VPT: Visible Particle Testing
A particulate reduction program that comprehensively addresses particulate matter risks with the aim of advancing discussions based on objective data rather than subjective risks.
Single-use systems (SUS) are increasingly being used in final filling, vaccine manufacturing, cell therapy, and gene therapy. Regulatory requirements regarding particulate matter are clear for final pharmaceuticals, but they are not clear for SUS used in the upstream processes of final pharmaceuticals. In 2016, Sartorius launched a particle reduction program to reduce uncertainty and minimize the risk of particulate matter contained in SUS being introduced into final pharmaceuticals. As a result of this initiative, the levels of particulate matter in SUS have visibly decreased.
basic information
▪ VDI (Visual Inspection) Inspection of visible defects, including visible particles, in all bag chambers. ▪ VPT (Particle Extraction and Measurement) Monitoring of visible particles on representative products using liquid extraction and microscopic counting. ▪ Lot-based VPT (Optional Service) Monitoring of visible particles extracted from actual manufacturing lots using liquid extraction and microscopic counting. VPT is just one step in Sartorius' particle reduction program. By monitoring events and trends over time, we can deepen our understanding of the sources and nature of particulate matter. Sartorius can embark on continuous improvement to reduce visible particle levels over time by combining other steps of the particle reduction program. VPT is one of the pillars to ensure consistency in quality between batches, leading to a reduction in risks related to patient safety. This new approach continues to support the use of SUS in critical applications.
Price range
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Applications/Examples of results
For more details, please refer to the PDF document or feel free to contact us.
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Notice of Participation and Seminar Presentation at the 31st Annual Meeting of the Japan PDA Pharmaceutical Sciences Society
This event has ended. We will be exhibiting and presenting at the 31st Annual Meeting of the Japan PDA Pharmaceutical Science Society, which will be held at Tower Hall Funabori on December 5th and 6th, 2024. In the luncheon seminar, we will introduce quality assurance for single-use products regarding foreign substances and our efforts towards sustainability. At our exhibition booth, we will showcase single-use and filter products, as well as validation services. Please stop by. 【Event Overview】 Date: December 5th (Thursday) - 6th (Friday), 2024 Location: Tower Hall Funabori, 4-1-1 Funabori, Edogawa-ku, Tokyo 134-0091 *Pre-registration required 【Our Seminar】 Title: Efficiency of Single-Use Products and Quality Assurance of Flexsafe Bags (Leak, E|L, Management of Foreign Substances) Seminar Date and Time: December 5th (Thursday) 12:45-13:45
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[Sending Recorded Video] Regarding the Final Filling Process in Compliance with the New EMA Annex 1 Guideline
Participation in this webinar has ended. If you wish to view it, please contact us. We will send you the URL for the recorded video at a later date. The revision of the EU GMP guidelines Annex 1 aims to deepen the relationship between Sartorius and our customers through mutual understanding of Quality Risk Management (QRM) and Contamination Control Strategy (CCS), while following its content. This time, we will particularly focus on the filling process and provide solutions using our products. [Seminar Overview] ▪ Date: February 8 (Thursday) at 15:00 (approximately 30 minutes) ▪ Method: Webinar recorded broadcast [Japanese, free of charge] *We kindly ask that participants refrain from joining with email addresses other than those from your own company or organization. Thank you for your understanding.
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"We will send you a recorded video" Single-use system compliant with the new EMA Annex 1 Guideline.
Participation in this webinar has ended. If you wish to view it, please contact us. We will send you the URL for the recorded video at a later date. We will introduce the content of the revised EU GMP Guidelines Annex 1. While reviewing this content, we aim to deepen the relationship between Sartorius and our customers through mutual understanding, particularly regarding Quality Risk Management (QRM) and Contamination Control Strategy (CCS). Additionally, we will provide information on Sartorius's sterilization validation and the latest information on Extractables and Leachables (E|L), which we hope you will find useful. [Seminar Overview] ▪ Date: December 7 (Thursday) at 3:00 PM (approximately 30 minutes) ▪ Format: Webinar recorded broadcast [Japanese, Free] *We sincerely apologize, but participation from companies in the same industry and email addresses other than those of your organization is not permitted. Thank you for your understanding.
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We will send you a recorded video regarding the integrity of single-use bags.
Participation in this webinar has ended. If you wish to view it, please contact us. We will send you the URL for the recorded video at a later date. Leaks are cited as one of the top three concerns regarding the use of single-use products. The rising cost of active pharmaceutical ingredients and the aspect of operational safety have also drawn attention to non-destructive testing before use. In this webinar, we will delve into Sartorius's concept of the integrity of single-use bags, focusing on pinhole size, water pressure, and intended use. 【Seminar Overview】 ▪ Date: February 2, 2023 (Thursday) from 3:00 PM (approximately 40 minutes) ▪ Method: Webinar recorded broadcast [Japanese, Free] If you are unable to participate on the day, please register first. We will send you the recorded video and a download URL for related product materials at a later date. *We apologize, but participation from other companies in the same industry and email addresses not associated with your organization is not permitted. Thank you for your understanding.
