# Event Details - **Event Name**: Aseptic Processing in the Manufacture of Biotech and Pharmaceutical Products - **Event Start and End Date**: Fri, 20 Feb, 2026 at 11:00 am – Fri, 20 Feb, 2026 at 05:00 pm - **Event Description**: For Agenda & Event Registration Visit: https://www.complianceonline.com/aseptic-processing-in-manufacture-of-biotech-and-pharmaceutical-products-seminar-training-80667SEM-prdsm?channel=alleventsUse coupon COMPLIANCE15 to get 15% discount on this virtual seminarAfter registration ComplianceOnline customer care will contact you on a day before the event with event link and proceedingsSterile products may be broadly classified into two main categories based on their production mode -- those that are terminally sterilized following the filling and sealing of the container and those that are aseptically sterilized, that is, filter sterilized as a bulk product, filled, and then sealed. Aseptic Processing play a critical role with large molecules that cannot be terminally sterilized. The verification of the process to produce sterile product is evaluated through the demonstration of various media fill process simulations that will vary in both numbers and size of the containers as well as the volumes filled over a defined period. The FDA and EMA require that any product that may be terminally sterilized be managed in that fashion. However, almost all large molecules and some small molecules can only be sterilized by aseptic processes, i.e., membrane filtration.With membrane filtration, it is essential to establish acceptable levels of microbiological contamination to ensure both product safety and compliance. Meeting sterility claims for Phase 1, 2, 3 and commercial products in a timely and effective manner is important in avoiding costly delays. In addition, since aseptic processes are associated with endotoxin control, it too, must be managed to acceptable levels.  The objective of this live, interactive training seminar is to explore the role of aseptic filling to assure that manufactured product will retain the sterility assurance level prescribed by GMPs. It will review the issues regarding preparing media and setting up the “filtration train”, environmental monitoring, interruptions that may occur during the operation of the Clean Room (planned and unplanned) and the cleaning of the room and its equipment. Equipment used to monitor the equipment and personnel will also be reviewed along with gowning issues that periodically arise. The seminar will also discuss media failures and how to “work through” them. Because of the sensitivity and importance of media fills, this live, interactive training seminar is a MUST for anyone in your organization that is involved in aseptic filling in general and media fills in particular. Please plan to attend this as part of an interactive group project.Learning Objectives:Seminar participants will learn the following:Gain an understanding of the fundamental principles and skills necessary to conduct Aseptic Processing of Sterile Drug Products with minimum riskAnalyze issues impacting Aseptic Processing to include the environment, personnel, gowning and sanitizationAcquire the skills necessary to control the process environmentMinimize media fill failures to permit production throughputDetermine how to develop media fill simulations to include the "worst case" scenariosLearn best practice techniques for determining media fill sizesUnderstand the "critical factors" required to maintain complianceDecrease inspectional observationsAvoid Warning Letters and Consent DecreesWho will Benefit:Aseptic ProcessingManufacturingQuality ControlQuality AssuranceRegulatory ComplianceMicrobiologyValidationProject Management - **Event URL**: https://allevents.in/sunnyvale/aseptic-processing-in-the-manufacture-of-biotech-and-pharmaceutical-products/80001937742313 - **Event Categories**: workshops, meetups, nonprofit - **Interested Audience**: - total_interested_count: 0 ## Ticket Details - **Ticket URL**: https://www.complianceonline.com/aseptic-processing-in-manufacture-of-biotech-and-pharmaceutical-products-seminar-training-80667SEM-prdsm?channel=allevents ## Event venue details - **city**: Sunnyvale - **state**: CA - **country**: United States - **location**: MetricStream Inc. - **lat**: 37.4180315 - **long**: -121.9791885 - **full address**: MetricStream Inc., 6201 America Center Dr, Sunnyvale, CA 94089, United States ## Event Organizer details - **affiliate_id**: 8 - **organizer**: ComplianceOnline (https://allevents.in/org/complianceonline/12919563) ## Event gallery - **Alt text**: banner - **Image URL**: https://cdn2.allevents.in/thumbs/thumb6942954a51686.jpg - **Alt text**: thumbnail - **Image URL**: https://dyn-image.allevents.in/generate-image?v=4&title=Aseptic+Processing+in+the+Manufacture+of+Biotech+and+Pharmaceutical+Products&date=20+Feb ## FAQs - **Q**: When is the event happening? - **A:** Fri, 20 Feb, 2026 at 11:00 am - **Q**: Where is the event happening? - **A:** MetricStream Inc., 6201 America Center Dr, Sunnyvale, CA 94089, United States - **Q**: Who is organizing the event? - **A:** ComplianceOnline - **Q**: What type of event is this? - **A:** workshops, meetups, nonprofit - **Q**: Where can I find ticket details about Aseptic Processing in the Manufacture of Biotech and Pharmaceutical Products ? - **A:** You can find ticket details about this event on AllEvents. ## Structured Data (JSON-LD) ```json [ { "@context": "https://schema.org", "@type": "Event", "name": "Aseptic Processing in the Manufacture of Biotech and Pharmaceutical Products", "image": "https://cdn2.allevents.in/thumbs/thumb6942954a51686.jpg", "startDate": "2026-02-20", "endDate": "2026-02-20", "url": "https://allevents.in/sunnyvale/aseptic-processing-in-the-manufacture-of-biotech-and-pharmaceutical-products/80001937742313", "location": { "@type": "Place", "name": "MetricStream Inc.", "address": { "@type": "PostalAddress", "streetAddress": "6201 America Center Dr, Sunnyvale, CA 94089, United States", "postalCode": "94089", "addressLocality": "Sunnyvale", "addressRegion": "CA", "addressCountry": "US" }, "geo": { "@type": "GeoCoordinates", "latitude": "37.4180315", "longitude": "-121.9791885" } }, "eventAttendanceMode": "https://schema.org/OfflineEventAttendanceMode", "description": "For Agenda & Event Registration Visit: https://www.complianceonline.com/aseptic-processing-in-manufacture-of-biotech-and-pharmaceutical-products-seminar-training-80667SEM-prdsm?channel=alleventsUse coupon COMPLIANCE15 to get 15% discount on this virtual seminarAfter registration ComplianceOnline", "organizer": [ { "@type": "Organization", "name": "ComplianceOnline", "url": "https://allevents.in/org/complianceonline/12919563", "description": "At ComplianceOnline, we are focused on:\nEnhancing global compliance, creating a world where quality and compliance professionals, regulators, and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates, ensuring continuous improvement in global operations, quality & safety.\n\nMaking sure that we are responsible corporate citizens helping our constituents build a more responsible enterprise, one which operates with high quality , under a code of ethics, and with process discipline to ensure greater shareholder returns.\n\nKeeping things simple and straight forward , so that we all can indeed improve the quality of our processes, our work, our businesses and enhance compliance globally.\n\nBeing inclusive, giving the process experts ( & novices! ), compliance professionals, quality champions, and regulatory agencies a voice so that all of us can contribute and make a difference." } ] } ] ```