Parker Hannifin
Engineering Your Success

Single-Use Systems for Bioprocessing and BioPharma
Single-Use Systems for Bioprocessing and BioPharma
Parker’s single-use systems (SUS) are polymer-based, fluid management solutions designed to be used once in bioprocessing and biopharma production, manufacturing, transportation, and dispensing. We have off-the-shelf and custom single-use solutions for process development; research and development; upstream bioprocessing; downstream bioprocessing; bulk filtration and dispensing; and cold chain transportation down to -85 degrees Celsius.
We manufacture our single-use solutions in cleanrooms globally and can provide custom solutions to meet your filling station requirements. Let us help you create a flexible efficient process by collaborating with us on your current filling station design. And, we can develop a custom single-use solutions to meet your station requirements. With open architecture, flexible processing designs, and patented cold-chain transportation technology our single-use systems are used in the production and transportation of the COVID-19 vaccine around the world.
SUS Applications & Processing Benefits
Our single-use systems are used in bioprocessing storage, sampling, and fill-finish applications for:
  • Vaccines
  • Antibodies
  • Therapeutics (Proteins, etc.)
  • Gene and Cell Therapies
With open architecture and flexible processing designs, our single-use systems are being used in the production and transportation of the COVID-19 vaccine around the world.
No Limits with Open Architecture
We provide the basis for a wide variety of customized solutions in upstream and downstream processes. By enabling the integration of your previously validated components such as tubing, our open architecture significantly helps reduce overall system costs.
Greater Processing Flexibility
Speed is everything – especially in today’s world when vaccines may be needed in unprecedented time. With Parker single-use systems, you’re able to interchange our SUS with your existing filling stations without redesigning your station. Our bottles are compatible with AdvantaPure and Merck Millipore filling stations. This enables you to start with any cleanroom or bioprocessing suite and ramp up trials and production quickly – while using your existing stations or working with our application engineers to design a solution to fit your needs. 
SUS vs. Reused Stainless Steel
When you need rapid implementation and zero tolerance for cross contamination, SUS are the way to go. Avoid weeks of cleaning, sterilizing and validation by switching to single-use systems that come sterile and ready-to-use. There are huge cost savings from reduced facility space to labor costs to processing time by using single-use systems. Talk with one of our experts to explore your potential cost savings.
BioPharm Process
RESEARCH AND DEVELOPMENT & PROCESS DEVELOPMENT
  • Protect Bioreactor sterility with flexible systems
  • Automate, control and enclose bioreactor additions
UPSTREAM PROCESSING
  • Reduce time during development
  • Avoid errors in process scale-up
  • Eliminate product contamination from the very start
DOWNSTREAM PROCESSING
  • Eliminate risk of contamination through full process enclosure
  • Ensure the sterility of the process
  • Automate and enclose NFF, TFF and buffer preparation
  • Configurable single-use solutions incorporating inline sensing
BULK FILTRATION AND DISPENSE & COLD CHAIN TRANSPORTATION
  • Automate and de-risk the bulk filling process
  • Protect product quality through perfect fluid flow
  • Eliminate contamination risk through full process enclosure
  • Perfect sealing at ultra low temperatures
Parker Single-Use System Products
Parker offers a range of custom container solutions for your SUS-based biopharma production applications.
Custom Container Solutions
Container systems like media preparation containers, buffering containers, final fill containers, bubble containers and storage containers are all vital components of any SUS-based biopharma production environment. We have an extensive overmolding portfolio, fully scalable range of technology, and with our open architecture we provide the basis for a wide variety of customized solutions in upstream and downstream processes.
Tube-to-Container Interface >>

Remove the limitations of standard ported caps and mitigate the risk of contamination for tube-to-container interfaces.

  • Open Architecture Means No Limits: Enable the integration of exactly the type of TPE/silicone tubing required by your application. This solution is not limited by tubing diameters or the number of lines, therefore very small and very large tubing can be integrated. There is also the option to easily integrate vent filters and aseptic ports – a key differentiator in perfectly matching the container system with your filling/draining operations.
  • Seamless Integration Allows for Non-Stop Product Flow: The tubing is seamlessly integrated in the silicone stopper, which acts as a combined cap seal and tubing feed-through. The stopper is developed specifically for each container system, irrespective of the container size, material (PET, PC, glass) or brand – enabling full scalability to your application. As no connection is required between the tubing and the container, a continuous flow path is guaranteed during filling and emptying without any dead zones or protrusions disturbing the product’s laminar flow.
  • Tamper-Proof for Handling, Transportation and Dispensing: We are the sealing experts and have extensive experience in developing customizable closure and tubing sizes and combining these solutions with state-of-the-art tubing manifold technology. Securing the tubing requires no cable ties because the tube-to-container interface seamlessly feeds through the tubing to the inside of the container. This proprietary tube-to-container interface is available for glass bottles in the form of "flex caps."

Tube-to-Tube Connections >>

Our proprietary overmolding technology offers secure, tailored tube-to-tube connections in a wide variety of combinations.

  • Overmolded connections are available in X, Y and T configurations and fully customizable. Due to our ability to integrate TPE and silicone tubing of any brand, tubing diameter and length, customers have the freedom to choose from their trusted and validated materials pool – a major benefit in reducing overall system costs. Our tube-to-tube connections are perfect for challenging final-fill and lab-scale applications with our small inner diameter tubing of 1.6mm.
  • Parker's gateway solutions have no edges or protrusions in the fluid path, which eliminates dead zones and guarantees a laminar flow of the product through the gateway. The TPE/silicone overmolded gateways provide a tubing connection that meets even the harshest cold chain transportation requirements. Their material performance is on par with that of the TPE/silicone tubing utilized.

In-Container Product Management >>

Eliminate the need for additional tubing connections with anti-foam and mixing solutions. The draining line continuously runs through the container system, thus mitigating any risk of contamination due to imperfect fluid flow while retrieving the product.

  • Anti-Foam Solutions: Our J-Tube anti-foaming feature makes it possible to gently guide the product toward the wall of the bottle where it can flow downward as intended without frothing. Proprietary overmolding technology connects the J-Tube to the adjacent tubing in the same way as a tube-to-tube connection – eliminating any protrusion into the fluid path and guaranteeing a tamper-proof connection. The J-Tube is fully scalable to fit all container types regardless of size, type, or brand. The angle of the J-Tube can be adapted to the customer’s requirements so that the end of the J-Tube faces the container wall at exactly the desired position.
  • In-Container Mixing: We can integrate magnetic stirring bars into containers, providing a ready-to-use, fully validated and sterilized system. This eliminates tube handling issues in mixing-draining processes to be performed in single containers. Our proprietary overmolding process ensures that the draining line is guided to the correct position on the container wall. This allows for a magnetic stirrer bar to be placed at the bottom of the container without any concerns about its uninterrupted operation due to collisions with the draining line.

Container Handling >>

Our container technology is used in various biopharma applications such as bubble traps designed to avoid air entrapments in vaccine production, waste containers to securely recycle by-product, and buffer systems that maximize safety by avoiding direct contact between fluids in two different serially connected bioreactors.

  • Tamper-Proof Seal: Tamper-evidence seal ensures full visibility of a container closure mechanism’s integrity. The seal, consisting of two overmolding TPE bands that are chemically bonded to the cap and bottle neck and interconnected, cannot be physically destroyed without cutting the interconnection. It is superior to shrink films in terms of thermal stability, robustness, and ease-of-use. Scalable for all types of containers.
  • Protection Cap: Customized protection caps can either cover cut-off or crimped tubing ends or guide tubing outside of the container into a position where it can be securely attached to the neck of the container. Easily applied by means of a click mechanism and manufactured from medical-grade plastics, cap shapes can be modified to suit the customer's container systems such as single-, dual- and multi-tubing systems.
  • Tube Fixation: Tubing that needs to be attached to the container, can be secured to the container’s neck with our tube fixation feature that sits on the container's neck and enables easy tubing clip-in. The clip-ins are designed to fit the respective tubing diameter and can be adjusted in terms of their numbers and positioning for high levels of handling safety and ease of operation.

Cold Chain Storage & Transportation >>

If you need to freeze your product or keep it extremely cold during storage and transportation, rely on us for your container needs up to -85C.

  • Integrity Seal: The torque with which the cap is screwed onto the container’s body is another factor that affects sealing performance. Due to the differences of cap and body shrinkage in the freezing process, torque degrades. The resulting degradation of the contact force acting on the sealing interfaces entails the risk of gap formation between the container cap and body, and compromises sealing performance.

    Our patented integrity seal wraps around the circumference of the bottom edge of the cap and the upper part of the bottle neck. It is applied by overmolding and the proprietary sealing material bonds the cap to the body of the container.

    The integrity seal ensures significantly lower torque degradation during the freezing process because the cap is held securely in place relative to the container body. The integrity seal prevents any opening of the container – guarantying a closed system.
  • Cold Chain Transport Containers: Our cold chain technology can be applied to all plastic containers (PET and PC) with a size factor from 125 ml to 20 l. We offer a container-integrated dip tube for easy and convenient draining, which can be produced from the same material as the container. Due to the system’s identical material profile, there are no concerns regarding leachables and extractables.

    After filling the container, tubing can easily be positioned in a secure way using the tube fixations and subsequently protected with a cap.

    We offer 100% helium leakage testing for every container. Using state-of-the-art mass spectrometry-based test methodologies, the container system is tested with 100% helium overpressure for sealing tightness. Every container tested is labeled with a unique product code for full traceability of the test results.


Custom Manifold Systems
We offer fully scalable customized manifold systems on all common single-use pharma components, mitigate the risk of contamination through excellent fluid path management and help reduce overall system costs by using your validated products.
Tailored Solutions >>

  • As an independent systems integrator, Parker can implement all common single-use pharma components (tubing, vent filters, aseptic connectors, etc.) from approved manufacturers into custom-made tubing manifolds. These tubing manifolds are fully scalable from lab to production scale, mitigate the risk of contamination through excellent fluid path management, and help reduce overall system costs as customers continue using their internally validated and established brands and products.

Overmolding Technology >>

  • Parker’s overmolding technology enables secure tailor-made tube-to-tube connections in a wide variety of combinations (X, Y and T configurations are fully customizable). With our ability to integrate silicone and TPE tubing irrespective of tubing diameter, tubing length or brand provides customers with the freedom to choose from their trusted and validated material pool and thus a major benefit in terms of overall system cost reductions.
  • Overmolding technology eliminates the need for cable ties, which ensures tamper-proof connection of various types of tubing and thus generates a closed system environment for processing your valuable product.

Optimized Fluid Paths >>

  • Minimizing stress on your product as it progresses through its manufacturing process was one of the milestone goals in the design and development process of our gateway solutions. As a result, there are no edges or protrusions present in the fluid path. This eliminates dead zones, mitigates the risk of contamination, and guarantees laminar flow of the product through the gateway.
  • The TPE/silicone overmolded gateways provide a tubing connection that meets even the harshest cold chain transportation requirements. Their material performance is on par with that of the TPE/silicone tubing used.

Micro-Overmolding >>

  • We offer highly precise overmolded manifold systems for final filling applications. To perfectly process fluid on a low volume level, we developed a micro overmolding process enabling us to manufacture manifolds with an inner tubing diameter down to 1.6 mm – perfect for peristaltic pumps.

Traceability >>

  • In addition to our standard tube connectors, which are available for various sizes of TPE and silicone tubing, we have developed special traceability solutions. Our molded-label technology enables us to integrate custom-designed labels into overmolded X, Y, T or stopper connections to guarantee maximum traceability even under challenging environmental conditions such as autoclaving and beta/gamma irradiation cycles or in contact with aggressive media.

Parker provides fully scalable customized manifold systems on all common single-use pharma components.

Parker's multi-functional cap solutions provide fully customizable tube-to-unit interfaces.
Flex Caps
Parker's multi-functional cap solutions provide fully customizable tube-to-unit interfaces with innovative fluid management capabilities. They mitigate the risk of contamination, allow for the integration of previously validated components such as tubing – significantly reducing overall system costs.
Risk Mitigation >>

  • Building on the excellent design flexibility of our tube-to-container interfaces, our design and process experts provide you with multi-functional cap solutions. Our smart product solutions mitigate the risk of contamination. The technology spectrum is fully scalable while our open architecture allows for the integration of previously validated components such as tubing and thus significantly helps reduce overall system costs.
  • Any desired TPE/silicone tubing can be integrated into the cap interface. By design, the flex caps are not limited in terms of the number of lines present in the cap interface or the tubing diameter. Peripherals such as needles, aseptic ports and vent filters can thus be easily integrated to allow for maximum operational flexibility.

Flexible In-Unit Fluid Management >>

  • Fluid management inside the bottle or container is facilitated by our anti-foam feature (“J-Tube”) and overmolding capability that enables tubing inside the bottle to be guided to the wall of the bottle. This allows for the integration of a draining line in parallel to a magnetic stirrer bar in the bottle in mixing applications.
  • Also, no additional tubing connections are necessary due to the design of in-container tube management – the draining line continuously runs through the container system, thus mitigating any risk of contamination due to imperfect fluid flow while retrieving the product.

Perfect Product Flow Through Seamless Integration >>

  • Being seamlessly integrated in the silicone stopper that acts as a combined cap seal and tubing feed-through, the product flowing through the tubing follows a perfect flow path. Due to the absence of any additional connections between the outside tubing and the in-bottle tubing, there are no protrusions disturbing the product’s laminar flow. The elimination of dead zones in the fluid path mitigates the risk of contamination. Full scalability is ensured as every flex cap is designed specifically for any given bottle or container size, irrespective of the material (PET, PC, glass).

Already using SUS?
Make the switch to Parker’s Single-Use Systems for greater processing flexibility, tamper-proof design, and -85°c storage and transportation capabilities. Let us help design a solution to fit your changing requirements.
LEARN MORE
To learn more about our custom single-use solutions and systems, talk with one of our application experts.

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Regulations & Standards
Applicable Regulations and Standards
  • ISO 13485: Quality Management Systems for Medical Devices
  • ISO 14644: Clean-Room Environmental Controls
  • ISO 11137: Sterilization of Medical Devices
  • ISO 11737: Bioburden
  • E.P. 2.6.14 and USP <85>: Bacterial Endotoxins Test
  • E.P. 2.9.19 and USP <788>: Particulate
  • ASTM F 1980:2007: Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
  • Materials of Construction (free of animal-derived ingredients or meeting EMEA410.01 rev.03)
  • USP <661> Extractables / BPOQ Protocol
  • ISO 10993 Biocompatibility
  • USP <87> / USP <88> Cytotoxicity/Bioreactivity
  • Transportation Validation (ISTA-2A or ASTM D7386-12)
Endotoxin Testing
Typical single-use consumables are frequently used for fluid management in both upstream and downstream processes. Consequently, they have direct product contact and can potentially add undesired materials to the process. Bacterial endotoxins are examples of such undesired materials.

Bacterial endotoxins are gram-negative bacterial products which can be toxic and may cause symptoms such as fever. These materials cannot be completely removed by sterilization as the sterilization process will not inactivate the toxins even when cleaning and sterilization is effective in killing the bacteria. Consequently, bacterial endotoxin testing is an essential component of batch release testing. Details on test limits and methods are available on request.
Sterility ISO 11137
The sterilization process of any product must be validated to verify that it effectively and reliably kills any organisms that may be present on the presterilized product. If requested, our single-use consumables are sterilized to achieve a sterility assurance level (SAL) of 10-6, which corresponds to the probability of one in a million items being nonsterile. Validation is performed according to the ISO 11137-2 VDmax 25 method. Based on the annual production volume of every item, the sterilization dose is audited during routine production runs.

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