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Consulting and Engineering

Our consulting department will work with you on your clean room’s design. We will provide solutions according to the industry’s needs: aerospace, medical, pharmaceutical, electronic, food, automotive, optic and others in general.

Definition of clean room:

A room in which the air particle concentration is controlled, and is built and used in a way to minimize the particle introduction, generation and retention within the room as well as other relevant parameters such as temperature, humidity, air floe, air movement, vibration, noise, pressure and lighting, all controlled as per their corresponding specifications.

Our services include:

Clean room design for solid wall, modular or standard, Air Shower, Pass Thrus Air Lock.

Supply of air flow, temperature, humidity and pressure systems

Supply of filtration systems for particle and gas control for air and water

Particle counter, air volume measurement; speed, pressure, temperature and
humidity takes.

Supply of dust collectors for clean areas and pharmaceutical processes.

ISO 14644-1 certification is now the world wide accepted norm to classify the air cleanliness in clean rooms and areas.

ISO Cleanroom Standards


ISO Document

Title

ISO-14644-1

Classification of Air Cleanliness

ISO-14644-2

Cleanroom Testing for Compliance

ISO-14644-3

Methods for Evaluating & Measuring Cleanrooms & Associated Controlled Environments

ISO-14644-4

Cleanroom Design & Construction

ISO-14644-5

Cleanroom Operations

ISO-14644-6

Terms, Definitions & Units

ISO-14644-7

Enhanced Clean Devices

ISO-14644-8

Molecular Contamination

ISO-14698-1

Biocontamination: Control General Principles

ISO-14698-2

Biocontamination: Evaluation & Interpretation of Data

ISO-14698-3

Biocontamination: Methodology for Measuring Efficiency of Cleaning Inert Surfaces

 

ISO 14644-1. Airborne Particulate Cleanliness Classes (by cubic meter).

ISO clasification numbers (N)

Maximum concentration limits (particles/m^3 of air) for particles equal to and larger than the considered sizes shown below

 

0.1 µm

0.2 µm

0.3 µm 

0.5 µm

1 µm 

5.0 µm

ISO 1

10

2

 

 

 

 

ISO 2

100

24

10

4

 

 

ISO 3

1 000

237

102

35

8

 

ISO 4

10 000

2 370

1 020

352

83

 

ISO 5

100 000

23 700

10 200

3 520

832

29

ISO 6

1 000 000

237 000

102 000

35 200

8 320

293

ISO 7

 

 

 

352 000

83 200

2 930

ISO 8

 

 

 

3 520 000

832 000

29 300

ISO 9

 

 

 

35 200 000

8 320 000

293 000

 

ISO 14644-2 determines the type and frequency of testing required to conform with the standard. The following tables indicate which tests are mandatory and which tests are optional.

Required Testing (ISO 14644-2)

 

Schedule of Tests to Demonstrate Continuing Compliance

Test Parameter

Class

Maximum Time Interval

Test Procedure

Particle Count Test

≤ISO 5

6 Months

ISO 14644-1 Annex A

> ISO 5

12 Months

Air Pressure Difference

All Classes

12 Months

ISO 14644-1 Annex B5

Airflow

All Classes

12 Months

ISO 14644-1 Annex B4



Optional Testing (ISO 14644-2)

 

Schedule of Additional Optional Tests

Test Parameter

Class

Maximum Time Interval

Test Procedure

Installed Filter Leakage

All Classes

24 Months

ISO 14644-3 Annex B6

Containment Leakage

All Classes

24 Months

ISO 14644-3 Annex B4

Recovery

All Classes

24 Months

ISO 14644-3 Annex B13

Airflow Visualization

All Classes

24 Months

ISO 14644-3 Annex B7

 

 

   

   


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Mechanical Consulting and Supply Inc.
619.392.3460
info@mechanicalconsultingandsupply.com