Rooms classification

Room Description Work Areas Encompassed in Description Clean Room Classification... 

It is easily understood that if the aseptic operation is performed in a separated small space from which personnel have been completely excluded, the necessity for room classification based on particulate and environmental microbiological monitoring requirements may be significantly reduced. In other words, critical operations in an aseptic area should be performed in the smallest space, and intervention by personnel should be minimized by indirect means through the use of protective glove ports and/or half suits. Application of these methods can minimize the chance of contamination. Following are such systems currently in place to reduce the contamination rate in aseptic processing. 

All of these documents stress a requirement for room classifications according to the concentration of non-viable airborne particles at 0.5 pm and larger. The EU GMPs subordinate classification of the various areas applicable to sterile manufacture according a broader based grading system. Grades A to D are defined in terms of a range of independent characteristics such as the concentration of non-viable airborne particles at two sizes in operational and non-operational conditions, the concentration of airborne... 

Both of the two mandatory sector-specific standards currently require room classification according to Federal Standard 209. This is a U.S. government standard its current revision is FS 209E, " and it will not be automatically replaced by IS 14644. Thus, we are dependent on the next revision of Annex I of the EU GMPs and of the FDA s Guideline on Sterile Drug Products Produced by Aseptic Processin to determine whether they will be adopted for the manufacture of sterile drug products. 

This condition relates to carrying out room classification tests with the normal production process with equipment in operation, and the normal staff present in the room. 

Room classification tests in the at-rest condition should be carried out with the equipment operating where relevant, but without any operators. Because of the amounts of dust usually generated in a solid dosage facility most clean area classifications are rated for the at-rest condition,... 

Clean Room Standards and Room Classification Clean room technology is the most typical feature of aseptic manufacture. The major regulatory sources of guidance to appropriate technology and air standards for aseptic filling [2,3,4]... 

BS 5295 was first published in 1976 its room classification standards were strictly comparable to those of FS 209B except for approximations needed to convert imperial units (FS 209B) to metric units (BS 5295). 

The two Clean Room Standards FS 209 and BS 5295 are referenced in the regulatory documents governing aseptic filling. Table 1 compares the air classifications recommended or required for aseptic filling clean rooms in these pharmaceutical regulatory documents and references the particular Standards cited in support. Strictly speaking, the only options for room classification are the 1976 revision of BS 5295 and the 1973 and 1988 revisions of FS 209. 

Clearly there are issues here that the pharmaceutical industry needs to address. Particles of the smaller sizes specilied for measurement in the Clean Room Standards are not of direct concern to particulate contamination issues facing manufacturers of sterile pharmaceuticals. Furthermore, it is the quality of clean room technology that is the factor of greatest importance to the pharmaceutical industry, of which the attainment of clean room classification is merely an indirect index. In these circumstances a major increase in the amount of testing required to claim compliance with a particular classification offers no benefit to the industry, and may indeed unnecessarily increase testing costs, downtime, etc. 

In some instances the terminology of room classification may be used where it is neither specifically necessary nor specifically correct. The FDA Guideline (2) refers to a "per-cubic-foot particle count of no more than 1(X) in a size range of 0.5 fim and larger (Class 1(X)) when measured not more than one foot away from the worksite and upstream of the air flow. The sampling requirements of the Clean Room Standards may be omitted when superfluous to the purposes of aseptic manufacture. 

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