Plastic Tube Fittings by Value Plastics

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Sanitary Fittings

Value Plastics offers a more robust alternative for bioprocessing needs.


As the leading global pharmaceutical component manufacturer, Value Plastics has developed a more robust alternative for bioprocessing needs with the RQC 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.*

These new applications are offered in two tubing sizes to fit 1/4” (6.4mm) and 3/8” (9.5mm) ID flexible tubing and feature platinum-cured, silicone o-rings. 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, Value Plastics offers samples in all available configurations. For samples or to order RQC products, contact Value Plastics directly. RQC Series products are available from Value Plastics through its direct sales force, web site, major industry catalog sources and worldwide business partners. 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 RQC Series with other connectors.

RQC Series Image

Features
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
 

Specifications
Material:
• Polypropylene, Tinted Polycarbonate
Sterilization:
• Gamma radiation stable
• EtO compatible
• Autoclavable to 121°C for up to 20 minutes
Testing:
• Bioburden, Cytotoxicity, Differential Non-Linearity
Tubing Sizes:
• 1/4" (6.4 mm) and 3/8" (9.5 mm) tubing IDs


Value Plastics introduces a more user-friendly, single-use sanitary clamp to the biopharmaceutical market.


The PharmaLok Series is a new line of ergonomic, single-use sanitary clamps for securing fittings to bag ports and filters in the biopharmaceutical market.

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, Value Plastics has been fortunate enough to have insight into the needs of the biopharm industry,” comments Ken Davis, Global Marketing Manager for Value Plastics. “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 three clicks to confirm a secure connection.

Value Plastics' new PharmaLok hygienic clamps are made of a glass-filled nylon material that is both USP Class VI and ISO 11137 certified, and ASME BPE 2009 DT-5-3 compliant.

Pharmalok Clamps

Features
ASME BPE 2009 DT-10.4 compliant
Multiple colors for color coding applications
Connects both plastic and stainless steel fittings
Easy to use, one-handed closure (no tools needed)
Zip tie compatible
360° compression
Tamper evident
SIP/CIP compatible
 

Specifications
Material:
• 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 max of 30 min.
Sizes:
• ¾" & 1-½", for use with “Mini” & “Maxi” flange sanitary fittings
Operating Temperature:
• -94° F (-70° C) to 140° F (60° C)
Maximum Pressure:
• 80 psi


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


Value Plastics’ new high tech series of bag ports offers a variety of benefits new to the biopharmaceutical industry through a combination of Value Pharma™ resin and 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.

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 3" (76.2 mm), 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.

Bag Ports

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 3” (76.2 mm) and ferrule 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
 

Specifications
Materials:
• Value Pharma™ 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)
• 3" (76.2 mm)
Interior Surface Finish:
• Surface finishes comply to ASME BPE-2009 Table SF-P-2 Ra Surface Roughness guidelines

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 Value Plastics and the perfect solution for biopharm applications.

SF Series sanitary fittings from Value Plastics 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.

Sanitary Fittings
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. Value Plastics also sells platinum cured silicone gaskets to complete the seal operation.

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

Value Plastics 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 VALUE PLASTICS ENGINEERING STANDARDS OR AS SPECIFIED ON THE PRINT. ALL INTERIOR AND EXTERIOR SURFACE FINISHES COMPLY WITH ISO:2852:1993 (E) SURFACE ROUGHNESS GUIDELINES.


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 Value Plastics’ 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.

BioClamps

Features & Benefits
Can be SIP repeatedly
Can be autoclaved repeatedly at 134°C for 5 minutes
Can be subjected to 60 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:
• 60 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.


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.

BioValves

Features & Benefits
Can be SIP repeatedly
Can be autoclaved repeatedly at 134°C for 5 minutes
Can be subjected to 60 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:
• 60 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

 
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Plastic Tube Fittings by Value Plastics