FLUID MANAGEMENT COMPONENTS

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Instrument Tees

Compatible with Existing Instrumentation

SF Series Instrument Tees work well with existing pharmaceutical instrumentation and are available in 1/2" and 1" tubing IDs. Critical to a successful single-use implementation, the fittings work for pressure testing, fluid transfer, and filtration applications. The configuration is a standard 1.5" TC style interface on the instrument side and tee style for the fluid path. The fittings also utilize Nordson MEDICAL’s popular 600 series barb, which is ideally suited for silicone and TPE tubing. Constructed of either Nordson MEDICAL’s standard polyethylene resin or as demand warrants, RENOLIT SOLMED Granuflex 4301 resin, the instrument tees utilize materials found in many single-use bags being used around the world.

All SF Series Fittings SF Series Datasheet SF Series Press Release

Features & Benefits
Works with existing pharmaceutical instrumentation
Single-use technology
ASME BPE compliant interface on the instrument side
Tee style for the fluid path
600 series barb
Common industry materials

Specifications
Materials:
• Animal-free Polyethylene
• RENOLIT SOLMED Granuflex 4301 resin
Tubing Sizes:
• 1/2" and 1" tubing IDs
Configuration:
• 1.5" TC style

RQ Series Quick Connects

Guard Against Disconnects with a Secure Lock

As the leading global pharmaceutical component manufacturer, Nordson MEDICAL has developed a more robust alternative for bioprocessing needs with the RQC Series and RQX Series offering a cost effective solution for flexible tubing connections in single use systems. The connector set is best in fit, form and function, and features a user-friendly interface that includes a large guarded button for a secure lock to guard against disconnects, and lofted lead-in for improved ease of connection. The more reliable locking feature gives you peace of mind knowing your connection is secure. The offer includes caps and plugs to support sterilization and shipment needs. Available in widely used polypropylene and polycarbonate materials, these connectors are compatible with industry standard quick connects to simplify qualification.*

All materials satisfy USP Class VI and ISO 10993 criteria and are suitable for autoclave and EtO or gamma sterilization.

For ease of testing concepts, Nordson MEDICAL offers samples in all available configurations. A complete set of validation and test results are available to support customer needs, including extractables and leachables profiles.

*Testing information available upon request on the interoperability of the RQ Series with other connectors.

All RQ Series Fittings RQ Series Datasheet RQ Series Press Release

Features & Benefits
Materials meet USP Class VI and ISO 10993 criteria
Several connector configurations available in commonly used polypropylene and polycarbonate materials
Large ergonomic button and thumb pad with secure latch and optional integrated locking mechanism
Platinum-cured silicone o-rings
Plugs and caps available to maintain fluid path integrity
Interchangeable with other quick connect fittings
Supports cryogenic applications to -60°C
 

Specifications
Materials:
• Polypropylene, Tinted Polycarbonate
Sterilization:
• Gamma radiation stable
• EtO compatible
• Autoclavable to 121°C for up to 20 minutes
Testing:
• Bioburden, Cytotoxicity, Extractables
RQC Tubing Sizes:
• 1/4" (6.4 mm) and 3/8" (9.5 mm) tubing IDs
RQX Tubing Sizes:
• 3/8" (9.5 mm) and 1/2" (12.7 mm) tubing IDs

PharmaLok Clamps

State-of-the-Art Design Allowing for Easy Operation

The biopharmaceutical industry has made a strong move towards single-use technology, so Nordson MEDICAL has developed ground-breaking clamp designs that simplify the assembly process by making it effortless to securely attach sanitary fittings to bag ports and filters.

Nordson MEDICAL’s PharmaLok™ clamps are ASME BPE compliant and operate at a maximum pressure of 80 psi. Single-use and easy-open clamp sizes include .5" (12.7 mm) to .75" (19.0 mm) and 1" (25.4 mm) to 1.5" (38.1 mm), and the tube clamp supports tubing sizes from .5" (12.7 mm) to 1" (25.4 mm).

Pharmalok clamps provide a significant advancement for the industry, as a number of existing solutions either require tools for closure or consist of multiple components, which turns what should be a simple operation into a difficult and awkward process.

"As a founding member of BPSA, Nordson MEDICAL has been fortunate enough to have insight into the needs of the biopharm industry,” comments Ken Davis, Global Marketing Manager for Nordson MEDICAL. “User-friendly solutions are increasingly demanded, and single-use systems have developed into an overwhelming market trend. Incorporating these factors into the PharmaLok™ has resulted in an ideal solution for our customers."

Easily operated with one hand, PharmaLok’s Patent pending design allows effortless attachment of fittings to bag ports and filters. The user simply rests the fitting in the PharmaLok’s regulation-sized slot, lightly grips the surrounding handles, and listens for the sound of clicks to confirm a secure connection.

All PharmaLok Clamps PharmaLok Datasheet PharmaLok Press Release

Single-Use Clamps & Easy-Open Clamps
Features & Benefits

ASME BPE 2014 DT-9.3.1 compliant
DIN compliant
Easy to use, one-handed closure - no tools needed
Tamper evident
Zip tie compatible
360° compression
Connects both plastic and stainless steel fittings
SIP/CIP compatible
 

Specifications
Materials:
• USP Class VI & ISO 11137 certified glass-filled nylon
Sterilization:
• Gamma Radiation up to 50 kGy
• Autoclavable up to 273°F (134°C) for a maximum of 30 min.
Single-Use & Easy-Open Clamp Sizes:
• .5" to .75" and 1" to 1.5"
Operating Temperature:
• -94°F (-70°C) to 140°F (60°C)
Maximum Pressure:
• 80 psi (conforms to ASME BPE-2014 PM-4.2.2)
PharmaLok Clamps

Unrivaled Tube Clamps

PharmaLok™ tube clamps effortlessly and securely close off flow. Tubing IDs range from .25" to .625" and .5" to 1.25".

Tube Clamp Features & Benefits
Designed for use with silicone and TPE tubing
Easy to use, one-handed closure - no tools needed
Tamper evident and zip tie compatible
SIP/CIP compatible

Specifications
Materials:
• USP Class VI & ISO 11137 certified glass-filled nylon
Sterilization:
• Gamma Radiation up to 50 kGy
• Autoclavable up to 273°F (134°C) for a maximum of 30 min.
Tube Clamp Sizes:
• .25" to .625" tubing ID and .5" to 1.25" tubing ID
Operating Temperature:
• -94°F (-70°C) to 140°F (60°C)
Operating Pressure:
• Up to 150 psi
 

PharmaLok™ Tube Clamp Compatibility

  Silicone and TPE Tubing  
  Tubing ID Tubing OD  
  5/8" 3/4" 7/8" 1" 1-1/8" 1-1/4" 1-1/2"
1/2" No Yes NA NA NA NA NA
5/8" NA No Yes Yes NA NA NA
3/4" NA NA NA Yes Yes NA NA
1" NA NA NA NA NA Yes Yes
     
  Reinforced Silicone and Reinforced TPE Tubing  
  Tubing ID Tubing OD  
  7/8" 1" 1-1/8" 1-1/4" 1-3/8"
1/2" Yes NA NA NA NA
5/8" NA Yes NA NA NA
3/4" NA NA Yes NA NA
7/8" NA NA NA Yes NA
1" NA NA NA NA Yes
     

Bag Ports

Nordson MEDICAL introduces a technologically advanced series of ports for the single-use bags used to transfer media and drug compounds in the biopharmaceutical industry.

Nordson MEDICAL's new high tech series of bag ports offers a variety of benefits new to the biopharmaceutical industry through a unique design. Value Pharma™ resin holds credentials that many manufacturers deem fundamental, such as animal derivative free qualification, USP Class VI certification, and the guarantee of heat sealing and conformance with polyethylene bags. The resin then goes even further to provide a strong, 24-hour resistance to alcohol stress cracking. RENOLIT SOLMED Granuflex 4301 resin demonstrates lower leachable levels and high purity.

Their unique design sets these new ports apart from existing solutions. They not only conform with frequently utilized tubing sizes from 1/8" (3.2 mm) to 1" (25.4 mm) and 1-1/2" (38.1 mm) to 3" (76.2 mm) TC style, but they are also designed to ASME and BPE ferrule specifications, allowing them to work with leading industry fittings, filters and other devices. However, the most notable of the bag ports’ specifications are those that are new to the industry – the parabolic lead and the alignment ribs. These two features, respectively, reduce the amount of time it takes to drain a bag by 24 percent and improve flow dynamics through the port.

Material data sheets available upon request.

All Bag Ports Bag Port Datasheet Bag Port Press Release

Features & Benefits
Compliant to ASME BPE ferrule specification
• Works with leading industry single-use bags
Barb sizes consist of range from 1/8" (3.2 mm) to 1" (25.4 mm) and 1-1/2" (38.1 mm) to 3" (76.2 mm) TC style
• Works with the frequently utilized tubing sizes found in the pharmaceutical industry
Parabolic lead
• Reduces the time it takes to drain a bag by 18 to 24 percent
• Similar results for both fluid and powder based applications
Alignment ribs
• Improves fluid dynamics of flow through the port
Value Pharma™ resin
• Ensures heat sealing with polyethylene bags
• Includes a USP Class VI certification
• Animal Derivative Free
• Resistant to alcohol stress cracking
RENOLIT SOLMED Granuflex 4301 resin
• Demonstrates lower leachable levels and high purity
 

Specifications
Materials:
• Value Pharma™ resin
• Renolit's Granuflex 4301 resin
Tubing Sizes:
• 1/8" (3.2 mm)
• 1/4" (6.4 mm)
• 3/8" (9.5 mm)
• 1/2" (12.7 mm)
• 3/4" (19.0 mm)
• 1" (25.4 mm)
• 1-1/2" (38.1 mm) TC connection
• 3" (76.2 mm) TC connection
Interior Surface Finish:
• Surface finishes comply to ASME BPE-2009 Table SF-P-2 Ra Surface Roughness guidelines
Sanitary Fittings

SF Series, Sanitary Fittings, offers more choices for single-use applications

Now Biopharmaceutical companies have additional choices for their single-use needs. The SF Series sanitary fitting line is the latest product addition from Nordson MEDICAL and the perfect solution for biopharm applications.

SF Series sanitary fittings from Nordson MEDICAL are designed for use in single-use container fluid transport systems, manifolds and wherever sensitive fluids must be transferred. The flanged fittings, which are offered in sizes of 1-½” (“Maxi”), and the popular ¾” (“Mini”) size commonly used with small tubing sizes, both work with flanges made to the ISO 2852 and ASME-BPE specifications*. SF Series sanitary fittings incorporate 600 Series barbs for easy use with silicone, C-Flex® or Tygon® tubing.

All SF Series Fittings SF Series Datasheet SF Series Press Release

Features & Benefits
Animal-free materials
• No BSE documentation required
Radiused flow surfaces
• Smooth uninterrupted flow
“Mini” & “Maxi” sizes
• Easy to retrofit current operations
• Works with commercially available biopharm clamps
No Particulate build-up
• Interior surface controlled to 15 Ra microinch
Specifications
Materials:
• Animal Free Polypropylene, Natural PVDF
Tubing Sizes:
• 1/4”, 3/8”, 1/2”, 3/4”, 1"
Leak Resistance:
• Tested at 80 psi air under water for 90 seconds with no leaks
Tubing Removal Force:
• 1/4” PP with C-Flex shore tubing: 21 lbs.
• 1/2” PP with C-Flex shore A tubing: 89 lbs.
• 1” PP with C-Flex shore A tubing: 121 lbs.
Interior Surface Finish:
• 15 Ra Microinch

These new components allow drug manufactures to realize the business advantages of single-use technology including

  • Less capital investment
  • Major reduction in labor and cleaning expense
  • Major reduction in turnaround time between campaigns
  • Simplified process layout
  • Reduced complexity
  • Reduced risk

The new SF Series is based on design concepts calling for a heavy-duty part with superior side load strength, while providing superior flow through characteristics; making them the connectors of choice for single-use bioprocesses. Pharmaceutical professionals find these plastic plastics fittings offer all the benefits of disposable parts while offering performance capabilities not found in earlier versions of flanged fittings.

The SF Series is available in two styles and animal-free materials to meet the industry's needs. Both mini and maxi flanges are available in animal-free polypropylene and Kynar®, the mini and maxi caps are available in animal-free polypropylene, and all materials are USP Class VI rated. Five size options range from 1/4” (6.4 mm) to 1” (25.4 mm) and include male 600 series hose single barbs configurations with no parting lines on critical sealing surfaces. These sanitary fittings can be sterilized using either EtO, autoclaving or gamma techniques. “Feedback from customers indicate they really like our new sanitary fitting caps because of the large surface area they provide for gloved operators to grab onto when handling them,” says Ken Davis, Global Marketing Manager. These new sanitary fittings and highly efficient caps have been tested to interconnect with other commonly available plastic and traditional stainless steel parts. Nordson MEDICAL also sells platinum cured silicone gaskets to complete the seal operation.

For ease of testing concepts, Nordson MEDICAL offers samples in all available configurations. For samples or to order the SF Series sanitary fittings, contact Nordson MEDICAL directly. SF Series single-use fittings are available from Nordson MEDICAL through its direct sales force, website, major industry catalog sources and worldwide business partners.

Nordson MEDICAL is a member of BPSA, a trade association leading the way in the adoption of single-use technology. Mr. Davis is a board member of BPSA. The trade association has been active in helping biopharmaceutical firms understand the benefits and issue involved in adopting this technology. BPSA has helped both suppliers and end users more rapidly bring Single-use to reality.

*ASME-BPE Maxi fittings have been tested to function with stainless steel fittings that conform to ASME-BPE standards, based on internal tests performed in-house.

ISO:2852:1993(E)VALUE PLASTICS SFMX SERIES PRODUCT MOUNTING FLANGES ARE DESIGNED TO COMPLY WITH ISO:2852:1993(E) FLANGE AND GASKET GROOVE DIMENSIONAL GUIDELINES. PRODUCT TOLERANCES COMPLY WITH NORDSON MEDICAL ENGINEERING STANDARDS OR AS SPECIFIED ON THE PRINT. ALL INTERIOR AND EXTERIOR SURFACE FINISHES COMPLY WITH ISO:2852:1993 (E) SURFACE ROUGHNESS GUIDELINES.

BioClamps

BioClamp® plastic quick-release clamps are specifically designed to meet the needs of busy pharmaceutical and bioprocessing laboratories, offering full flexibility in single-use applications.

The clamps are specifically designed to work with Nordson MEDICAL's SF Series sanitary fitting Mini and Maxi flanges, related caps and gaskets, and in conjunction with OEM filters and bioprocessing bags. The clamp is lightweight and easy for technicians to install and provides for quick and convenient assembly release.

All BioClamps BioClamp Datasheet

Features & Benefits
Can be SIP repeatedly
Can be autoclaved repeatedly at 134°C for 5 minutes
Can be subjected to 40 kiloGrays without weakening
Reduced distortion on polymeric components
More compatible with current manufacturing than steel
• Greater flexibility in operation
• Single-use disposal
Applications
• Bioprocessing
• Single-use technology (SUS)
• Drug discovery and development
• Fluid transport
• Pharmaceutical scale up
• Sterile bag systems

Specifications
Materials:
• Glass reinforced Nylon 66
Tubing Sizes:
• 1/2" to 1 1/2"
Max. Operating Pressure:
• 150 psig
Max. Cumulative Gamma Dose:
• 40 kiloGrays
USP Class VI Certified Materials

BioClamp is a registered trademark of BioPure Technology Ltd, UK. BioClamp Patents: UK Pat No: GB2361753; USA Pat No: US 6,708,377 B2; India Pat No: 199286; UK Pat No: GB2362428; USA Pat No: 10/026,215; Australian Pat No: 774546.

BioValves

BioValve® pinch valve is a precision restriction flow controller and shut-off valve for silicone tubing used in bioprocessing and pharmaceutical manufacturing applications.

BioValve products offer full flexibility in single-use applications. It can be installed over most common silicone tubing.

All BioValves BioValve Datasheet

Features & Benefits
Can be SIP repeatedly
Can be autoclaved repeatedly at 134°C for 5 minutes
Can be subjected to 40 kiloGrays without weakening
Can be calibrated to minimize flow path turbulence
Can be used with one hand
Thread pitch is calibrated to 2mm per turn
• Permits accurate estimation of flow restriction

Specifications
Materials:
• Glass reinforced Nylon 66
Tubing Sizes:
• 1/4" to 1"
Max. Operating Pressure:
• 150 psig
Max. Cumulative Gamma Dose:
• 40 kiloGrays
USP Class VI Certified Materials

BioClamp is a registered trademark of BioPure Technology Ltd, UK. BioClamp Patents: Patent Pending No. 0605408.4; International Patent No. PCT/GB2007/000579


Click here for a full list of Nordson MEDICAL's bioprocessing fittings.