rhinostics and Technimark,” said Mary Wagner, senior vice president at P&G and CEO of iMFLUX. “When we began this program, our intention was simply to help relieve bottlenecks in COVID-19 swab supply and bring a novel collection device to bear on the problem.”

About Technimark

Technimark is a global manufacturing solutions provider for the healthcare, consumer packaging and specialty industrial market. Technimark specializes in precision injection molding, value-added assembly and full supply chain services. Technimark provides clients with customized, end-to-end solutions based on technology and innovation that improve quality, reduce risk, lower costs and speed products to market. With facilities in the United States, Mexico, United Kingdom, Ireland, Germany and China, Technimark delivers high-quality products worldwide. For more information, visit technimark.com.

About Rhinostics

Rhinostics Inc. commercializes simple and elegant solutions to bring efficiencies and cost savings to the laboratory workflow. The Rhinostics nasal swab provides features that increase sample throughput by more than 10-fold while removing labor and errors from the laboratory workflow. The swab is integrated onto a cap that can be automated for removal from the tube while all 96 samples are simultaneously accessioned through scanning a 2D barcode on the bottom of the tubes. The product provides an immediate impact to increasing COVID testing efficiencies while being applicable to broader respiratory viral, bacterial, and genetic testing using the polymerase chain reaction (PCR) and next generation sequencing (NGS). The Rhinostics product is registered as Class I exempt medical device with the FDA and is available for purchase. To learn more, visit https://www.rhinostics.com.

About iMFLUX

A subsidiary of P&G, iMFLUX is a team of innovators, operating globally to transform the future of plastic injection molding. Join us on our journey to autonomous molding™ and learn how we provide meaningful sustainability solutions. Please visit www.imflux.com for more information about iMFLUX, our patented game-changing processing software, and our mold design and innovation center.

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Come See Technimark Healthcare at MD&M East – Booth #1429

MD&M East

Technimark Healthcare brings together decades of product innovation and a deep understanding of the healthcare market.

What does that mean for you?

You now have a manufacturing partner who can not only keep up with a changing medical and pharmaceutical landscape, but help you stay on top of the latest technological advances while maintaining the highest levels of quality.

Come see for yourself. Stop by while you’re in New York, and let’s see what we can create when we put our heads together.

MD&M West 2017

Booth #1429

June 13-15, 2017

Jacob K. Javits Convention Center

New York, NY

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Technimark China Facility Earns Key ISO Medical Device Certification

ISO 13485:2003 Demonstrates Adherence to Strict Quality Management Principles

Suzhou, China (June 10, 2016) – Technimark’s facility in Suzhou, China recently earned its ISO 13485:2003 certification after an extensive internal operations audit. Suzhou has been certified to ISO 13485:2003 by the certification body, SGS, for the manufacture and assembly of plastic parts used for medical devices.

According to the International Organization on Standardization (ISO), the primary objective of ISO 13485:2003 is to facilitate harmonized medical device regulatory requirements for quality management systems. ISO 13485:2003 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.

Technimark plans to obtain ISO 13485:2003 certification in all of its global operations to ensure its healthcare business is fully compliant with all regulatory quality management guidelines.

Preparation for the certification process began in 2014 when the company entered into the medical device manufacturing space in China with the construction of an ISO 14644­1 certified Class 8 cleanroom. As the infrastructure was developed, the current ISO 9001 quality management system was expanded to meet the additional requirements of ISO 13485, including implementation of a formal risk management program as well as other regulations unique to the medical device industry.

“The rigorous training and certification system we’ve adopted positions Technimark well to meet our customers’ need to demonstrate regulatory compliance throughout their development and manufacturing process,” said Carlos Diaz, senior vice president of Global Operations at Technimark. The Suzhou facility, which is currently being expanded, also maintains its ISO 9001:2008 certification for customers whose products do not need the specialized requirements of ISO 13485:2003.

The ISO standards for quality management systems (QMS) serve as the basis for the Good Manufacturing Practices (GMP), Good Clinical Practices (GCP) and Good Laboratory Practices (GLP) required by most government regulatory bodies as well as a foundation for compliance with the U.S. Food and Drug Administration’s 21 CFR Part 820 guideline and similar international standards for medical device manufacturers.

“To support our customers’ work to develop life­saving medical devices, Technimark provides consistent, high-quality performance while meeting – and often exceeding – all relevant regulations,” said Mr. Diaz. “Incorporating ISO quality management process standards into all Technimark global operations mirrors our commitment to high-quality production methods and full regulatory compliance.”

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Technimark acquires Ci Medical Technologies

A new approach to healthcare manufacturing. Thanks to a new combination of resources.

Technimark has always been known for using innovative thinking to come up with new and better ways to get the job done. What you might not know is that this approach extends well beyond the manufacturing floor.

Case in point? Technimark recently announced the purchase of Ci Medical Technologies, a top manufacturer of injection-molded components used in medical, pharmaceutical and consumer healthcare products.

With the addition of Ci Medical’s medical expertise and worldwide infrastructure to our existing resources, we’re creating a new division: Technimark Healthcare. It’s not just about getting bigger; it’s about sharpening our focus on the healthcare market, so we’re better able to serve customers around the world.

Operations at Ci Medical meet ANSI and ISO standards and FDA regulations for the products it manufactures, including insulin pumps, surgical tools and other specialized devices. All of which complements Technimark’s parallel development of a robust healthcare manufacturing infrastructure, including class 8 clean rooms and ISO 13485 certification.

By combining Technimark’s innovative technology-based offering, strong balance sheet and global scale with Ci’s medical market experience, infrastructure and deep capabilities, we’re uniquely positioned to meet a full range of needs today—and to provide many new technologies, solutions and manufacturing options in the future.

Download Press Release here: Technimark Acquires Ci Medical – Press Release – 12-08-15

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Technimark to Double China Capacity, Add Cleanroom.

To stay ahead of growing demand in Asia, Technimark is doubling the size of the facility in Suzhou, China.

The yearlong project will double the current manufacturing capacity and add enough space to accommodate more than two dozen new injection molding manufacturing cells.

A key aspect of the expansion is the creation of an ISO class 8 clean room environment that will conform to ISO 14644-1 air cleanliness standards. New program awards and strategic medical customer requirements for advanced technology have necessitated the initial expansion of Technimark’s Suzhou facility. This will enable us to produce and distribute a wide range of custom medical device and consumer healthcare-related products throughout Asian markets.

Thinking even further ahead, plans are already in place to double the cleanroom capacity as demand warrants. Technimark also has the ability to further expand the footprint at the Suzhou facility to continue to meet the needs of this rapidly growing market well into the next decade.

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