Post on 2023-06-02 / 708 Views
Taiwan International Professional Exhibition Report
Link: https://www.taiwantradeshows.com.tw/zh_TW/news-info-31245/004.html
Medical Taiwan Special Feature: Double Certification with CE and UKCA – Chien Kang Biotechnology Expands into the International Market, Pioneering Innovation in Taiwan Masks
Chen Kang Biotechnology, a company specializing in the production of medical masks, has achieved remarkable success in just three years since its establishment. In March 2022, Chien Kang's FFP2 masks, manufactured to European Union standards, obtained dual certifications from BSI, including CE (EU) and UKCA (UK). Their flagship product, the N99 high-level protective mask, is named for its 99% bacterial filtration efficiency and is already being adopted by major medical institutions in Taiwan. Currently, the company is preparing to enter the medical surgical mask markets in the European Union and the United Kingdom.
Stepping into Chen Kang's production facility, the staff undergoes a series of processes in a sterile environment, including changing into cleanroom suits, manufacturing, and quality control checks. The cleanroom for mask production is rated at level 10,000, and all production equipment is automated and enclosed to minimize unnecessary human contact and dust contamination. Even the final logistics and transportation have separate entrances and exits. Each batch of completed masks undergoes rigorous testing in Chien Kang's in-house laboratories, including tests for breathing resistance, blood splatter, and earloop tensile strength.
To elevate safety standards, Chen Kang places a strong emphasis on protecting the health of its employees. Within the company, there is a "Home-Use PCR Nucleic Acid Testing Device" developed by Fu Jia Life Sciences, a subsidiary of Foxconn. If any employees experience discomfort, they can immediately determine whether they are infected using this device.
The establishment of Chen Kang Biotechnology began with the sentiment of several men who simply couldn't bear it any longer. It seems like just yesterday when Mr. Jiang Xinyuan, the General Manager of Chen Kang Biotechnology, recalls that one day at lunch, he and a few friends were dining at a small restaurant. At that time, the news on television continuously reported the worsening COVID-19 situation in Taiwan, and people were anxiously unable to buy masks. Even healthcare workers were concerned about the lack of sufficient protective equipment.
In that moment, a group of men looked at each other. Some had expertise in developing non-woven fabric support materials, others were familiar with technology films, and there were those experienced in biopharmaceuticals who understood the needs of healthcare workers. With everyone on board, they dove into the competitive mask market, aiming to improve mask filtration efficiency and comfort through material and technological innovation. The complex operational management was entrusted to Jiang Xinyuan, who specifically recruited a talented production manager from a technology factory. Three months later, Chen Kang began mask production, with a maximum monthly output of up to one million pieces.
According to the National Health Research Institutes (NHRI), whether it's a medical or surgical mask, it can be divided into three layers, from outer to inner: polypropylene (PP) water-repellent non-woven fabric, melt-blown non-woven fabric, and polypropylene or polyethylene (PP or PE) skin-friendly non-woven fabric. In Chen Kang's mask design, they ingeniously incorporated technology film. Its advantage lies in being unaffected by prolonged wear or environmental humidity. Additionally, its uniform and consistent pore structure facilitates filtration and separation. As a result, larger particle sizes are first blocked by the melt-blown fabric, while smaller particles are absorbed by the technology film. This not only enhances the mask's protective capabilities but also significantly improves breathability.
"It's like having a mask with a dual-filter concept," explained Jiang Xinyuan. Moreover, they put a lot of effort into the details, such as attaching the nasal sponge directly to the mask and carefully testing the position of the ear loops before finalizing it.
This innovative mask, the result of collective efforts, has given the Chen Kang team tremendous confidence in entering the international medical market. However, Jiang Xinyuan is well aware that this alone is not enough. "The European Union and the United Kingdom are crucial regions in the global mask market. They have very high requirements for mask quality and standards. Obtaining verification is a necessary condition for entering these markets."
Chen Kang's management team conducted extensive research and explored various testing services throughout Taiwan. They also conducted meticulous price and strengths-weaknesses analysis reports internally. Finally, they decided to collaborate with BSI Testing and Verification, a specialist in Personal Protective Equipment (PPE) testing.
"Chen Kang has made so much progress today, and BSI deserves a lot of credit for helping us identify blind spots," expressed Jiang Xinyuan with gratitude. Reflecting on the entire verification process, the biggest challenge was ensuring that their products met BSI's stringent standards and requirements. This required a substantial investment of time and resources for testing and improvements to ensure that their products could provide effective protection in various situations.
Initially, Chen Kang's masks met the standards in Taiwan but were rejected the first time they were sent to BSI's laboratory in the UK. This was because they failed in the breathing resistance part, where the air density was too high. BSI's specifications are even higher than those of the European Union, requiring both airtightness and breathability. Upon receiving the results, the Chen Kang team did not lose heart. They immediately purchased a high-speed microscope camera that revealed details invisible to the naked eye. It turned out that there was a problem with one of the molds, causing leaks at the seams of the masks. They not only promptly corrected the mold but also invested over 4 million TWD to purchase a PMI through-hole pore size analyzer, which matches the specifications of BSI's laboratory. This instrument not only analyzes the pore structure of porous materials but also measures parameters such as liquid permeability and gas permeability.
After these adjustments, Chen Kang finally succeeded in obtaining dual certifications from BSI for CE (EU) and UKCA (UK). This achievement attracted more foreign customers, expanding their market sales. Furthermore, by enhancing production efficiency and quality control, Chen Kang can assist OEM customers in applying for the BSI OBL brand certificate, further expanding their business scope and market influence.
Chen Kang's journey to optimize mask quality is far from over. Recently, Huang Derong, the General Manager of Dashing Filter, imported a container of the latest non-woven fabric materials from Belgium. They intend to reconfigure the original formula to further enhance mask filtration efficiency and comfort. "It's like a high-quality suit; when the fabric is good, it feels both stiff and comfortable when worn," likened Huang Derong.
Throughout their three years in business, their main concern has been whether healthcare professionals can receive more complete protection. Jiang Xinyuan and Huang Derong carefully study the daily needs of healthcare workers and contemplate how to use their expertise in non-woven fabric along with innovative materials to safeguard the safety of more healthcare professionals both domestically and internationally. "This gives us a sense of purpose and happiness in our efforts!" they both passionately expressed.
For more information about these companies, you can visit the Medical Taiwan International Medical and Healthcare Exhibition at the Nangang Exhibition Hall from June 8th to 10th!
Visitor Information:https://www.medicaltaiwan.com.tw/zh-tw/menu/7EB43B97FCB8AED7D0636733C6861689/info.html