With the adoption of Disposable and Single-use manufacturing equipment on the rise, it is logical there is an industry push to develop a standardised set of testing requirements to thoroughly evaluate the impact of extractable and leachable (E&L) contaminants on patient safety. The main objectives of this work are to critically evaluate the preliminary research previously undertaken on the subject area of Single-Use Systems (SUS) with emphasis on the data currently generated from vendors of single-use systems, the need for harmonised supplier data, current methodologies and best practices employed for E&L testing, and also identification of key areas that warrant further study.
This will be accomplished using both quantitative and qualitative research methods where primary data is sourced directly from interviews with experienced professionals in the field. The secondary information is obtained from the critical analysis of scientific publications, scholarly articles, databases, and use of statistical data generated from recent surveys on the challenges E&L present and how industry have addressed this matter thus far.
From an extractables and leachables viewpoint the regulatory outlook is still quite uncertain. Some SUS suppliers deliver a very strong data package which satisfies the needs of the drug product manufacturer while others fail in this regard. So, in that sense the evaluation of extractables and leachables remains a grey area at present. The challenge for the industry now is to achieve uniformity of data across multiple single-use vendors to facilitate end user risk assessment and compliance for future regulatory submissions and better patient care.
Inhaltsverzeichnis (Table of Contents)
- Introduction
- Literature Review
- Overview
- Single-Use Technology (SUT)
- Advantages of SUT
- Concerns with SUT
- Regulatory Outlook
- Primary Data
- Current Methodologies for E&L testing
- Extractable and Leachable studies
- Solvent selection
- Worst-case conditions
- Extraction Techniques
- Analytical techniques
- Evaluation of Data
- Leachables Studies
- Application-specific evaluation
- Regulatory Perspective
- Official guidance documents
- Industry groups contributions
- Current Regulatory Outlook
- Risk Assessment & Current Best Practice
- Risk Identification
- Risk Analysis
- Quality by Design
- Risk Control
- Risk reduction
- Discussion
Zielsetzung und Themenschwerpunkte (Objectives and Key Themes)
This dissertation aims to critically evaluate the research surrounding Single-Use Systems (SUS) in the context of extractables and leachables (E&L), focusing on data from SUS vendors, the need for harmonised data, current E&L testing methodologies, and areas requiring further research. The work utilizes both qualitative and quantitative research methods to gather primary data through interviews with industry professionals and secondary information from scientific publications, scholarly articles, and statistical data analysis.
- The impact of E&L contaminants on patient safety in the context of SUS adoption
- The need for standardised testing requirements to evaluate E&L in SUS
- The evaluation of data generated from SUS vendors
- The importance of harmonised supplier data for risk assessment and compliance
- Current methodologies and best practices employed for E&L testing
Zusammenfassung der Kapitel (Chapter Summaries)
The introduction sets the context for the research by highlighting the growing adoption of disposable and single-use manufacturing equipment. It outlines the need for a standardised approach to E&L testing to ensure patient safety.
The literature review provides an overview of single-use technology, its advantages and concerns, and the current regulatory landscape. The chapter also examines the historical context of SUT development and the evolution of regulatory requirements.
The chapter on primary data details the current methodologies employed for E&L testing, including solvent selection, worst-case conditions, extraction techniques, analytical techniques, and data evaluation. It also explores the specific challenges posed by leachables studies and the need for application-specific evaluations.
The regulatory perspective chapter examines official guidance documents, industry group contributions, and the current regulatory outlook on E&L testing for SUS. It highlights the uncertainties and challenges in achieving regulatory compliance for E&L in this context.
The chapter on risk assessment and best practice outlines the key steps involved in risk identification, analysis, control, and reduction related to E&L in SUS. It explores the role of Quality by Design (QbD) in mitigating risks and ensuring patient safety.
The discussion chapter summarizes the findings of the research and explores future trends and potential improvements in E&L testing for SUS. It emphasizes the need for continued collaboration and research to address the evolving challenges in this field.
Schlüsselwörter (Keywords)
This work focuses on the critical aspects of disposable technology and single-use systems, examining extractables and leachables (E&L) from a regulatory perspective, best practices, and future trends. The key themes and concepts explored include patient safety, standardized testing requirements, harmonized supplier data, risk assessment, quality by design, and the evolving regulatory landscape for E&L in the context of single-use systems.
- Quote paper
- Suzanne Culleton (Author), 2015, Disposable Technology and Single-Use Systems. Regulatory Perspective, Best Practices and Future Trends of Extractables and Leachables, Munich, GRIN Verlag, https://www.grin.com/document/507038
