Webinar – Corso Camera Bianca – Clean Room Training – ISO 14644:2015 – Classificazione, Progettazione, Controllo Qualità, Comportamento Operatori [ITALIANO]

Webinar – Corso Camera Bianca – Clean Room Training – ISO 14644:2015 – Classificazione, Progettazione, Controllo Qualità, Comportamento Operatori [ITALIANO]

– Recorded Live Webinar –

Clean Room

Durata: 60 min. + 10 min. Questions Time.

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Descrizione (Start Training Now):

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 delinea le pratiche e le procedure necessarie per gestire il rischio di contaminazione . I primi due della serie sono stati appena aggiornati per tener conto dei più recenti sviluppi tecnologici e delle esigenze del mercato

Questo corso webinar fornisce le informazioni necessarie a comprendere come funzionano le clean room come vengono progettate e come ne viene garantità la conformità agli standard di riferimento.

In particolare affronta i seguenti punti :

  • Nuova norma ISO 14644 : 2015
  • Progettazione Clean Room e costruzione
  • Comportamento del personale
  • Mantenimento della conformità

 Chi beneficierà del Webinar Training (Start Training Now):

  • Responsabile Produzione
  • Controllo Qualità
  • Responsabile Qualità
  • Quality Engineer
  • Regulatory Affairs specialist
  • R&D Engineer
  • Pharmaceutical Engineer
  • Validation Engineer
  • Ingegnere di Processo

 

Requisiti per il rilascio dell’ Attestato:

Gli studenti devono visualizzare l’ intero programma e superare con successo un test a scelta multipla con una valutazione finale  > 80 %. Il Certificato sarà stampabile in formato PDF dopo aver soddisfatto i requisiti.

Il Webinar Online Include:

  • Risposta alle domande sottoposte durante il corso
  • Un test finale.
  • Il rilascio di un attestato per il superamento del test.

 

Live Course Presented and Commented by:

2adc791[1]Alice Ravizza is a Biomedical Engineer, graduated at Politecnico di Milano. She has great and extensive experience in R&D and QA / RA in the biomedical field. She is specialized in supporting Medical Device companies in building up and improve Quality System Management and assure Compliance through all the internal processs. She assist companies during the registration process for CE Mark making sure all the technical documentation is compliant to applicable standards and regulations. She is aswell an experienced Trainer and Lecturer.

Early bird booking Promotion:

Get 25% Off!! –  Send email to info@mdpharmacourses.com to get the discount code.

 

Cleanroom Overview

Cleanrooms can be very large. Entire manufacturing facilities can be contained within a cleanroom with factory floors covering thousands of square meters. They are used extensively in semiconductor manufacturing, biotechnology, the life sciences, and other fields that are very sensitive to environmental contamination.

The air entering a cleanroom from outside is filtered to exclude dust, and the air inside is constantly recirculated through high-efficiency particulate air (HEPA) and/or ultra-low particulate air (ULPA) filters to remove internally generated contaminants.

Staff enter and leave through airlocks (sometimes including an air shower stage), and wear protective clothing such as hoods, face masks, gloves, boots, and coveralls.

Equipment inside the cleanroom is designed to generate minimal air contamination. Only special mops and buckets are used. Cleanroom furniture is designed to produce a minimum of particles and to be easy to clean. Common materials such as paper, pencils, and fabrics made from natural fibers are often excluded, and alternatives used. Cleanrooms are not sterile (i.e., free of uncontrolled microbes);only airborne particles are controlled. Particle levels are usually tested using a particle counter and microorganisms detected and counted through environmental monitoring methods.

Some cleanrooms are kept at a positive pressure so if any leaks occur, air leaks out of the chamber instead of unfiltered air coming in.

Some cleanroom HVAC systems control the humidity to low levels, such that extra equipment (“ionizers”) is necessary to prevent electrostatic discharge problems. Low-level cleanrooms may only require special shoes, with completely smooth soles that do not track in dust or dirt. However, for safety reasons, shoe soles must not create slipping hazards. Access to a cleanroom is usually restricted to those wearing a cleanroom suit.

In cleanrooms in which the standards of air contamination are less rigorous, the entrance to the cleanroom may not have an air shower. An anteroom (known as a “gray room”) is used to put on clean-room clothing. Some manufacturing facilities do not use fully classified cleanrooms, but use some cleanroom practices to maintain their contamination requirements.

Personnel contamination of cleanrooms

In the healthcare and pharmaceutical sectors, control of microorganisms is important, especially microorganisms likely to be deposited into the air stream from skin shedding. Studying cleanroom microflora is of importance for microbiologists and quality control personnel to assess changes in trends. Shifts in the types of microflora may indicate deviations from the “norm” such as resistant strains or problems with cleaning practices.

In assessing cleanroom microorganisms, the typical flora are primarily those associated with human skin (Gram-positive cocci), although microorganisms from other sources such as the environment (Gram-positive rods) and water (Gram-negative rods) are also detected, although in lower number. Common bacterial genera include Micrococcus, Staphylococcus, Corynebacterium, and Bacillus, and fungal genera include Aspergillus and Pencillin.

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