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Journal of Infectious Diseases & Therapy | ISSN: 2332-0877 | Volume 6
&
Nosocomial and Healthcare Associated Infections
2
nd
International Congress on
Decontamination, Sterilization and Infection Control
International Conference on
October 15-16, 2018 | Las Vegas, USA
Prevention of contamination in pharmaceutical industry
C
ontamination of pharmaceutical products can cause catastrophic consequences in the pharmaceutical industry; from
patient safety and patient access to drug shortages through business viability and sustainability. In the manufacturing
of sterile pharmaceutical products, contamination prevention is a critical component for complying with state and federal
regulations as well as protecting the safety of the public. In the wake of the meningitis outbreak of 2012, FDA and other
regulatory agencies have heightened their approach and expectations on monitoring products for contamination. Although
bioburden levels may be able to be controlled with suitable cleaning methods, preventing the occurrence is the best approach
when assessing the risk of contamination for a facility and/or drug product. Cleanroom suites play a critical role in the creation
of sterile pharmaceutical drug products. Although many methods of decontamination and sterilization have proven successful,
prevention of the contamination is key to maintaining optimal microbial levels in an aseptic environment. This talk will discuss
the top potential sources of contamination and how to effectively prevent them from contaminating product, the cleanroom
suites and the significant impact an outbreak may have on the organization as a whole. Additionally, this talk with also evaluate
the top potential sources of contamination in detail based on risk and the specific role they play in the pathway to contamination.
Discussion topics include facility design, cleanroom behavior, gowning and cleaning requirements, etc.
Biography
Melissa Stefko is an experienced pharmaceutical and biotechnology professional with a background in Quality Assurance and Quality Control in aseptic sterile
processing. Prior to joining Wells Pharmacy Network, She served as Head of Quality with a start-up 503B outsourcing pharmacy and gained a strong CGMP
understanding through previous positions within pharmaceutical manufacturers. She is an active member of the American Society for Quality as a Certified Quality
Auditor and is a member of Institute of Environmental Sciences and Technology, American Society for Microbiology, Parenteral Drug Association, and IACP. She
holds Masters in Business Administration, Masters of Science in Biotechnology, and Regulatory Affairs Certificate.
melissastefko@gmail.comMelissa Stefko
Wells Pharmacy Network, LLC, USA
Melissa Stefko, J Infect Dis Ther 2018, Volume 6
DOI: 10.4172/2332-0877-C4-046