Microrite, Inc.

brings you this unique learning experience in understanding, detecting, preventing, testing, removing planktonic microorganisms and controlling microbial biofilms

MICROBIAL CONTAMINATION CONTROL A HOLISTIC APPROACH FOR CONTROLLING PLANKTONIC MICROORGANISMS AND BIOFILMS IN PHARMACEUTICALS, BIOTECHNOLOGY AND MEDICAL DEVICES erience in understanding, detecting, preventing, testing, removing and controlling microbial biofilms
Microbial Contamination Control should never be an afterthought for Pharmaceutical, Biotechnology, Medical Devices and other Healthcare Industries. Understanding the different considerations and components needed for the development of an effective contamination control program is needed to successfully control contamination by planktonic and biofilm microorganisms. How often have Quality and Manufacturing personnel asked Is there a problem with my water system? when noticing intermittent spikes in water bioburden and endotoxin results. When biofilms are involved it is very common for a system to suddenly spike and then return to control for a number of days and then spike again. Microbial biofilms may also pose a public health problem for persons requiring indwelling medical devices. The microorganisms in biofilms are difficult or impossible to treat with antimicrobial agents; detachment from the device may result in infection. In Biotechnology unintentional biofilm formation within bioreactors can have serious detrimental effects on equipment performance. These range from reduced heat-transfer efficiency, increased frictional resistances, and fouling of internal diagnostic probes to the more atypical econiches, species- or strain-specific adhesion, and inaccurate estimates of culture stoichiometric and kinetic parameters. Formation of a biofilm begins with the attachment of free-floating microorganisms to a surface which then adhere to the surface initially through weak, reversible van der Waals forces. If not separated from the surface, they can anchor themselves more permanently and facilitate the arrival of other cells by providing more diverse adhesion sites and beginning to build the matrix that holds the biofilm together. Once colonization has begun, the biofilm grows through a combination of cell division and recruitment. Bacteria living in a biofilm can have significantly different properties from free-floating bacteria, as the dense and protected environment of the film allows them to cooperate and interact in various ways. Biofilms have increased resistance to disinfectants, cleaning agents and antibiotics, as the dense extracellular matrix and the outer layer of cells protect the interior of the community. The best strategy to control biofilms is to prevent them in the first place. Prevention involves scientifically sound cleaning and disinfectant programs, performing disinfectant qualification studies, implementing procedures that avoid ingress of and destroy any contaminating microorganisms before they can colonize surfaces and develop into biofilms.

Which industries does this conference apply to?

Industries that will benefit from this training are Pharmaceuticals, Biotechnology, Medical Device, Dentistry, Hospitals, Water Utilities, Biofuels, and vendors that supply water systems, tubing, piping, fermentation and other equipment associated with biofilms.

Who will benefit?

Quality Assurance, Quality Control, Microbiologists, Validation, Production Managers, Engineering and other Health industry professionals and related vendors.

Who will be teaching?

The speakers include Dr. Lucia Clontz, a well published author on topics relevant to Microbial Contamination Control, Quality Systems for QC Microbiology Labs, Pharmaceutical Microbiology, and Biofilms, Ziva Abraham a well known Microbial Contamination Control, Disinfectant Qualification, and Microbial Identification expert, and Dominique Leclercq from Minntech/Marcor specialized in filtration and bio-decontamination of Water Purification Systems and an initiator in the development of Minntechs Dry Fog System.
Microrite, Inc. 5019 New Trier Avenue + San Jose, CA 95136 + Ph: 408-445-0507 + Fax: 408-445-1236 w w w . m i c r o r i t e . c o m

MICROBIAL CONTAMINATION CONTROL A HOLISTIC APPROACH FOR CONTROLLING PLANKTONIC MICROORGANISMS AND BIOFILMS IN PHARMACEUTICALS, BIOTECHNOLOGY AND MEDICAL DEVICES

DAY 1: 21 November, 2010

Lecture: Recent Enforcement Trends Pertaining to Sterility Assurance in India by Madhu Raju Saghee
General considerations on inspection procedures-What does an inspector expects to find to assess the compliance of aseptic manufacturing with GMP principles? Review of Recent Warning Letters sent to Indian Companies-A picture of inspection findings Topics that are addressed in this seminar that will help you to preclude WLs and avoid inspectional observations Contamination control and Biofilms-Takeaways from this unique workshop 2 words about the conference speakers.Dr. Lucia Clontz and Ziva Abraham Key messages

Lecture: Biofilm Basics by Dr. Lucia Clontz

Biofilms are sessile communities of microorganisms that occur wherever a non-sterile aqueous fluid is in contact with a surface. Biofilms are typically comprised of bacterial (and fungal) organisms and the extracellular matrix in which they are embedded. Biofilms are important in industrial, medical and environmental contexts and are frequently problematic, leading to loss of product quality, the degradation of pipe materials, and chronic infection. This presentation covers the basics of biofilm growth and prevention including: Biofilm formation and detection Truths and Myths about surface colonization Why biofilms are hard to kill and remove Antimicrobial action against biofilms Standard methods for biofilm growth and analysis

Lecture: Microbial Contamination Control in Drug Processing by Dr. Lucia Clontz

In recent years, the field of microbiology and contamination control has expanded to include the study of biofilms and their impact on pharmaceutical and cosmetic production/processes, equipment and water systems. It is therefore imperative for those responsible for the microbial quality of pharmaceutical and biopharmaceutical products to keep abreast of the latest technologies and studies on microbial and biofilm control and prevention. Topics addressed in this presentation include: Regulatory Expectations for Contamination Control Main types and sources of microbial contaminants in drug processing Biofilms in Water Systems and Bioprocessing Equipment Best approaches for monitoring and managing data for Water Systems Best approaches for monitoring and controlling microbial contamination in drug processing Setting up meaningful Alert and Action Levels Risk Management applied to Contamination and/or Biofilm control and prevention Case studies

Lecture: Using Biofilm Reactors to Test Chemical Antimicrobials by Dr. Lucia Clontz
In recent years, equipment known as Biofilm Reactors have been developed and used in laboratories to grow biofilms under various environmental and physical conditions. This presentation will cover: Types and uses of Biofilm Reactors Discussion of method optimization Creating static biofilms using 96-well microtiter plates Creating medium/high shear biofilms using the CDC Biofilm reactor

Wrap up for Day 1

Q & A and Panel Discussion
Microrite, Inc. 5019 New Trier Avenue + San Jose, CA 95136 + Ph: 408-445-0507 + Fax: 408-445-1236 w w w . m i c r o r i t e . c o m

Microrite, Inc. 5019 New Trier Avenue + San Jose, CA 95136 + Ph: 408-445-0507 + Fax: 408-445-1236

MICROBIAL CONTAMINATION CONTROL A HOLISTIC APPROACH FOR CONTROLLING PLANKTONIC MICROORGANISMS AND BIOFILMS IN PHARMACEUTICALS, BIOTECHNOLOGY AND MEDICAL DEVICES

DAY 2: 22 November, 2011

Lecture: Sanitizers, Disinfectants and Sterilants by Ziva Abraham
Chemical antimicrobials; disinfectants, sanitizers and sterilants are widely used to prevent and control microbial contamination. However, not all agents produce the same desired effect. In addition, there is a regulatory expectation that companies qualify such agents for their antimicrobial effectiveness as they are prepared and used. This presentation will cover the various chemical sanitizers, disinfectants, and sterilants used in the pharmaceuticals, biotechnology, medical device and other healthcare industries, typical contaminants in cleanrooms, and disinfectant qualification studies performed at the user site. Types and uses of Sanitizers, Disinfectants, and Sterilants Common flora in classified cleanrooms and controlled environments Disinfectant Qualification Methods using Planktonic Cells; Discussions on the variants, benefits, and shortcomings of each method Guidance on drafting a Disinfectant Study Protocol for each of the methods discussed Points to consider when planning an disinfectant efficacy study Expiry Dating Study for Disinfectants How to review disinfectant efficacy data to identify execution errors Translating disinfectant qualification results to cleaning procedures to prevent contamination Monitoring efficacy of a facility cleaning program Commonly observed deficiencies in Disinfectant Qualification studies that may lead to contamination or FDA observations

Lecture: Combating and Cleaning Biofilms by Dominique Leclercq

3 myths in Water Purification Different methods and chemical agents removing biofilm and disinfecting water systems Development about the Peracetic Acid Technology Peracetic Acid: How to use it on water purification systems Practical approachHow to prevent or limit biofilm growth in your water purification system Lets learn from Failure & Success Stories

Hands On Session: Biofilm Setup Testing by Dr. Lucia Clontz and Ziva Abraham
All biofilm reactors, flow cells and plates for this course are provided by BioSurface Technologies Corporation (Bozeman, MT, USA This two-day course will conclude with a hands-on learning experience. During this session, you will: View and examine various types of Biofilm Reactors Learn techniques used to recover biofilms from selected reactors Handle and learn how Flow Cells are used to create Biofilms in a laboratory setting for recreating medical device , wound and tubing TM Learn about using variety of microtiter plates including MBEC Biofilm Assay Plates for creating and testing biofilms in laboratory setting biofilms in laboratory setting and address attendee questions

Panel Discussion

Speakers and audience will discuss the approaches to understand common biofilm forming organisms, discuss case studies, brainstorm on the various pointers to suspect biofilms in water systems, possibility of evaluating biofilms in laboratory

setting and address attendee questions.

Microrite, Inc. 5019 New Trier Avenue + San Jose, CA 95136 + Ph: 408-445-0507 + Fax: 408-445-1236 w w w . m i c r o r i t e . c o m

MICROBIAL CONTAMINATION CONTROL A HOLISTIC APPROACH FOR CONTROLLING PLANKTONIC MICROORGANISMS AND BIOFILMS IN PHARMACEUTICALS, BIOTECHNOLOGY AND MEDICAL DEVICES

VENUE AND CONFERENCE AGENDA

21 and 22 November, 2011 Mirage Hotel International Airport Approach Road, Marol, Andheri (E), Mumbai 400 059. PROGRAM Day 1 (21 November, 2011): Registration and Breakfast Opening Remarks by Madhu Raju Saghee Biofilm Basics by Dr. Lucia Clontz Break Microbial Contamination Control in Drug Processing by Dr. Lucia Clontz Questions and Answers Lunch Break Microbial Contamination Control in Drug Processing by Dr. Lucia Clontz Coffee Break Using Biofilm Reactors to Test Chemical Antimicrobials by Dr. Lucia Clontz Q & A and Panel Discussion Day 2 (22 November, 2011 ): Breakfast and Networking Sanitizers, Disinfectants and Sterilants by Ziva Abraham Break Sanitizers, Disinfectants and Sterilants by Ziva Abraham Question and Answers Lunch Break Combating and Cleaning Biofilms by Dominique Leclercq Questions and Answers Coffee Break Hands On Session: Biofilm Setup and Testing by Ziva Abraham and Dr. Lucia Clontz Panel Discussions 8.00 AM to 8.30 AM 8.30 AM to 9.00 AM 9:00 AM to 10.00 AM 10.00 AM to 10.15 AM 10.15 AM to 11.45 AM 11.45 AM to 12.00 PM 12.00 PM to 1.00 PM 1.00PM to 3.00 PM 3.00 PM to 3.15 PM 3.15 PM to 4.30 PM

4.30 PM to 5.00 PM 8.00 AM to 8.30 AM 9.00 AM to 10.00 AM 10.00 AM to 10.15 AM 10.15 AM to 11.45 PM 11.45 AM to 12.00 PM 12.00 PM to 1.00 PM 1.00 PM to 2.30 PM 2.30 PM to 2.45 PM 2.45 PM to 3.00 PM 3.00 PM to 4.30 PM

4.30 PM to 5.00 PM

Microrite, Inc. 5019 New Trier Avenue + San Jose, CA 95136 + Ph: 408-445-0507 + Fax: 408-445-1236 w w w . m i c r o r i t e . c o m

REGISTRATION FORM MICROBIAL CONTAMINATION CONTROL A HOLISTIC APPROACH FOR CONTROLLING PLANKTONIC MICROORGANISMS AND BIOFILMS IN PHARMACEUTICALS, BIOTECHNOLOGY AND MEDICAL DEVICES Personal Information of One Registrant Last Name: Title: Mailing Address: Mr. Ms. Dr. First Name: Organization:

Telephone: Email: Fee: $575.00 per attendee (Includes 2 day seminar fee, breakfast, lunch, break for both days, and course material)
Cutoff date for registration is semi 1800.00 including two day 01 November, 2011. No door registrations will be permitted. All payments should be received by 01 November, 2011.

Additional Attendees First Name: First Name: First Name: First Name: Last Name: Last Name: Last Name: Last Name: Title: Title: Title: Title:

Method of Payment: Credit Card and Check payments only. Attendees can register and make payments on Microrites website-www.microrite.com or complete this form and fax to 408-445-1236. Check payments must be cleared before the cutoff date. If you have any questions regarding payment methods feel free to contact Microrite at 408-445-0507 or send your enquiry to info@microrite.com.
Confirmation of registration will be sent via email. For credit card payment on website, a payment receipt will be considered as confirmation of registration. For credit card information faxed to Microrite an email confirmation will be sent with a copy of payment receipt. Please call 408-445-0507 in due time if confirmation is not received after payment.

About the Venue

Mirage Hotel International Airport Approach Road, Marol, Andheri (E), Mumbai 400 059. Phone: +91-22-6672 1234 , +91-22-6672 1200 ;Email:res@miragehotel.in www.miragehotel.in The hotel is conveniently located in close proximity to Mumbai International Airport. Microrite has negotiated a rate of INR 5500.00 per night for the sleeping rooms.

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PAYMENT INFORMATION MICROBIAL CONTAMINATION CONTROL A HOLISTIC APPROACH FOR CONTROLLING PLANKTONIC MICROORGANISMS AND BIOFILMS IN PHARMACEUTICALS, BIOTECHNOLOGY AND MEDICAL DEVICES
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Microrite, Inc. 5019 New Trier Avenue + San Jose, CA 95136 + Ph: 408-445-0507 + Fax: 408-445-1236 w w w . m i c r o r i t e . c o m

Our presenters are experts in their fields and passionate about teaching. You will wholeheartedly agree to this after attending this workshop.
Dr. Lucia Clontz is an expert microbiologist who works for Fujifilm Diosynth Biotechnologies, in North Carolina, USA. For more than 25 years, Dr. Clontz has managed numerous validation projects, established quality systems for microbiology laboratories, and participated in compliance audits. Dr. Clontz has successfully developed innovative approaches to the application of microbiology in pharmaceuticals and is a well-regarded instructor, presenter and author in the area of pharmaceutical microbiology. Dr. Clontz has B.S. degrees in Chemistry, minor in Chemical Engineering, and in Marine Sciences. She also holds a Masters of Science degree in Microbial Biotechnology and a Doctorate in Health Sciences. Her doctoral applied research project evaluated the synergistic effect of an antibiofouling chemical, developed by professors at the North Carolina State University, and antibiotics to prevent and disrupt biofilms of clinically relevant bacteria. Dr. Clontz is co-founder of the Biofilm Networking Group, co-developer of the Contamination Control by Design (CCbD) concept, and member of the USP Pharmaceutical Waters Expert Committee (2005-2010) and Panel (2010-2015). 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 Masters 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. Dominique Leclercq is an Engineer specialized in Bio-Technologies and for more than 20 years he supplies equipments and consumables to Pharmaceutical Companies. In 2002 he started in Minntech/MarCor Purification and he is now responsible for Sales and Technical Support in Europe, India, Middle East and Africa.Dominique is specialized on filtration and biodecontamination and has lectured on Water Purification Systems and Clean Room Disinfection at seminars in Europe, at CPhI and recently at a private round seminar in different locations in China.Very technical oriented and working on the field he is also well aware about the pharmaceutical procedures and FDA / USP Requirements. Together with Pharma people he developed for instance the famous Minncare Dry Fog System as an innovative and unique airborne bio-decontamination system adapted to pharma aseptic areas. Madhu Raju Saghee is working in corporate quality department at Gland Pharma Limited, a producer of small volume parenterals located in Hyderabad, India. In this position, he is responsible for implementing a robust quality system, review of sterility assurance validation documents for all regulatory submissions, ensuring micro-compliance and involved in qualification and validation of sterile and aseptic manufacture for parenterals. He is a Microbiologist by education and a Quality Assurance & Regulatory Affairs specialist by training and experience. He has written many articles pertaining to regulatory compliance, quality assurance, quality risk management, cleanroom contamination control and microbiology. Raju is the co-editor of the book Microbiology and Sterility Assurance in Pharmaceuticals and Medical Devices He is the co-author of IDMAs technical monograph, Environmental Monitoring in Cleanrooms. Raju has a Master of Science in Microbiology from Andhra University and Master of Science in Chemistry from Nagarjuna University.
Microrite, Inc. 5019 New Trier Avenue + San Jose, CA 95136 + Ph: 408-445-0507 + Fax: 408-445-1236 w w w . m i c r o r i t e . c o m

Workshop Sponsors

Pacific BioLabs offers GLP/cGMP testing services to the biopharmaceutical, medical device, and combination product industries. PBLs services include General Toxicology, PK, Radiolabeled ADME, Potency Bioassays, Biocompatibility testing, Cleaning and Disinfection Validations and Sterility Assurance and Pharmaceutical Microbiology. We specialize in preclinical studies in support of FDA and international regulatory submissions. PBL is AAALAC accredited and ISO 9001 and 13485 certified. Pacific BioLabs has a 30-year history of serving companies worldwide. Our location in the San Francisco Bay Area is ideal for providing close support services to the many life sciences companies located nearby, yet we have the experience and capabilities to serve global companies. Our clients range from small biotech and medical device startups to Fortune 500 pharmaceutical giants.

Microremediz is a state-of-art Microbiological Public Testing Laboratory located at Thane, near Mumbai, Maharashtra, India. We specialize in microbiological testing and analyze products from a wide variety of industries. Our microbiological testing facility is designed in compliance with cGMP standards and comprises of a highly experienced team of microbiologists who are experts in testing ASTM, AOAC, AATCC, FDA, EPA, USDA, USP, CTFA, JIS, ISO and other methods of analysis. Our team of competent professionals has decades of experience in routine microbiological analysis, special microbiology, research microbiology, and a variety of other microbiological testing. Microremediz provides impeccable microbiological services to pharmaceutical, disinfectant, cosmetic, food, personal care, medical device, antimicrobial, paper and other miscellaneous industries. Quality - Our Commitment Microremediz is fully dedicated to its customers and determined to provide expert microbiological solutions, ensuring the delivery of an industry leading service to all its customers, and to follow the best professional practice around testing and consulting services.

Established in the year 2001, Filfab Corporation is a professionally managed trading company, having offices in Bombay and Jaipur. Filfab Corporation has entered into a Exclusive Business Arrangement with M/s MarCor Purification ,USA/Netherlands (www.mcpur.com) for marketing and re-selling their High Tech Disinfection Products and Technology to the Indian BioPharma Industry enabling the Indian industry to avail of the products of international standards. With this arrangement with MarCor , Filfab Corporation is in a position to supply their World Class Disinfectants Minncare & Actril and Dry Fog System in India. Filfab Corporation has been supplying these products to various Pharmaceutical Companies and Original Equipment Manufacturers of Highly Purified Water systems. In addition to this Filfab Corporation has entered into a Exclusive Business Arrangement with M/s Zeus Inc., USA (www.zeusinc.com) for marketing and re-selling their Fluoro-polymer tubes for Medical devices & Fluid extraction applications. Filfab has regional Sales Reps at various strategic locations in India which enables them to have quick access to important customers on Pan India basis.

Venue: Mirage Hotel

International Airport Approach Road, Marol, Andheri (E), Mumbai 400 059. Phone: +91-22-6672 1234 , +91-22-6672 1200 ;Email:res@miragehotel.in www.miragehotel.in The hotel is conveniently located in close proximity to Mumbai International Airport. Microrite has negotiated a rate of INR 5500.00 per night for the sleeping rooms.