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
 
17 list items

Product

Bodies

AQSTC2331000HT product photo

AQSTC2331000HT

AQSTC2331000HT
1-1/2 Sanitary AseptiQuik STC - High Temperature
Product ID: AQSTC2331000HT
AQX33024 product photo

AQX33024

AQX33024
1-1/2 Sanitary AseptiQuik X Body
Product ID: AQX33024
AQSTC2331000 product photo

AQSTC2331000

AQSTC2331000
1-1/2 Sanitary AseptiQuik STC
Product ID: AQSTC2331000
AQX33024HT product photo

AQX33024HT

AQX33024HT
1-1/2 Sanitary AseptiQuik X Body, High Temperature
Product ID: AQX33024HT

Genderless

AQL33024HT product photo

AQL33024HT

AQL33024HT
1½" Sanitary Genderless AseptiQuik L Connector Body High Temperature
Product ID: AQL33024HT
AQG33024 product photo

AQG33024

AQG33024
1½" Sanitary Genderless AseptiQuik G Connector Body
Product ID: AQG33024
AQGSTC2331000HT product photo

AQGSTC2331000HT

AQGSTC2331000HT
1-1/2 Sanitary AseptiQuik G STC - High Temperature
Product ID: AQGSTC2331000HT
AQG33024HT product photo

AQG33024HT

AQG33024HT
1 1/2" Sanitary Genderless AseptiQuik G Connector Body
Product ID: AQG33024HT
AQGSTC2331000 product photo

AQGSTC2331000

AQGSTC2331000
1-1/2 Sanitary AseptiQuik G STC
Product ID: AQGSTC2331000
AQL33024 product photo

AQL33024

AQL33024
1-1/2" Sanitary Genderless AseptiQuik L Connector Body
Product ID: AQL33024

Inserts

MPX44024T39M product photo

MPX44024T39M

MPX44024T39M
1-1/2 Sanitary Non-Valved MPX Coupling Insert
Product ID: MPX44024T39M
AQX44024 product photo

AQX44024

AQX44024
1-1/2 Sanitary AseptiQuik X Insert
Product ID: AQX44024
17 list items