The PDA technical report
PDA recently formed a task force to write a technical report about single-use equipment, and part of the document will help
the reader address extractables and leachables. The task force includes more than 20 people from biopharmaceutical companies,
suppliers, consulting–engineering firms, and regulatory authorities, says Paul Priebe, director of fluid-management technologies
at Sartorius Stedim Biotech North America and member of the PDA Single-Use Task Force. PDA plans to publish the report before
the end of 2011.
The technical report is intended to be a comprehensive document to guide users in evaluating, qualifying, and implementing
single-use systems. The report's main thrust will be the application of risk analysis as the basis for all activities involved
in implementing disposable components, including assessing extractables and leachables. "The risk-based approach is not a
novel concept, but the formal promotion of this approach in a consensus document should give end users the confidence to use
it to implement single-use technologies in their own processes," according to Priebe.
"The goal is to offer a flexible approach to developing a well-designed strategy, so end users can customize their strategy
based on their needs and capabilities, thereby developing a robust process that includes process and logistic controls supporting
the desired states of patient safety and product availability," says Priebe. For a low-risk application, an end user could
develop a strategy based on supplier documentation, but a high-risk application could require validation using process-specific
parameters.
Because the document will promote a risk-based approach to qualification and implementation, the task force decided that proposing
specific limits or analytical methods would be inappropriate. Instead, the report will refer readers to other documents for
guidance, such as the Bio-Process Systems Alliance's guide to extractables and leachables, which readers could use to define
their analytical strategy.
One part of controlling extractables and leachables is the careful qualification of equipment suppliers. The technical report
will describe how end users can qualify suppliers of single-use systems and what responsibilities the end user should expect
the supplier to fulfill. "One key approach championed in the document is developing a partnership with suppliers so that science-
and risk-based discussions and decisions can be made effectively during supplier audits and evaluations of single-use system
supply chains," says Priebe.
To ensure that it addresses PDA members' concerns about extractables, leachables, and single-use equipment, the task force
is developing a tool for the PDA website that will help start a dialog. PDA members also will be able to raise these subjects
with the task force during PDA's workshop on single-use systems in Bethesda, Maryland, on Jun. 22–23, 2011.
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