Aseptic Connectors for Single-Use Filtration Systems

Filtration is the most commonly used technique for separating organic material and culture filtrate. In downstream processing, the filtration step separates solids, usually cells, from the liquid growth medium. Other forms of separation include centrifugation and flocculation. Sterile filtration is used at several stages of the harvest process and for the preparation of other processing fluids (purified water, buffers, sanitizing agents, etc.) Since single-use filtration systems can be automated easily, they are widely used by biomanufacturers around the world to enhance production efficiency and performance.

Sterile Filtration Process Basics

Sterile filtration is a method of separating suspended particles from a liquid or gas using porous medium which retain the particles but allows the liquid or gas to pass through. The solid particles deposited on the filter form a layer, which is known as Filter cake. All the solid particles from the feed are stopped by the cake and the cake grows at the rate at which particles are brought to its surface. All of the fluid goes through the cake and filter medium.

CPC Comes Through the Filter as a Winner

CPC’s biopharma technology experts understand the use of components in single-use filtration systems help manufacturers streamline the filtration process and get products to market faster. As a recognized leader in single-use connection technology, CPC offers a wide variety of solutions including sterile connects, sterile disconnects and AseptiQuik^® Connectors. Our innovative designs offer the flexibility to easily combine multiple components and systems to meet the needs of a broad range of filtration systems and processes.

The Role of Bioprocess Filtration

Filters perform a wide variety of functions in downstream processing—from harvest, clarification, buffer exchange, volume reduction to final sterile filtration. The first phase of downstream processing filtration often starts with centrifugation or primary filtration followed by secondary filtration before purification involving chromatography.

Types of Filters Used in Filtrations

Depth
Hollow Fiber
Absolute
Plate frame
Ultrafiltration/diafiltration
Tangential (TFF)
Surface
Centrifugal
Rotary drum
Vacuum
Membrane

From Traditional Filtration Systems to Single-Use Filtration Systems

Conventional bioprocessing facilities use replaceable filter elements in stainless steel filter housings that require setup, validation and post-production cleaning. Single-use components used with filter integrity test systems reduce the risk of contamination while improving process flexibility. Single-use components used in filtration and filter integrity testing include disposable capsule filters, bags, tubing, clamps and aseptic connectors. According to a survey by BioPlan Associates, a biotechnology and research firm, filters are one of the most popular single-use technologies, with 91% of companies currently using filter cartridge disposables.

CPC Aseptic Connectors: A Critical Sterile Filtration Component

CPC aseptic connectors are a vitally important interface between filtration components, providing quick and easy integration of filter subsystems into the complete bioproduction process. Bag systems with integrated capsule filters allow the media to be filtered into a sterile hold bag. Using valved CPC sterile disconnect couplings, the filter is then quickly and easily detached for post-filtration integrity testing. Lab technicians are able to remove the filter―without the risk of contaminating the media in the holding bag―and keep the filter wetted for integrity testing.

Versatility and Flexibility

CPC aseptic connectors provide flexibility for biopharmaceutical manufacturers to easily combine multiple components including process containers, tubing manifolds, filters, single-use and metal transfer lines, bioreactors and other bioprocess equipment. When changeovers need to occur, genderless CPC aseptic connectors make it easy to connect and disconnect components and processes. Multiple termination options meet today’s mounting and flow requirements.

Innovative Design

Our team of biopharma design and application engineers develop innovative, high-quality products that make filtration media transfer safe and easy. Single-use filtration systems and processes differ widely, and CPC’s comprehensive portfolio of aseptic connectors meet the need for a wide variety of sizes, configurations, termination options and materials. Innovative connection methods help eliminate contamination risk and ensure connection assurance.

Trusted Reliability

CPC sterile connectors are engineered for upstream and downstream applications including sterile filtration. By helping maintain aseptic transfer of media, CPC sterile connectors facilitate reaching the best cell yields at a cost-effective price. All CPC aseptic connection solutions are rigorously tested ─ including materials testing, product testing and torture testing to failure ─ to meet product specifications. As a matter of fact, CPC offers reliable, reproducible performance and provides validation and extractable reports that support the performance attributes.

Overall Robustness

CPC aseptic connectors deliver optimized flowrates with excellent flow to size ratio for superior performance to manage the media transfer and flow required during various filtration stages. CPC purpose-built connectors are designed to be compatible with the wide variety of sterile filtration systems, media chemicals and processes. We provide a unique combination of industry expertise with the broadest portfolio of products including sterile connects, sterile disconnects, SIP connections and quick connects.

Sterility Assurance

Increased cell densities and product diversity is driving manufacturers to design their facilities for shorter production runs with multiple changeovers. Single-use bags and transfer lines use CPC MPC or MPX Connections and SaniQuik^™ Adaptors for quick changeovers. Robust and easy-to-use, single-use, aseptic connectors from CPC maintain flow path sterility and integrity while enabling biopharmaceutical manufacturers to use the necessary sterile filtration processes and systems to improve cell yields and reduce costs.

Assurance of Supply

CPC has a proven track record of providing products consistently under their stated specifications and quality requirements through having a strong supply assurance program. The program includes control of the manufacturing process from raw materials to final product manufacturing. Investments in extra capacity and redundant manufacturing ensure capacity before it’s too late. Biopharma customers have confidence in CPC’s ability to fulfill demand acquired by a track record of accurate lead times, identifying and communicating potential delays and, most importantly, by sound supply chain management.

Sterile Connectors

Easy-to-use AseptiQuik® and MicroCNX® Connectors provide quick and sterile connections, even in non-sterile environments—a critical capability for your biopharmaceutical manufacturing.

Sterile Disconnectors

With an easy push of the connector thumb latch, our sterile disconnectors maintain sterility on both sides of the system during disconnection.

Sterile Combination Connectors

Be assured of both a sterile connect and sterile disconnect with our all-in-one, single-use AseptiQuik® DC connection technology.

Open Format Connectors

Transfer media quickly and easily between single-use bag systems, tube sets and stainless process equipment.

Steam-In-Place (SIP) Connectors

Steam-Thru® single-use SIP design saves time and money by eliminating cleaning validation concerns.

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Bioprocess Filtration