Hangzhou, China
In 2019, we expanded our global filtration portfolio for pharmaceutical, medical, and microelectronics industries by establishing local manufacturing in Mainland China. This facility allows regional development and manufacturing capabilities to enable our customers to achieve process yield and device performance.
- Location: Fuyang District, Hangzhou P.R. China
- Size: 33,000 m2 world-class facility
- Employees: near 400
- Certifications: ISO9001, ISO13485, ISO14001, ISO45001
Technical Capabilities
The Hangzhou facility is more than a manufacturing plant; it is supported by broader capabilities:
- R&D for filtration element and filters
- Manufacturing for filter element and filters
- Membrane handling
- Quality control
- Validation service
Quality Control
- Complies with Entegris’ global SOP (standard operation specification) standard
- Dedicated SQE team ensures stringent raw materials selection and supplier management
- Inhouse molding allows shorter delivery time and greater quality control
- Every filter is subjected to integrity tests correlated with bacterial challenge test (BCT) results and must pass 100%
Incoming quality control
Process quality Control
Finished Products
Quality Control
Factory Quality Control
Diversified Expertise
Our team of contamination control manufacturing experts apply their experience and expertise in biological science, materials science, filtration, macromolecule, chemistry, chemical engineering, and machinery to solve critical microcontamination challenges in the manufacturing processes for life sciences customers globally.
Validation Services
We provide testing and comprehensive validation services for pharmaceutical companies and filter manufacturers to ensure all international regulations are being met. This includes filtration protocols and global regulatory compliance documents for large volume parenterals (LVP), small volume parenterals (SVP), freeze-dried powder, vaccines, and other scientific processes.
Our validation team consists of experts with 10+ years of experience. They provide actual, accurate, timely, and traceable data as well as help customers comply with GMP data integrity standards.
Compliance with Global Regulations and Standards
Our products comply with United States Pharmacopoeia (USP) and other international pharmaceutical regulations per customer requirements. We apply USP665/1665 risk methodology for risk assessment.
Customized Validation Services
We customize validation reports and deliver to global customers within 45 days on average, much shorter than the industry average lead time of 90-120 days.
Data Integrity and Reliability
The laboratory uses GAMP5 analytical software, electronic records, signatures (21 CFR Chapter 11) and is equipped with UPS uninterruptible power supply to ensure data integrity and reliability.
State-of-the-Art Laboratories
Physiochemical Lab
- Integrity testing
- Organic impurity testing
- Element impurity testing
- Analytical method validation
Microbiology Lab
- Bacterial testing
- Environmental monitoring
- Sterility testing
- Microbial limit testing