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Cleaning Agent and Detergents used in Pharmaceutical Industry

Cleaning Agent Used For Pharmaceutical Industry
  • In order to ensure high quality products, the pharmaceutical industry must use cleaning agents designed to sanitize and protect the equipment used. Although we use several types of cleaning products in everyday life, pharmaceutical companies uses specialized cleaning agents such as nonionic detergents that are designed to uphold the quality of the product.
  • There are several varieties of cleaning agents used by the pharmaceutical industry that are selected depending on the situation and the level of cleaning required. Each type of cleaning agent has its own properties that are often based on the surfactant nature of the detergent used.
Types of Detergents
  1. Anionic detergent
  2. Cationic detergent
  3. Amphoteric detergent
  4. Alkaline detergent
  5. Others
  • The above mentioned detergents are all what are called ionic detergents, meaning that they contain free ions. Although effective for cleaning, the free ions can be left behind on the cleaned surface which can affect stability of the products as well as other negative effects. For example, when glassware is cleaned with ionic detergents, the remaining ions can interfere with analysis and alter the results. To overcome this, nonionic detergents are used to clean equipment used in the manufacture of pharmaceutical products.
  • Nonionic detergents are produced by reacting molecules containing hydroxyl groups, such as ethylene oxide and alkylphenol, which react together in an exothermic reaction, meaning it gives off heat. The chemicals used however, such as the ethylene oxide, are toxic and unstable, and must be synthesized using specialized equipment.
  • As the name suggests, nonionic detergents do not ionise when dissolved in water. Moreover, the detergent is made of both acidic and alkaline components, and therefore remain at a neutral pH when dissolved in water. Finally, nonionic detergents typically produce less foam when mixed with water compared to ionic detergents such as the cationic or anionic varieties. As well as being good detergents for removing oil from surfaces, nonionic detergents are easier to wash away from the equipment being cleaned and leaves less residue behind than ionic detergents, thereby reducing the chance of any contamination and preventing any interference with analysis.
  • Nonionic detergents are often available in liquid forms for easy use.

Detergent Used For Pharmaceutical Industry
  • To choose a proper detergents is the primary issue of cleaning process development. 
  • Detergents are used for the cleaning of ground floor, wall surfaces as well as pipes and equipments in pharmaceutical industry. To choose a proper detergents is the primary issue of cleaning process development. There are different types of detergents for pharmaceutical industry as below.

Organic Detergents
  • Organic detergent is used sometimes in pharmaceutical industry. For example, methanol can be used for cleaning during the synthesis of small molecule APIs. Isopropanol can also be used to clean parts during the preparation process manually.

Alkaline Detergents
  • Alkali detergents are often used in the alkaline washing process. Sodium hydroxide solution is one common choice, of which the high alkalinity increases the solubility of residues during organic synthesis process . Compared with other detergents, sodium hydroxide is easy to detect, and easy to verify the removal. High pH value of sodium hydroxide solution will act with ions such as calcium, magnesium and iron during the cleaning process.

Cationic Detergents
  • Cationic detergents are more strongly absorbed on fabrics that are anionic or nonionic surfactants.
  • They are used as wetting agents, fabric softeners, bacteriostats and emulsifiers. This type of synthetic solution is a common quaternary ammonium salt disinfectant.

Anionic Detergents
  • Anionic detergents, such as ammonium lauryl sulfate, sodium laureth sulfate, sodium lauryl sarcosinate and sodium myreth sulfate, are the sodium salts in which a lipophilic hydrocarbon group of the molecule is an anion.

Water as Detergent
  • Water is usually used in the preparation of pre-rinsing, post-rinsing, and diluents in pharmaceutical equipment cleaning. However, water can also be used as a detergent if residues are easily soluble in water. Normally, the water used as detergent should be at least as good as the water used for pharmaceutical production. And the microbiological and endotoxin limits also should be considered while choose water as detergent.

Except for types of detergents, some factors such as cleaning time, concentration of detergents and temperature are also important for develop pharmaceutical equipment cleaning process development.

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