EN 12462:1998

Overview

EN 12462:1998 - Biotechnology: Performance criteria for pumps is a European Standard published by CEN that specifies performance and safety criteria for pumps used in biotechnological processes where the release of microorganisms must be limited or prevented. The standard covers pumps intended for use with hazardous or potentially hazardous microorganisms and applies both to standalone pump units (bounded by their connections) and to pump systems equipped with the auxiliary equipment needed for operation, cleaning and sterilization. EN 12462 has been adopted by national bodies (e.g., SIST EN 12462:1999).

Key Topics

The standard focuses on practical performance and containment considerations relevant to biotechnology pumps and typically addresses the following technical topics and requirements:

• Containment and leakage control - requirements to limit or prevent release of microorganisms during normal operation.
• Cleanability and sterilizability - design features that enable effective cleaning-in-place (CIP) and sterilization-in-place (SIP).
• Materials and surface finish - selection of materials compatible with bioprocess media and sterilization methods.
• Seals and connections - design of seals, flanges and process connections to minimize contamination risk.
• Operational performance - criteria for reliable flow, pressure handling and durability in biotechnology environments.
• Validation and testing - requirements for demonstrating that pumps meet containment and sterilization performance objectives (functional testing, inspection, documentation).

(Note: EN 12462 sets performance criteria and scope rather than prescribing specific test values; manufacturers and users must validate compliance per the standard’s principles.)

Applications

EN 12462 is applicable wherever pumps handle hazardous or potentially hazardous microorganisms and containment is required:

• Sterile transfer and circulation in bioprocessing and fermentation
• Aseptic sampling, media handling and downstream processing
• Pilot plants and production-scale bioreactors
• Pharmaceutical and biotech manufacturing facilities requiring validated sterilization and containment

Who Uses This Standard

• Pump manufacturers and equipment designers developing bioprocess pumps
• Process engineers specifying pumps for sterile and containment-critical systems
• Quality assurance, validation and safety teams ensuring compliance and risk control
• System integrators and OEMs of bioprocess equipment
• Regulatory and conformity assessment bodies assessing equipment suitability

Related Standards

EN 12462 complements standards and guidance on hygienic design, aseptic processing, equipment validation, sterilization protocols and pressure/construction codes. Users should apply EN 12462 alongside relevant hygienic and regulatory standards for a complete compliance and validation strategy.

Keywords: EN 12462, biotechnology pumps, pump performance criteria, bioprocessing pumps, containment, sterilization, hygienic design, microorganism release prevention.