Cleanroom measurement standards

I do not know of any standard that requires a certain number of temperature, humidity or dp readings per M^2. The ISO reference you stated is for airborne particulate ratings but does not describe the need for the measurements you asked about. In my experience these are more process dependent than regulatory. If your process is sensitive to heat then you want to monitor at the point you are processing... Differential pressures are only needed at the point where the process dictates and I do not know what type of process you are dealing with.

What you are looking for is available in ISO standard 14644. hisis standard is applicable to any type of industry. This standard is particularly for non-viable air particulate count only. This standard states the requirments for number of particle permitted in various class of the clean room area. This will also help you in deciding no. of sampling locations depending upon the area of the room, for which a formula is given.

Apart from this if you are looking for total environment monitoring of the area and if you belong to pharma industry than the standard which can help you is EU GMP Annex-I, which state different type of monitoring to be performed. This includes settle plate count, micobial air sampling, surface monitoring. This is basically for monitoring of viable particle counts.

Hi Solrac,

The first question that you are due to do is that application is going to have this cleanroom; hospitable, biological, electronic, etc…, second it is as they are my allowed maximum and minimum parameters, do not to contaminate to means that I am going to work, third is whatever I am available to use in money to obtain the wished results.

If you do not know the subject and is critical its implementation, I suggest to contact with a specialist in Bio-safe, in the end it goes has to be less expensive than to solve a design badly, in the field of engineers in CR4 you are going to find specialist Engineers in biomedicine, there are three enrolled ones, one of them I am, and I can assure to you that it is not only learned reading. A particle accountant can get to cost more than 8.000,00 dollars in EU and single he serves to measure once, whenever it changes to s filters HEPA or ULPA, class ISO 14644 (Standard 209E) single recommends the average of the speed of the air in the fourth clean and whichever air changes per hour, you need the plant of residual water treatment, the control of temperature and humidity, particle accountant in the air sensitivity of 0,001 microns (according to applications), biological filters type UV (germicides - his has formulates), coal filters for scents, filters impregnated in copper and silver nitrate, you are going to use positive or negative pressures, you know so that use is each one, ozone equipment (they are well dangerous), copper conduits for water, conduits of electrical PVC for no smaller to one inch, curved corners, special painting against fungi, static floor, etc., etc…., I forgot, the cleanroom go of degree (I to the IV), I with 25 years of single knowledge commit myself of the I to III, I do not implement the IV, you must have a big money bag or to be part of a very important investigation, or of the government in order to implement a cleanroom one from degree IV.

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La primera pregunta que te debes de hacer es que aplicación va a tener este cuarto limpio; Hospitalario, biológico, electrónico, etc.…, la segunda es cuales son mis parámetros máximos y mínimos permitidos, para no contaminar al medio que voy a trabajar, la tercera es cuanto estoy disponible a usar en dinero para obtener los resultados deseados.

Si no conoces del tema y es crítico su implementación, te sugiero que te contactes con un especialista en bioseguridad, al final va ha ser menos costoso que solucionar un mal diseño, en el campo de ingenieros en CR4 vas a encontrar a Ingenieros especialistas en biomedicina, hay tres inscritos, uno de ellos soy yo, y te puedo asegurar que no se aprende solamente leyendo. Un contador de partículas puede llegar a costar más de 8,000.00 dólares en EU y solo sirve para medir una vez, cada vez que cambia s filtros HEPA o ULPA, la clase ISO 14644 (Standard 209E) solo recomienda el promedio de la velocidad del aire en el cuarto limpio y cuantos cambios de aire por hora, te falta la planta de tratamiento de agua residuales, el control de temperatura y humedad, contador de partículas en el aire sensibilidad de 0.001 micrones (según aplicaciones), filtros biológicos tipo UV (germicidas – tiene su formula), filtros de carbón para olores, filtros impregnados en nitrato de plata y de cobre, vas a usar presiones positivas o negativas, sabes para que uso es cada una, equipos de ozono (son bien peligrosos), conductos de cobre para agua, conductos de PVC para eléctricos no menores a una pulgada, esquinas boleadas, pintura especial contra hongos, piso estático, etc., etc.…, me olvidaba, los cuartos limpios van de grado I al IV, yo con 25 años de conocimiento solo me comprometo del I al III, no implemento el IV, debes de tener un costal de dinero o ser parte de una investigación muy importante, o del gobierno para implementar un cuarto limpio de grado IV.

Best Regards - Grage Tesla

I have a particulate counter and air sampling equipment for sale if needed. ellisd@comcast.net

Thank you all for the information. My main concern is monitoring existing cleanrooms, particularly in the semiconductor industry. While it's a good practice to monitor areas which are critical to production, there must be a standard out there to say which is the correct frequency, location, etc. For example a manufacturer will say that he puts temp sensors every 10m^2, and when a customer audits the facility, the customer will require a sensor every 5m^2. Of course the customer is always right (but not always correct :-0), but similar to a legal case, the letter of the law must be followed. The question is, what is the law (or standard in this case), or does it exist?

I'll check out the standards mentioned - thanks a lot!

I would try GSFCC.org. They have good information. Their newsletter contains information as well. They are Global Society for Contamination Control.

There is a free online tool available for estimating the HEAP filtration needed for specific clean room classifictations. The tool is available at www.rapwall.com and is free to use by anyone. No need to login or sign up or anything. There is use information regarding clean room ISO standards, Air changes Per hour, USP 797, etc.

Good luck

J. P.

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