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Nuovo Live Webinar - Camera Bianca:Nuova ISO 14644:2015, design and construction, compliance

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Camera Bianca : Nuova ISO 14644, design and construction, proof of continuous compliance, personnel behaviour - [ITA] - Recorded Live Webinar -



Descrizione:

Controllare la contaminazione è essenziale in molte attività di produzione e di ricerca.



L'uso di camere bianche, insieme a processi rigorosi e stringenti, lo rende possibile.



ISO ha una serie di norme dedicate alle camere bianche, che delineano le pratiche e le procedure necessarie per gestire il rischio di contaminazione. I primi due nella serie sono stati appena aggiornati per tener conto dei più recenti sviluppi tecnologici e dellle esigenze del mercato.



Questa corso webinar registrato fornisce le linee guida sulle camere bianche con particolare riferimento allo standard. ISO 14644: 2015.



In particolare si discuterà i seguenti punti:



  • Nuova norma ISO 14644: 2015
  • Design e Costruzione di una Camera Bianca
  • Mantenimento della conformità continua
  • Comportamento del personale



    • Why Should You Attend:

    A cleanroom or clean room is an environment, typically used in manufacturing, including of pharmaceutical products or scientific research, with a low level of environmental pollutants such as dust, airborne microbes, aerosol particles, and chemical vapors.



    Food production, pharmaceuticals, aerospace and automotive manufacturing are just some of the many areas where controlled and classified clean rooms are essential. Clean rooms are zones where contaminants in the air are highly controlled. Without effective control, contamination can wreak havoc on products and processes.



    ISO has a series of standards dedicated to clean rooms , outlining the practices and procedures required to manage the risk of contamination. The first two in the series have just been updated to take into account the latest technological developments and market requirements.



    ISO 14644-1:2015, Clean rooms and associated controlled environments – Part 1: Classification of air cleanliness by particle concentration , and ISO 14644-2:2015, Clean rooms and associated controlled environments – Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration , provide the framework for classifying and monitoring the cleanliness of the air in cleanrooms.



    ISO 14644-1:2015 specifies the classification of air cleanliness in terms of concentration of airborne particles in cleanrooms and clean zones ; and separative devices as defined in ISO 14644‑7.Only particle populations having cumulative distributions based on threshold (lower limit) particle sizes ranging from 0,1 µm to 5 µm are considered for classification purposes. The use of light scattering (discrete) airborne particle counters (LSAPC) is the basis for determination of the concentration of airborne particles, equal to and greater than the specified sizes, at designated sampling locations. ISO 14644-1:2015 does not provide for classification of particle populations that are outside the specified lower threshold particle-size range, 0,1 µm to 5 µm. Concentrations of ultrafine particles (particles smaller than 0,1 µm) will be addressed in a separate standard to specify air cleanliness by nano-scale particles. An M descriptor (see Annex C) may be used to quantify populations of macroparticles (particles larger than 5 µm). ISO 14644-1:2015 cannot be used to characterize the physical, chemical, radiological, viable or other nature of airborne particles.



    ISO 14644-2:2015 specifies minimum requirements for a monitoring plan for cleanroom or clean zone performance related to air cleanliness by particle concentration, based upon parameters that measure or affect airborne particle concentration. ISO 14644-2:2015 does not address condition monitoring of aspects such as vibration or general maintenance of the engineering systems. It does not provide for monitoring of particle populations that are outside the specified lower threshold particle-size range, 0,1 µm to 5 µm. Concentrations of ultrafine particles (particles smaller than 0,1µm) will be addressed in a separate standard.