Single-use systems are increasingly popular in biomanufacturing. Their adoption offers numerous advantages for greater efficiency and productivity in applications such as final filtration, mixing and aseptic connections.
Safe and efficient transportation of your large bulk liquid substances is critical. These liquids could include sterile water, buffers, media, intermediates, bulk drug substances and final drug products. Therefore, we completed an extensive ISTA shipping validation to provide the safest transportation for your critical bulk liquids.
Single-use technologies are increasingly being incorporated into the biomanufacturing workflow to achieve greater efficiency and productivity, reduce capital investment in facilities and equipment, and minimize the risk of cross-contamination.
The Ultimus® Film Difference Designed with a proprietary woven nylon structure, Ultimus® film demonstrates superior strength and resilience to protect against leaks, abrasions, tears and material fatigue.
PureFlex™ film is used to construct our Mobius® single-use assemblies and Novaseptum® sampling bags. These single-use products are used in biopharmaceutical processes, improving efficiency and productivity while reducing the risk of contamination.
Ultimus® film was designed to meet the needs of more challenging single-use applications such as large-volume liquid processing. Our Ultimus® film technology provides enhanced bag strength, improved durability and leak resistance through a novel strength layer reinforced by woven nylon.
The successful adoption of single-use technologies in a biopharmaceutical process largely relies on confidently selecting the right components for use in the fluid path of a product, within a specific process. An important step in choosing such components requires generating an extractables profile, which can be done by carefully selecting the solvent streams and extraction conditions to model the product and process steps complemented with the right analytical strategy.
This webinar will give an overview of the E&L evaluation workflow and practical study approaches from both supplier and end-user perspective, in accordance with the latest industry’s standards and upcoming USP <665> requirements. Case studies will be presented on how the data from suppliers are used to mitigate risk associated to SU materials, highlighting the key role of collaboration between the supplier and the drug manufacturer.
Biopharmaceutical manufacturing capacities have expanded dramatically which has resulted in an increased demand for single-use systems (SUS) as they have their own advantages. Although SUS are well established in the biopharmaceutical industry there is limited guidance on regulatory expectations. During this webinar we will focus on points to consider assuring sterility and integrity of a single-use assembly, and how collaboration between supplier and end-user can support the overall contamination control strategy of final filtration and filling operation.
A successful adoption of single use technology in a Biopharmaceutical process largely relies on the confidence in selection of such materials. Understanding the regulatory and industry expectations are important to streamline the implementation and approval process.
Single-use plastic systems are being utilized more frequently especially for COVID-19 vaccine manufacturing. However, there are issues regarding standardization of quality information that limits implementation efficiencies. One of the challenges is the evaluation of leachables derived from a variety of different plastic components in a timely manner.
This webinar will give an overview of the E&L evaluation workflow and practical study approaches from both supplier and end-user perspective, in accordance with the latest industry’s standards and upcoming USP <665> requirements. Case studies will be presented on how the data from suppliers are used to mitigate risk associated to SU materials, highlighting the key role of collaboration between the supplier and the drug manufacturer.
A Single-Use System (SUS) is typically designed for a specific process step. In many cases, single-use components are chosen based on their functionality. The challenge arises when there are multiple processing steps- as the different applications and product matrices are evaluated, the complexity of the risk assessment increases. Complexity includes component evaluation, process conditions, and model solvents streams which ultimately relates to the patient safety risk.
The successful adoption of single-use technologies in a biopharmaceutical process largely relies on confidently selecting the right components for use in the fluid path of a product, within a specific process. An important step in choosing such components requires generating an extractables profile, which can be done by carefully selecting the solvent streams and extraction conditions to model the product and process steps complemented with the right analytical strategy.
