Taiwan International Medical and Health Care Exhibition Special Report

Medical Taiwan Special Feature / CE and UKCA Dual Certification: Chen Kang Biotechnology Ventures into the International Market as a Pioneer of Innovative Taiwanese Masks

Chen Kang Biotechnology, a company specialized in producing medical masks, was founded just three years ago but has already achieved remarkable success in the market. In March 2022, their FFP2 mask, manufactured to meet European Union standards, obtained dual certifications from BSI, CE (EU), and UKCA (UK). Their flagship product, the N99 high-level protective mask, is named for its exceptional bacterial filtration efficiency of 99%. It has been adopted by large medical institutions across Taiwan and is currently preparing to enter the medical surgical mask market in the European Union and the United Kingdom.

Stepping into Chen Kang's production facility, the staff undergo a series of procedures within a sterile environment. The cleanroom used for mask production is rated at level 10,000, ensuring a high level of cleanliness. All production equipment is automated and enclosed to minimize unnecessary human contact and prevent dust contamination. Even the final logistics and transportation processes have separate entry and exit points. Each batch of completed masks undergoes rigorous testing in Chen Kang's internal laboratory, including assessments for respiratory resistance, blood splatter, and ear strap tensile strength.

To elevate the safety standards, Chen Kang takes comprehensive measures to protect the health of its employees. Within the company, there is a "Home PCR Nucleic Acid Testing Device" developed by Foxconn's subsidiary, Richen Bioscience. If any employee experiences discomfort or symptoms, they can promptly determine whether they are infected using this device.

Out of compassion for healthcare workers, Chien Kang is dedicated to producing the highest standard of masks.

Chen Kang BioTech's inception began with the reluctance of a few big-hearted men. It seems like it happened just yesterday, as recalled by Mr. Jiang Xin-yuan, the General Manager of Chen Kang BioTech. One day, during lunchtime, he and several friends were dining in a small restaurant. At that time, the television news repeatedly broadcasted the worsening situation of the COVID-19 pandemic in Taiwan. People were anxiously trying to purchase masks, and even healthcare professionals were concerned about the insufficient protective gear they had.

In that moment, these determined men looked at each other, each possessing unique skills and knowledge. Some were experts in self-developing non-woven fabric support materials, others were familiar with technology membranes, and there were those experienced in biopharmaceuticals who understood the needs of healthcare professionals. With everyone's skills and expertise aligning seamlessly, they collectively entered the fiercely competitive mask market. Their mission was clear: to enhance mask filtration efficiency and comfort through material and technological innovation. To manage the intricate operations, they entrusted Mr. Jiang Xin-yuan, who had a background in environmental engineering. He quickly assembled a capable production team, and within three months, Chen Kang BioTech began mask production, reaching a peak monthly production of up to 1 million units.

According to the explanation provided by the National Health Research Institutes (NHRI), both medical and surgical masks are typically composed of three layers, from outer to inner: polypropylene (PP) hydrophobic non-woven fabric, melt-blown non-woven fabric, and polypropylene or polyethylene (PP or PE) skin-friendly non-woven fabric. Chien Kang BioTech has cleverly incorporated technology membranes into their mask design. The advantage of these membranes is that they are not affected by prolonged wear or environmental humidity. Additionally, their uniform pore structure facilitates filtration and separation. As a result, larger particles are first blocked by the melt-blown fabric, while smaller ones are absorbed by the technology membrane. This not only enhances the protective capabilities of the mask but also significantly improves breathability.

"It's like having a dual-filter concept within a single mask," explained Jiang Xinyuan. But that's not all; they have also paid meticulous attention to details. For example, the nose sponge is directly adhered to the mask, and the positioning of the earbands has undergone extensive testing to ensure the final placement is optimal."

This innovative mask, which has brought together the efforts of many, has given the Chengkang team great confidence to enter the international medical market. However, Jiang Xinyuan is well aware that this alone is not enough. "The EU and the UK are very important regions in the global mask market, and they have high standards and requirements for mask quality. Obtaining verification is a necessary condition for entering these markets," he said.

Through verification, we have created quality and value for the international market.

"Chen Kang has made significant progress today, and BSI played an indispensable role in this. It helped us uncover our blind spots," expressed Jiang Xinyuan with gratitude. Reflecting on the entire verification process, he acknowledged that the most significant challenge was ensuring that their products met BSI's stringent standards and requirements. It required substantial time and resources for testing and improvement to ensure their products delivered effective protection under various conditions.

Interestingly, Chen Kang's masks had met the standards during testing in Taiwan, but they faced a setback when they first sent them to BSI's laboratory in the UK. The issue was related to the respiratory resistance, where the air density was too high to pass. BSI's specifications were even more stringent than the EU's requirements, demanding both air-tightness and breathability. Upon receiving the results, the Cheng Kang team didn't lose heart. They immediately purchased a high-speed microscopic camera to capture the invisible details. It was revealed that one of the molds had issues, causing leaks at the mask seams. They not only promptly rectified the mold issue but also invested over 4 million NTD to acquire a PMI (Pore Size Analysis Instrument) with specifications matching BSI's laboratory. This instrument not only analyzes the pore structure of porous materials but also measures liquid permeability and gas permeability, among other factors.

Following these adjustments, Chen Kang successfully obtained dual certifications from BSI for CE (EU) and UKCA (UK). This achievement not only attracted more international customers, expanding their market sales but also improved production efficiency and quality control. Furthermore, Chen Kang can now assist contract manufacturing clients in applying for BSI OBL (Own Brand Label) certification, further expanding their business scope and market influence.

Chen Kang's journey to optimize mask quality is ongoing. Recently, Mr. Huang De-Rong, the General Manager of Dashing Filter Fabric, imported a container of the latest non-woven fabric materials from Belgium. They plan to restructure the original formula to further enhance the mask's filtration efficiency and comfort. Mr. Huang likens this process to crafting a high-quality suit – when the fabric is of superior quality, the wearer feels both well-supported and comfortable.

Over the past three years of entrepreneurship, their primary concern has always been ensuring that healthcare professionals receive comprehensive protection. Jiang Xin-Yuan and Huang De-Rong have meticulously studied the daily needs of healthcare workers and are continuously exploring how to leverage their expertise in non-woven fabrics and innovative materials to safeguard the safety of medical professionals both domestically and internationally. They express a strong sense of purpose and happiness in their efforts to achieve this goal.

For more information about the companies, we welcome you to visit the "Medical Taiwan - Taiwan International Medical and Healthcare Exhibition" at the Nangang Exhibition Hall 2 from June 8th to 10th!
Visiting Information:https://www.medicaltaiwan.com.tw/zh-tw/menu/7EB43B97FCB8AED7D0636733C6861689/info.html