Microcontrol as the basis, health as the core - the way to protect the microbial safety of high-end silica (pharmaceutical excipient grade)

In the field of life and health, the value of high-end materials lies not only in their functionality, but also in their extreme adherence to safety boundaries. As a core material widely used in pharmaceutical excipients, high-end food additives and other fields, the high-end demand for silica is essentially a strict pursuit of "purity and undisturbed" - among which, the precise control of microbial indicators is the core threshold for classifying product grades and ensuring application safety. The total viable count (TVC), total fungal count (TFC), and Escherichia coli (E. coli), as internationally accepted core indicators of microbial safety, have become indispensable compliance bottom lines and quality standards for high-end silica (especially pharmaceutical excipient grade).

1. Under the demands of life and health, microbial control is an insurmountable safety red line.

Microbial contamination may seem hidden, but it may have a fatal impact on the safety and stability of end products. This is also the core reason why strict microbial control requirements are imposed on materials in the life and health field:

- Total Viable Count (TVC): As a "comprehensive ruler" to measure the degree of microbial contamination of materials, excessive TVC means that the material may carry a large number of harmful or harmless microorganisms. In the application of pharmaceutical excipients, excessive amounts of live bacteria can destroy the stability of pharmaceutical formulas, cause component degradation, attenuate efficacy, and even cause bacterial imbalance in the human intestine, posing potential risks to patients with weak immunity. Even high-end food-grade silica, high TVC may lead to shortened food shelf life and deterioration of flavor, violating the original intention of healthy consumption.
- Total Fungi Count (TFC): The harm of fungi (including molds and yeasts) goes far beyond "pollution" - the toxic substances such as aflatoxins and ochratoxins produced by their metabolism are highly carcinogenic and teratogenic, and are resistant to high temperatures and difficult to degrade. If TFC in pharmaceutical excipient-grade silica exceeds the standard, these toxins may enter the human body along with the drugs and accumulate over a long period of time, causing serious health damage. At the same time, the mycelium and metabolites produced by fungal reproduction can also cause drug agglomeration and discoloration, directly affecting the safety and effectiveness of medication.
- Escherichia coli (E. coli): As an "indicator bacteria" for intestinal pathogenic bacteria, the detection of E. coli is almost equivalent to direct evidence that the material is contaminated by human and animal feces. This bacterium may not only cause gastrointestinal infections, but some strains of it can also produce Shiga toxin, leading to serious illnesses such as hemorrhagic enteritis. For silica that comes into direct contact with drugs and may even be used as excipients for injections, the strict prohibition limit for E. coli (usually requiring "no detection") is the core line of defense to ensure zero risk in drug use.

Whether it is the "curing diseases and saving lives" attribute of pharmaceutical excipients or the "health empowerment" positioning of high-end silica, microbial control is by no means an "additional requirement", but a "must-answer question" directly linked to life and health.

2. The ultimate requirements for pharmaceutical excipients: the “ceiling” standard for microbial control

As an important part of drugs, the quality of pharmaceutical excipients directly affects the safety, effectiveness and stability of drugs. Therefore, the control requirements of global drug regulatory agencies on their microbial indicators are called "the most stringent in the industry" - and this is the core competitiveness of high-end silica:

- Rigid constraints of international standards: Chinese Pharmacopoeia (ChP), United States Pharmacopeia (USP), and European Pharmacopoeia (EP) all clearly stipulate the microbial limits of pharmaceutical excipients: total viable count (TVC) must be ≤100 CFU/g (some injection-grade excipients require ≤10 CFU/g), total fungal count (TFC) must be ≤10 CFU/g, and Escherichia coli (E. coli) must be "not detectable." This means that pharmaceutical-grade silica must be controlled through the entire process to control microbial residues at an almost "zero pollution" level.
- Precise empowerment of the production process: In order to meet the microbial control requirements of pharmaceutical excipients, high-end silica adopts a full-chain control system of "source purification + strict process control + terminal detection": raw materials are selected from more than 99.5% ultra-high-purity silicon sources to avoid microorganisms from the source. The entire production process is carried out in D-level and above clean areas, and air purification, personnel aseptic operation, equipment sterility verification and other aspects are in compliance with GMP specifications; processes such as high-temperature calcination and aseptic crushing are used to further kill potential microorganisms while avoiding secondary contamination.

- Extremely accurate testing system: Establish a microbial testing laboratory that meets the requirements of the Pharmacopoeia, and use internationally recognized testing methods such as plate counting and membrane filtration to conduct special testing for TVC, TFC, and E. coli on each batch of products. Among them, the E. coli test uses dual verification of selective culture culture + biochemical identification to ensure "zero missed detection"; the total fungal count test strictly distinguishes molds and yeasts to accurately control the risk of contamination. All test data are traceable and verifiable, ensuring that each batch of products meets the strict standards for pharmaceutical excipients.

3. The core value of high-end silica: protecting health with micro-control and empowering industries with compliance

When silica breaks through the application boundaries of ordinary industrial grade and enters the fields of pharmaceutical excipients and high-end health, its core value is upgraded from "functionality" to the dual empowerment of "safety + function". The ultimate control of microbial indicators such as TVC, TFC, and E. coli is the core embodiment of this value upgrade:

- For the pharmaceutical industry, high-end silica that meets microbial standards can be widely used as fillers, disintegrants, adsorbents, etc. in tablets, capsules, granules and other drugs. It not only ensures the physical stability of drugs, but also avoids medication risks caused by microbial contamination, helping pharmaceutical companies achieve compliant production and protect patient health;
- For high-end health industries (such as functional foods and health products), strict microbial control allows silica to perform functions such as adsorption and anti-caking without introducing additional health risks, which meets consumers' high-end demand for "purity and safety";

- From an industrial perspective, by meeting the microbial control requirements of global pharmacopoeias, high-end silica breaks international technical barriers, provides a safety guarantee for localized substitution of pharmaceutical excipients, and promotes the upgrading of China's high-end materials industry in the direction of "quality is king."

Health is no small matter, micro-control is the key. High-end silica (pharmaceutical excipient grade) is based on strict control of TVC, TFC, and E. coli, and integrates the concept of "life and health first" into every production link. It not only meets the rigid compliance requirements of pharmaceutical excipients, but also provides reliable material support for the life and health field with extremely pure quality - this is where the responsibility and value of high-end materials lie.