ASTM E3051-25 PDF

Full title and description

Standard Guide for Specification, Design, Verification, and Application of Single-Use Systems in Pharmaceutical and Biopharmaceutical Manufacturing (ASTM E3051-25). The guide provides a risk‑based, practical framework for specifying, designing, verifying and applying single‑use systems (SUS) and hybrid systems used in drug and biologics manufacturing, addressing sourcing, design, installation, operation and performance expectations for suppliers and end users.

Abstract

ASTM E3051-25 is a concise guide intended to complement Guide E2500 and to help manufacturers and suppliers ensure single‑use systems are fit for intended use. It applies risk‑based principles aligned with FDA and ICH process‑validation and quality frameworks, and references industry technical reports on SUS topics such as extractables/leachables, particulate control, integrity testing and biocompatibility. The guide is applicable across clinical through commercial scale manufacturing and may be used by end users, SUS suppliers, and upstream sub‑suppliers.

General information

• Status: Active.
• Publication date: January 1, 2025 (last updated January 30, 2025).
• Publisher: ASTM International.
• ICS / categories: 11.120.99 (pharmaceuticals and related technical standards).
• Edition / version: E3051-25 (current active version).
• Number of pages: 11.

Scope

This guide complements Guide E2500 and applies to single‑use systems and hybrids used in pharmaceutical and biopharmaceutical manufacturing, including materials of construction, components, assemblies, manifolds, supporting utilities, monitoring and control systems, automation and controlled environments that could affect product quality or patient safety. It is intended for new designs and for implementing changes or continuous improvements from clinical to commercial scale; it does not address single‑use packaging/primary containers, combination products, or local regulatory/health & safety requirements.

Key topics and requirements

• Risk‑based specification and design principles for single‑use and hybrid manufacturing systems.
• Verification and qualification approaches to demonstrate SUS are fit for intended use throughout the supply chain.
• Integration with regulatory and quality frameworks (FDA risk‑based CGMP guidance; ICH Q7/Q8/Q9/Q10).
• Considerations for extractables/leachables, particulate control, integrity testing/leak detection, biocompatibility and raw material controls.
• Roles and responsibilities for end users, SUS suppliers, and sub‑suppliers in specification and validation activities.
• Applicability to change control, continuous improvement and scale‑up from clinical to commercial manufacturing.

Typical use and users

Intended users include pharmaceutical and biopharmaceutical manufacturers (process engineers, validation/quality/regulatory teams), SUS suppliers and component manufacturers, contract development and manufacturing organizations (CDMOs), and technical consultants focused on single‑use technology implementation, risk management and process validation. The guide is used when specifying new SUS, selecting suppliers, performing verification/qualification, and when implementing design changes or scaling processes.

Related standards

Directly complements ASTM Guide E2500. The guide references and aligns with FDA process‑validation and CGMP guidance and ICH documents (Q7, Q8(R2), Q9(R1), Q10), and draws on PDA Technical Report No. 66. It is published by ASTM Committee E55 and is intended to be used alongside other SUS‑focused ASTM and industry practices addressing extractables/leachables, particulate testing, biocompatibility and integrity testing.

Keywords

single‑use systems; SUS; pharmaceutical manufacturing; biopharmaceutical manufacturing; specification; verification; design; process validation; extractables and leachables; integrity testing; E3051-25.

FAQ

Q: What is this standard?

A: ASTM E3051-25 is a guide for specifying, designing, verifying and applying single‑use and hybrid systems used in pharmaceutical and biopharmaceutical manufacturing.

Q: What does it cover?

A: It covers risk‑based approaches to SUS specification, design and verification; supply‑chain roles; considerations for extractables/leachables, particulate control, integrity testing and biocompatibility; and alignment with regulatory quality frameworks.

Q: Who typically uses it?

A: Process engineers, validation and quality/regulatory teams at pharma/biotech companies, SUS suppliers, CDMOs and consultants implementing or managing single‑use technology.

Q: Is it current or superseded?

A: It is the active (current) version, designated E3051-25 and published in 2025.

Q: Is it part of a series?

A: It is published by ASTM Committee E55 and is intended to be used alongside related ASTM E55 documents and other industry guides (notably Guide E2500).

Q: What are the key keywords?

A: single‑use systems, SUS, specification, verification, design, extractables, leachables, integrity testing, process validation, biopharmaceutical manufacturing.