Welcome to Shandong Zhonglian Chemical Co., Ltd. Equity Code:880747
Ultra-High Purity Medical Grade Silicon Dioxide (Sterile Grade)
Classification :
Pharmaceutical Excipient Silicon Dioxide
Keywords :
Ultra-High Purity Medical Grade Silicon Dioxide (Sterile Grade)
PRODUCT DETAILS
1. Product Description
This medical grade silicon dioxide is an ultra-high purity, safety-validated material designed exclusively for the most stringent medical and sterile pharmaceutical applications. Produced via a proprietary refined purification process, it delivers an exceptional minimum SiO₂ assay of 99.9%, with harmful impurities eliminated and heavy metals below the limit of detection (LOD). Fully compliant with global medical-grade raw material manufacturing standards, it delivers dual glidant and dispersing functions for sterile and high-end medical formulations.
2. Key Specifications
Parameter | Specification |
Product Name | Medical Grade Silicon Dioxide (Ultra-High Purity Sterile Grade) |
Appearance | White, ultra-fine micron-grade, odorless, tasteless powder |
Particle Size Range | 1–30 μm (medical-specific particle size, customizable) |
SiO₂ Assay | ≥99.9% |
pH (5% Aqueous Suspension) | 3.5–7.0 (medical-grade standard) |
Typical Dosage | 0.1%–3% (subject to medical formulation requirements) |
Shelf Life | 24 months |
Packaging | 20 kg medical-grade sterile sealed drums |
Sample Availability | Complimentary sterile-packaged samples available on request |
3. Core Applications
This ultra-high purity sterile grade is engineered for the most demanding medical applications, including sterile injectable powders, topical ointments and creams, and medical dressings. Beyond core glidant and anti-caking performance, it delivers exceptional uniform dispersion for medical powders, with no harmful impurities, fully meeting the strict safety and quality requirements of medical formulation manufacturing.
4. Manufacturing Advantages
As a National High-Tech Enterprise, we operate a dedicated production line for medical grade silicon dioxide within an ISO Class 5 (Class 100) cleanroom, with fully aseptic manufacturing processes. Our facility is certified to medical raw material GMP standards, with every batch undergoing rigorous medical-specific testing for heavy metals, microbial limits, bacterial endotoxins, and other critical safety indicators, ensuring full compliance with global medical-grade raw material specifications.
5. Packaging, Storage & Logistics
- Standard Packaging: 20 kg medical-grade sterile sealed drums with sterile PE inner liners, processed via full aseptic encapsulation.
- Storage & Handling: Store in a cool, dry, sterile environment in the original unopened sealed packaging. This product is classified as non-hazardous, with support for both standard and cold chain medical-grade transportation.
- Labeling: All packaging features clear medical-grade labeling, including core specifications: medical grade, ultra-high purity ≥99.9%, sterile, and free of harmful impurities.
6. Frequently Asked Questions
Q: Can this product be used in sterile injectable pharmaceutical formulations?
A: Yes. Manufactured in an ISO Class 5 (Class 100) cleanroom with full aseptic processing and encapsulation, this medical grade silicon dioxide is free of harmful impurities and fully meets the raw material requirements for sterile injectable formulations.
Q: Do you perform medical-specific microbial and safety testing?
A: Yes. Every batch undergoes comprehensive medical-grade testing, including microbial limits, bacterial endotoxins, and heavy metal analysis, with all results meeting the strict limits for medical-grade raw materials.
Packaging and Shipping
Zhongqi (Guangdong) Silicon Materials Co., Ltd., with over 20 years of experience in the food-grade silica field, is a national high-tech enterprise and a Guangdong Province specialized and innovative enterprise. Trusted by numerous international food giants, it is a leader in high-end food-grade silica. Shandong Zhonglian Chemical Co., Ltd. is Zhongqi's sole officially authorized overseas sales subsidiary.
laboratory
The company has established a world-leading R&D and intelligent manufacturing system, built GMP-standardized workshops, constructed 10,000-ton intelligent production lines, established a national-level testing center equipped with cutting-edge international equipment, and built its own high-standard microbiological testing laboratory. From raw material screening to finished product delivery, the entire process strictly adheres to domestic and international food safety management certifications, achieving simultaneous leadership in both "quality" and "quantity."
Customer Visit
We are committed to silicon dioxide for 20 years, our product is well know in the world and cooperate with some Fortune 500 companies, such as the Nestlé，Yihai Kerry，COFCO，China Resources，Budweiser，Symrise, and so on.
HONOR
In 2021, the company was listed on the Guangdong Stock Exchange, marking the beginning of its international expansion. Today, Zhongqi Silicon Industry, with an open vision, empowers the global food industry's safety system with the power of "Made in China." Going forward, the company will continue to focus on molecular-level safety to ensure peace of mind and, with a global perspective, to create a purer quality of life. Because true strength lies in making invisible protections visible to the world.
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Jinan City, Shandong Province,China
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Guangzhou City, Guangdong Province
