Designing Critical Cleaning Processes to Mitigate Microbial Risk in Multiproduct Facilities
Paul Lopolito, Technical Services Manager, STERIS Corporation will be presenting at INTERPHEX 2012
“Designing Critical Cleaning Processes to Mitigate Microbial Risk in Multiproduct Facilities”
Wed. May. 2, 2012
9:00 am - 10:00 am
Microbial contamination of process equipment is a concern for pharmaceutical, biopharmaceutical, medical device, dietary ingredients and personal care industries.
Microbial contamination can lead to costly delays and is specifically challenging for multiproduct facilities. Designing critical cleaning processes used during product change-over is an important step in any contamination control risk-based strategy. This presentation will focus on three critical elements. The first element is a review of the different types of microbes and the microbial efficacy of alkali cleaning agents. The different microbes include vegetative bacteria, endospores, mycobacteria, mycoplasma, fungi, viruses and prions. The second element is a review of the surface and equipment design. Surface and design issues may include materials of construction, rouge, length and orientation of dead legs, slope of piping, crevices and drainability. The third element is defining the critical cleaning parameters to ensure effective product and process residue removal. A simplified laboratory screening process will also be discussed along with specific examples on how information generated from these studies can be used to develop effective cleaning strategies. This presentation will also include numerous industry references and case examples to help assess risk of microbial cross-contamination from one batch or product to another.