Are you Manufacturer?
Yes, we are a professional manufacturer of pharmaceutical and laboratory sterilizers, integrating R&D, production, and international trade. We warmly welcome on-site factory visits and remote video factory inspections, so you can verify our production capacity and quality control system.
Do your sterilizers comply with GMP and FDA requirements?
Yes. Our sterilizers are designed and manufactured following GMP guidelines, FDA 21 CFR Part 11 (electronic records & signatures), and other global pharmaceutical regulatory requirements. They are fully suitable for use in GMP-compliant production environments in pharmaceutical factories and laboratories.
Can you provide the required validation documents for our project?
Absolutely. We provide complete, audit-ready documentation packages in accordance with pharmaceutical industry practices and GAMP 5 guidelines, including but not limited to design documents, validation documents, SOPs, FAT, SAT, IQ/OQ/PQ, material certificates, calibration records, and other supporting documents. This documentation fully supports your regulatory audits for pharmaceutical and laboratory applications.
Please share your URS with us, and our experts will provide a tailored solution to meet your specific needs.
Yes, of course. Three points:
1.We have 15 years of experience in R&D, manufacturing and after-sales service. Our reliable quality and solutions have earned the trust of long-term customers and widespread recognition.
2.Every product undergoes rigorous testing and inspection to ensure superior performance and consistent quality.
3.We hold certifications including ISO 9001, TS certification and software copyrights.