PMF Fall Forum 2017: Non-Sterile Manufacturing Challenges

Submitted by moderator, Bob Westney


This year’s Fall Forum focuses on the challenges we as GMP microbiologists face in the non-sterile manufacturing industries.  For many years, regulatory, compendial and industry guidance has primarily focused on aseptic manufacturing.  Collectively, I believe this guidance has allowed those of us who work in the sterile manufacturing industries to understand the systems we must have in place and the regulatory compliance we must meet.  However, those of us who work in the non-sterile manufacturing industries have had little, and sometimes conflicting, guidance.  We’ve often had to look to aseptic manufacturing guidance to try to “cobble together” a set of “rules” that govern our environmental monitoring, contamination control and testing regimens.  The advent of USP <1115>, “Bioburden Control of Non‐sterile Drug Substances and Products”, in 2014 (only three years ago!) was an instrumental first step toward offering guidance.


As we seek to further enrich our understanding of the risks associated with non-sterile manufacturing, and how to mitigate them, we look to our industry experts.  This year’s Fall Forum provides this expertise.  Our speakers are recognized industry experts, and you’ll leave the conference far more knowledgeable than when you arrived.


I’ve provided a list of our speakers, highlighting their experience and presentation topics.


Dr. Dilip Ashtekar will present “Technical and Regulatory Framework: Microbiological Aspects of Cleaning Validation for Non-sterile and Biotechnological Equipment”.  Cleaning validation is an aspect of non-sterile manufacturing that has received little attention, so this presentation is seminal to the Forum.  Dilip is a long-standing member of the USP Microbiology Expert Committee, among many other major career accomplishments.


Don Singer will present “Raw Materials Quality – You and Your Supplier Have Significant Impact”.  In one regard, contamination control truly starts when the raw materials arrive at your facility.  Therefore, the quality of these materials as they enter your manufacturing process is a critical consideration.  Don is also a long-standing member of the USP Microbiology EC, currently serving as Vice-Chair.


Frank Settineri will present “Objectionable Microorganisms in Purified Water: Current Regulatory Expectations”.  Frank will tackle the often-confused topic of “objectionable organisms”, and help us to understand its role in purified water.  Frank is a well-known consultant and a member of the Microbiology Network consortium of consultants.


Amy Jo Karren will present “Training on the Right Things in the Microbiology Laboratory”.  Microbiology laboratory operations is one of the pillars for meeting the challenges of non-sterile manufacturing.  Amy is an accomplished expert, also serving as Chair for the USP Chemical Medicines 5 Expert Committee (our third USP EC member!).


Andrew Dick will present “Contamination Prevention in Nonsterile Manufacturing of Pharmaceutical Drugs, Cosmetics and Medical Devices”.  This informative presentation will include such topics as sanitary equipment design, risk assessment, and cleaning and sanitization of equipment.  Andrew has a wealth of experience in non-sterile manufacturing, and co-authored PDA Technical Report No. 67, “Exclusion of Objectionable Microorganisms from Nonsterile Pharmaceuticals, Medical Devices and Cosmetics”.


I will present “Qualifying an Environmental Monitoring Program for Non-Sterile Manufacturing: A Case Study”.  I’ve audited and consulted for myriad non-sterile manufacturers, and based upon a real-life case study, I will walk you through how to qualify an EM program, and establish the path forward for monitoring, investigation of excursions and trend reporting.


We hope you are able to join us for this informative conference this October!  Early bird registration ends August 1st.


Register Here

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