- Datum:
-
- Webinar
Cross Contamination Control - Live Online Training
- Veranstaltungsort:
- online
- Veranstalter:
- CONCEPT HEIDELBERG GmbH
Regulatory Requirements: Contamination Control Strategy & Cross Contamination
- The view of EMA
- The view of US-FDA
- Shared facilities regulations
- Contamination and sterile products
Sources of Contamination – Modes of Cross Contamination – Segregation
- Do different sources mean different impact?
- Where cross contamination could occur and different likelihoods
- Is segregation a no brainer?
- Cross contamination in Biotech
Containment Solutions – Avoiding Exposure – Minimizing Cross Contamination
- Exposure and how to calculate
- Equipment and containment concepts
- Closed product handling
- Sampling
- Material Transfer
- The PDE/ADE concept: how much contamination is allowed?
- Avoiding of cross contamination
- Air born contamination
- Contamination of surfaces
- Verification of the tightness of a containment system
Cross Contamination through poor Organisation
- Organisational points to consider
- The human factor
- The importance of training and motivation
Cross Contamination through poor HVAC Design
- Airborne particles
- Pressure / hygienic zones – maintaining over pressure
- The clean corridor Concept
- Simulation and visualisation of air flow
- Classification of ventilation Systems
- Concepts for HVAC Systems
- Components of AHUs (filters, Duct work, etc...)
- Classification and change of filters
- Control and monitoring strategies
Cross Contamination through poor Equipment Design
- Cleanability of equipment as the key to avoiding crosscontamination
- In-line cleanability? – Cleanability for parts that are disassembled?
- Importance of drainability (cross-contamination by product and detergent residues)
- Gap-free and dead-space-free design of system components
- Components (connections, valves, pumps, sensors)
- Mixing and preparation vessels, bioreactors
- Cross-contamination due to lack of technical support
- Deterioration of surface Quality
- Wear of static and dynamic seals
Cleaning & Cleaning Validation
- Poor Cleaning – main reason for cross contamination
- Dealing with multipurpose strategies in cross contamination Control
- Cross Contamination – main focus of cleaning validation
Documentation: CCS, HBEL assessment, QRM
- Cross contamination control and CCS
- HBEL – from the environmental risk to patient’s risk
- Cross contamination control – it is all about QRM
CONCEPT HEIDELBERG GmbH
Rischerstraße 8
69123 Heidelberg
Deutschland
Telefon: +49 6221 844415
Telefax: +49 6221 844464
eMail: info@concept-heidelberg.de
Internet: http://www.gmp-navigator.com/
