Successful Project Management for Implementing Single-Use Bioprocessing Systems - - BioPharm International


Successful Project Management for Implementing Single-Use Bioprocessing Systems

BioPharm International

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 optimization.
  • The construction project timeline was much faster because they were able to separate the process flow from the construction project.
  • 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 will:

  • 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?

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