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Application of silicification technology in injection packaging

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1. Introduction 

Polydimethylsiloxane (PDMS), commonly known as silicone oil, has been the preferred material for surface treatment of injection-use packaging components since 1950. Its coating acts like a magical protective layer, on the one hand promoting the uniform distribution of the drug solution, and on the other hand, by reducing the surface energy, successfully preventing the drug solution from wetting the inner wall of the container, thus ensuring the uniformity and quality of the drug. 

2. Silication Technology
Silication is a remarkable surface treatment technique. By applying a silicone-containing solvent or emulsion to a clean, dry surface, a thin film of silicone oil can be created.
The silication process is like a carefully choreographed dance. By applying a silicone-containing solvent or emulsion in a low concentration evenly to a clean, dry surface, it can be demonstrated in various ways such as spraying, wiping, or dipping. Then, the coating is dried naturally or baked at high temperature to solidify, as if it were given strong adhesion. The quality control of silicone oil is particularly critical, and it must be ensured that it does not have any adverse effects on the safety, quality, and purity of pharmaceutical products. 

3. Silicone Product Overview
There are three main types of silicone products available on the market, each with its own strengths to meet different application needs.
3.1 Non-reactive Silicone Oils
IOTA-201 is a representative of non-reactive silicone oils, which are clear and colorless linear polymers with a variety of standard viscosities available. Its structure consists of repeating dimethyl siloxy units, with trimethyl siloxy units at the end, resembling a beautiful piece of art, ensuring the purity and consistency of the product.
Silicone fluid, like a graceful dancer, has a low surface tension and exhibits hydrophobic repellency, making it an excellent lubricant for glass, rubber, and plastic.
The extremely thin PDMS film, like a fairy, delicately covers the glass and plastic syringe barrels, ensuring smooth operation of the plunger while providing a hydrophobic surface to minimize drug wetting. It can also perform magic on subcutaneous injection needles, making the needle tip easier to penetrate the skin. Toxicology studies serve as an impartial judge, declaring these materials to have low toxicity.
3.2 Non-reactive Silicone Emulsions
Non-reactive silicone emulsions are water-dispersible, non-reactive PDMS fluid emulsions containing non-ionic emulsifiers. At room temperature, it behaves like a pure angel, visually appearing as a clean, white, low-viscosity liquid that is fully soluble in water. However, like angels can sometimes be temperamental, separation or sedimentation may occur, so it should be thoroughly mixed before use and, if necessary, at other times.
Non-reactive PDMS emulsions have excellent delivery performance in water-dispersed systems, making them a favorite in many applications. Like non-reactive silicone oils, the thin films made from silicone emulsions can also be enhanced in durability by "baking" treated items.
3.3 Reactive Silicone Dispersions
Reactive silicone dispersions are amino-functional silicone polymers dispersed in 

This dispersion offers a host of surprises:
· Provides a room temperature curable coating that gives surfaces a tough armor-like finish.
· Has chemical functional groups that adhere the coating to polar surfaces (metals and certain plastics), demonstrating strong adhesion.
· Produces a more durable coating than pure dimethylpolysiloxane silicone oil, showcasing its superior quality.
· Is widely used as a lubricating coating for subcutaneous injection needles, contributing to the medical field. 

4. Sterilization Methods
The stability and low reactivity of silicone oil allow it to withstand a variety of sterilization techniques, including steam autoclaving, dry heat, ethylene oxide, and radiation sterilization. Ethylene oxide sterilization is like a gentle guardian, particularly suitable for disposable subcutaneous injection needles and syringes, but proper venting procedures must be followed.
Steam autoclaving or dry heat sterilization are also reliable partners and have been proven to be acceptable sterilization techniques. Research has found that radiation sterilization usually has a minimal effect on liquids when a dose of up to 2.5 Mrad is used. However, at high doses of radiation (>2.5 Mrad), radiation may cause PDMS to crosslink, 

5. Clean Technology
The cleaning of PDMS is a delicate cleaning process that is a key step in ensuring the quality of pharmaceutical products. Aliphatic and aromatic solvents are effective tools for removing PDMS, but considering the safety requirements in cleanroom areas, on-site cleaning (CIP) cleaning agents (such as potassium hydroxide or phosphoric acid) act as a safety guardian, providing a safe and effective alternative solution, which is widely used in pharmaceutical factories to remove PDMS from equipment. 

6. Conclusion
Silicone treatment is a shining star in the lubrication process for injection packaging components, playing a crucial role. By carefully selecting the type of silicone oil and application method, as well as strictly following sterilization and cleaning procedures, it is possible to ensure efficient operation of injection packaging components and provide a solid guarantee for the safety and quality of drugs. As the pharmaceutical industry's requirements for product quality continue to rise, the development and application of silicone treatment will undoubtedly continue to receive great attention.

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