1. Speed in one area affects other parts of the project. The simplicity of the building, its layout, and lack of process infrastructure allow a project that is largely based on disposables
to be built more quickly than a stainless-steel facility. This means that other aspects of the project, such as process and
validation activities, vendor audits, and extractables and leachables studies, must be started earlier.
2. Separating process design from building design. Process and technology are still important but they can be quickly separated from the building project. Here the emphasis
is to define the mass balance and assess the available technologies for the particular applications. It is important that
all effort be made to eliminate or minimize all clean utilities, CIP, and process pipework. Use of modeling tools helps in
the cost–benefit assessment and the analysis of process, material, and people requirements. Where possible, develop vendor-independent
disposables design specifications.
3. Plan for more manual handling. This type of facility relies more heavily on manual handling, rather than pipework, to move product and materials around
the facility. Therefore, it is important that early prototypes be developed of the disposable systems that will be used and
that the operations be laid out at scale to allow for ergonomic and functional evaluations to be completed before commission-ing
and start up.
4. Engage the procurement team early. When a lot of disposable technologies will be used in a new facility, it is important to involve the procurement organization
from the outset of the project design. The procurement team will need to carry out the vendor assessments in terms of pricing,
risk, and security of supply, and ensure their requirements are effectively communicated to the engineering project team.
LATEST TECHNOLOGIES IN THE MARKET
As the industry demand for disposables increases, the suppliers are striving to add new technologies and innovations to their
disposable technology offerings. Examples of most recently announced new developments include:
New offerings in large-volume bags for holding fluids:
- Pall Corporation has launched a new large-volume bag range called "Allegro" with capacities of 100, 200, and 500 L.
- The Millipore Mobius line now includes includes bags from 200 to 2,000 L. The Mobius stainless-steel totes have a patented
registration plate that makes it possible to adapt the ports at the bottom of the container to work with bags from multiple
suppliers. Millipore's large-volume bags (1,000 and 2,000 L), branded "EZ fold," also feature walk-away filling in which the
bags unfold as they are filled.
- Sartorius Stedim Biotech has recently added a 50-L volume Palletank to its Flexel 3D range.
Single-use pH probes
New measurement and control systems greatly expand the use of disposable bags. Of particular interest is Sartorius Stedim
Biotech's newest single-use pH probes, which can measure pH levels from 0 to 11 with a +/–0.1 precision.
New aseptic connectors
When configuring fluid handling systems, aseptic connectors are an enabling technology that has greatly extended the use of
disposable systems. This was spearheaded by the Pall KleenPak connector,but recently many other vendors have developed their
own connectors:
- Saint Gobain has recently launched its new sterile connector, the Pure Fit SC.
- GE Healthcare's Bioquate is a genderless connector that is popular with end-users.
- Millipore offers a wide range of connectors in both dry-to-dry and dry-to-wet formats, with internal diameters (IDs) up to
1 inch. The Lynx ST, for connecting to stainless steel, was recently launched in 1-inch ID format. This is a membrane-free
system that facilitates integrity testing and is simple to manipulate.
In addition to making technical developments, vendors are also looking at ways to improve supply-chain security; a common
approach is to achieve this through product standardization. By offering standard, off-the-shelf products, vendors are able
to shorten lead times and improve the security of supply. This standardization should benefit the end-users as the industry
develops generic design standards, thus making it easier for end-users to work with multiple suppliers.
REFERENCES
1. Roebers J. Future trends in biopharmaceutical manufacturing. PDA Meeting; 2008 Jun 25; Dublin, Ireland.
2. Data presented is for a typical monoclonal antibody process generated using Biopharm Services bps Biosolve process model.
3. Andrew S, Miriam M. Biomanufacturing for the 21st century: designing a concept facility based on single-use systems. BioProcess
Int. 2004;Oct supplement:26–32.
Andrew Sinclair is the managing director and Miriam Monge is the vice president of marketing and disposables implementation, both at Biopharm Services, Chesham, Bucks, UK, +44 1494
793 243, disposables@biopharmservices.com
Miriam is also the European chair of ISPE's Community of Practice for Disposable Technologies.
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