Clipster^® Aseptic Point-of-Use Disconnectors Clipster^® is a single-use solution for disconnecting tubing at any stage in the process while maintaining sterility. Its unique design allows installation on assembled products. The Clipster^® is robust, quick and easy to use. Operators perform the disconnection with a handheld tool, ensuring quick and easy execution even in limited space. As Clipster^® is not in contact with any fluids, it can be easily validated.

Clipster® was designed to meet the demand for increased flexibility within disconnection operations in the biopharmaceutical industry. Clipster® can serve as validated backup for unplanned disconnections. Its simple 4-step process (without product contact) eases validation and supports disconnections from R&D up to commercial production scale.

Key Features

1. Point-of-Use Installation
   At any point during assembly and processing, an operator can aseptically disconnect units

2. 4-Step Operation
   Easy-to-use operation ensures quick, robust, and repeatable disconnection
3. Sterility Assurance
   Proven during validation with bacterial challenge via immersion in Bacillus astropheus at 106 CFU/mL

The Sartocheck® 5 Plus perfectly meets today’s key industry requirements for filter integrity testing in demanding GMP environments. By combining a unique approach to Quality Risk Management, with optimal data integrity, intuitive usability and minimized risk factors for Health, Safety and Environment (HSE), it sets a new standard for filter integrity testing devices.

The regulatory focus on QRM (cf. ICHQ9 and the new Annex 1 written by EMA in cooperation with the US-FDA, WHO and PICs) also applies to filter integrity testing, as a fundamental element of sterility assurance.

The Sartocheck® 5 Plus Filter Tester uses program specific parameters allowing the automatic identification of testing anomalies in advance or during the test. This avoids time-consuming and costly deviations, potential drug recalls and 483 warning letters.

The Fast, Flexible and Intelligent Single-Use Mixer for All Mixing Steps in cGMP Bioprocessing.

Quality and efficiency are critical when it comes to mixing operations in a bioprocessing environment, and the choice of mixing equipment can dramatically affect both. In fact, a fast and flexible single-use mixer can be a competitive advantage, helping manufacturers maximize throughput and increase production.

This is what 20 years in single-use fluid management has taught us — and what we heard from customers. The Flexsafe^® Pro Mixer was designed with those principles in mind.

With the flexibility to accommodate both low-shear and rapid-mixing applications, the Flexsafe^® Pro Mixer brings unique single-use technology to a wide range of mixing steps in upstream and downstream processes.

The Flexsafe^® Pro Mixer supports quality and efficiency by reducing the risk of operator error, allowing inline monitoring and control and protecting shear-sensitive products. These benefits, along with fast installation and easy setup, make the Flexsafe^® Pro Mixer a long-term investment with an immediate return.

Sartorius hollow fiber tangential flow filtration (TFF) modules provide high-performance separation in various upstream and downstream bioprocessing unit operations, including cell harvest, clarification, perfusion, diafiltration and concentration. They feature low binding modified polyethersulfone membranes (m-PES) that deliver consistently high process flux and product yields.

Available in three product lines, our hollow fiber (hollow fibre, HF) TFF modules have a small footprint and are easy to set up.

Sartorius hollow fiber (hollow fibre, HF) TFF modules are the ideal solution to save money, time and space. They come in a range of batch volumes, membrane surface areas and module diameters, which means they can provide a linear and predictive scale-up from laboratory to pilot-scale to manufacturing-scale by using matching materials, fluid-path length and performance characteristics.

Three different product lines are available to accommodate your specific process needs: the Single-use Line, the autoclavable Steamer Line, and the Re-use Line, which can be cleaned, stored and used repeatedly.

Key Features

•  Single-use and Re-use Line
• Pore size: 0.1 µm, 0.2 µm, 0.45 µm, 0.65 µm, 3 kD, 5 kD, 10 kD, 30 kD, 50 kD, 100 kD, 300 kD, 500 kD, 750 kD
• Fiber ID: 0.5 mm, 1.0 mm, 2.0 mm