Cleaning Validation

Bench-scale methods for assessing the relative cleanabilities of process soils are useful tools for applying a risk-based approach to full-scale cleaning validations, troubleshooting cleaning issues, and developing cleaning strategies. In this study, the authors explored a coupon soiling method, referred to as the “spreading method,” that controls soil size and shape during sample preparation.


“Know and understand the cleaning processes you must validate” Dawn Tavalsky orated in the finale of her workshop at 17th...
The following proposed standard is intended to reflect desirable contemporary practices, is not binding in any way, and can be...Download
For multi-product biopharmaceutical facilities, setting the acceptable level of process residues following equipment cleaning...Download
While considerable attention has been given to the development of visual residue limits (VRLs) in a laboratory setting,...Download
At IVT's 17th Annual Validation Week, Dawn Tavalsky gives a must-see presentation for any organization looking to implement or reimplement a cleaning validation program from scratch. At the beginning of the presentation, Tavalsky discusses the definition of cleaning validation; the FDA, Health Canada, and European regulatory expectation for cleaning validation; and the realistic scope of a...
Special Edition
A scientific approach to cleaning validation is robustly explained in this special edition. Cleaning validation as it applies to all aspects of the product lifecycle are discussed, including topics on: Equipment cleaning validation, Cleaning validation documentation, Total organic carbon analysis, and Detergent selection.
This discussion of “Effective GMP” addresses key considerations in the development of manual cleaning procedures, documents reflecting these procedures, and their subsequent use in cleaning performance. Manual cleaning procedures may comprise the entire method of cleaning manufacturing equipment, or may be performed in conjunction with automated cleaning methods. For example, mixing tanks may...
The following key points are discussed in this article: Good personal hygiene is a requirement of all pharmaceutical activities, from operating on the line through laboratory good manufacturing practice (GMP) studies. However, studies show poor hand washing compliance is the rule in a variety of occupations. Poor hand washing technique may result in increased absenteeism, particularly in...
The following key points are addressed in this article: Swab sampling is a direct surface sampling technique for sampling surfaces Personnel who perform swab sampling should be qualified for performance Swab efficiency (i.e., % recovery) for the method and product contact material should be determined Extractables from the swab or protein binding to the swab must not interfere with the...