« SINGLE-USE
costs rise with the number of parts, and operational flexibility decreases when unique parts are specified for each product or process.
Engineers need a library of specifications for the qualified SUS collection. The library should contain controlled information such as drawings, validation guides, and internally generated testing and validation data. The library should also hold technology and supplier-specific references.
If the library does not contain an adequate match to the URS, then external sourcing of new parts is required. The URS will be combined with business requirements before contacting suppliers. Procurement and supply chain management should participate in all URS development. However, their level of involvement and leadership increases in external sourcing projects.
Building the SUS Collection
Components: Te simplest form of single-use technology
Components are items such as silicone tubing, polypropylene connectors, and capsule filters. These are examples of single-use items that have been accepted in biopharmaceutical manufacturing for years
[2]. Despite familiarity with these purchased items, users may not fully understand the parts or know why particular parts were selected. Design guidance is needed to help with replacements, upgrades, or extensions to other processes.
The internal standard for components should define: •
• •
Preferred materials of construction (MOC): A selection guide will help match MOC with process parameters.
Dimensions: Tubing lengths and diameters should be limited.
Junctions: Choices are made from a restricted set of validated tubing/fitting/fastener combinations.
It is advisable to qualify “off the shelf” catalog components for the standard collection.
Assemblies: Groupings of components
Components are linked together to form fluid transport assemblies. Before starting design, the need for connections should be challenged. Does the fluid have to be moved or can the process be conducted in a single container? Is it possible to move the container rather than transferring fluid?
There are four common options for combining components into a complete processing system:
Small, simple, precise pumps
The compact 120 peristaltic pump for biopharm, science and research saves bench space and improves yield. Exceptional 2000:1 speed range offers precise flows to 190ml/min.
BioPharmaceutical Division awmb_120 half 7x4
rev1.indd 1
Watson-Marlow Flexicon Tubing
wmpg120.com 800-282-8823
www.americanpharmaceuticalreview.com |
10/9/2013 2:35:18 PM | 19
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