Contents
Pharmaceutical and life‑science companies face increasing pressure to implement a robust and risk based Contamination Control Strategy (CCS). The Certification Program Cleanroom Expert equips specialists with exactly the competences they need: a strong regulatory foundation, hands‑on technical understanding, and a deep understanding of cleanliness‑critical principles and interrelations.
Through practical exercises, interactive workshops, as well as training and simulation sessions in the comprei cleanroom facility, participants gain the ability to transfer their knowledge directly into everyday operational processes.
- Practical
- Regulatory
- Future-ready
Your benefit at a glance
Participants develop a solid understanding of current regulatory expectations, essential GMP guidelines, and the technical and organizational fundamentals required for contamination‑controlled cleanroom operations. The program enables graduates to:
- Make informed, risk‑based decisions aligned with modern GMP principles
- Plan, operate, and monitor cleanroom processes effectively
- Integrate hygiene and technical concepts seamlessly into a CCS framework
- Implement quality assurance measures efficiently and state‑of‑the‑art
Program structure
The Certification Program Cleanroom Expert consists of three modules, each lasting three days. Between modules, participants work on an exam‑relevant project assignment that translates theory into real‑world application. After completing the final module, participants undergo a concluding oral examination to demonstrate their acquired expertise.
Module 1: Quality assurance
This module establishes a clear and structured understanding of the regulatory landscape, including the EU GMP Guide and other key standards. Participants learn how these regulations shape an effective Contamination Control Strategy.
Key takeaways:
- Principles of risk‑based pharmaceutical quality management
- Core QM tools: Change Control, CAPA, and Deviation Management
- Practical application of these tools in cleanroom environments
- How to prepare for and navigate audits and regulatory inspections
Module 2: Cleanroom hygiene
Human behaviour, facility design, and product characteristics are central risk factors in contamination‑critical environments. This module focuses on deriving and implementing hygiene measures that align with a coherent CCS.
Topics include:
- Effective, GMP‑compliant personnel and operational hygiene concepts
- Cleaning and disinfection strategies, including agent rotation
- Practical gowning and airlock system design
- Risk‑based monitoring of microbial and non‑microbial contamination
Module 3: Cleanroom technology
Participants receive a comprehensive overview of the technical foundations required for designing, qualifying, and maintaining cleanrooms according to ISO 14644‑1 and EU GMP standards.
Topics include:
- Cleanroom classification and normative requirements
- Technical aspects of equipment and process design (incl. V‑model)
- Continuous monitoring and correct execution of particle measurements
- Comparison of barrier systems and their hygiene demands
- Fundamentals and validation of sterilization and decontamination processes
