SIST EN 12298:1999

Overview

Standard Reference: EN 12298:1998
Title: Biotechnology - Equipment - Guidance on testing procedures for leaktightness
Organization: CEN

EN 12298:1998 provides guidance on general testing procedures to assess the leaktightness of equipment (components and units) used in biotechnological processes. The standard focuses on preventing the release of process microorganisms that could impact occupational health or the environment, offering a framework for evaluating the integrity of containment systems used in biotech facilities.

Key topics

The standard covers high-level, practical guidance rather than prescriptive laboratory protocols. Key technical topics and requirements include:

• Scope of assessment - defining which equipment and components require leaktightness evaluation (e.g., vessels, connectors, seals, transfer systems).
• Testing strategy - selecting appropriate general testing procedures and test types based on the equipment, process risk and containment need.
• Test parameters - guidance on relevant test conditions such as operating pressures, temperatures and expected stresses during normal and abnormal operation.
• Selection of indicators - considerations for using biological or surrogate indicators to detect potential microbial release.
• Sampling and detection - principles for sampling locations, frequency and detection sensitivity to demonstrate leaktightness.
• Interpretation and documentation - how to interpret test results, record findings, and document conformity or corrective actions.
• Risk and safety focus - emphasis on protecting workers and the environment from process organism release, including integration with workplace biosafety assessments.

(Note: EN 12298 gives guidance on the above areas; it does not prescribe detailed laboratory procedures or numeric acceptance criteria.)

Applications

EN 12298 is useful for organizations and roles involved in design, verification and maintenance of biotechnological equipment:

• Equipment manufacturers seeking to design and validate containment features.
• Validation and QA teams responsible for commissioning, routine testing and documentation.
• Biosafety officers and facility managers evaluating operational risk and worker safety.
• Contract testing laboratories and third-party auditors performing containment assessments.
• Regulatory and compliance personnel aligning facility practices with European guidance.

Practical applications include pre-installation validation, periodic leak testing, post-maintenance verification, and incorporation into equipment risk management and safety files.

Related standards

EN 12298:1998 is a European guidance document and is typically used alongside other national and international biosafety, containment and equipment validation standards and regulations to form a complete compliance and safety program.

Keywords: EN 12298, CEN, leaktightness testing, biotechnology equipment, containment, biosafety, occupational health, environmental protection, equipment validation.