Destin A. LeBlanc

Cleaning Validation Technologies

Technical Consulting Services

JUNE 1995

Policy Questions on Cleaning Validation: 

Reference: 21 CFR Sec. 211.67, Equipment cleaning and maintenance; and,  Guide to Inspections of Validation of Cleaning Processes, July 1993 (reformatted May 1994).  

What is the level of detergent residue that would be acceptable  to FDA?  What is the basis for arriving at this level, if any?  

FDA has repeatedly stated that it is the firm's responsibility to  establish acceptance limits and be prepared to provide the basis for  those limits to FDA.  Thus, there is no fixed standard for levels of  detergent residue.  Any residues must not adversely alter drug product  safety, efficacy, quality, or stability.  

If the ability of a procedure to clean a piece of equipment made  of a particular material, such as 316 stainless steel, is shown to be  acceptable and validated, can that "material" specific cleaning  procedure be used without "extensive" validation for other pieces of  equipment and compounds?  

No.  The design of the equipment is a major component of its  cleanability.  Therefore, firms should have data that relate to a given  piece of equipment.