Question 1

What Is a Cleanroom?

Accepted Answer

A cleanroom (or clean room) is a room that has HEPA filtration to remove particles from the air. Cleanrooms are used for manufacturing where high levels of cleanliness and sterility are required. Common applications are medical devices, pharmaceutical and semiconductor manufacturing. The FDA mandates the use of cleanrooms to create GMP manufacturing factories.

Question 2

What Are Cleanrooms Used For?

Accepted Answer

Cleanrooms are used for manufacturing where high levels of cleanliness and sterility are required. Common applications are medical devices, pharmaceutical and semiconductor manufacturing. Cleanrooms use HEPA filters to remove particles from the air.

Question 3

How Clean Is a Cleanroom?

Accepted Answer

Very clean. A class 100 cleanroom has 100 particles per cubic foot. By comparison your typical office space has between 500,000 and 1 million particles per cubic foot. Cleanrooms come in different classes from class 100 to 100,000.

Question 4

When Is A Cleanroom Required?

Accepted Answer

Medical device and pharmaceutical manufacturing requires sterile environments to produce their products. Cleanrooms provide this sterile super clean manufacturing space which reduces the chance of contamination getting in your medicine. Semiconductor manufacturers produce devices with ultra small super dense features. Examples are computer chips for your cell phone or PC. If contamination were to get on the chip during manufacturing, they would not work.

Question 5

¿Qué se debe y qué no se debe hacer en una sala limpia?

Accepted Answer

Do:
- Do wipe down all surfaces on a regular basis to remove contamination.
- Do make sure doors are always closed to maintain positive pressure.
- Do always have all staff were cleanroom suits over their street clothes to prevent bringing contamination into the cleanroom.
Don't:
- Don’t eat or drink in your cleanroom.
- Don’t bring dirty equipment or material into cleanroom – always wipe it down before bringing it in.
- Don’t turn off the HEPA fan filter units – it will take several hours after you turn them back on before the cleanroom is clean again.

Question 6

ISO 5 Cleanroom Specifications?

Accepted Answer

ISO 5 is a super clean cleanroom classification. A cleanroom must have less than 3,520 particles >0.5 micron per cubic meter and 250-300 HEPA filtered air changes per hour. The equivalent FED standard is class 100 or 100 particles per cubic foot. Common applications are semiconductor manufacturing and pharmaceutical filling rooms.

Question 7

ISO 6 Cleanroom Specifications?

Accepted Answer

ISO 6 is a very clean cleanroom classification. A cleanroom must have less than 35,200 particles >0.5 micron per cubic meter and 180 HEPA filtered air changes per hour. The equivalent FED standard is class 1000 or 1000 particles per cubic foot.

Question 8

ISO 7 Cleanroom Specifications?

Accepted Answer

ISO 7 is a common clean cleanroom classification. A cleanroom must have less than 352,000 particles >0.5 micron per cubic meter and 60HEPA filtered air changes per hour. The equivalent FED standard is class 10.000 or 10,000 particles per cubic foot. Common applications are pharmacy USP800 compounding rooms, electronics manufacturing and medical device manufacturing.

Question 9

ISO 8 Cleanroom Specifications

Accepted Answer

ISO 8 is the least clean cleanroom classification. A cleanroom must have less than 35, 200,000 particles >0.5 micron per cubic meter and 20 HEPA filtered air changes per hour. By comparison a typical office space would be 5-10 times more dirty. The equivalent FED standard is class 100,000 or 100,000 particles per cubic foot. Common applications include plastic extrusion for medical devices, e-liquid manufacturing, and nutraceutical packaging.

Question 10

What Does ISO Stand For?

Accepted Answer

ISO is the International Standards Organization. It has created the ISO 4644-1 Cleanroom Standards that describe the allowed number of particles, the allowed size of particles and HEPA filtered air flow changes per hour meet ISO-4, ISO-5, ISO-6, ISO-7, and ISO-8 standard. It relies on measurements per cubic meter. It corresponds to the USA based Fed Standard 209E which relies on measurements per cubic foot. Fed Standard 209E corresponding classes are 10, 100, 1000, 10k and 100k.

Question 11

What is Clean Room in Pharma?

Accepted Answer

In pharma a clean room is a controlled environment using HEPA filtration to minimize particulate contamination. Pharmaceutical manufacturers are subject to FDA validation of their manufacturing which typically specify use of a clean room to ensure the quality of the manufactured pharmaceutical product. Sterility is highest priority. Pharma cleanrooms focus on both non viable (inanimate) and viable (live) contamination. They typically use laser particle counters to measure non viable contamination levels and settling plates with culture media to measure viable contamination levels. Pharmaceutical cleanrooms use aggressive chemical and UV light cleaning techniques to maintain sterility.

Question 12

What is a Data Cleanroom?

Accepted Answer

A data cleanroom is a secure isolation virtual platform that typically stores anonymized marketing data from multiple sources. It is used to protect privacy and share data from multiple sources. It is very different from physical cleanrooms used for manufacturing.

Question 13

How Do Cleanrooms Work?

Accepted Answer

Cleanrooms rely on HEPA or ULPA filtration to remove particles from the air and create an ultra clean environment. With sufficient air changes per hour and laminar air flow it is possible to reduce particulate count from greater then 500k/ft3in typical office space to as low as 100/ft3(class 100 cleanroom). Airlocks are used to prevent contamination from entering the cleanroom. Workers inside cleanrooms typically wear cleanroom garments such as booties and bunny suits to prevent them from bringing contamination into the room. Eating and drinking are never allowed in cleanrooms.

Question 14

Who Needs a Cleanroom?

Accepted Answer

Industries such as pharmaceutical, medical device and USP797 compounding pharmacies are required by the government to manufacture in sterile environment and must use cleanrooms. Other industries such as semiconductor, electronics, aerospace and optics find the ultra-clean environments in cleanrooms are the only way to cost effectively manufacture their products. Other industries that use cleanrooms include food, beverage, e-liquid, CBD and vitamins.

Question 15

What is a Pharmaceutical Cleanroom?

Accepted Answer

Pharmaceutical manufacturers are subject to FDA validation of their manufacturing which typically specify use of a clean room to ensure the quality of the manufactured pharmaceutical product. Sterility is highest priority. Pharmaceutical cleanrooms focus on both non viable (inanimate) and viable (live) contamination. They typically use laser particle counters to measure non viable contamination levels and settling plates with culture media to measure viable contamination levels. Pharmaceutical cleanrooms use aggressive chemical and UV light cleaning techniques to maintain sterility.

Question 16

What is a Class 1 Cleanroom?

Accepted Answer

A class 1 cleanroom refers to ISO standard allowing less than 2 particles greater than 0.3 microns and no particles greater than 1.0 microns per cubic meter. A class 1 cleanroom typically has from 500-750 air changes per hour and typically utilizes ULPA filtration. Other common characteristics are 100% ULPA ceiling coverage and raised floors. It is the cleanest classification.

Question 17

What is a Class 2 Cleanroom?

Accepted Answer

A class 2 cleanroom refers to ISO standard allowing less than 11 particles greater than 0.3 microns and no particles greater than 1.0 microns per cubic meter. A class 2 cleanroom typically has 500-750 air changes per hour and typically utilizes ULPA filtration. Other common characteristics are 100% ULPA ceiling coverage and raised floors. It is the 2nd most clean classification.

Question 18

How Many Types of Cleanrooms Are There?

Accepted Answer

The most common type cleanrooms are modular cleanrooms, stick-built cleanrooms (or standard), and softwall cleanrooms. Modular cleanrooms utilize prefabricated modular wall systems which allow for faster installation, easy modification(s) and reasonable cost. Stick built or standard cleanrooms rely on conventional steel stud(s) drywall construction. It can be slightly cheaper. Softwall cleanrooms use clear vinyl curtains suspended from metal frames. Small softwall cleanrooms are often mounted on casters so they can be easily moved around.

Question 19

What is a Class 4 Cleanroom?

Accepted Answer

A class 4 cleanroom refers to ISO standard allowing less than 1020 particles greater than 0.3 microns and less than 2 particles greater than 5.0 microns per cubic meter. A class 5 cleanroom requires from 500-600 air changes per hour and typically utilizes ULPA filtration. Other common characteristics are 100% ULPA ceiling coverage and raised floors. It is the 4th most clean classification.

Question 20

How Do You Prepare For Cleanroom / Installations?

Accepted Answer

If you need an ISO-7 cleanroom you should prepare your facility for the modular cleanroom installation. Check that area is free and clear up to height of cleanroom. Frequently existing electrical conduit, lighting, sprinklers, and HVAC ducting need to be relocated. When installing new cleanroom flooring make sure the existing concrete is in good shape. Have any cracks and depressions filled to level the floor.

Clase	>0.1 um	>0.2 um	>0.3 um	>0.5 um	>5 um	ISO Equivalente
1	35	7	3	1		ISO3
10	350	75	30	10		ISO4
100				100		ISO5
1000				1000	7	ISO6
10,000				10,000	70	ISO7
100,000				100,000	700	ISO8

Clase	>0.1 um	>0.2 um	>0.3 um	>0.5 um	>1 um	>5 um	ISO Equivalente
ISO 1	10	2
ISO 2	100	24	10	4
ISO 3	1,000	237	102	35	8		Class 1
ISO 4	10,000	2,370	1,020	352	83		Class 10
ISO 5	100,000	23,700	10,200	3,520	832	29	Class 100
ISO 6	1,000,000	237,000	102,000	35,200	8,320	293	Class 1,000
ISO 7				352,000	83,200	2,930	Class 10,000
ISO 8				3,520,000	832,000	29,300	Class 100,000
ISO 9				35,200,000	8,320,000	293,000	Room Air

Criterio	Clase 10 ISO4	Clase 100 ISO5	Clase 1000 ISO6	Clase 10,000 ISO7	Clase 100,000 ISO8
Cambios de Aire por HR / Min	500-600 / 8 to 10	300 to 480 / 5 to 8	180 / 3	60 /1	20 /0.33
% de Cobertura por Filtros	90 – 100	60 – 70	20 – 30	7 – 15	4 – 5
CFM por pie Cuadrado	85 – 90	36 – 65	18 – 32	9 – 16	4 – 8
Eficiencia de Filtro	99.9997% ULPAs	99.997% HEPAs	99.997% HEPAs	99.997% HEPAs	99.97% HEPAs
Tipo de Techo	Cielo Raso Barra T Perfil de Aluminio	Cielo Raso Barra T Perfil de Aluminio	Cielo Raso Barra T Perfil de Aluminio	Cielo Raso Barra T Convencional	Cielo Raso Barra T Convencional
Tipo de Accesorio de Iluminación	Para Techos Suspendidos o Empotrados	Para Techos Suspendidos o Accesorio para Cuarto Limpio de 2’x4′	Accesorio para Cuarto Limpio de 2’x4′	Accesorio para Cuarto Limpio de 2’x4′	2’x4’ standard fixture
Panel de Techo	FRP, Vinilo o Mylar	FRP, Vinilo o Mylar	Vinilo o Mylar	>Vinyl rock or Mylar	Vinilo o Mylar
Sistema de Pared	Modular o Construido Estándar	Modular o Construido Estándar	Modular o Construido Estándar	Modular o Drywall	Modular o Drywall
Cubierta de Suelo	Vinilo Laminado Soldado o Epoxi	Vinilo Laminado Soldado o Epoxi	Vinilo Laminado Soldado o Epoxi	Hoja de Vinilo o VCT	Hoja de Vinilo o VCT
Base de Suelo	Cabinas de 2” to 6”	Cóncavas o Canal con Base de Aluminio	Cóncavas o Canal con Base de Aluminio	Cóncavas o Canal con Base de Aluminio	Cóncavas o Canal con Base de Aluminio
Retorno de Flujo de Aire	Piso Elevado o Centro de Retorno de Aire	Pared Baja en Eje Largo	Pared Baja en el Perímetro	Pared Baja	Pared o Techo Bajo

Grade	At Rest >0.5 um/M³	At Rest >5um/M³	Operational >0.5um/M³	Operational >0.5um/M³	Equivalent ISO at rest/operational	Equivalent Fed209E at rest / operational
A	3,520	20	3,520	20	ISO-5/5	100/100
B	3,520	29	352,000	2,900	ISO-5/7	100/10k
C	352,000	2,900	3,520,000	29,000	ISO-7/8	10k/100k
D	3,520,000	29,000	not defined	not defined	ISO-8/na	100k/na

Grade	At Rest >0.5 um/M³	At Rest >5um/M³	Operational >0.5um/M³	Operational >0.5um/M³	Equivalent ISO at rest/operational	Equivalent Fed209E at rest / operational
A	3,520	20	3,520	20	ISO-5/5	100/100
B	3,520	29	352,000	2,900	ISO-5/7	100/10k
C	352,000	2,900	3,520,000	29,000	ISO-7/8	10k/100k
D	3,520,000	29,000	not defined	not defined	ISO-8/na	100k/na

American Cleanroom Systems® Clasificaciones de Cuartos Limpios

US FED STD 209E Estándares de salas limpias | Clasificaciones de salas limpias

ISO 14644-1 Estándares de salas limpias | Clasificaciones de salas limpias

Requisitos de diseño para clasificaciones de salas limpias

GMP Annex European Community Cleanroom Standards

Types of Cleanrooms:

Cuarto limpio modular

Cuarto limpio híbrido

Cuarto limpio de pared blanda

Sala limpia de dispositivos médicos

Sala limpia farmacéutica

Cuarto limpio completamente preconfigurado

Cuarto limpio de fabricación

Laser Cleanroom

Cuarto limpio disipador de estática

Cuarto limpio de E-líquidos

Los cuartos limpios USP797/800

CBD Extraction Cleanroom

Common Cleanroom Standards

Preguntas frecuentes sobre Cuartos limpios de bahía alta

P: ¿Qué es una sala limpia?

P: ¿Qué es importante para los productos certificados para cuartos limpios?

P: ¿Qué tan limpia es una sala limpia?

P: ¿Cuándo se requiere una sala limpia?

P: ¿Qué significa ISO?

P: ¿Qué es un cuarto limpio farmacéutico?

P: ¿Qué es un cuarto limpio de datos?

P: ¿Cómo funcionan los cuartos limpios?

P: ¿Quién necesita un cuarto limpio?

P: ¿Qué es un cuarto limpio en la industria farmacéutica?

P: ¿Qué es un cuarto limpio de clase 1?

P: ¿Qué es un cuarto limpio de clase 2?

P: ¿Cuántos tipos de cuartos limpios existen?

P: ¿Qué es un cuarto limpio de clase 4?

Q: How Do You Prepare For Cleanroom / Installations?

¿Qué se debe y qué no se debe hacer en una sala limpia?

Hacer:

Don't:

Especificaciones de sala limpia ISO

Planificación