Standard of Clean Room In Food & Beverage Company

Sterile Environment Technologies practices proper procedures to Decontaminate your Cleanroom, Data Center, and other critical environments. ISO 14644 Standards can be found through IEST, the Secretariat of ISO/TC209. Data Centers What is Federal Standard 209e for Data Centers? The outmoded (replaced by ISO 14644) benchmark for optimum and safe operating levels is compared to Federal Standard 209e for Data Centers at 100,000 particles at .5 microns per cubic foot of air space. Optimum levels for temperature should normally be 70 to 72 degrees Fahrenheit, with humidity levels at 50%. Please note: equipment manufacturers have varying optimum operating levels. Notice: Federal Standard 209E has been replaced with ISO Standard 14644. The first subsection in ISO 14644 (ISO STND. 14644-1) has some unique changes from the old Federal Standard - however they are very similar. This standard is now in effect for critical environments (Cleanrooms, Data Centers, etc.) worldwide. Some companies have been successful with the federal Standard 209E, and may not have switched over yet. It is important for these companies to know the main differences are easy to implement and may not be a costly change. The main differences between Federal Standard 209E and ISO 14644-1 (Testing Standards) are: ISO Establishes 0.1um as the "Standard" Diameter ISO Creates 3 New Cleanliness Classes- 2 "Cleaner" classes (ISO class 1 and ISO class 2) than Federal Standard 209E 1 "Dirtier" Class (ISO Class 9) which is allows more particulate than Fed Standard 209E class 100,000 Allows for discarding of "Outliers" - Federal Standard 209E did not. International Standards for Cleanrooms and Critical Environments International Cleanroom Standards: ISO/TC209 has proposed ten (10) documents which will make up the cleanroom standards. These documents are in their final voting stages and can be legally used in trade. The tables and sections below outline the first seven of these documents in order. ISO-14644-1 Classification of Air Cleanliness Cleanliness class designations and quantity have changed from FS209E (see Table 1). Along with the obvious change to metric measure of air volume, ISO 14644-1 adds three additional classes. (Table 1) Airborne Particulate Cleanliness Classes (same as table above)  Class Number of Particles per Cubic Meter by Micrometer Size  0.1 um  0.2 um 0.3 um  0.5 um  1 um  5 um   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  (Table 2) Comparing FED STD 209E to the new ISO 14644-1. Airborne Particulate Cleanliness Class Comparison  ISO 14644-1  FED STD 209E 1      2     3 1   M1.5 4 10   M2.5 5 100   M3.5 6 1,000   M4.5 7 10,000   M5.5 8 100,000   M6.5 9     ISO-14644-2 Cleanroom Testing for Compliance This document determines the type and frequency of testing required to conform with the standard. Strategic Testing: (Table 1) Schedule of Tests to Demonstrate Continuing Compliance.  Test Parameter Class Maximum Time Interval Test Procedure  Particle Count Test < or = 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 Strategic Testing: (Table 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 ISO-14644-4 Cleanroom Design & Construction This document will be a primer on the design and construction of cleanrooms. It will cover all aspects of the process from design development to startup and commissioning. ISO-14644-5 Cleanroom Operations This document will be an introduction on cleanroom operation. It will cover all aspects of the operation of a cleanroom including entry and exit procedures for equipment and personnel, education and training, cleanroom apparel, and facility issues such as maintenance, housekeeping, monitoring, system failure, etc. ISO-14644-6 Terms, Definitions & Units This document will provide a consistent reference for all terms, definitions and units discussed across all ISO cleanroom standards. ISO-14644-7 Minienvironments & Isolators This document will focus on specialized stand-alone clean spaces including their design, construction, and operations. Home | Contact Us | Disaster Recovery | Data Center Cleaning | Cleanroom Cleaning | Sub Floor Services | Products | Company

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