Disinfectant Qualification and Cleanroom Disinfection A Step by Step Workshop

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1 Microrite, Inc. brings you this unique advanced course in ; part of Microrite s Step by Step Workshop Series Participate in the only workshop which will guide you through the process of choosing a cost effective and compliant disinfectant qualification method, which suites your company budget, personnel availability, urgency and time limit Also learn how to plan study execution schedule and supplies, how to budget costs, and how to execute each step and assess errors that may occur This workshop will also cover data analysis, establishing expiry dates for diluted and undiluted disinfectants and how to apply the findings to the cleaning procedures Do not miss this opportunity if planning a disinfectant qualification study or have performed one and wish to verify it Learn from the case studies presented at this workshop. Also learn the basics about creating biofilms and testing biofilms against different disinfectants in laboratory setting. In designing a disinfection programs, how to meet the three main objectives (ESS): Efficacy, Safety and Savings is the key. Which industries does this seminar apply to? Industries that will benefit from this training are Pharmaceuticals, Biotechnology, Medical Device, and In Vitro Diagnostics Who will benefit? Microbiologists performing, and reviewing Disinfectant Qualification Studies, Quality Assurance, Facilities, Regulatory, Training and Manufacturing personnel

2 DAY 1 Disinfectants commonly used in the industry, their modes of action, efficacy, and toxicity Understanding the nature of contaminants in the cleanroom and which disinfectants will be effective against them Overview of the many methods and variations used for disinfectant qualifications o Tube dilution method Using filtration Using neutralizing broth o Representative Hard Surfaces Using contact plates Using Swab Recovery Method Using Rinse Method Using Neutralizing Broth Using Sonication Discussions on the variants of each of the methods and the benefits and shortcomings of each method Discussion on the pitfalls expected when choosing each method available Disinfectant Qualification Protocol o Guidance on drafting a Disinfectant Study Protocol for each of the methods discussed Planning the Study-Scheduling and Costs o Using planning templates, guidance will be provided for breaking up the study components to manage scheduling, costing and ordering supplies to avoid waste due to expiry of media and buffers Managing personnel o Planning each section of protocol for execution o Planning of daily activities while maximizing testing Method Validation for Bacteria and Fungi o How to validate each method o What to look for as acceptance criteria Recovery Study o Guidance on how to perform swabbing studies to get maximum recovery o How to plan a recovery study for various methods of efficacy testing o Understand the facts and myths about recoveries Efficacy Testing o Points to consider when planning an efficacy study o How to mitigate inoculum count drop o Application of inoculum and disinfectants-what to pay attention to o Log reduction calculation

3 DAY 2 Time 0 Verification o Understand why this additional step gives more confidence in the data generated from the efficacy study Expiry Dating Study for Disinfectants o How to review efficacy data to abbreviate expiry study which will generate dependable results for assigning expiry date for pre-diluted disinfectants and concentrated disinfectants that do not have an expiry assigned by the manufacturer Log Reduction Calculation o Data analysis o Common errors o Detecting false positive or false negative log values Reviewing Data o How to identify execution errors when reviewing data. Establish and Implement corrective actions Overview of testing disinfectants using biofilms Translation of disinfectant qualification results to cleaning procedures to prevent contamination o Cleaning procedures-what should be addressed o Importance of cleanroom cleaning supplies controlling contamination Commonly observed deficiencies in Disinfectant Qualification studies that may lead to contamination or FDA observations Cleanroom Disinfection Clean room disinfection is very critical for pharmaceutical industries. Different chemicals and procedures are used for getting the rooms classified according to specific guidelines. In designing a disinfection programs, it is trying meeting 3 objectives (ESS): Efficacy, Safety and Savings. Potentially more effective than a simple sporicide according to USP<1072> definitions, the use of a Cold Sterilant to disinfect surfaces in clean rooms definitely meets the 3 ESS objectives and even more Definitions and Guidelines about bio-decontamination of surfaces in pharmaceutical aseptic rooms Available biocide technologies, strengths and weaknesses Cold Sterilant: Development about the H202/Peracetic Acid technology Strengths and weakness How to use HP/PAA in pharmaceutical production areas: - Daily and Periodic disinfections - Manual and automatic airborne bio-decontamination Let s learn from European success stories

4 Day 1 (September 19 th, 2013) Registration and fast Overview of Disinfectants Overview of Methods Lunch VENUE AND CONFERENCE AGENDA Castleknock Hotel & Country Club September 19 th & 20 th,2013 Porterstown Road Castleknock Dublin 15 Telephone : +353 (0) Planning the Study and Study Details Common errors in performing disinfectant qualification studies Questions and Answers Day 2 (September 20 th, 2013) fast Data review to understand study execution errors-discussion Cleaning procedures-importance of cleaning supplies Questions and Answers Lunch Achieving EES in cleanroom disinfection Creating and testing Biofilms against disinfectants FDA 483 Observations Questions and Answers-Group discussion PROGRAM 8.00 AM to 8.30 AM 8.30 AM to AM AM to AM AM to AM PM to 1.00 PM 1.00 PM to 3.00 PM 3.00 PM to 3.15 PM 3.15 PM to 4.15 PM 4.15 PM to 5.00 PM 8.00 AM to 8.30 AM 8.30 AM to AM AM to AM AM to PM 11.45AM to PM PM to 1.00 PM 1.00 PM to 3.00 PM 3.00 PM to 3.15 PM 3.15 PM to 3.45 PM 3.45 PM to 4.15 PM 4.15 PM to 5.00 PM Castleknock Hotel & Country Club Dublin, a part of FBD Hotels & Resorts is an award winning 4 star hotel in Dublin specializing in conferences, weddings and leisure breaks. Walking through the hotel you will sense a range of styles from the ultra-hip to the elegant and classic. Its unique idyllic setting creates the allure of a country resort yet the hotel is located just 15 minutes from Dublin city center and close to Dublin Zoo, the Guinness Storehouse and Blanchardstown Shopping Centre

5 REGISTRATION FORM 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 all days, and course material) Additional Attendees 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 seminar 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. Hotel Accommodation Limited Sleeping rooms available. Mention Microrite s Room Block ID when booking sleeping rooms Castleknock Hotel, Porterstown Road, Castleknock, Dublin 15 Telephone : +353 (0)

6 PAYMENT INFORMATION Choose One (Place X) VISA Master Card American Express Card Holder s Name Address of Card Holder: Enter firm address for corporate card or personal address for personal card 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 workshop. We would like to thank them..

7 Our presenters are experts in the field of disinfectants and disinfect qualification and passionate about teaching! Ziva Abraham has over 25 years of academic, research, clinical and industrial experience in Microbiology, and Quality Assurance. She has established clinical laboratory systems in Israel, and Microrite, Inc. a consulting company based in San Jose, CA that helps pharmaceutical, medical device, and biotechnology companies in the areas of microbiological contamination control, quality assurance and validation. She has trained personnel from various industries in microbiology techniques and methods. She has also trained microbiologists in hands on fungal identification and disinfectant qualification for well over 10 years. Her in depth understanding of the clinical implications of the microorganisms isolated in cleanroom environment has enabled her to look at disinfection and disinfectant qualification as means of keeping the patient safe instead of just an exercise. Ziva has received her Master s Degree in Microbiology and has conducted research on developing microbial insecticides using entomogenous fungi and bacteria. She is a mentor for graduate students and a supporter of science education for young female students through her participation in American Women in Science, Math and Science Network and Expanding Your Horizons. 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..