Microrite, Inc. brings you this unique learning experience in microbial contamination investigations; part of Microrite s Practical Series Seminars.

Transcription

1 Microrite, Inc. brings you this unique learning experience in microbial contamination investigations; part of Microrite s Practical Series Seminars. MICROBIAL CONTAMINATION INVESTIGATIONS Microbial Contaminations have many consequences; inconclusive investigations and continuing contamination events are frequently associated with voluntary or involuntary plant shutdowns, product recalls, and warning letters. This comprehensive two day course on investigation of microbial contamination in cleanroom, manufacturing processes, water systems, laboratory testing, and product will provide the tools for conducting in-depth investigations. Investigations are cost and labor intensive; detection of microbial contamination requires prompt attention and good understanding of contaminants. Which industries does this seminar apply to? Industries that will benefit from this training are Pharmaceuticals, Biotechnology, Medical Device, In Vitro Diagnostics, and vendors that supply water systems, tubing, piping, fermentation and other equipment. Who will benefit? Quality Assurance, Quality Control, Microbiologists, Validation, Facilities, Purchasing, Materials, Production Managers, Engineering and other Health industry professionals and related vendors. Who will be teaching? The speakers include Ziva Abraham, President of Microrite, Inc., with over 25 years of academic, research, clinical and industrial experience in Microbiology, and Quality Assurance. Bob Livingston, who is the Chief Technical Officer of Arion Water, Inc., a 30-year-old Water System Equipment and Service provider. Arion provides expert consulting, design, engineering, turnkey systems and analytical testing addressing all aspects of high purity water for pharmaceutical, semiconductor and related industries. Robert Bettis, who has over 25 years of experience in the biotechnology industry. His expertise includes aseptic operations, environmental control, production facility design and startup, process design, and continuing improvement programs.

2 DAY 1: 30 May, 2013 Lecture: Investigating Mold Contaminations by Ziva Abraham Mold contaminations are the least understood in the Pharmaceutical or Medical Device Industry. Many do not discover there is an existing mold issue until it has made its presence in the cleanroom in large quantities or has ended in the product circumventing antimicrobial efficacy. Mold unlike bacteria has various methods of propagation and in spore form can remain dormant till conditions are favorable. Understand how not to create favorable conditions for mold to grow. This crash course in mold classification, methods of reproduction and their ability to withstand many disinfectants will help understand and prevent product contamination. Understanding the three major groups of mold found in cleanrooms Knowing how variants within each group differ in nature and structure Simple keys to understand the different mold Why fungal identification results could be misleading Common contaminants in facilities that can proliferate How different groups react to different disinfectants What type of mold to consider when conducting disinfectant qualification Points to consider when investigating mold contamination Why excessive cleaning and disinfection is not the solution After this training you will never put all mold contaminants in the same basket-you will want to know the real cause Lecture: Investigating Environmental Monitoring Excursions by Ziva Abraham The first step for investigating environmental monitoring excursions is to ensure that the excursion is not due to operator error. Often lot of energy is expended in investigating excursions that are not due to environment being out of control but due to analyst or laboratory errors. Learn how to identify true and false excursions and proceed accordingly with the investigation. Verify it is not an error Validate the microbial identification Separate Excursions from Out of specifications Developing and action plan when an excursion occurs o Are the counts correct? o Is the ID correct? o Is it an objectionable? Planning an investigation information to be collected How far back should you go or can you go for data review Three step approach o Estimated cause(s) o Probable cause(s) o Root cause What are corrective actions and how effective are they When is it appropriate to use EM data as a product release criterion?

3 DAY 1 (Continued): 30 May, 2013 Lecture: Investigating Sterility Test and Media Fill Failures by Ziva Abraham This presentation will discuss the importance of Media Fills as the true parameter for assuring that a manufacturing process is capable of producing sterile pharmaceuticals using an aseptic process. Investigating sterility test and media failures have to be thorough for ensuring product quality and patient safety. Discussion on Aseptic Media Fills and Sterility Testing Common errors that may cause sterility test failures Discussion on Validation of Aseptic Processing Guidance for Industry Media fill protocol discussion What to investigate in: o Facility o Equipment o Personnel o Training Consequences of contamination during media fills Lecture: Investigation of Microbiological Out of Specification Results by Ziva Abraham Understanding the difference between an excursion and a true OOS is the first step. Many laboratory errors may contribute to OOS in Microbiology. A step by step evaluation of laboratory techniques and differentiating a lab error from a true representation of risk to product. Investigating o True OOS vs. Laboratory errors o Common Lab. errors that may look like a true OOS o Equipment related OOS-Case studies o Calculations a common cause o Contamination related OOS o Media quality and quality control o Improperly maintained stock cultures o Aseptic techniques not followed Retesting strategy Resampling, when and how How to document an OOS investigation Panel Discussion Speakers will address questions that arise from the first day of training sharing their experiences and their approaches they have taken under similar conditions.

4 DAY 2: 31 May, 2013 Lecture: Microbial Investigations of Pharmaceutical Water Systems by Bob Livingston Investigations of Microbial problems associated with Pharmaceutical Water Systems are required and useful, but are often hindered and sidetracked by numerous fallacies and misconceptions. The result of poorly drawn conclusions often do not solve the problems or worse, result in ridiculous and expensive modifications to water systems that invite new problems while retaining the original problems. Learn how to quickly identify and address the root causes of microbial problems in water systems such as: Pretreatment Microbial Control Problems o Learn to live with microbial presence in the parts of the system that have no microbial specifications, while eliminating microbiology and Endotoxin where it matters, at the Points of USE. Learn why WFI Systems have almost no microbial water quality problems Ambient Temperature USP Purified Water systems should never have Endotoxin much less bacteria, and without any sanitizations Learn to conduct succinct Microbiological Investigations of Distribution Systems and corrective actions for Out of Specification anomalies Learn sampling strategies for differentiating the microbial quality of the product water vs. water in distribution vs. the use points o Learn why hot water sanitizations do not solve microbial problem o Learn how distribution design will prevent microbiological proliferation without sanitization o Learn how Action Limits may be used to prevent sanitization Distribution Loop Materials of Construction - many a pipe and distribution system design has been unfairly blamed for microbial water quality issues o Understand why plastic became the cgmp choice for Purified Water distribution loops o Pro s and con s of 316 Stainless Steel vs. polymeric plastics Learn why Sampling for microbiology remains problematic, and how to fix it Lecture: Biofilm formation in Water Systems by Bob Livingston Biofilms reside in many parts of Pharmaceutical water systems, if not ALL PARTS. Learn where biofilms are helpful in water processing, and where they are detrimental. o Pretreatment biofilm acceptance and maintenance o Learn why pretreatment biofilms can improve carbon performance. o Pro s and Con s of pretreatment chemical additions (Chlorine, Bisulfite, Sequestrants) RO Biofouling o Learn why RO biofilms are a symptom, not a cause of problems Distribution and Points of Use Can an ambient distribution system NOT grow biofilm? How can a biofilm be removed? Heat? Chemical? Ozone?

5 DAY 2 (Continued): 31 May, 2013 Lecture: Investigating Bioreactor Contaminations by Robert Bettis If you have ever been responsible for determining the source of a bioreactor contamination, you know how frustrating such an investigation can be. If you are lucky enough to have caught the contamination early and have a source that is obvious, easily proven and easily corrected, it may be no big deal. Unfortunately, most bioreactor contamination investigations don't wrap up with such a simple and clear conclusion. A bioreactor is a complex system designed to promote cellular growth within a protected environment. The protective barrier relies on physical and procedural mechanisms with many points of possible failure. Once in, a contaminating organism can quickly grow from a tiny population on an unsterilized surface to a tank load of misery, bathing your system with new potential contamination sources. This short course in bioreactor contamination investigations will provide you with a methodical approach to finding, confirming and eliminating the cause of your contamination. We will also look at some common contamination sources and investigational mistakes. Topics include: The importance of data collection before and after an incident Sources of contaminations Human error Piping and Connections Cleaning SIP Filtration Primary versus secondary sources Biofilm formation Microbial versus Mammalian cell culture Phage contamination investigation challenges Investigation mistakes that can be avoided Environmental factors Good preventive practices Panel Discussion Speakers will share case studies and water system and bioreactor contamination control and remediation strategies they have used.

6 VENUE AND CONFERENCE AGENDA 30 and 31 May, 2013 IIALS-A Missouri Innovation Center 4221 Mitchell Ave St Joseph MO Phone Day 1 (30 May, 2013): Registration and Breakfast Investigating Mold Contaminations by Ziva Abraham Break Investigating Environmental Monitoring Excursions by Ziva Abraham Lunch Break Investigating Sterility Test and Media Fill Failures by Ziva Abarahm Coffee Break Investigation of Microbiological Out of Specification Results by Ziva Abraham Panel Discussion and Q&A Day 2 (31 May, 2013 ): Breakfast and Networking Microbial Investigations of Pharmaceutical Water Systems by Bob Livingston Break Biofilm formation in Water Systems by Bob Livingston Lunch Break Investigating Bioreactor Contaminations by Robert Bettis Coffee Break Case Studies and Panel Discussion PROGRAM 8.00 AM to 8.30 AM 8.30 AM to AM 10.15AM to AM AM to AM PM to 1.00 PM 1.00PM to 2.30 PM 2.30 PM to 2.45 PM 2.45 PM to 4.00 PM 4.00 PM to 4.30 PM 8.00 AM to 8.30 AM 8.30 AM to AM AM to AM PM to PM PM to 1.30PM 1.30PM to 3.15 PM 3.15 PM to 3.30 PM 3.30 PM to 4.00 PM

7 REGISTRATION FORM MICROBIAL CONTAMINATION INVESTIGATIONS Personal Information of One Registrant Last Name: Mr. Ms. Dr. First Name: Title: Organization: Mailing Address: Telephone: Fee: $ per attendee (Includes 2 day seminar fee, breakfast, lunch, break for both days, and course material) Cutoff date for registration is 05 May, No door registrations will be permitted. All payments should be received by 01 April, Additional Attendees First Name: Last Name: Title: First Name: Last Name: Title: Method of Payment: Credit Card and Check payments only. Attendees can register and make payments on Microrite s website- or complete this form and fax to Check payments must be cleared before the cutoff date. If you have any questions regarding payment methods feel free to contact Microrite at or send your enquiry to info@microrite.com. Confirmation of registration will be sent via . For credit card payment on website, a payment receipt will be considered as confirmation of registration. For credit card information faxed to Microrite an confirmation will be sent with a copy of payment receipt. Please call in due time if confirmation is not received after payment. Accommodation Stoney Creek Inn & Conference Center 1201 North Woodbine Road, St. Joseph, MO ( ) - stoneycreekinn.com SHUTTLE SERVICE FROM KANSAS CITY AIRPORT CMN Transportation (816)

8 PAYMENT INFORMATION MICROBIAL CONTAMINATION INVESTIGATIONS Choose One (Place X) VISA Master Card American Express Card Holder s Name Address of Card Holder: Enter the billing address for the credit card used Street: City: Zip Code: Country: Contact Ph No & Card Number: Expiration(Month/Year): Name on Card: Amount (US Dollars): Signature: Name of Attendee(s) Referred by: Kindly note the name of the company or person that referred you to this training. We would like to thank them..

9 Our presenters are experts in their fields and passionate about teaching. Ziva Abraham has over 25 years of academic, research, clinical and industrial experience in Microbiology, and Quality Assurance. She has trained personnel from various industries in microbiology techniques and methods. Ziva has received her Master s Degree in Microbiology and has conducted research on developing Microbial Insecticides. She has established clinical laboratory systems in Israel, Microrite, Inc. a consulting company based in San Jose, CA and Microrite Training Center in Santa Clara, CA. Microrite helps Pharmaceutical, Medical Device, Biotechnology and Combination Product Companies in the areas of Quality Assurance, Validation, Process Development and Microbiological Quality Control. Ziva has also developed BACTISPELL a microbiology spellchecker to spell check genus and species names of microbes and other microbiology related terms. She is a member of PDA, ISPE, AAMI, and PMF and is an active mentor for graduate students at Stanford University working through the American Woman in Science Organization (AWIS). She is involved in Expanding Your Horizons, a program through the Math and Scientific Network to educate young girls about careers in science. Ziva serves on the editorial board of Pharmaceutical Microbiology Forum (PMF) Newsletter. Bob Livingston is the Chief Technical Officer of Arion Water, Inc., a 30-year-old Water System Equipment and Service provider. Arion provides expert consulting, design, engineering, turnkey systems and analytical testing addressing all aspects of high purity water for pharmaceutical, semiconductor and related industries. Arion Water provides ambient USP and HP Purified Water Systems that require no sanitization. Bob has spoken on numerous occasions for the ISPE, ASQ the ASPE, and taught the course on Pharmaceutical Water System Design for the PDA. Robert Bettis has over 25 years of experience in the biotechnology industry. His expertise includes aseptic operations, environmental control, production facility design and startup, process design, and continuing improvement programs. Mr. Bettis began his career at Amgen where he spent over 12 years in manufacturing operations. During his tenure at Amgen, Mr. Bettis filled key leadership roles in the start up and licensure of their first two microbial manufacturing facilities and the launching of Neupogen. He has also served as Director, Operational Excellence at VaxGen Inc., and as Associate Director of Master Virus Seed development at MedImmune Inc. He has been consulting since 2008 during which time he has conducted microbial contamination investigations in many environments and operations from pharmaceutical manufacturing processes to surgical suites focusing on source identification and increasing process robustness through system design and procedural improvements. Mr. Bettis holds a Bachelor s degree in Genetics from the University of California at Davis.