All times metioned are CEST.
Zielsetzung
The primary focus of this conference is the newly updated ISPE SMEPAC Guideline and its impact on modern containment strategies. By examining real-world measurement techniques, Hazard assessments, and compliance best practices, participants will learn how to implement and validate robust containment measurements under the latest requirements, ensuring safety for workers as well as patients by reducing the risk of cross contamination.
Hintergrund
In our highly regulated environment GMP sets the baseline for safe and consistent production. Containment strategies Bridge the gap between operational efficiency and regulatory compliance. By minimizing the risk of cross-contamination and exposure, effective containment systems not only safeguard product quality but also protect employees from potent or hazardous substances.
Recent developments underline the growing importance of containment. The new ISPE SMEPAC (Standardized Methodology for the Evaluation of Pharma Airborne Particle Emissions from Containment Systems) Guideline represents a significant milestone, offering a unified approach to assess and validate Containment performance. This guideline provides clear methodologies for measuring airborne particulate concentrations, thus helping manufacturers align their processes with stringent safety and quality requirements. As advanced therapies continue to emerge – often involving highly potent active pharmaceutical ingredients (HPAPIs) – the need for robust containment Systems becomes all the more critical.
This conference will delve into the multifaceted aspects of containment, focusing on how to effectively integrate GMP principles with cutting-edge technological solutions. Industry experts will share best practices for designing, implementing, and maintaining containment measures that meet current Regulatory standards.
Zielgruppe
This conference targets professionals from production, engineering, quality and occupational health, as well as suppliers of containment solution, dealing with the tightness of containment systems.
Date & Technical Requirements
Date
Thursday, 26 June 2025, 10.00 to approx. 16.50h
All times mentioned are CEST.
All times mentioned are CEST.
Technical Requirements
We use Webex for our live online training courses and webinars. At www.gmp-compliance.org/training/online-trainingtechnical-information you will find all the information you need to participate in our events and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. Webex is a standard nowadays and the necessary Installation is fast and easy.
Programm
Gesamtes Programm als PDF herunterladen
Introduction to Containment
- Occupational health and GMP aspects
- Containment Systems
- Primary and secondary Containment
- How much containment?
- Assessing the hazard (potency & toxicity)
- OEBs and OELs as determinants for containment
Presentation of the new SMEPAC Guideline
- The new guide
- Why was there a need for a new version?
- Who participated in it?
- What has changed?
Carrying out SMEPAC Measurements
- Monitoring concepts
- Roles and responsibilities
- Monitoring strategy (air, surface, direct reading, sampling heads)
- Do’s and don’ts for SMEPAC Monitoring
- Results as an example
- Statistical evaluation if not discussed otherwise
Comparability of Measurements
- The project dilemma: where are we now with expectations on containment performance and the reality of „measurement after delivery“?
- What does the new SMEPAC guideline say on comparability of measurements?
- Avoid misunderstanding: drug load vs. „total dust“
- Which factors are influencing a containment measurement?
- Case study: comparison of measurement results for the same equipment in different environments
Handling Limit Values in Practice
- SMEPAC vs occupational exposure measurements
- Monitoring occupational exposure for new Containment Systems
- Handling of occupational exposure measurement results
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