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SINGLE-USE
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While recognizing the many other critical roles in SUS supply chain management, the remainder of this article emphasizes component engineering tasks.
Good Engineering Practices for Design and Deployment of Single-Use Technologies
Component engineers collaborate with process engineering and operations groups to match SUS options with process design, ergonomics, and facility requirements. Component engineers design and manage parts that will operate reliably and support robust supply chain performance. Simplification and standardization are key objectives.
Good engineering practices and standards are the foundation for engineering work. Single-use technology engineering standards describe SUS that can be supported by engineering and supply chain management. Standard SUS should be validated to meet the anticipated range of process requirements. Engineering standards also provide design principles and qualification methods to address those rare situations where new parts are required. Effective internal standards will influence and align with industry standards. Standards become evident when good engineering practices yield business success.
The following practices are recommended: •
Start design projects with user requirements
• Maintain a library of specifications for all qualified components
• Match user requirements to solutions in the library; follow standard practices to create new designs only if necessary
• Generate a carefully selected and diverse set of qualified items that can be deployed in a range of applications
• •
Limit changes and require high returns from continuous improvement activities, whether initiated internally or externally
Negotiate with suppliers to maintain stable product offerings
User Requirements
Those who are new to SUS frequently jump to the design, or even the purchasing stage without a proper understanding of process requirements. Do not start by making drawings of assemblies, looking at existing parts, or leafing through supplier literature. Know what your assembly must do before you start designing it. A formalized process for generating a user requirements specification (URS) will support fast and accurate SUS deployment.
URS preparation starts with a process description supplied by the product manufacturing area expert.
18 | | November/December 2013 The chemical composition,
temperature, and pressure at each point in the process must be known before proceeding to detailed design and parts selection. An annotated block flow diagram showing where material enters and exits the process, and listing critical process parameters, will suffice to guide discussions about the process details required to define the assembly subparts.
Time invested in URS preparation benefits the component engineer, supplier, and end user.
Process details lead to proper choices of
materials of construction and component sizes. The details also assist in the establishment of a component qualification program that supports the intended process use.
In a high-performing organization, many of the requirements will be standardized. For example, information about the following attributes is necessary to make design selections and fulfill quality expectations:
• Biocompatibility
• Mechanical properties • Gas/Vapor transmission • • • • • • • • • • • •
Sterilization validation Container Closure Integrity (CCI)
Particulates (USP <788>, EP 2.9.19, visible) Calibration of embedded instrumentation
These attributes, how they are measured, and related regulations and standards are described in the literature [1,9,10]. There is no need to discuss these requirements during each SUS design project. A standard URS approach will allow focus on the novel aspects of the process.
Specifications and Knowledge Management
The next step is to match the URS with the engineering standards. Rather than custom designing parts to meet the needs of product- specific project teams, the component engineer should equip the organization with a catalog of items that will meet the needs of most biopharmaceutical processes.
should strive to do very little new design.
Build and maintain a collection of parts and assemblies that may be used in a product independent fashion. Adding similar parts to the collection should be avoided as each additional part contributes to supply chain and inventory management complexity.
Support Component engineering programs
Compendial physicochemical properties TSE-BSE status TOC analysis
pH/conductivity of rinsate Extractables and leachables Chemical compatibility Protein adsorption studies Endotoxin testing
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