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A particulate reduction program that comprehensively addresses particulate matter risks with the aim of advancing discussions based on objective data rather than subjective risks.

▪ 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.

Please check the Japanese version catalog for a significant increase in operability and stirring power!

<Features> ▪ Providing unprecedented performance and quality assurance ▪ Control over the entire manufacturing process ▪ Quality assurance for fluid contact components ▪ Validation and quality assurance ▪ Guaranteeing the integrity of container closures ▪ Safe and reliable handling and shipping solutions from 5L to 500L ▪ Safe, self-expanding robust solutions

Filtration, storage, and transportation in all process stages. Take Your Facility Into The Future.

By downloading the PDF, you can view the following information regarding Flexsafe 2D and 3D: 2D media preparation 3D media filtration, storage, and transportation 2D buffer preparation 3D buffer filtration, storage, and transportation 2D cell harvest and downstream intermediates 3D cell harvest and downstream intermediates filtration, storage, and transportation 2D active pharmaceutical ingredient 3D active pharmaceutical ingredient filtration, storage, and transportation 2D formulation adjustment 3D formulation filtration, storage, and filling

Specifically developed to meet the various application requirements of fluid management in the biopharmaceutical industry.

Please check the details in the related catalog.

Freeze-thaw solutions for seamless scalability to commercial production.

▪ Celsius CFT End-to-End Platform Celsius CFT (Controlled Freeze & Thaw) is a freezing and thawing system using plates with controlled freezing rates. It is a fully integrated end-to-end freezing and thawing solution that minimizes low-temperature concentration while reducing risks by minimizing the handling of active pharmaceutical ingredients. ▪ Celsius FFT: Stackable Freezing Container to Simplify Operations Celsius FFT (Flexible Freeze and Thaw) is a sterilized, pre-assembled freezing container that is ready for immediate use, featuring a unique bag-in-shell system that operates seamlessly within any conventional or blast freezer. ▪ Celsius FFTp: Single-Use Container Designed for Horizontal Plate Freezers Celsius FFTp (Flexible Freeze and Thaw for Plate Freezers) offers a unique bag-in-shell system while featuring a flat and more compact design that fits perfectly on the surface of horizontal plate freezers.

A robust, complete, and scalable solution for frozen storage and frozen transportation.

【Robustness confirmed down to -70℃】 ▪ A single-use freezing and thawing platform designed to maximize safety throughout the product lifecycle. ▪ Proven freezing and thawing performance protected by structural containers and complete logistics, with the S71 single-use bag validated through extensive low-temperature functionality qualification. ▪ The highest level of robustness enabling the frozen transport of expensive active pharmaceutical ingredients worldwide, validated according to ASTM D4169 Guarantee Level 1 (AL1). 【Meeting customers' needs for frozen storage and transfer】 Celsius PDS offers a range of general S71 films and all types of single-use containers that can be selected and scaled according to the process, from process development to clinical and commercial production. The feasibility can be easily assessed with process development tools.

Smart condition setting, a genuine end-to-end integrated freeze-thaw system.

Make smart decisions with Celsius Lab Scale Solutions ▪ Compatibility Create models that accurately simulate the temperature profiles of various freeze/thaw technologies. ▪ Scalability Use the same relevant materials for all Celsius commercial scale solutions (Celsius CFT, FFT, FFTp) to ensure reproducible freeze/thaw conditions. ▪ Versatile environmental settings The Celsius platform enables rapid, economical, and adaptable frozen transport for process development through diverse solutions.