ASTM E2968

ASTM E2968 is the ASTM standard guide for applying continuous manufacturing (CM) in the pharmaceutical industry. It provides a technical framework for understanding how continuous processing may be used in pharmaceutical production, helping teams align process design, implementation, and evaluation with a recognized industry reference. As an ASTM standard, it supports clearer communication across development, manufacturing, quality, and procurement activities where continuous manufacturing is being considered or adopted.

Purpose of ASTM E2968

The purpose of this guide is to describe the application of continuous manufacturing in a pharmaceutical setting and to organize the key considerations involved in that transition. ASTM E2968 is intended to help users think about CM in a structured way, from process integration to operational consistency and product quality. It is especially useful where organizations need a common technical document to support planning, evaluation, and informed decision-making around continuous pharmaceutical manufacturing systems.

Common use cases of ASTM E2968

This guide is commonly used by pharmaceutical manufacturers, process engineers, quality professionals, and technical teams working with continuous manufacturing workflows. It may support internal development efforts, technology transfer discussions, and assessments of CM systems used for drug product or related pharmaceutical operations. ASTM E2968 is also relevant when comparing process approaches, documenting implementation strategies, or reviewing how continuous production methods fit within existing quality and compliance practices.

Why ASTM E2968 matters

ASTM E2968 matters because continuous manufacturing can affect process control, consistency, and overall product evaluation in ways that differ from batch production. A recognized guide helps reduce ambiguity when defining expectations, reviewing technical approaches, and supporting quality control decisions. For organizations evaluating CM adoption, ASTM E2968 can also aid procurement and compliance conversations by providing a stable reference point for specifications, documentation, and risk-aware implementation planning.

• Continuous manufacturing in pharmaceutical operations
• Process planning and implementation guidance
• Quality and consistency considerations
• Technical evaluation and documentation support
• Compliance-focused decision making