Sterile Connectors and Disconnectors

Pall provides a variety of single-use sterile connector and disconnector devices that are used across biopharmaceutical processes to connect or disconnect two separate fluid paths with sterility assurance, even in unclassified environments. These devices ensure sterile connections and fluid paths that deliver quality, purity, and integrity in single-use fluid handling. Sterile connectors and disconnectors prevent process contamination and protect the end product.

Sterile connectors and disconnectors enable the transfer and processing of liquids while preventing unwanted organisms, such as bacteria, and environmental contaminants like dust and dirt from entering the process stream or drug product. Sterile connectors and disconnectors are used across disposable processes in drug production, from upstream and downstream to formulation and filling.

Selecting the right sterile connector or disconnector technology for any processing application is crucial in meeting product quality standards and process compliance. To ensure smooth and reliable process flow, single-use fluid management systems comprise various components designed to preserve sterility. Among these critical devices are sterile connectors and disconnectors, which manage the connection or disconnection of sterile fluid tubing from product development to cGMP commercial operations.

Kleenpak Sterile Connectors Kleenpak Presto Sterile Connectors Kleenpak Sterile Connectors Kleenpak II Sterile Connectors Kleenpak Sterile Disconnectors

Product images are a representation of product family for illustration purposes only. Actual products may vary.

Order Products

Kleenpak™ sterile connectors, 5⁄8 in hose barb connection, female, box of 25 product photo

Kleenpak™ sterile connectors, 5⁄8 in hose barb connection, female, box of 25

Product ID: KPCHT02F11
Unit of Measure
1/BOX
Min Order Qty
1
Kleenpak™ sterile connectors, 5⁄8 in hose barb connection, male, box of 25 product photo

Kleenpak™ sterile connectors, 5⁄8 in hose barb connection, male, box of 25

Product ID: KPCHT02M11
Unit of Measure
1/BOX
Min Order Qty
1
Kleenpak™ sterile connectors, 3⁄8 in hose barb connection, female, box of 25 product photo

Kleenpak™ sterile connectors, 3⁄8 in hose barb connection, female, box of 25

Product ID: KPCHT02F10
Unit of Measure
1/BOX
Min Order Qty
1
End caps for the Kleenpak™ sterile disconnector, female, bag of 10 product photo

End caps for the Kleenpak™ sterile disconnector, female, bag of 10

Product ID: KPD01FEC
Unit of Measure
1/BAG
Min Order Qty
1
Kleenpak™ sterile connectors, 1⁄2 in hose barb connection, female, box of 25 product photo

Kleenpak™ sterile connectors, 1⁄2 in hose barb connection, female, box of 25

Product ID: KPCHT02F6
Unit of Measure
1/BOX
Min Order Qty
1
Kleenpak™ sterile connectors, 1⁄2 in hose barb connection, male, box of 25 product photo

Kleenpak™ sterile connectors, 1⁄2 in hose barb connection, male, box of 25

Product ID: KPCHT02M6
Unit of Measure
1/BOX
Min Order Qty
1
Kleenpak™ sterile connectors, 3⁄8 in hose barb connection, male, box of 25 product photo

Kleenpak™ sterile connectors, 3⁄8 in hose barb connection, male, box of 25

Product ID: KPCHT02M10
Unit of Measure
1/BOX
Min Order Qty
1
Kleenpak™ sterile disconnectors, 1⁄4 in hose barb connection, box of 25 product photo

Kleenpak™ sterile disconnectors, 1⁄4 in hose barb connection, box of 25

Product ID: KPD01HB7
Unit of Measure
1/BOX
Min Order Qty
1
Kleenpak™ sterile connectors, 1⁄4 in hose barb connection, female, box of 25 product photo

Kleenpak™ sterile connectors, 1⁄4 in hose barb connection, female, box of 25

Product ID: KPCHT02F7
Unit of Measure
1/BOX
Min Order Qty
1
Kleenpak™ sterile connectors, 1⁄4 in hose barb connection, male, box of 25 product photo

Kleenpak™ sterile connectors, 1⁄4 in hose barb connection, male, box of 25

Product ID: KPCHT02M7
Unit of Measure
1/BOX
Min Order Qty
1
Kleenpak™ sterile disconnectors, 3⁄8 in hose barb connection, box of 25 product photo

Kleenpak™ sterile disconnectors, 3⁄8 in hose barb connection, box of 25

Product ID: KPD01HB10
Unit of Measure
1/BOX
Min Order Qty
1
Kleenpak™ sterile disconnectors, 1⁄2 in hose barb connection, box of 25 product photo

Kleenpak™ sterile disconnectors, 1⁄2 in hose barb connection, box of 25

Product ID: KPD01HB6
Unit of Measure
1/BOX
Min Order Qty
1

Description

Sterile Connectors: As the name suggests, a sterile connector is a device that connects two separate fluid paths while maintaining the sterile integrity of both pathways, even in uncontrolled environments.

 

Sterile Disconnectors: A sterile disconnector is a device that separates the fluid pathway into two separate fluid paths, without impairing the integrity and purity of both paths. Sterile disconnectors, too, can be used in uncontrolled environments.

 

Gendered vs. Genderless Sterile Connectors 

 

Gendered sterile connectors are comprised of two different device designs, a male device and a female device, that interconnect to form a sterile dry connection between two separate fluid paths without the need for a laminar flow hood or isolator.

 

Genderless sterile connectors feature a device design that enables two units to interconnect with each other to form a sterile dry connection between two separate fluid paths, also without laminar flow hoods or isolators. These sterile connectors provide greater flexibility during installation and reduced inventory complexity.

 

Choosing Sterile Connectors and Disconnectors for Various Applications

 

Single-use technologies offer many advantages over traditional stainless-steel assemblies and are widely adopted within the biopharmaceutical industry. To help our customers achieve sterile connectivity across a wide range of applications, Pall offers three different families of sterile connectors.

 

Identifying the right type of sterile connector or disconnector for your single-use application will help ensure quality, maintain sterility, and provide flexibility in biomanufacturing.

 

Product Family Name Type of Connection Features and Benefits Biopharmaceutical Applications

Kleenpak® Presto Sterile Connectors

Genderless
  • Intuitive operation enabling sterile connections to be carried out in a simple 3-step operation, even in an unclassified environment, without compromising the sterility of the fluid paths
  • Sterility of the fluid path is maintained by a vented peel-away strip on each connector that protects the port prior to connection and fluid transfer 
  • Anti-actuation tabs and a tamper-resistant protective cap provide confidence in operation
  • Suited to a wide range of process fluids and solvents due to the broad chemical compatibility offered by the bisphenol-A-free polyethersulfone material of construction
  • Wide range of connection sizes allows handling of different volumes – a universal face allows for step-up and step-down connections
  • Each connector size has a different colored cap providing users with a clear visual identification of the size being used
  • 100% inspected at point of manufacture with device traceability and serialization linked to a rigorous quality control process
 
  • Media preparation and transfer
  • Buffer preparation and transfer
  • Bioreactor harvest
  • Inoculum transfer to bioreactors
  • Sampling during fermentation or cell culture
  • Sterile fluid transfer between unit operations
  • Bulk handling of sterile material in non-classified environments
  • Insertion of probes into bioreactors, mixers and 3D bio-containers
  • Sterile filtration manifolds
  • Hybrid stainless steel and single-use system connection
  • Bulk sterile material connections to filling machine
  • Sterile waste removal from process streams

Kleenpak™ Sterile Connectors

Gendered
  • Sterility of the fluid path is maintained by a vented peel-away strip on each connector that protects the port prior to connection and fluid transfer
  • Wide range of connection sizes allows handling of different volumes – a universal face allows for step-up and step-down connections
  • Ideal for suite-to-suite fluid transfer due to the slim fit offered by the narrow diameter of the sterile connector design

Kleenpak™ II Sterile Connectors

Gendered
  • Enables the connection of large processing equipment to obtain fast, safe, and reliable sterile fluid transfer of large volumes
  • Used with large single-use systems (> 100 L), such as Allegro™ systems, with minimal fluid restriction in the tubing lines
  • Resistant to caustic solutions due to the polysulfone material of construction
  • Wide range of connection sizes allows handling of different volumes – a universal face allows for step-up and step-down connections
  • Connection to/from large bio-containers or tanks
  • Connection to equipment such as bioreactors
  • Connection to handle bulk material in an uncontrolled environment
  • Connection to bioreactor harvest equipment
  • Connection to a disposable system
  • Connection to tangential flow filtration (TFF) equipment for ultrafiltration

Kleenpak™ Sterile Disconnectors

Gendered
  • Designed to maintain sterile integrity even in cramped and uncontrolled environments, before and after separating the tubes
  • The locking mechanism eliminates the risks associated with clamping and cutting, and it needs no tools, calibration, or maintenance
  • Disconnection is performed in less than 30 seconds
  • Flow paths cannot be reopened or reconnected following disconnection, further securing product integrity

Disconnection following:

  • Transfer of inocula to fermenters or bioreactors
  • Product transfer between bioreactors or mixers
  • Sampling
  • Handling bulk material in a non-sterile environment
  • Tank to filling line
  • Waste removal

Documents

Validation Guides

  • Kleenpak® Presto Sterile Connector

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White Papers

  • Expanding Adoption of Single-Use Systems Drives Need for Wider Range of Sterile Connector Technologies

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    • Albania
    • Algeria
    • American Samoa
    • Andorra
    • Angola
    • Anguilla
    • Antarctica
    • Antigua and Barbuda
    • Argentina
    • Aruba
    • Australia
    • Austria
    • Bahamas
    • Bahrain
    • Bangladesh
    • Barbados
    • Belgium
    • Belize
    • Benin
    • Bermuda
    • Bhutan
    • Bolivia
    • Botswana
    • Brazil
    • British Indian Ocean Territory
    • Brunei Darussalam
    • Bulgaria
    • Burkina Faso
    • Burundi
    • Cambodia
    • Cameroon
    • Canada
    • Cape Verde
    • Cayman Islands
    • Chad
    • Chile
    • China
    • Christmas Island
    • Cocos (Keeling) Islands
    • Colombia
    • Comoros
    • Cook Islands
    • Costa Rica
    • Croatia
    • Cuba
    • Cyprus
    • Czech Republic
    • Denmark
    • Djibouti
    • Dominica
    • Dominican Republic
    • Ecuador
    • Egypt
    • El Salvador
    • Equatorial Guinea
    • Eritrea
    • Estonia
    • Ethiopia
    • Falkland Islands
    • Faroe Islands
    • Fiji
    • Finland
    • France
    • French Guiana
    • French Polynesia
    • French Southern Territories
    • Gabon
    • Gambia
    • Germany
    • Ghana
    • Gibraltar
    • Greece
    • Greenland
    • Grenada
    • Guadeloupe
    • Guam
    • Guatemala
    • Guinea
    • Guinea-Bissau
    • Guyana
    • Haiti
    • Honduras
    • Hong Kong
    • Hungary
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    • Indonesia
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    • Israel
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    • Latvia
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    • Liberia
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    • Luxembourg
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    • Sierra Leone
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    • Slovenia
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    • Somalia
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    • St Kitts and Nevis
    • St Lucia
    • Sudan
    • Suriname
    • Swaziland
    • Sweden
    • Switzerland
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    • Togo
    • Tonga
    • Trinidad and Tobago
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Specifications

Attribute Kleenpak Presto
 Sterile Connectors
Kleenpak Sterile
 Connectors
Kleenpak II Sterile
 Connectors
Kleenpak Sterile
 Disconnectors
Type of connection Genderless Gendered Gendered Gendered
Connection sizes ¼ in., ⅜ in., ½ in., ⅝ in., ¾ in. hose barb; ½ in. mini sanitary clamp ¼ in., ⅜ in.; ½ in., ⅝ in. hose barb ¾ in, 1 in. hose barb; 1-1½ in. sanitary flange ¼ in., ⅜ in., ½ in. hose barb
Sterilization

Gamma up to 50 kGy

Autoclave: 130 oC for 75 minutes

Gamma up to 50 kGy

Autoclave: 130 oC for 75 minutes

Gamma up to 50 kGy

Autoclave: 130 oC for 75 minutes

Gamma up to 50 kGy

Autoclave: 130 oC for 75 minutes

Operating range

Up to 3 barg for 90 days at 2-60 oC

Up to 4 barg for 2 days at 2-60 oC

Storage at -80 oC

Up to 3 barg at 40 oC

Storage at -80 oC

Up to 3 barg for 30 days at 2-40 o

Up to 4 barg for 2 days 2-40 oC

Up to 3 barg at 4-40 oC
No. of operational steps to connect 3 4 3 4

Regulatory compliance

  • Bacterial Endotoxins, USP<85>
  • Biological Reactivity Tests, in vitro, USP<87>
  • Biological Reactivity Tests, in vivo, USP<88>
  • Physicochemical Tests, USP<661>
  • Particulate Tests, USP<788>
  • Bacterial Endotoxins, USP<85>
  • Biological Reactivity Tests, in vitro, USP<87>
  • Biological Reactivity Tests, in vivo, USP<88>
  • Physicochemical Tests, USP<661>
  • Particulate Tests, USP<788>
  • Bacterial Endotoxins, USP<85>
  • Biological Reactivity Tests, in vitro, USP<87>
  • Biological Reactivity Tests, in vivo, USP<88> 
  • Physicochemical Tests, USP<661>
  • Particulate Tests, USP<788>
  • Bacterial Endotoxins, USP<85>
  • Biological Reactivity Tests, in vitro, USP<87>
  • Biological Reactivity Tests, in vivo, USP<88>
  • Physicochemical Tests, USP<661>
  • Particulate Tests, USP<788>

Applications/Uses

Kleenpak Presto Connector Operator
  1. Single-use fluid transfer lines: Sterile connectors in single-use fluid transfer lines improve flexibility and reliability, reducing operational costs compared to stainless steel piping and valves. Applications extend to seed trains and suite-to-suite transfer where they help avoid cross-contamination. Unlike stainless steel assemblies, single-use fluid transfer lines and sterile connectors do not consume time in maintenance, cleaning, and validation in unit operations. They also eliminate the chances of contamination and reduce mobile vessel weight, enabling manufacturers to manage operational cycles more efficiently by quickly changing process steps or converting to a new product.
  2. Sterility assurance:  By incorporating flexible, single-use products, manufacturers are experiencing significant advantages and improvements in sterility. As the variety and volume of biopharmaceutical products increase, the demands for change require the operational flexibility, rapid implementation, and reduced costs that sterile connectors offer. With focus on purity and quality in cGMP production, sterile connectors provide a safe, single-use solution, which reduces storage space and cleaning and maintenance costs.
  3. Flexible connections:  Sterile connectors can connect small sterile equipment to large equipment (e.g., bioreactors).
  4. Non-sterile environments: Sterile connectors can handle bulk material transfer even in non-sterile environments.
  5. Bioreactor/mixing/in-line sampling: Many flexible sampling lines with biocontainers, bottles, and/or syringes can be linked to each other via sterile connectors, and the entire assembly can be sterilized by autoclaving or gamma irradiation. This sterile connection to the sample point minimizes the risk of false positives.

 

For instance, bioreactor sampling at multiple sites requires a large capital investment in equipment, is labor-intensive, and introduces contamination risk. By utilizing a sterile connector for bioreactor sampling at multiple sites, the process is now secured and capital equipment costs and overhead labor can be significantly reduced.

FAQs

Kleenpak Presto Gloves Allegro Tote

1. What must be considered while choosing sterile connectors or disconnectors?

Manufacturers should carefully assess their application and sterile connection and disconnection requirements before purchase.

  • Check if the sterile connector or disconnector can be pre-assembled before sterilizing and using systems
  • Confirm if the process system application is clean, aseptic, or sterile
  • Confirm the dimensions of the intended tubing and fitting type required (hose barb or sanitary)
  • Check all the process parameter requirements for the sterile connection and sterile disconnection 
  • Check the chemical compatibility of the process fluid with the sterile connector
  • Identify the user interface and confirm the expected level of manual handling and associated training and maintenance required

 

2. What important parameters should be considered while purchasing sterile connectors?

Some factors to be considered are temperature range (especially in autoclaving), pressure range (crucial for single-use systems), flow rate, fluid compatibility, exposure to high temperature, shelf life, and manufacturing environment (check for particulate contamination, and extractables or animal-derived raw material requirements).

 

3. What are the connector types used in biopharmaceutical manufacturing processes?

Connectors cover a wide range of liquid and air applications in biopharmaceutical manufacturing.  Broadly speaking, fluid transfer applications can be split into two types: (1) sterile fluid transfer or (2) non-sterile fluid transfer, each requiring a different type of connection. For sterile fluid transfer between two separate fluid paths, sterile connectors can be used without the need for laminar flow hoods or isolators. 

 

Sterile connections can also be made if a laminar flow hood or isolator is used to ensure sterility is maintained. For non-sterile fluid transfer between two separate fluid paths, connectors such as quick-connects can be used. These fluid transfer connectors are available with different fitting types such as a sanitary fitting or hose barb fitting and a variety of sizes to suit different tubing diameters, making them suited to a wide range of bioprocessing applications.

 

4. Why are single-use systems beneficial in biopharmaceutical processing?

  • Eliminate the need for cleaning and validation
  • Reduce capital expenditure, fast setup and turnaround times
  • Eliminate the risk of cross-contamination
  • Enable Quality by Design (QbD), process analytical technology, and continuous processing 
  • Provide flexibility for system reconfiguration
  • Ideal for multi-product facilities that can be replicated in multiple locations

 

5. What are the various tests performed to validate sterile connectors?

On a broad scale, connectors undergo the following tests:

  • Functional (soiling) Testing: Provides information on the ability of the sterilized sterile connector to maintain a sterile fluid pathway after being intentionally contaminated with bacterial spores
  • Extractables Testing: Quantification and characterization of extractables from devices in various solvents based on recommendations of the BioPhorum Operations Group (BPOG)
  • Compatibility Testing:  Demonstrates the suitability of the connectors with a wide variety of solvents and solutions that are used in biopharmaceutical applications
  • Leak Testing: Demonstrates that the integrity of the sealed connectors is not impacted by sterilization or freezing/thawing post-sterilization
  • Burst Testing: Subjected to autoclave sterilization, withstanding maximum pressure
  • Shelf Life Testing: Subjected to gamma irradiation and accelerated storage conditions to simulate 3 years of storage, proving intact functionality