Microbiology Laboratory
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Taiwan's first medical manufacturer with an in-house lab for TAF-accredited testing.
New Deantronics' in-house microbiology lab conducts multiple Taiwan Accrediation Foundation (TAF) tests to monitor environmental cleanliness and ensure product sterility. By integrating validation, risk assessment, and quality management, we provide reliable medical devices to ensure patient safety.
Laboratory Services
Environmental Monitoring
New Deantronics utilizes its TAF-accredited in-house testing capabilities to monitor environmental cleanliness and ensure product sterility. Our data-driven trend analysis and risk management provide customers with the most reliable foundation for high-quality medical device manufacturing.
Microbiological Testing
New Deantronics offers a complete suite of TAF-accredited microbiological testing services, including bioburden and sterility assessments. We empower our clients to achieve global regulatory compliance with precision and reliability.
Endotoxin Testing
New Deantronics utilizes international standards for endotoxin testing, providing medical device manufacturers with credible, traceable, and regulatory-compliant results that ensure the highest level of safety.
Quality Assurance
Continuous Improvement · Quality Excellence · Win-Win Partnerships
With the vision of being a "World-Class Medical Device Developer and Manufacturer," New Deantronics took the lead in Taiwan by establishing an in-house microbiology laboratory and achieving multiple TAF-accredited testing scopes for medical devices. This milestone demonstrates our unwavering commitment to the highest standards of quality, safety, and sustainable management.
From environmental monitoring and sterility testing to bioburden and endotoxin assessments, we enforce rigorous quality control at every stage. By integrating seamless R&D and testing services, we ensure every product enters the global market with professional excellence — standing as a trusted partner for the medical device industry.
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TAF Accreditation Certificate
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TAF Accreditation Certificate
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TAF Accreditation Certificate
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Biorisk Management System
TAF Certification Items
Test |
Items |
|---|---|
| Environment Test | Environment Passive Air Sampling (Settle Plates), Active Air Sampling (Viable Particles), Surface Sampling (Personnel & Equipment) |
| Bioburden Test | Medical Device Aerobic & Anaerobic & Fungi & Endospore Former Enumeration |
| Bioburden Inhibition Test 1 | Medical Device Aerobic & Anaerobic & Fungi & Endospore Former Enumeration Method Suitability |
| Bioburden Recovery Test | Medical Device Aerobic & Anaerobic & Fungi & Endospore Former Enumeration Method Recovery |
| Bacteriostasis / Fungistasis Test2 | Medical Device USP <71>, ISO 11737-2 Method Suitability |
| Sterility Test | Medical Device USP <71>, ISO 11737-2 Method |
| Endotoxin Test | Medical Device Endotoxin Analysis: Kinetic Chromogenic Method |
Notes
- To verify if test samples inhibit microbial growth, ensuring the accuracy and reliability of bioburden test results.
- To verify if test samples inhibit microbial growth, ensuring the accuracy and reliability of sterility test results.
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Contact Us
If you need further information about
testing items or collaboration requirements,
please feel free to contact the
New Deantronics' Microbiology Laboratory.
We will have professionals provide
expert explanations and assistance.
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Address9F., No. 51, Sec. 4, Zhongyang Rd., Tucheng Dist., New Taipei City 236, Taiwan
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Phone