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 Class Limits. 4 Jan By law, Federal Standard E can be superseded by new international standards.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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Federal Standard E Cancellation

Optional tests, to be applied at the user’s discretion, are also identified. It is available from: The most recent E version fsderal accepted a metric nomenclature.

Shown in Table 6 is a comparison of the classes given in the standards discussed above. This information had been included in a series of Recommended Practices which are written by the federal standard 209e Institute as has written the Federal Standardnamely the Institute of Environmental Sciences. The intervals between tests are related to the class of room or device and are given later in this manual in that section relating federal standard 209e the validation and testing of cleanrooms.

Cleanroom Testing for Compliance. Required Testing ISO Preparation of solutions, when unusually at risk. Clean areas for the manufacture of sterile products are classified according to federal standard 209e required characteristics of the environment. Intermediate ISO classification numbers may be specified, with 0. Classification of Air Cleanliness. It is accepted that it may not always be possible to demonstrate conformity with particulate standards at the point of fill when filling is in progress, due to the generation of particles or droplets from the product itself.

A working group on metrology and testing methods. Aseptic preparation and filling.

Classification in accordance with this standard is specified and accomplished exclusively in terms of concentration of airborne particles. Because of the number of countries involved and the problems with translation it may be over a year before it is published.


The above information on cleanroom standards have been extracted from the handbook ‘Cleanroom Technology’ written by Bill Whyte. Federal Standard E has federal standard 209e been the only definition of cleanroom classification levels available from a standards organization.

Inat the urging of the Federal standard 209e of Environmental Sciences, the American National Standards Institute petitioned ISO to create a technical committee on cleanrooms and associated controlled environments. Part 0 – General introduction and terms and definitions for cleanrooms and clean air devices. ISO”Classification of Air Cleanliness” Three new classes have been added federal standard 209e the existing standard, Federal Standardtwo cleaner and one dirtier.


Isolator and Blow Fill Technology extract only. It also provides guidance on the basic elements of design and construction. The standard also gives a method by which the performance of a cleanroom may be verified i.

C Federal standard 209e of solutions to be filtered.

The most recent set of standards for Europe has come into operation on the 1 January federal standard 209e It does not give any information on how a cleanroom should be operated. Also given in the specification of Part 1 are other requirements for cleanrooms to comply with.

C Preparation of solutions, when unusually at risk. The table is derived from the following formula: Preparation of components and most products should be done in federal standard 209e least a grade D environment in order to give low risk of microbial and particulate contamination, suitable for filtration and sterilisation. Return to contents Summary of FS E and ISO and -2 The cleanliness fedeeral 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 three additional classes – two cleaner than Class 10 and one beyond than ClassPreparation federal standard 209e solutions and components for subsequent filling.


Grade Examples of operations for aseptic preparations. Normally such conditions are provided by a laminar air flow work station. Part 1 federal standard 209e ‘Specification for cleanrooms and clean air devices’.

The definitions have been drawn together and presented in this section. Many of these documents are at the final voting stage and can be legally used in trade. Additional tests are also specified, to be carried out based on the requirements of this International Standard. ISO Annex B This paper gives a general overview of the required particle count measurements stanfard in federal standard 209e standards.

Met One Product Menu. If these limits are exceeded operating procedures should prescribe corrective action. It also includes a method for specifying a room using particles outside the size range given in the table federal standard 209e.

Federal Standard 209E and ISO Standard 1446

This part also provides a basic introduction to the main parts of the federal standard 209e, particularly for those unfamiliar with cleanrooms or the standard itself. These requirements invoke the test described in ISO for the classification of the cleanroom or clean zone.

ISO Annex B5. Cleanroom and clean air equipment standards have for many years defined classes of cleanliness and how they are to be assessed. The actual text of the standards must be ordered from the appropriate standards organization see Sources and Links.

Schedule of Additional Optional Tests. This incorporates guidance for those drawing up procedures for personnel, operations, cleaning, garments and garment federal standard 209e. The International Standards Organisation is producing such a document. ISO determines the type and frequency of testing required to conform with the standard.