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
The staff of IVT were onsite at the 2015 EU Validation Week held in the center city of Amsterdam's Crowne Plaza Hotel. Check out some photos from the conference's opening speeches.
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...
This paper has discusses the implications of the process hold times on microbial growth during pharmaceutical manufacturing. Microbiological risk exists -- especially with biological products. If microbial contamination occurs where microorganisms enter a product in sufficient numbers and if the process hold time is long enough, the process hold time may be problematic.
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.
Certain pharmaceutical products must be sterile, including injections, ophthalmic preparations, irrigations solutions, and hemodialysis solutions. This is due to the route of administration and in relation to the intended patient population. The first paper looked at designing media fills for multiple product lines, by using a matrix; the second considered how interventions can be risk assessed.