Disposable Technologies Implementation: Understanding and Managing Risks - In new disposables projects, it is critical that engineering, procurement, and operations groups work together early on to ma

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Disposable Technologies Implementation: Understanding and Managing Risks
In new disposables projects, it is critical that engineering, procurement, and operations groups work together early on to manage supply chain risk.


BioPharm International
Volume 21, Issue 12


Figure 1. In the design of a new facility, an integrated approach is needed that includes the engineering, procurement, and operations groups, focusing on both hardware and the consumables.
Figure 1 illustrates this point, which was covered in a great more detail at a recent conference.1 The key to this approach is to get these three groups—operations, engineering, and procurement— together as part of an integrated working team. The role of the operations group is to identify requirements, assess the operability issues associated with disposables, and define the overall cost and schedule targets. To do this, they need to understand risks, including supply chain and quality risks, and be prepared to compromise where necessary. For the engineering group, the key point is not just identifying the best technology that is fit for purpose but to design in a way that includes the consumable components and considers the entire lifecycle. In addition to considering the usual requirements of cost, time, and quality, they must ensure that designs support procurement goals. The other key team that needs to be involved in the engineering project early on is procurement. While the technical evaluations are being carried out, the procurement group should be developing the supplier strategy by understanding supply chain risk and making sure that the engineering design minimizes supplier dependencies. Through this approach it is possible to integrate procurement's lifecycle responsibilities with the capital project.

We have highlighted some factors to consider as the technology and supplier base rapidly develops in this fast evolving area. Of course, there is a lot more to the subject in terms of the implementation of these approaches. At the project level this highlights the need to consider an integrated approach early. If we take an even broader view, we should consider that as an industry we need to share our user experiences, develop best practices, and communicate our expectations to suppliers. We shall return to this theme in a later column.

TECHNOLOGY ROUNDUP

Disposables for Upstream and Downstream Applications

Mixing Systems

The mixing system in the Thermo Scientific HyClone S.U.B. (single-use bioreactor) has been used as the basis for the Thermo Scientific HyClone Single-Use Mixer (S.U.M.) platform. This product line was recently expanded to cover a wide range of upstream and downstream mixing applications in unit volumes from 200 to 1,000 L. Alternative hardware systems as well as open and closed singleuse mixing bioprocess containers (BPC) are now available.

Millipore launched the MIX500, a 500-L disposable mixing system based on levitated, magnetically driven impeller technology.

Sartorius Stedim launched the Flexel 3D Levmix System. This system uses the Levtech levitated impeller and Sartorius Stedim Biotech's Flexel 3D bag. The Levtech superconducting drive unit delivers strong torque for efficient mixing of a wide variety of solutions from process intermediates to final drug product. The system is available in sizes from 50 to 650 L.

Disposable Bioreactors

In 2008, Thermo Scientific HyClone increased the S.U.B. unit volume range from 50 to 1,000 L. The platform S.U.B. development program has also resulted in alternative sparging systems and integration of disposable non-invasive sensors to increase the range of potential applications. The installed base of over 200 units has produced a large body of experience with most of the common animal-cell platforms and an increasing range of compatible control systems supplied by Thermo Scientific HyClone's integration partners. Further developments are planned for 2009.

Single-use bioreactors from Xcellerex are fully-integrated, fully-characterized systems designed for GMP clinical and commercial production. XDR systems are available with working volumes of 200, 500, 1,000 and most recently 2,000 L. XDR has been proven to deliver stirred-tank performance that closely tracks and often exceeds the productivity of conventional stainless-steel systems.

The ATMI/Pierre Guérin and Artelis collaboration provides the Nucleo bioreactor. Nucleo is currently available in volumes of 20 to 200 L, and 500 L and 1,000 L volumes will become available in first half of 2009.

The Sartorius Stedim Biostat Cultibag stirred tank bioreactor is now available in a 200-L volume. A full range of volumes from 50 L to 1,000 L will be available by summer 2009. Twin 200-L systems that work with the same controller are already available. A 2 x 50-L setup or a 50-L + 200-L combination will be available in Q1 2009. Sartorius indicates that these twin systems allow for significant space savings and also reduce investment costs. The system offers disposable sensors for oxygen and pH.

Sartorius Stedim offers the possibility of twin 50 L and 200 L systems that work with the same controller. The system offers disposable sensors for oxygen and pH.


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