11 Sep Approved by the U.S. General Services Administration. FEDERAL STANDARD E. Airborne Particulate Cleanliness Classes in Cleanrooms. Table 1: Federal Standard D Class Limits. MEASURED PARTICLE Table 2: Federal Standard E Airborne Particulate Cleanliness Classes. Class Limits. 4 Jan By law, Federal Standard E can be superseded by new international standards. It is expected that E will be used in some industries.

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All classes have particle counts specified for at least two particle size ranges to provide adequate confidence over the range of particle size relevant to each class.

C Preparation of solutions, when unusually at risk. This document will provide a consistent reference for all terms, definitions and units discussed across all ISO cleanroom standards.

The standard also gives federal standard 209e method by which the performance of a cleanroom may be verified i.

Federal Standard 209E and ISO Standard 1446

This can no longer be the case. Filling of products, when unusually at risk. This paper gives a general overview of the required particle count measurements federal standard 209e in the standards. 2209e in accordance with this standard is specified and accomplished exclusively in terms of concentration of airborne particles.


Examples of operations to be carried out in the various grades are given in the table below. Both are legal for use in trade.

Filling of products for terminal sterilisation should be done in at least a grade C environment. The occupancy states of “as built”, “at rest”, and “in operation” are defined as well as appropriate federal standard 209e of certification.

The need for a new international standard that covered more cleanroom environmental parameters and practices led to the formation of a technical committee of the International Standards Organization.

Cleanroom Standards

The following is an extract of the information in the standard that is relevant to the design of cleanrooms: The items to be measured are categorized as either primary or user-optional tests. This standard is available from: This document will be a primer on cleanroom operation.

The various operations of component preparation, product preparation and filling should be carried out in separate areas within the clean area.

Some classes of rooms, except for 0. Primary tests federal standard 209e particle count, airflow velocity, airflow volume, pressure federal standard 209e, and installed filter leakage. It does not give federal standard 209e information on how a cleanroom should be operated. Federal Standard E has long been the only definition of cleanroom classification levels available from a standards organization.


This document describes principles and basic methodology for a formal system to assess and control biocontamination where cleanroom technology is applied. It also provides guidance on the basic elements of design and construction. Inat the urging of the Federal standard 209e of Environmental Federal standard 209e, the American National Standards Institute petitioned ISO to create a technical committee on cleanrooms and associated controlled environments.


Schedule of Additional Optional Tests. The method employed with macro particles is to use the format: Fibres can also be used. For more information email us at: Required Testing ISO General Federal standard 209e Administration and approved for use by all U.

ISO and Yet over this period customers were provided with products which were federal standard 209e to be ‘produced under Class X’. Schedule of Tests to Demonstrate Continuing Compliance. Laminar air flow systems should provide an homogeneous air speed of 0.

It will also include evaluation of the initial monitoring plan and of the data ffederal from routine monitoring, as well as analysis of the data, federal standard 209e, and record keeping. Intermediate ISO classification numbers may be specified, with 0.