Cleaning is an important part of pharmaceutical manufacturing to manufacture contamination-free quality products. Facility cleaning and sanitization is an important part of GMP compliance. In this post, we will explore the importance and use of detergents used in the cleaning of pharmaceutical equipment used in manufacturing.
Detergents are specially formulated cleaning agents used to remove various types of contaminants from the surface. Many types of detergents are there in the market like anionic, cationic, amphoteric, alkaline detergents etc. This nature of any detergent depends upon the cleaning nature of the surfactant found in the detergent. All these detergents have their specific use due to their surface cleaning properties.
1. The detergent used in cleaning must be compatible with the equipment materials such as stainless steel, glass and plastic.
2. Most of the detergents leave residue after cleaning and may contaminate the products. A residue-free detergent is necessary for cleaning.
3. Detergent should have antimicrobial properties to control the microorganisms present on the surface of the equipment.
All of the above detergents have free ions and these are left after cleaning the cleaned surface. A mixture of nonionic and anionic detergent is found to be an anionic detergent. These free ions can have a harmful effect on the pharmaceutical products and affect their stability.
Therefore, nonionic detergents are used for cleaning of equipment in pharmaceutical manufacturing. Nonionic detergents are also required to clean the glassware used in the pharmaceutical analysis because these free ions can alter the results of the analysis.
These are prepared by the reaction of molecules containing hydroxyl groups like alkylphenol and ethylene oxide. This reaction is an exothermic reaction which generates heat. Ethylene oxide is very toxic and explosive in nature. Therefore, these are synthesized carefully in special equipment.
Nonionic detergents do not ionize when these are dissolved in water. These are manufactured using the same quantity of acids and bases of the same strength and don’t have the acidic or basic nature.
Therefore pH value remains neutral. These detergents make less foam than cationic or anionic detergents when used with water. Due to this property, these can be cleaned easily from the equipment surface. These are very much effective against the oily material. Generally, these pharmaceutical detergents are found in liquid form.
Key Considerations for Selecting Detergents
You can not compare the cleaning of cloths with the cleaning of pharmaceutical equipment used in manufacturing. You should consider the following things before selecting a detergent for pharmaceutical use.1. The detergent used in cleaning must be compatible with the equipment materials such as stainless steel, glass and plastic.
2. Most of the detergents leave residue after cleaning and may contaminate the products. A residue-free detergent is necessary for cleaning.
3. Detergent should have antimicrobial properties to control the microorganisms present on the surface of the equipment.
Therefore, nonionic detergents are used for cleaning of equipment in pharmaceutical manufacturing. Nonionic detergents are also required to clean the glassware used in the pharmaceutical analysis because these free ions can alter the results of the analysis.
These are prepared by the reaction of molecules containing hydroxyl groups like alkylphenol and ethylene oxide. This reaction is an exothermic reaction which generates heat. Ethylene oxide is very toxic and explosive in nature. Therefore, these are synthesized carefully in special equipment.
Nonionic detergents do not ionize when these are dissolved in water. These are manufactured using the same quantity of acids and bases of the same strength and don’t have the acidic or basic nature.
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