Contamination Risk Assessment in Aseptic, Non-Sterile and Terminally Sterilized Products March 7 th & 8 th Raleigh, NC

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Jeremy Briggs
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Contamination Risk Assessment in Aseptic, Non-Sterile and Terminally Sterilized Products March 7 th & 8 th Raleigh, NC Contamination risk levels differ in aseptic, and non-sterile and terminally

1 Contamination Risk Assessment in Aseptic, Non-Sterile and Terminally Sterilized Products March 7 th & 8 th Raleigh, NC Contamination risk levels differ in aseptic, and non-sterile and terminally sterilized products. Within the non-sterile products risk levels vary per mode of administration. In terminally sterilized products, contamination for a terminally sterilized medical device may differ from a terminally sterilized drug product. Contamination risk in a non-sterile drug product may be different for a healthy patient as compared to an immunocompromised patient or children. Contamination risk assessment initially begins with understanding the nature of a product, release specifications and which organisms are objectionable. In some medical device manufacturing, particulate contamination could also be objectionable because of the electronics involved. The manufacturing facility is designed to mitigate and reduce contamination risks. Facility controls vary depending upon final product requirements. Contamination may also result due to inadequate cleanroom/rabs/isolator/design and maintenance. Similarly, if a risk based approach is not adopted right from the beginning, contamination risks can occur due to utilities, raw materials, excipients, process and also inadequate testing. With ICH Q9, Q10, ISO and EU all aligned on a risk based approach; it is time to explore performing a real risk assessment to control contamination in your product. In this two day workshop, Microrite experts will address how to perform contamination risk assessment in sterile, various non-sterile and terminally sterilized drugs and devices. Which industries does this workshop apply to? Pharmaceuticals, Biotechnology, Medical Device, and In Vitro Diagnostics, Nutraceuticals and Pharmacies Who will benefit? QC Microbiologists, Manufacturing, Quality Assurance, Validation, Facilities and Training

2 Overview Cleanroom Requirements for Aseptic Facilities Discussion of the various guidances on facility design and operations for aseptic facilities Misunderstandings in interpretation of these guidances and standards Common errors in airflows and airflow pattern analysis Barrier systems Commonly observed deficiencies in barrier systems such as open/closed RABs and Isolators that can lead to contamination Understanding airflows and contamination risks when operating in RABs and Isolators Why airflows adequate during certification testing, but environmental monitoring, media fill and batch failures are persistent Understand the sources of EM excursions in RABs or ISO 5/7 or Grade A/B areas Risk Based Monitoring of Aseptic Facilities-A Paradigm Shift Monitoring of Cleanrooms for Aseptically manufactured products-what you should know and understand before and after qualification Discrepancies between standards and guidances for monitoring aseptic environments Choice of equipment-what you should know o Non-Viable particle monitoring o Viable particle monitoring Learn about the design of monitoring equipment to avoid errors Common errors companies make during choice and set up of monitoring devices Cleanroom Requirements for Manufacture of Terminally Sterilized Drugs and Devices Depending upon the process, pre-sterilization bioburden and the method of sterilization, facility requirements may vary Though strict facility controls and barrier systems may not be required for such products, performing a risk assessment is the correct choice when designing facilities for manufacture or terminally sterilized products Discussion of cleanroom guidances and standards pertinent for terminally sterilized products How should facilities with relatively low contamination risk be maintained Risk Based Monitoring for Terminally Sterilized Products Discussion of standards for monitoring of facilities making terminally sterilized products How to set limits as such standards do not have limits for viable particles Performing risk assessment to select sites, importance of trending organisms that may be difficult to sterilize Facility Controls for Non-Sterile Products Level for allowable bioburden in non-sterile product varies; though some products may require limited facility controls, others need considerable controls Adopting a risk based approach using the product s inherent anti-microbial properties, facility costs may be reduced How should such moderately to minimally controlled environments be maintained Discussion on guidances related to non-sterile facilities, especially oral dosage forms Risk Based Monitoring for Non-Sterile Products Non-viable particulates may not be a concern in non-sterile products, once classified facilities should be monitored to meet class requirements Monitoring for viable organisms is critical in all non-sterile facilities, with special attention on those objectionable in the product via mode of administration Learn how to set up a risk based EM program considering that product bioburden cannot exceed specifications and the product is void of objectionable microorganisms Discussion on how to use product characteristics to adjust frequency of monitoring

3 Overview Continued Water Quality Risk Assessment Learn how to perform risk assessment for quality of water used for process, equipment cleaning and cleaning of facilities depending upon the final product release criteria Learn how to choose which ports to test at what frequency to avoid onerous sampling while evaluating water quality consistently Asses water quality risk by understanding biofilm formation and endotoxins Assessing Risk of Added Gases Understand the contamination risks that each type of process gas poses to product Depending upon the risk, develop a monitoring program; evaluate the risk of aerobes and anaerobes Evaluate contamination risk of anaerobes and document rationale when anaerobes are not tested Gowning requirements for Aseptic, Non-Sterile and Terminally Sterilized Products Understanding garment/supplier selection as well as garment cleaning, sterilization and testing Develop a risk based gowning program Learn about the various standards that gown suppliers are required to adhere to Audit and conduct surveillance according to these standards Gown qualify and monitor gowning practices of personnel to protect product Process Risk Assessment In aseptic operation; every equipment setup, assembly, adjustment, operation, aseptic connections, interventions and environmental monitoring is a contamination risk Learn how to identify and mitigate risk In terminally sterilized product, contamination risk exists due to predominance of certain microorganism, inadequate facility controls and maintenance, and microbial quality of materials and components In non-sterile products contamination risk during processing is critical as well as microbial reduction methods should be a part of process risk assessment Learn about the critical control points in each type of product by understanding where and how contamination can enter and proliferate Understand what level of contamination can be allowed in what step of the process and is contamination reduction strategies such as cleaning, cleaning validation, sterile filtration, or drying are adequate for the level of risk. Assessing Risk during testing False positive and false negative laboratory testing results can lead to loss of product or risk to patient Learn how to perform risk assessment in laboratory operations and testing: o Media o Test methods o Method validation o Laboratory facilities o Proficiency

4 PROGRAM March 7 th & 8 th B-Tec Golden LEAF BTEC 850 Oval Drive, Suite 195 Raleigh, NC (919) Day 1 Agenda Registration and fast Cleanroom Requirements for Aseptic Facilities & Risk Based Monitoring of Aseptic Facilities-A Paradigm Shift Cleanroom Requirements for Manufacture of Terminally Sterilized Drugs and Devices & Risk Based Monitoring for Terminally Sterilized Products Lunch Facility Controls for Non-Sterile Products Risk Based Monitoring for Non-Sterile Products Questions and answers Day 2 Agenda fast Water Quality Risk Assessment & Assessing Risk of Added Gases Gowning requirements for Aseptic, Non-Sterile and Terminally Sterilized Products Lunch Process Risk Assessment Assessing Risk during testing Questions and answers and discussions 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 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

5 REGISTRATION FORM Personal Information of One Registrant Last Name: Mr. Ms. Dr. First Name: Job Title: Organization: Mailing Address: Telephone: Fee: $ per attendee (Includes 2 day workshop fee, breakfast, lunch, break, 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 workshop date. If you have any questions regarding payment methods feel free to contact Microrite at or send your enquiry to labraham@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. Workshop cancellation must be received 10 business days prior to the workshop less a 10% service fee, cancellation requests will be accepted via only. The organizations primary contact or credit card holder must make all refund requests. Refunds will be credited to the original credit card used to purchase the workshop..

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/State: Zip Code: Country: Contact Ph No & Card Number: Expiration(Month/Year): 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 About the Presenter Ziva Abraham is the President and Founder of Microrite, Inc., a California based consulting firm providing consulting and training services to pharmaceuticals, biotechnology, medical devices and in vitro diagnostics in the areas of quality assurance, quality control, microbiology, and validation. Ziva has over 25 years of academic, research, clinical and industrial experience in microbiology, and quality assurance. Ziva has received her Master s Degree in microbiology with a focus on Mycology and has conducted research on developing microbial Insecticides using entomogenous bacteria and fungi. Her career also includes founding and managing clinical laboratories for Maccabi Medical in Israel. She has trained personnel from various industries in microbiology techniques and methods. She uses her extensive experience to teach why assessing risk of microbial contamination should be in the forefront of any company that has products for human/veterinary use. Her experience in clinical laboratories has provided her with the framework to understand the effects of microbial contamination in products from a patient safety perspective. Morgan Polen has been involved with cleanrooms and contamination control since He has Worked in over 40 countries involved with projects ranging from cleanroom design, construction, validation, monitoring program development, particle counter design and product management for cleanroom related products and systems. He has addressed monitoring and control solutions in a wide variety of clean industries such as pharmaceutical, medical device, semiconductor, data storage, aerospace, defense, automotive, optical and others. Company Microrite s goal is to provide practical solutions through consulting and training Consulting Services Microrite is a San Jose, CA based Consulting Company helping Pharmaceuticals, Biotechnology, Medical Devices, In-Vitro Diagnostics and Combination products in the areas of Quality Assurance, Microbiology, Process Development, Process Validation, Facility and Utility Validation Visit to learn more about us

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