Selecting suitable cleaning agents and determining justifiable cleaning process parameters are critical prerequisites for cleaning validation. Proper selection of these cleaning agents and parameters could simplify cleaning validation efforts immensely.
Process cleaners may range from a single component, such as an organic solvent, to multi-component formulations that use multiple cleaning mechanisms such as solvency, solubilization, emulsification, wetting, chelation, dispersion, hydrolysis, and oxidation. Although the most important cleaning parameters are cleaning time, impingement level, cleaning solution concentration and temperature, other factors that influence cleaning performance may include nature of the substrate surface finish, soil conditions, soil levels before cleaning, level of mixing, water quality, and rinsing. Proper selection of cleaning agents and parameters can be achieved through laboratory evaluation followed by field confirmation, and requires an understanding of substrate and design constraints, residue limits, desired cleaning objectives, cleaning chemistry and the contribution of various parameters to performance. (Verghese, Selection of Cleaning Agents and Parameters for cGMP Processes, 1998)
Alkaline Detergents are used for the majority of cleaning applications due to their ability to remove a wide range of organic soils using alkaline hydrolysis.
Acid Detergents are commonly used for the removal of inorganic residues and salts. Additionally, they are widely used for rouge removal and passivation of stainless steel equipment found in pharmaceutical process equipment trains.
Neutral Detergents are commonly used in manual cleaning applications or with sensitive substrates due to their mild pH and enhanced compatibility.
Specialty Chemistries are formulated for applications which respond to other cleaning mechanisms (like oxidation) or require other unique characteristics (like heavy foam).
Simplify Detergent Selection with STERIS Technical Support
A highly qualified, industry-recognized team of chemists, microbiologists and engineers are available to offer product and process consultation. STERIS Technical Support currently provides both on- and off-site seminars with topics focusing on process cleaning and cleaning validation. An extensive library of technical data, laboratory reports, analytical methods and case studies has been developed including toxicity and substrate compatibility studies.
Our technical support services also include the Process And Cleaner Evaluation (PACE®) program, which is an evaluation service designed to provide our Customers with recommendations for an effective cleaning protocol. Once an evaluation has been completed, STERIS provides a report that assists Customers in developing a cleaning protocol by defining parameters based on chemical type, concentration, cleaning time, temperature, cleaning method and water quality. The PACE program is an essential first step for any cleaning application.