WHAT IS EN 17141?

1. Introduction to EN 17141

EN 17141: Cleanrooms and Controlled Environments – Biocontamination Control is a European standard introduced in 2020 that defines best practices for controlling microbiological contamination in cleanrooms and controlled environments.

This standard applies specifically to cleanrooms in pharmaceutical, biopharmaceutical, healthcare, and food industries, as detailed in the annexes of the document.

2. Structure of EN 17141

EN 17141 consists of six key sections, including:

• Sections 1–3: Define the purpose, scope, and terminology.

• Sections 4–6: Provide guidance on how to establish, demonstrate, and measure microbiological contamination control in cleanrooms.

• Annexes: Include industry-specific guidance and sampling verification methods.

At GERA Hi-Tech Vietnam, we focus on the three most critical parts of the standard: EN 17141-4, EN 17141-5, and EN 17141-6.

3. EN 17141-4: Establishing Microbiological Control Systems

This section emphasizes the creation of a comprehensive microbiological contamination control system, which includes:

• Identifying contamination sources: such as personnel, supply air, raw materials, equipment, and utilities.

• Risk assessment and management: determining contamination risks and implementing control measures.

• Developing an Environmental Monitoring Plan (EMP): defining sampling frequency, sampling locations, alert/action limits, and corrective measures.

• Personnel training: ensuring staff are trained in cleanroom procedures.

• Documentation and periodic review: maintaining traceable records and continuous system verification.

➡️ The main goal of EN 17141-4 is to ensure proactive, traceable, and risk-based contamination control.

EN 17141-5: Demonstrating Microbiological Control

An effective contamination control system must be validated and verifiable.
According to EN 17141-5, monitoring results must be:

• Recorded, analyzed, and trended for long-term data evaluation.

• Fully documented, including personnel identification, testing methods, evaluations, and reports.

• Regularly reviewed, especially in cases of out-of-specification (OOS) results.

All measurements must maintain data integrity, considering factors such as:

• Application-specific test parameters,

• Sampling methods and locations,

• Sensitivity and detection limits (LOD),

• Transparency and traceability of data collected.

🎯 EN 17141-5 requires organizations to maintain a reliable microbiological data management system for auditing and verification purposes.

EN 17141-6: Microbiological Measurement Methods

EN 17141-6 provides guidance on selecting and validating appropriate measurement methods and instrumentsdepending on cleanroom application.
When choosing sampling methods, it is essential to consider:

• Cleanroom operation duration and process conditions,

• Accessibility of sampling points,

• Potential impact of sampling on cleanroom performance,

• Accuracy and efficiency of the method.

Common microbiological sampling methods include:

1. Volumetric Air Sampling Devices (Active Air Samplers)

2. Culture Media and Incubation Methods

3. Microbiological Incubators

The standard also requires that all equipment be qualified before use, with incubators maintaining temperature stability within ±2.5°C and requalification at least once every three years.

4. Compliance Is the Key

Ensuring compliance with EN 17141 means understanding and implementing:

• The relevant regulations, standards, and evaluation criteria,

• Data transparency and traceability,

• Standardized procedures for sampling, monitoring, and data analysis.

If your facility currently operates under ISO 14698-1:2003 or ISO 14698-2:2003, conducting a Gap Analysis is highly recommended to evaluate compliance with EN 17141.

5. GERA Hi-Tech – Supporting Manufacturers in Achieving EN 17141 Compliance

At GERA Hi-Tech Vietnam, we provide comprehensive solutions for viable and non-viable particle monitoringthat fully comply with global cleanroom standards, including:

• Portable and fixed particle counters

• Active air samplers for microbiological monitoring

• Remote monitoring and data management systems

💡 With advanced instruments such as the ActiveCount100H, compliant with ISO 14698-1 and EN 17141, we help our clients:

• • Maintain GMP, ISO Class, and EU Annex 1 requirements,

  • Ensure effective microbiological contamination control,

  • Optimize auditing and validation processes.