Training Cleanroom Validation
Purpose
A Cleanroom is a working environment in which air quality and purity are the most important starting points to guarantee contamination in the production process or research. In practice, this means that micro-organisms, fine dust or chemical vapors can affect the quality of the product. To regulate this, Cleanrooms are classified in categories / classes depending on the type of work and air quality. The polluting elements, such as people, raw materials, semi-finished products and the supply of air, determine the polluting particles per m3. In this training we will introduce you to the different types of Cleanrooms, dress code, air locks, HVAC systems, air pressure and turbulent / laminar air flows. In addition to the concept formation, we also introduce you to the ISO regulations (ISO 14644-1 /2 /3 and BS 5295). As a practice, in addition to the changing procedures in the different class of Cleanrooms, we will also focus on drawing up and simulating the implementation of a qualification protocol.
Target Audience
Employees of organizations who work directly or indirectly in Cleanrooms and/or are involved in the validation of these environments. Examples of industries are pharmaceutical, food, semiconductors, biotechnology, optics, research centers, etc.
Intent
This training consists of 2 days and covers the approach, the behavior, the determination for activities, the drawing up of a protocol and the implementation.
Program
· Introduction Cleanroom
· What does GMP regulation say about this
· How do you determine the measurement values
- air volumes
- pressure differences
- filter integrity
- airspeeds
- particle classification
- microbiological sample
- airflow patterns: visualization and registration
- recovery time
- temperature
- relative humidity
- light
- sound
· Write protocol
· Determining the frequency of execution of measurements
· Calculate and document results
Qty participants 8 - 12