Disposable Technology and Single-Use Systems. Regulatory Perspective, Best Practices and Future Trends of Extractables and Leachables

Master's Thesis , 2015 , 51 Pages , Grade: 1.1

Medicine - Biomedical Engineering

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.

Table of Contents

Abstract

List of Figures Tables

List of Acronyms

1. Introduction

2. Literature Review
2.1 Overview
2.1.1 History
2.2 Single-Use Technology (SUT)
2.2.1 Advantages of SUT
2.2.2 Concerns with SUT
2.3 Regulatory Outlook
2.4 Primary Data

3. Current Methodologies for EL testing
3.1 Extractable and Leachable studies
3.1.1 Solvent selection
3.1.2 Worst-case conditions
3.2 Extraction Techniques
3.3 Analytical techniques
3.4 Evaluation of Data
3.5 Leachables Studies
3.5.1 Application-specific evaluation

4. Regulatory Perspective
4.1 Official guidance documents
4.2 Industry groups contributions
4.3 Current Regulatory Outlook

5. Risk Assessment Current Best Practice
5.1 Risk Identification
5.2 Risk Analysis
5.2.1 Quality by Design
5.3 Risk Control
5.4 Risk reduction

6. Conclusion
6.1 Discussion
6.2 Future trends and improvements

7. Bibliography

8. Appendices
8.1 Appendix – A
8.2 Appendix – B
8.3 Appendix – C
8.4 Appendix – D
8.5 Appendix – E

• Course: MSc. Industrial Pharmaceutical Science
• Grade: 1.1
• Author: Suzanne Culleton (Author)
• Publication Year: 2015
• Pages: 51
• Catalog Number: V507038
• ISBN (eBook): 9783346064783
• ISBN (Book): 9783346064790
• Language: English
• Tags: disposable, extractables, trends, future, practices, best, perspective, regulatory, systems, single-use, technology, leachables