Benefits of Plastic Process Piping
With more than 30 years of experience molding fluoropolymers, Fluoroware invested over $4 million and conducted 10 studies over the course of four years to develop Cynergy. "We came up with a business plan for serving the pharmaceutical marketplace around four-and-a-half years ago," explained Jim Fleming, marketing manager for Cynergy, "and our first products were introduced around a year ago."
Fluoroware considers the system as a "stainless steel alternative" for manufacturing metal-sensitive proteins or for handling corrosive chemicals such as sulfuric or hydrochloric acid. Originally conceived as providing tubing, fitting, and valves, the Cynergy idea has evolved and will continue evolving. "We now offer nonmetallic filter housings and are working on a technique for lining stainless steel vessels with Teflon," Fleming told Pharmaceutical Online. He indicated that when this part of the business is up and running, entire processes will be conducted in Teflon rather than stainless steel. "Right now the alternatives aren't too appealing. It's either stainless, which introduces metal ions that may interfere with sensitive proteins, or alloy-based equipment costing seven times as much as stainless. Our Cynergy line offers a complete alternative to stainless, from tubing and fittings to valves and filter housings."
Semiconductor and pharmaceutical processors both have traditionally been concerned with contamination in process liquids, but the former worry more about particles—any particle—whereas pharmaceutical manufacturers try to avoid biofilms and pyrogens. One concern they both share are metal ions, Fleming indicated. "Metals can short-circuit a semiconductor, but they can also inactivate therapeutic proteins. Since many new pharmaceuticals fall into this category [of metal sensitivity] the pharmaceutical marketplace has been very receptive to Cynergy products. It's almost as if they were waiting for us."
Benefits of Nonmetallic Fluid Handling
Fluoroware selected Teflon PFA (perfluoroalkoxy) for Cynergy components because of the material's ability to withstand the harsh operating environments of steam-in-place (SIP) and clean-in-place (CIP) processing. Teflon PFA is a fully fluorinated, slightly flexible polymer with a low coefficient of friction and exceptional anti-stick properties. This translucent material resists stress-cracking and attack by nearly all chemicals and solvents. Teflon PFA also can be used in both high- and low-temperature ranges. It is chemically stable and has excellent mechanical strength.
Pharmaceutical processing, especially bioprocessing, will depend more and more on the use of plastic materials that are either easily cleaned or simply discarded after use. With 90 percent of pharmaceutical production cost associated with product purification, manufacturers need ways to continually reduce contamination and maximize efficiency. Cynergy components can help by providing nonmetallic fluid handling systems with the following benefits:
- Inertness. Plastics do not interact with proteins and other metal-sensitive pharmaceuticals. Stainless steel components can reduce product yield in these cases, whereas Fluoroware has accumulated enough data to suggest that Cynergy nonmetallic components may actually increase yields of metal-sensitive actives.
- Biofilm Resistance. Cynergy components resist biofilm growth and do not pit or rouge like stainless steel assemblies.
- Easy to clean. Compared with stainless steel, the smoother Teflon PFA surface is easier to clean, minimizing downtime and the potential for cross-contamination and subsequent yield loss.
- Inexpensive. Cynergy components are comparably priced with stainless steel. Economic benefits may be realized with a Cynergy assembly because of its potential to decrease operating costs and increase yield.
Design Parameters
Fluoroware has set the following parameters for Cynergy fluid handling components:
- All materials must be FDA, USDA, dairy industry 3-A, US
- Pharmacopeia Class 6 approved
- Complete system Trainability
- Compatibility with headless welding assembly
- Capable of SIP operations (52 pounds per square inch gauge at 300° F)
- 100 psig working pressure at ambient temperature
- 60 psig working pressure at 35° F
- Vacuum capable between 35 and 300° F
All internal wetted surfaces are made from resins that comply with FDA regulation 21 CFR 177.1550 (perfluorocarbon resins as articles or components of articles intended for use in contact with food). These resins also comply with the criteria in 3-A Standards for Multiple-use Plastic Materials Used as Product Contact Surfaces for Dairy Equipment, Number 20-17. In addition, Cynergy products are made according to Current Good Manufacturing Practices (cGMP), U.S. Department of Agriculture (USDA) regulations and US Pharmacopoeia (USP) Class Vl criteria.
When manufacturing Cynergy components such as piping and fittings, Fluoroware verifies sealing surfaces and flange geometries. The company uses finite element analysis and mold flow analysis to assist in component production. Cynergy fittings are reinforced with a PEEK (polyether ethyl ketone) overmold to enhance sealing performance.
Qualification Testing—SIP
Cynergy components are tested at Fluoroware's A2LA (American Association for Laboratory Accreditation) Product Development Laboratory. This is the first A2LA-accredited product development laboratory for mechanical testing of tubing and fluid-handling components. All Cynergy components are evaluated at the company's in-house steam plant to ensure SIP capability. Prototype Cynergy components, equipped with standard industry fittings, were tested to determine product life and to identify any design deficiencies. For example, two years' exposure to SIP was simulated by exposing Cynergy products to 730 one-hour cycles of 52 psig steam at 300 F. with one hour at ambient temperature between steam cycles.
Post-SIP tests included burst tests at ambient temperature, bubble leak tests at 100 psig air after 365 and 730 SIP cycles, and gasket leak detection with fluorescent fluids.
Product Quality
Fluoroware has been 9001-registered since 1994, with Class 100 cleanroom manufacturing and assembly areas. Each resin lot is inspected before molding, and the company uses statistical process control (SPC) tools to ensure product quality. An in-line laser system continuously measures inner and outer diameters of Cynergy tubing, for example, to ensure they match product specifications.
Each Cynergy sanitary component is coded with a lot number. This nondestructive, non-contaminating serial marking allows 100 percent traceability to a specific material lot, production date and production inspection record. Extruded tubing has a six-digit code that is laser-marked.into the tube. Injection-molded products have a two-digit code molded into the body. This code changes with every work order.
Since Teflon PEA is too flexible to support itself, Fluoroware also offers a Cynergy tubing support system. The support minimizes the stress and strain within the pipe wall and promotes trainability. In applications where complete trainability is needed, continuous tubing support is recommended. Common extruded shapes such as channels, conduits, and angles work well as continuous supports. Support hangers should not clamp the pipe so tightly that they restrict movement. Vertical pipe sections must be supported top to bottom with brackets at five-foot intervals. Washable, perforated stainless steel can be used for support systems. Even with required support, Cynergy assemblies are still cost-competitive with traditional stainless steel.
Non-pitting Teflon Cynergy products are assembled with a patent- pending headless welding process, so there are no hiding places for fluid entrapment. Cynergy tubing has an exceptionally smooth bore, which provides low drag and low turbulence at high flow rates (Fig. 1). Cynergy assemblies are fully drainable at a 2 percent slope. Complete draining can be easily monitored since Cynergy piping is translucent.
Fig. 1: Weldable Tubing
Cynergy components are designed to work with other industry-standard components. For example Fluoroware offers other polymer-based components for applications which don't require steam sterilization. The company's PVDF (polyvinylidine fluoride) adaptors (made of FDA-approved material) (See Fig. 2) provide transition between standard clamp fittings and silicone tubing while reducing the entrapment areas created by barb fittings. Unlike permanently crimped hose assemblies, PVDF adaptors allow easy field replacement of silicone tubing—minimizing the risk of cross contamination.
Fig. 2: Adaptor Fittings
Dimensions: Pressure, Steam Parameters For Cynergy Clamps
Cynergy clamp, clamp-to-Flaretek, clamp-to-FlareLock, and clamp-to-PureBond adaptors withstand a maximum operating pressure of 100 psig at ambient temperature and 60 psig at 35°F.
Cynergy clamp, clamp-to-FlareLock and clamp-to-PureBond adaptor withstand steam conditions of 52 psig saturated steam at 300°F.
Cynergy clamp connection components are available in the following dimensions:
| Sweep Elbows | ½ to 2 inches | Tees | ¼ to 2 inches | Eccentric Reducers | ½ x ¼ inch to 2 x 1 ½ inches | Concentric Reducers | ½ x ¼ inch to 2 x 1 ½ inches | Cynergy End Caps | ¼ to 2 inches | Ferrules | ¼ to 2 inches |
|---|
To maintain Cynergy fluid handling systems, Fluoroware offers tube cutters and groove, flare and heating tools. Cynergy technicians will train customers for on-site installation.
Fig. 3: Clamp Fittings
Custom Products
Fluoroware will customize components or assemblies using its patent-pending headless welding process. Fluoroware technical service representatives help identify customer needs and develop quotations. Upon customer design approval, assemblies are fabricated at Fluoroware headquarters. Delivery and installation are scheduled on an individual basis.
Custom products are not subject to Fluoroware's new-product testing protocol. Test requirements for custom products will be addressed on an as-needed basis. Fluoroware will soon train customers to use its headless welding service on-site. Customers will be able to rent the welding equipment. In addition, Cynergy valves soon will be added to the sanitary product line. As additional Cynergy products are introduced this year, the line will expand to include 71 fittings, six sizes of tubing, tubing supports, headless PEA welding equipment and nearly 50 valve configurations.
Materials Testing
Research published in the fall 1997 issue of The Journal Of Industrial Microbiology And Biotechnology compared the adherence and removal of biofilms from stainless steel and PFA. In the study, 31 6L stainless steel, 240 grit and 400 series Teflon PFA were exposed to various bacterial strains, including K. Pneumonia, E. Coli, salmonella and tap water. After two weeks, the samples were rinsed, half with water and half with a 50 ppm bleach solution.
The water- and bleach-rinsed surfaces were examined by fluorescence microscopy. Surface topography was measured using atomic force microscopy (AFM). Results showed that PFA retained its smooth, rounded slopes, while stainless steel had a sharp jagged profile. For all organisms tested, removing growth was most efficient from PFA. Furthermore, the PFA surface has a very high hydrophobicity, making it difficult for water and/or biofilms to adhere to its surface. In contrast, stainless steel's hydrophillic mixed metal oxide surface is much more chemically active and subject to rouging and pitting.
Cynergy Assemblies: Beadless Welding & Support Systems
Fluoroware can manufacture custom assemblies using its patent-pending headless welding process. This process ensures that weld joints are fully drainable and have a burst strength three times the standard 100-pound pressure rating.
Fluoroware can weld spool pieces in lengths up to 10 feet with one-inch or two-inch diameters. Fluoroware has also subjected beadless welding assemblies to SIP testing, and found no significant joint degradation of welded assemblies.
Beadless welded spool pieces allows plant engineers to specify up to 100-foot runs of tough, inert seamless tubing made of Teflon PEA. Like all Cynergy products the nonmetallic spool pieces, which Fluoroware introduced in March 1998, withstand corrosive steam-in-place/clean-in-place processing cycles without rouging or pitting. The easy-to-install pieces are compatible with industry-standard fittings. Applications include biomedical, pharmaceutical and chemical processing, especially to produce metal-sensitive proteins or to carry corrosive chemicals.
Fluoroware's patent-pending headless welding process produces a smooth inner surface that allows full trainability and compliance with cGMP. Individual pieces range from ¼ to 2 inches in diameter and up to 100 feet long.
"As with other Cynergy products, the spool pieces are easy to clean, which minimizes downtime, cross contamination and yield loss," Fleming said. "Cynergy spool pieces resist biological growth and contamination. Since the pieces are translucent, process engineers can see their product and easily check hard-to-flush assembly areas. And like our other Cynergy products, our spool pieces don't require expensive passivation steps."
Product contact surfaces of the headless welded spool pieces, as all Cynergy products, are made of FDA-approved materials, which also comply with U.S. Department of Agriculture (USDA) regulations, US Pharmacopoeia (USP) Class VI criteria and dairy industry 3-A standards. For quality assurance, each welded fitting is engraved with a serial number for lot traceability. Fluoroware also offers support racks to contain spool piece thermal expansion for complete Trainability and cGMP compliance.
For more information: Jim Fleming, Marketing Manager, Fluoroware, 3500 Lyman Boulevard, Chaska, MN 55318. Tel: 612-448-8196. Fax: 612-368-8022.