Camera Bianca : Nuova ISO 14644, design and construction, proof of continuous compliance, personnel behaviour – [ITA]
– Recorded Live Webinar –
Durata: 60 min. + 10 min. Questions Time.
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:
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.
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.
Who Will Benefit from the Webinar Training:
Students must view the entire program and successfully pass an online, multiple choice final assessment with >80% passing grade.Certificate will be printable in PDF format immediately after satisfying requirements.
Online Training Programs Includes:
Live Course Presented and Commented by:
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.