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GMP Cleaning, Isolation and Decontamination Systems for the Pharmaceutical Industries.

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2nd Cleaning Process & Validation Conference

// November, 2025

2nd Cleaning Process & Validation Conference

A systematic approach to cleaning process design, data integrity, and risk control

We recently participated in the 2nd Cleaning Process & Validation Conference, an international event organised by Speak Pharma, entirely focused on enhancing cleaning strategies in regulated manufacturing environments.

During the conference, our colleague Fabio Buscaglia delivered a technical session offering an engineering-driven perspective on how Quality by Design (QbD) principles underpin the development of modern cleaning technologies.

His presentation highlighted the importance of a clearly defined User Requirement Specification (URS) as a foundation for effective communication between users and equipment suppliers.

Fabio’s contribution focused on the pillars that define a robust and compliant cleaning strategy in the pharmaceutical industry:

Key Topics

  • Quality by Design (QbD) for Cleaning Processes
    Applying structured, data-driven, risk-based design methods to minimize chemical and microbial cross-contamination while meeting user needs through well-defined URS.
  • Critical Elements of URS
    Providing complete and accurate technical requirements, including safety margins for future production changes and avoiding misinterpretation during project execution.
  • Critical Process Parameters
    Controlling variables such as water quality, temperature, pressure, detergent type and concentration, and designing appropriate load baskets to guarantee repeatable cleaning results.
  • Data Integrity as a Quality Pillar
    Ensuring reliable GxP decisions through ALCOA/ALCOA+ principles for accurate, complete, and trustworthy data.
  • Equipment Construction Quality
    Developing sanitary designs and maintaining surfaces to ensure cleanability and consistent performance.
  • Risk Management in Cleaning
    Identifying contamination risks and applying worst-case assessments to ensure compliance and patient safety.
  • Supplier Communication and Collaboration
    Establishing clear, technically detailed dialogue to reduce risks and align system capabilities with cleaning objectives.
  • Technical Documentation & Design Qualification (DQ)
    Creating comprehensive documentation that explains system function and design intent, forming the basis for qualification and validation.

Adopting a structured approach to cleaning strategy is no longer optional it is essential to achieving compliance, protecting patients, and supporting high-quality pharmaceutical manufacturing.

Our participation in the 2nd Cleaning Process & Validation Conference reinforces IWT’s commitment to supporting manufacturers with engineering-driven GMP washing solutions, designed to strengthen process control, reduce variability, and ensure long-term compliance.

If you would like to deepen this discussion or explore how these principles can support your cleaning strategy, our team is available.

Contact us at info@iwtpharma.com


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