February 1, 2009
The current lack of best practices for implementing single-use manufacturing technologies in pharmaceutical and biopharmaceutical manufacturing is a recognized challenge in the industry. At the 2008 BioProcess International Conference and Exhibition in Anaheim there was a lively debate from end users perspectives, “Developing Best Practices for Disposables.” This discussion identified the work that various industry associations are doing in this area, outlined here.
The Bioprocess Systems Alliance (BPSA www.bpsalliance.org) plastics trade organization has developed a series of guidelines relating to disposables implementation that includes component quality tests, extractables and leachables testing, irradiation and sterilization, and validation of single-use bioprocess systems. BPSA members have been exclusively vendor companies until recently. The organization is now opening up its membership to include end users and build a wider consensus. BPSA is currently addressing waste management and the environmental impact of disposables.
The Parenteral Drug Association (PDA, www.pda.org) Single-Use System Task Force is developing a technical document outlining an actionable framework for implementing single use technologies. This taskforce will augment the efforts of several industry working groups that are already active in this area.
The International Society for Pharmaceutical Engineering (ISPE) has set up a disposables community of practice (www.cop.ispe.org/COP/DisposablesCOP) with more than 500 members including engineering, end-user, and vendor companies working toward guidelines and best practices for disposables. The COP has set up three interest groups:
Design for Disposables: understanding disposable technologies and how they can be integrated into processes; understanding how process modeling, cost of goods, and simulation can support effective selection and implementation of disposables
Applications: identifying and understanding disposable technologies that currently exist and their impact on qualification, validation, and GAP analysis.
Implementation: scheduling timelines necessary for implementation, waste management, and environmental impact of disposables.
The American Society of Mechanical Engineers (ASME, www.asme.org) has been in existence for more than 100 years. It publishes the Bioprocessing Equipment Standard (BPE), which focuses on equipment to improve the quality, safety, sterilization, and consistency of vessels, piping, tubing, valves, and joining methods for the bioprocessing industry. The group plans to publish the standard in the 2009 edition of BPE, which will provide a framework for key issues in the implementation of single use components.
Discussions at BPI 2008
The Anaheim workshop concluded that there is a need to coordinate the workings of those various groups to facilitate the development of guidance and standards (where required). Here are some questions that were raised during this discussion.
Should we as users be looking for standardization of systems and components? If so, in what areas, and how should this be driven? The group concluded there is a need to standardize the methods by which equipment is evaluated, including definitions of measurable characteristics.
What is the reality regarding supply chain and security of supply? What are the issues that are seen in practice? Because systems and components are not standardized from one supplier to another, ensuring supply chain security through validation of two suppliers, for example, is difficult. In the drive for standardization, industry end-users need to communicate their expectations and requirements to suppliers.
How can industry build constructive relationships with suppliers that won’t compromise their competitiveness? What real problems do end-users see in implementation, especially for retrofits? Where do the real risks lie? What are the recommendations for risk mitigation for disposable technologies? This subject was covered in some depth at the Anaheim conference where a formal approach to risk management for disposables implementation was presented (1).
Looking at the risks, there was a question about responsibility of design: Who does it stay with? If an end-user designs a bag against the recommendations of a supplier, and if that results in a subsequent failure, who is responsible? Are there lessons to be learned from the way we manage other consumables? Is the issue one of scale, or is it more significant? Can we learn from other industries? In setting standards for disposables, we may learn from other industries that have already gone down this route, notably the semiconductor equipment manufacturers association.
How do we ensure system integrity? Regarding standards for integrity testing: Should testing be random, burst testing, and/or post integrity testing? What is the purpose/objective of integrity testing — to detect gross system defects or prove that a system is integral from a microbiological perspective?
Many questions remain unanswered in this debate. The industry associations have a role to play in developing best practices. But a higher level of end-user input and better coordination across all groups will be essential.
1.) Monge, M. 2008.. Disposables: Process Economics — Selection, Supply Chain, and Purchasing Strategies.
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