Category

    Termination Size

      Termination Type

        Pressure Range

          Valved?

            Seal Options

              Mounting Options

                Bioprocessing

                For pharmaceutical manufacturers it can be just as hard to keep up with demand as it is to keep up with the highly competitive market. Now you can do both with easy-to-use single-use connectors from CPC. They help maintain flow path sterility and integrity while enabling you to improve production yields, decrease time-to-market and reduce costs. Our genderless sterile connectors simplify process integration, maximize flexibility and streamline your supply chain efficiencies.

                    For mounting to the processing equipment, engineers may specify the connection with either a ¾” or 1-½” sanitary termination on the middle port. Tri-clover clamps are used to secure the middle sanitary to the equipment and the lower sanitary to the steam trap. Once attached, these two lower ports allow a true steam-through SIP process to eliminate potential “dead legs” that trap contaminants. With Steam-Thru® II, you can perform a SIP cycle of up to 135°C or 35 PSI for up to 60 minutes to “steam on” the connector to the equipment. Effectiveness of the “steam on” cycle was confirmed through bacterial challenge testing using Bacillus stearothermophilus performed at the University of Minnesota’s Biotechnology Research Center.

                    Once the SIP cycle is complete, the operator simply depresses the thumb latch to allow valve transition from the steam position to the flow position. This creates a sterile flow path between the stainless equipment and the single-use system, allowing aseptic fluid transfer. A benefit of the Steam-Thru® II valve design is a maximum Cv value of 8.2, which translates to a flow rate of 43.9 liters per minute at 2 PSI, making it appropriate for high volume applications.

                    After fluid transfer is complete, depressing the thumb latch again allows repositioning of the valve back to the steam position for a second SIP or “steam off” cycle. This eliminates any biologic residual remaining between the process equipment and the single-use system, minimizing the potential for environmental contamination at disconnection.

                    In addition to the bacterial challenge testing completed on the “steam on” cycle, bacterial challenge tests were performed following media transfer on the “steam off” cycle. Bacterial ingress tests using Brevendimonas diminuta were conducted by Northview Labs to verify post-sterilization seal performance. Other performance tests, including helium/steam leak, tensile and maximum burst were completed to assure design and process integrity. The Steam-Thru® II is comprised of non-animal origin USP Class VI polysulfone and platinum-cured silicone seals, which were tested for biocompatibility.

                 

                Single-Use Applications

                Transfer Lines

                    Especially in multiproduct facilities, the risk of cross contamination in the suite-to-suite transfer process is high and can potentially lead to product loss or reduced production yields. Pre-sterilized, single-use assemblies reduce these risks and improve the speed and safety of drug development and delivery.

                Single-Use Transfer Lines: Final Fill Operations

                    Traditionally, final fill operations included stainless steel equipment connected via reusable valves, rigid tubing and steel pipes. Today, many process engineers are designing this operation with single-use transfer lines instead of stainless steel equipment to reduce sterilization time and cost.

                    Final fill tanks are designed to transfer formulated product from formulation suites to storage areas and ultimately to filling suites. To allow sterile connection to and from these vessels, designers traditionally added three-way valve assemblies to fill and drain ports. Replacing these heavy assemblies with single-use transfer lines and connectors eliminates cleaning validation and maintenance, while reducing mobile vessel weight by tens of kilograms.

                 

                Sterility Assurance
                Filter Integrity Testing
                 

                Product

                Bodies

                80700 product photo

                80700

                80700
                1/2 Hose Barb Valved In-Line Coupling Body (HFCD17835 NSF)
                Product ID: 80700
                HFC161235 product photo

                HFC161235

                HFC161235
                3/4 Hose Barb Non-Valved Panel Mount Coupling Body
                Product ID: HFC161235
                86400 product photo

                86400

                86400
                1/2 NPT Non-Valved Coupling Body (HFC10835 NSF)
                Product ID: 86400
                FFC101235BSPT product photo

                FFC101235BSPT

                FFC101235BSPT
                3/4 BSPT Non-Valved Coupling Body
                Product ID: FFC101235BSPT
                HFC101235GHT product photo

                HFC101235GHT

                HFC101235GHT
                3/4 GHT Non-Valved Coupling Body
                Product ID: HFC101235GHT
                80200 product photo

                80200

                80200
                1/2 NPT Valved Coupling Body (HFCD10835 NSF)
                Product ID: 80200
                80500 product photo

                80500

                80500
                3/4 Hose Barb Valved Panel Mount Coupling Body (HFCD161235 NSF)
                Product ID: 80500
                HFC171035 product photo

                HFC171035

                HFC171035
                5/8 Hose Barb Non-Valved In-Line Coupling Body
                Product ID: HFC171035
                HFCD191235BSPP product photo

                HFCD191235BSPP

                HFCD191235BSPP
                3/4 BSPP Valved Coupling Body
                Product ID: HFCD191235BSPP
                80100 product photo

                80100

                80100
                3/8 NPT Valved Coupling Body (HFCD10635 NSF)
                Product ID: 80100
                HFC16835 product photo

                HFC16835

                HFC16835
                1/2 Hose Barb Non-Valved Panel Mount Coupling Body
                Product ID: HFC16835
                HFC10635BSPT product photo

                HFC10635BSPT

                HFC10635BSPT
                3/8 BSPT Non-Valved Coupling Body
                Product ID: HFC10635BSPT