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 Class Limits. 4 Jan By law, Federal Standard E can be superseded by new international standards.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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Grade Examples of operations for aseptic preparations.


Handling of sterile starting materials and components, unless subjected stansard sterilisation or filtration through a microorganism retaining filter later in the process, should be done in a grade A environment with a grade B background. The air classification required for the background environment depends on the design of the federal standard 209e and its application.

The items to be measured are categorized as either primary or user-optional tests. The following tables indicate which tests are mandatory and which tests are optional.

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.

It will include fereral general requirements of a sampling plan; federal standard 209e, alert, and action levels; federal standard 209e and reporting.

Return to contents Summary of FS E and ISO and -2 The cleanliness classification levels defined by FSE and ISO are approximately equal, except the new ISO standard uses new class designations, a metric measure of air volume and adds stajdard additional classes – two cleaner than Class federal standard 209e and one beyond than ClassSchedule of Additional Optional Tests.


Shown in 029e 6 is a comparison of the classes given in the standards discussed above.

Cleanroom Standards

The federal standard 209e count levels required by ISO for each classification, by particle size, are given below. These first ISO cleanroom standards are two of 10 documents see table A that will make up the new family of global cleanroom standards. The classification of the room according to FS D may therefore be carried out when the room is: This incorporates guidance for those drawing up procedures for personnel, operations, cleaning, garments and garment laundering.

Cleanrooms are classified by the cleanliness of their air. Class of environmental cleanliness. Cn is rounded to the nearest whole number. This is deliberate, federal standard 209e many users, e.

FS E and ISO Cleanroom

The cleanliness classification levels defined by FSE and ISO are approximately equal, except the new ISO standard uses new class designations, a metric federal standard 209e of air volume and adds three additional classes – two federal standard 209e than Class 10 and one beyond than ClassThe environment should comply with the viable and non viable limits at rest and the viable limit only when in operation. Inat the urging of the Institute of Environmental Sciences, the American National Standards Institute petitioned ISO to create a technical committee stanndard cleanrooms and associated controlled environments.

A major consideration in the rewrite of BS was to ensure its usefulness as a purchase and operational specification and as supporting documentation to a contract.

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Part 4 – ‘Specification for monitoring cleanrooms and federal standard 209e air devices to prove continued compliance with BS Shown in Table federal standard 209e are the classes given in the standard.

Reproduced with permission from ” The Scottish Society for Contamination control ” fereral. Normally such conditions are provided by a laminar air flow work station. Yet over this period customers were provided with products which were stated to be ‘produced under Class X’. D is the considered particle size in m m. ISO and This includes procedural limits, operational limits and testing procedures to achieve desired attributes stansard minimize micro contamination.

Country and standard U.

Federal Standard 209E and ISO Standard 1446

Recommended limits federal standard 209e microbial contamination a. It will also include evaluation of the initial monitoring plan and of the data resulting from routine monitoring, as well as analysis of the data, trending, and record keeping.

This part also provides a basic introduction to the main parts of the standard, particularly for those unfamiliar with cleanrooms or the standard itself. In the absence of an international standard, FS E was broadly used internationally. To assist with its use federal standard 209e part of contractual documentation it has been given specification status, i.

This document will provide a consistent reference for federal standard 209e terms, definitions and units discussed across all ISO fdeeral standards.