ABSTRACT
In the pharmaceutical industry cleaning is an important component of the manufacturing process. Regulatory agencies both in Europe and North America require that the cleaning process be validated [1]. It must be clearly shown that product residues are removed to an acceptable level. In addition, not only do the manufacturers have to show that they have cleaned their product to an acceptable level but they have to demonstrate that they have removed the cleaning agent also to an acceptable level. Cleaning validations require tools to measure the residue levels left on surfaces. These tools are required to be validated. This poses a challenge to analytical chemists in that they must first choose the appropriate method to measure the residues and then they must validate that method. If the method cannot be validated it cannot be used to measure residue levels. There are many types of analytical techniques that can be used for these analyses. The methods can be specific or non-specific. The chemist can also utilize complementary techniques such as total organic carbon (TOC) determination or high performance liquid chromatography (HPLC). The analytical chemist must examine the pros and cons of each technique in order to choose the appropriate technique. Again, whichever method or methods are chosen they must be validatable.
