For the past 13 years, microbiologist Guenther Gapp has operated as an independent consultant, providing specialized expertise to clients and contractors across the globe. He has successfully completed over 100 assignments spanning Europe, the USA, India, Korea, Japan, and South America. Guenther is highly regarded as an Aseptic Processing Expert, frequently assisting organizations in remediation efforts following regulatory Warning Letters, while also contributing extensively to audits, facility start-ups, comprehensive training programs, and various other strategic remediation initiatives.

Early in his career at Sandoz, Guenther developed the Sterile Product Contamination Risk Assessment (SPCRA) tool. This innovative methodology was designed to systematically identify and mitigate microbial contamination and compliance risks within sterile manufacturing environments. The tool has proven highly effective when utilized by qualified professionals. In recognition of his contribution to the field, the publication of this assessment tool earned him the 2011 PDA (Parenteral Drug Association) Journal of Pharmaceutical Science and Technology Award. Furthermore, in April 2022, he was honored with the prestigious James Agalloco Award for delivering the top-rated PDA training course on aseptic processing in Europe.

From June 2017 to June 2023, Guenther served as a member of the PDA Science Advisory Board and as Co-Chair of the PDA PTC “Isolator Technology in the Pharmaceutical Industry”, published in 2020. He also contributed to the PDA EU Annex 1 Team (recipient of the Michael S. Korczynski Award in April 2022), was one of the authors of PDA Technical Report 13 (Environmental Monitoring), and participated in the revision of TR 22: Aseptic Processing Simulation / Media Fill, which was published in Q3 2025. In addition, he was involved in the update of PDA “Points to Consider No. 1: Aseptic Processing” (revised 2023) and, since 2023, has served as Co-Lead of the new PDA working group “PTC 12 for RABS”, published in June 2025.