Saturday, 30 January 2021

Compatibility (chemical and biological) of disinfection agents and processes with Pharmaceutical and Biopharmaceutical products


 

When selecting cleaning agents and disinfectants, a User Requirement Specification (URS) should be drawn up. One of the important points is compatibility. This refers to three key areas[i]:

a) Compatibility between the selected disinfectant(s) and the in-use detergents,

b) Compatibility with the selected disinfectant(s) and the different surface materials to which they are applied,

c) Disinfectant residues which might contain trace toxic compounds.

 

 

With detergents, it is important that any detergent used should be compatible with the disinfectants used, for some detergents can leave residues which can neutralise the active ingredient in certain disinfectants thereby reducing the microcidal properties of the disinfectant. Non-ionic detergents are the most commonly used in healthcare and pharmaceuticals because such detergents are compatible with most commercial disinfectants.

 

With surfaces, it is important to specify the range of surfaces that the disinfectant is intended to be used on, such as stainless steel, glass, vinyl, terrazzo and so on. This is important as some disinfectants corrode or discolour particular materials. Furthermore, some disinfectants may be less effective with certain materials or may cause excessive damage to certain materials, such as the reaction of chlorine dioxide against stainless steel.

 

With disinfectant residues, as well as theoretically leading to a risk of resistant strains, toxic compounds could be left behind at the end of the disinfection process which might contaminate the drug product. Where this risk exists, surfaces should be cleaned with a pharmaceutical grade water to remove residue traces.

 

When selecting a new disinfectant it may be important that compatibility trials are undertaken as part of the qualification.



[i] Sandle, T. (2012). The CDC Handbook: A Guide to Cleaning and Disinfecting Cleanrooms, Grosvenor House Publishing: Surrey, UK

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

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