New ASTM International standard supports sampling in pharmaceutical manufacturing

A new ASTM International standard could help pharmaceutical manufacturers support product quality through sampling done with certain instruments. ASTM International’s committee on manufacturing pharmaceutical and biopharmaceutical products developed the new standard (E3177), which covers both the sample from which data is taken and the sample that is taken for reference.

ASTM members say this standard describes for the first time the considerations around sampling using process analytical technology, which most new pharmaceutical products rely on during development and manufacturing.

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ISA adopts FDT 2.0 as American national standard

FDT 2.0 technology has been fully adopted as the International Society of Automation’s (ISA) American standards. The standard will meet demands in the region for open, standardized device integration on an enterprise-wide basis. It will enhance the integration and application of various fieldbusesand devices, in addition to promoting widespread implementation of standards-based automation solutions.

FDT Group is a member-based, international nonprofit corporation that promotes the proliferation of an open standard for network and asset integration.

The FDT 2.0 standard addresses market requirements in the American market by defining the interfaces for both vertical and the horizontal data flow, called Function Control and Data Access, in the framework of a client-server architecture. It allows application software and configuration tools to interact with field devices in a unified way, while hiding the manufacturer-specific interaction with devices or sub-systems in a software module.

ASTM International, UK groups develop international additive manufacturing standards

Global standards organization ASTM International and three United Kingdom-based groups are partnering to fast-track the creation of technical standards needed by the additive manufacturing industry.

ASTM International identified three potential areas for standardization.

British Standards Institution will coordinate the development of the three standards, which are focused on directed energy deposition (DED), one of seven categories of additive manufacturing as defined by ASTM International and the International Organization for Standardization (ISO/ASTM 52900). DED uses focused thermal energy such as lasers, electron beams and plasma arcs to fuse materials by melting as they are being deposited.

ASTM International officials say DED is not as widely used nor understood as some of the other additive manufacturing processes, and the lack of standards is evident.

The three DED standards under development are:

  1. A specification for using wire as a DED feedstock, helping address key requirements including composition, dimensional tolerances, contamination, packaging, handling and storage.
  2. A standard for nondestructive testing (NDT) that aims to address typical causes and natures of DED defects while also reviewing traditional test methods for applicability to DED.
  3. A standard for DED wire-and-arc additive manufacturing (WAAM), which aims to cover terminology, material opportunities and restrictions, geometrical constraints, finishing requirements and inspection.

After the specifications are created through BSI, ASTM International’s committee on additive manufacturing technologies (F42) plans to develop international standards based on each through a new licensing agreement.