Wassard says that the key benefits her company saw in working with disposables on this project were:
- They were able to delay final process design as long as possible to allow more time for final process development and scale-up
- The construction project timeline was much faster because they were able to separate the process flow from the construction
- Reducing initial investment cost, by lowering equipment costs as well as reducing the floor space needed for processing.
- Cleaning validation was minimized, and this saved time and effort during commissioning. Also, if the facility is ever changed
to a multiproduct site, cleaning and cleaning validation efforts between product runs would be reduced.
- More flexibility due to shorter change-time than with conventional technology, and no need for shut-down.
Perspective 2: Retrofitting Disposables into an Existing Facility
Adam Goldstein, director of operations at Amgen, has experience in implementing disposables into existing facilities. According
to Goldstein, the most important aspect of implementing disposable systems in a facility is to assign a project manager who
- Define the project
- Define the process and applications where disposable systems will be used
- Discuss applications with area managers in the QA and validation groups
- Identify engineering leads for each application and for facility fit
- Determine vendor options and industry standards
- Develop a schedule and project plan for testing and other critical steps.
- Conduct a technical assessment to conduct extractables testing and a product impact evaluation
- Determine storage locations and material flows throughout the plant.
Goldstein and his team worked extensively on the validation approach to disposables. The questions they raised at the start
of this analysis were:
- Where is the solution used in the process? Upstream or downstream?
- Has the solution held in the disposable system been sterile fitered or not?
- How does the solution affect the product?
- How long will the solution be in contact with the disposable system?
- What are the different plastic materials out of which the disposable system is manufactured?
- What is the ratio of the solution to the contact surface?
- What are the possible extreme conditions the solutions will be stored in?
In both Goldstein's and Wassard's cases, the industry end-users devised their own project management strategy for evaluating
disposables. Some parts of the project went very smoothly; others proved more time consuming than expected (for example, connector
validation by suppliers and initial operator training at Bavarian Nordic). This planning was facilitated by the fact that
both companies had previous experience working with disposables. It is not surprising, therefore, that there is a growing
lobby in the biotech industry for developing guidelines and standards to facilitate the implementation of disposable technology.
Guidelines for implementing disposable technologies
BioPharm Services1 and Stedim Biosystems have developed a project management approach for implementing disposables in both new facilities and
retrofit projects. This approach has been fine-tuned through experience in numerous disposable implementation projects in
the United States, Europe, and Japan.
The project management approach that has been developed to ease implementation of single-use systems into new and existing
facilities covers the following areas: 1) new technology risk analysis; 2) conceptual design and facility layout; 3) workflow
and process optimization through process simulation; 4) economic analysis; 5) validation; and 6) supplier evaluation.
Risk analysis of new technologies
Several key questions should be asked before embarking on a project to implement a new technology such as disposables. For
example, How much risk is the company prepared to take in moving away from traditional processes? How significant a role will
disposables have within the project?
It is also important to ask whether the company is prepared to use only disposable technologies with which staff has experience,
and whether the company is prepared to consider what the engineers recommend. And are they prepared to install technologies
straight from the supplier?