What We Offer

HyNetics™ has created a family of standard mixing systems ranging from a 20-L unit up to a 10,000-L size. Options are available to configure the systems to meet your needs.  The modular, skid-based hardware allows the integration of completely disposable mixing systems. In other words, all product contact surfaces are single-use, permitting their disposal after each batch, and their replacement with a new system. The mixing technology is the same, whether at the 20-L size or the 10,000-L end of the product range. Since the contact surfaces change with each batch, the same module can be used for making different products; even animal derived component-containing products followed by non-animal derived component-containing products, without concern about segregation.

At the heart of the HyNetics™ mixing technology is the mixing disk itself. The disk consists of rigid, engineered plastic, with multiple slots extending completely through the disk. On the underside of the slots are simple film flaps, attached only on one edge down a given radius of the disk. Thus, the underside of the disk is composed of pie-shaped flaps. These flaps open as the disk moves up from the bottom of the mixing bag on the drive’s upstroke, and fluid flows through the disk’s slots.  With the downstroke, the flaps close and the energy is directed toward the vessel bottom and up the walls of the vessel, producing very effective mixing. The mixing disk, flaps, plastic mixing shaft, and the shaft cover which attaches to the bag film, are all disposable and made of materials that pass Class VI testing.

Mixing Drive with Patented Disk Technology

The mixing bag contains a powder port on the top, to which a powder feed bag, containing either medium or buffer powdered material, mates using a tri-clamp, and through which powder is then delivered in a dust-free manner. There is a port with tubing and end treatment at the top of the powder feed bag through which one can feed purified water if one desires to rinse down the powder bag. A water/liquid port is also located on top of the mixing bag. To this can be connected a WFI source, for example. An integral part of this port, internal to the bag, is a spray device. Thus, as water or fluid is added to the mixing bag, it sprays out to wash down any powder either in the headspace or on the bag walls, and rains on any powder still floating on the liquid surface, all of which helps ensure that the powder goes quickly into solution.  A vent port is also located on top of the mixing bag. On the bottom of the mixing bag are two ports. One is to evacuate the bag; the other is a re-circulation port so that if sampling or supplementing are desired, either can be accomplished via a re-circulation loop. The preferred filtration scheme may be placed downstream of the peristaltic pump, and down from that the customer’s choice for either filling or other use of the mixed contents of the system.

• HyNetics Process Modules (Single Tank Skid Systems)

• Product Brief

Process Hardware

• Philadelphia, Pennsylvania (USA) - This Philadelphia-based headquarters of Alfa Laval Biokinetics houses the engineering and project management resources available for the design and manufacture of the process hardware systems.

• Wilmington, Delaware (USA) - This location is dedicated to manufacturing modular HyNetics™ process hardware and includes resources to fully test the system prior to shipment to customers.

• Toronto, Canada - Secondary location for process hardware manufacturing and testing.

Disposable Products

All three of the following HyClone manufacturing facilities are fully capable of producing HyNetics™ disposables:

• Logan, Utah (USA) - HyClone's 31,000 sq. ft., ISO-9001 certified, cGMP compliant, bioprocess container manufacturing complex is key in the production of HyNetics™ disposables.

• Novato, California (USA) – The Novato facility houses HyClone’s automated processes for the high throughput manufacture of its advanced, proprietary medical-grade film products.  This facility contains a Class 10,000 clean room, and operates under cGMP guidelines.

• Cramlington (UK) – HyClone and HyNetics™ disposables are also manufactured in the Cramlington, UK facility.  Final assembly is performed in a Class 10,000 clean room.  All manufacturing processes, key raw materials, documentation, and quality assurance systems are consistent with those of the Logan BPC manufacturing facility.  This ensures full lot traceability and worldwide consistency allowing BPC and HyNetics™ products to satisfy global customer needs.  A major facility expansion commences in 2004, allowing the facility to better support the rapid growth of the European disposables market.

HyNetics, as a joint venture between HyClone and Alfa Laval Biokinetics, utilizes its two parent companies for the production of its products.  HyClone and Alfa Laval Biokinetics qualify all equipment and systems, and validate products and production processes in compliance with cGMP and ISO 9001 principles.  HyClone’s production control process ensures complete lot traceability for each disposables batch.  Customer audits and visits are welcomed and can be arranged for through a company representative provided a current non-disclosure agreement is in place.  During audits, applicable validation data, lot records, certificates of analysis, and other documents will be made available for review.

Master validation plans are written for product types and production processes.  Validation project protocols are written as defined in the applicable validation master plan.  Product validation demonstrates compliance with release criteria and approved marketing claims.

Processes are challenged and monitored during validation.  Changes in production processes are reviewed by Validation, Product Management, and Quality Assurance to determine if revalidation of the process is required before implementation of the change.

Standard HyNetics modules are validated.  We will work with customers on their specific application needs and assist them if additional validations are required.

HyNetics™ process hardware can be manufactured to your individual requirements for purchase. Smaller systems are also available for demonstration at your facility or through a lease program for internal development purposes. HyNetics™ provides disposable packages for system operation.

HyNetics™ has a vision to create an entirely disposable bioprocess train from media manufacturing through purification and final packaging including the main bioreaction step.

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