By Eric Langer, president and managing partner, BioPlan Associates, Inc.
Standards setting is a frequently cited stumbling block to single use systems’ (SUS) acceptance. As adoption of SUS devices advance, there is a new urgency to press for setting standards. In our 8th Annual Report and Survey of Biopharmaceutical Manufacturing, 2011, we examined who is expected to be setting disposables’ standards. We received a surprisingly broad range of responses regarding who in the industry (both on the vendor side and on the end user side) should set the various standards associated with single use equipment. Our industry trend analysis of 352 global biotherapeutic developers and contract manufacturing organizations queried participants on which organizations they expect to set standards in the following key categories:
design and engineering
leachables and extractables
component manufacturing control (quality)
We compared responses from both end users and vendors. Expectations of which organizations should be responsible for SUS Design and Engineering Standards are similar for both end users and suppliers. ISPE (International Society of Pharmaceutical Engineers) and ASME (American Society of Mechanical Engineers — BioProcessing Equipment Standard, BPE) are the top organizations. They are followed by the BPSA (Bio-Process Systems Alliance) and PDA (Parenteral Drug Association). Responses differed between end users’ and suppliers’ perspectives on who should be responsible for SUS leachable and extractable and quality standards. Both groups listed regulatory agencies first. ICH (International Conference on Harmonization) was top for the end users and the FDA for the suppliers. Interestingly both groups placed the nonregulatory groups of USP (United States Pharmacopeia), PDA, and BPSA near the top of their responses.
For setting design and engineering standards, the industry organization ISPE edged out others, among both end users and vendors/suppliers (29.9% and 37.6%, respectively). The ASME followed with 19.7% of end users and 35.5% of vendors/suppliers.
For leachables and extractables (L&E), the regulatory body ICH was chosen most often. Broken down by industry, 19.7% indicated regulatory body ICH and 19.7% indicated standards organization USP. Among vendors/suppliers, 28.4% indicated ICH should be responsible for L&E standards, and 24.1% indicated USP should be the responsible organization.
For component manufacturing control (quality), ICH was indicated first among end users, followed as a distant second by PDA (24.8% and 8% of end users, respectively). Among vendors and suppliers, 22% indicated ICH should be responsible for “component manufacturing control (quality)” standards.
Criticality Of Standards Setting
Our study reveals that respondents believe a lack of regulatory guidance significantly inhibits adoption of disposables. Of respondents, 40.3% agree or strongly agree that lack of clear regulatory guidance on usage of disposables in L&E limits single-use adoption. Similarly 38.3% agree that this regulatory absence negatively impacts SUS use in all other areas. Lack of standards in testing and measurement is seen as a deterrent to disposable device adoption by 37% of survey respondents.
According to James Dean Vogel of the BioProcess Institute, “Standards routinely come from industry organizations and from the consensus standards (ASME BPE and AAMI [Association for the Advancement of Medical Instrumentation]), not the regulatory authorities. The consensus standards look to the regulatory authorities and industry organizations to start the process with regulations. Unfortunately for this fast-moving sector of the industry, the process to agree on best practices, guidelines, and standards takes time.”
Differing Standards Expectations
Industry members and standard-setting regulatory/educational organizations are working together to further develop and implement educational materials, consensus guides, specifications, and standards. But, it is clear there are differing expectations of standards for single-use systems. This is partly due to the quickly evolving field and the different perspectives within the community. It is getting more complicated as disposables have both raw material attributes (e.g. lot tracking and certification of quality attributes) as well as specific materials of construction issues. Standards organizations, end users, and suppliers are attempting to meet the needs, but it is not fast enough.