Silicone defoamers are highly effective, environmentally friendly chemical additives that are widely used in a variety of industrial applications. Its unique low surface tension, chemical stability, and foam control performance make it play an important role in the pharmaceutical industry. Why are silicone defoamers used in the pharmaceutical field?
The pharmaceutical industry requires a high degree of purity and safety in the production process. Silicone defoamers not only effectively eliminate surface foam but also ensure the quality and safety of drugs. Silicone defoamer has a low surface tension and physiological inertia. is the pharmaceutical industry used as defoaming efficacy of the original auxiliary materials, is widely used in the research and production of drugs, to bring vitality to the pharmaceutical industry, improve the quality of drugs, promote the progress of medical diagnosis.
The following are six aspects of the silicone antifoam agent in the pharmaceutical industry:
- What is the principle of silicone defoamer?
- What are the requirements for defoamers?
- What are the characteristics of silicone defoamers?
- What is the application of silicone defoamer in the pharmaceutical industry?
- How to deal with the challenges of the pharmaceutical industry on the silicone defoamer?
- How to make silicone defoamer performance better?
1. What is the principle of silicone defoamer?
In the use of microorganisms in the production of antibiotics, vitamins and other drugs, often encounter foam trouble, especially the use of air to stir the material in the fermentation process, there will be a large number of bubbles, easy to lead to liquid flooding material, have to reduce the loading coefficient, reduce or stop the aeration and stirring, so that the efficiency of the fermentation and the production capacity affected. Adding a small amount of silicone defoamer can replace a large amount of edible oil, effectively eliminating foam and thus improving production capacity and fermentation units.
The mechanism of action of silicone antifoam agent is generally believed to be a low surface tension antifoam agent into the localization of the two-component oriented bubble film, disrupting the mechanical balance of the oriented bubble film and leading to the breakage of the bubble (or foam suppression). The defoaming process is divided into three steps: first, the low surface tension of the defoamer particles penetrates into the bubble liquid membrane; second, the defoamer film is further extended to the bubble liquid membrane and thinned; finally, the defoamer film is pulled through, resulting in existing foam rupture.
2. What are the requirements for defoamers?
(1) Safety and non-toxicity
The pharmaceutical industry has very high requirements for product safety, and the defoamer must comply with the relevant norms and regulations of the pharmaceutical industry to ensure that it is non-toxic, harmless, and will not have an adverse effect on human health. Compared with mineral oil, it's safer. For example, in biopharmaceuticals, the commonly used silicone antifoam agent has excellent performance, but its residue may introduce impurities, so it is necessary to control the residual amount.
(2) Chemical stability
Antifoam agents need to remain stable in the pharmaceutical process, even under extreme conditions such as high temperature, acid, and alkali. For example, in the fermentation process, a defoamer should have good temperature stability and pH stability.
(3) High efficiency and low dosage
The pharmaceutical industry requires high-efficiency defoamer and foam inhibition, while the dosage is low, in order to reduce production costs. For example, silicone defoamer is widely used because of its high-efficiency defoaming performance, but attention to its stability in high temperature and acidic conditions.
(4) Compatibility
The defoamer should be compatible with other chemicals and microbial strains in the pharmaceutical process and will not negatively affect the fermentation process or product quality. For example, in the fermentation process, the defoamer needs to be compatible with the medium components and microbial strains.
(5) Environmental friendliness
With the tightening of environmental regulations, the pharmaceutical industry is increasingly demanding the environmental protection of defoamers. Defoamers need to comply with the principles of green chemistry to reduce their impact on the environment. For example, the development of degradable defoamers or the use of bio-based materials has become a future trend.
(6) Residue detection and control
Residues of antifoam agents may affect the quality and safety of drugs, so the residues need to be strictly detected and controlled. For example, liquid chromatography is used to test the residue of silicone defoamer to ensure that the content is within the safe range.
(7) Customized solutions
The pharmaceutical industry has diverse needs, and defoamers need to be customized and developed according to specific processes and drug types. For example, to develop suitable defoamer products for different aspects of fermentation, extraction, and concentration.
(8) Multifunctionality
In the future, defoamers will develop in the direction of multifunctionality, such as combining antibacterial, antioxidant, and other functions to meet the higher requirements of the pharmaceutical industry.
(9) Regulations and supervision
The pharmaceutical industry has strict regulations on the use of defoamers, companies need to ensure that the use of defoamers is in line with the relevant standards. The application of defoamers in the pharmaceutical industry needs to comply with the relevant quality control standards to ensure that the safety, quality, and purity of the drug does not adversely affect. For example, in the EU CEP certification, the defoamer residue of fermentation APIs will be focused on.
In summary, the pharmaceutical industry's requirements for defoamers not only involve safety, stability, and efficiency but also emphasize environmental friendliness, residue control, and customized solutions. With the advancement of technology and the improvement of regulations, the application of defoamers in the pharmaceutical industry will be more extensive and strict.
3. What are the characteristics of silicone defoamers?
(1) Highly efficient defoaming and foam inhibition ability
The core component of silicone antifoam agent is silicone oil. Its surface tension is very low and can quickly spread on the surface of the foam, destroying the elastic film of the foam, so as to realize rapid defoaming and long-lasting foam suppression.
(2) Chemical stability
Silicone-based defoamer can remain stable under extreme conditions such as high temperature, acid and alkali, and will not react with other chemical substances to ensure the continuity of the production process and product quality.
(3) Safety and environmental protection
Silicone defoamer does not contain toxic and harmful substances, is in line with green environmental standards, and is suitable for the pharmaceutical industry, which requires a high degree of safety.
(4) Good compatibility
Silicone defoamer has good compatibility with a variety of liquids and materials and will not affect the composition and performance of drugs.
XJY-6010/XJY-6011/XJY-6012 methyl silicone defoamer
The product is a solid powder resin with good defoaming, hydrophobic, and waterproof performance. It can be used in aqueous systems.
4. What is the application of silicone defoamer in the pharmaceutical industry?
(1) Defoaming in the fermentation process
In the pharmaceutical fermentation process, microbial metabolism will produce a large number of bubbles, affecting the fermentation efficiency and product quality. Silicone antifoam agents can effectively control the foam to ensure the smooth progress of the fermentation process.
(2) Drug extraction and refining
In the drug extraction and refining process, a silicone antifoam agent can be used to prevent foam overflow and improve extraction efficiency and product quality.
(3) Injection production
The production of injectables requires high sterility and purity. Silicone defoamers can be used for the surface treatment of packaging components of injectables (such as glass vials and rubber stoppers) to reduce the liquid wall and foam formation, ensuring the uniformity and safety of injectables.
(4) Oral liquid and syrup production
In the production of oral liquids and syrups, silicone antifoam agents can effectively prevent the foam generated during mixing and blending to ensure the appearance and quality of the product.
(5) Medical device lubrication
Silicone defoamer can also be used for surface lubrication of medical devices (such as syringes, needles, etc.) to reduce friction and improve ease of use and safety.
5. How to deal with the challenges of the silicone defoamer?
(1) Environmentally friendly product development
With the increasing awareness of environmental protection, the pharmaceutical industry is increasingly demanding the environmental protection of silicone defoamers. In the future, the development of more environmentally friendly and biodegradable silicone defoamers will become an important trend.
(2) Customized solutions
Due to the diversified needs of the pharmaceutical industry, the future of silicone defoamer will be developed in the direction of customization to meet the needs of different production processes and types of drugs.
(3) The application of nanotechnology
The application of nanotechnology will enhance the performance of silicone defoamers so that they play a greater role in more complex pharmaceutical and many industrial processes.
6. How to make silicone defoamer performance better?
Silicone defoamers play an important role in the pharmaceutical industry due to their high defoaming efficiency, chemical stability, and safety. Its application in fermentation, extraction, injection production,n and medical device lubrication has significantly improved the efficiency of pharmaceutical production and product quality. With the strengthening of environmental regulations and the continuous progress of technology, silicone defoamer will have broader application prospects in the pharmaceutical industrial process. How to improve the competitiveness of products?
XJY Silicones is one of the leading silicone MQ resin and VMQ silicone manufacturers in China, with more than 30 years of R&D and manufacturing experience in the silicone industry, as well as more than 15 related patents and technical support. Our silicone raw material products can meet the needs of the silicone defoaming field and support the provision of diversified, customized solutions.
