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Saturday, January 14, 2023

Clean room classification Pharma area classification particle count Required class as per Pharma Dosage forms Tablet Oral Injection

Clean room classification in Pharmaceutical Manufacturing. 

In pharmaceutical industry clean rooms are classified by three Standards, ISO, United States Federal Standard FS 209E, and European Union and WHO Good manufacturing practices Guidelines standards for Clean Room Classification . 

In the Pharma industry both ISO and European Union Guidelines Standard are used in classification of a clean room. 

In 2001 United States Federal Standard FS 209E was cancelled and ISO (International organization of Standers) Standards superseded over that ISO standard, ISO 14644 series of standards are accepted in place of United States Federal Standard FS 209E, still the guidelines limits provided FS 209E are referred in the industry for reference purpose only. 

ISO Standard makes use of the lowest particle size which should be measured to count the particle. In ISO Standard Class 1 or ISO 1 Class area there should not be more than 10 number of particles of size not greater than 0.1 micrometer, per cubic meter of air filtered through HEPA filter

Likewise, for ISO 2 Limit for particle count is not more than 100 particles of size and also there are two more particle sizes that are considered in limit, as not more than 24 particles of particle size 0.2 micrometer and not more than 10 particles of particle size 0.3 micrometer. 

For ISO 3 Limit for particle count is not more than 1000 particles of size not more than of particle size 0.1 micrometer and not more than 237 particles of particle size 0.2 micrometer and not more than 102 particles of particle size 0.3 micrometer. ISO 3 also considers the particle limit of particle size not more than 0.5 micrometer particles not more than 35. 
For ISO 4, ISO 5 and ISO 6 Particle size of 1 micrometer and 5 micrometer is considered as well. 

Federal Standard FS 209E classified clean rooms as Class 1, Class 10, Class 100, Class 1000, Class 10000, Class 100000. It used to consider particle size of 0.5 micron and greater as limit. ISO makes use of various particle sizes for limits. After cancellation of FS 209E, the Class 100 area is equivalent to ISO 5, Class 1000 is equivalent to ISO 6 and Class 10000 is equivalent to ISO 7, Class 100000 is equivalent to ISO 8. 

Currently ISO 14644 series of standards are in use. Detail for the limits is provided in the table below. 
ISO Pharmaceutical area classification

WHO Guidelines area classification
WHO guidelines classify the manufacturing area as Level 1, Level 2, Level 3, Level 4 Level 1 is equivalent to Class 100 or ISO 5 and Level 2 is equal to ISO 6 and Class 1000 Level 3 is equal to ISO 7 And Class 10000 Level 4 is Equal to ISO 8 and Class 1000000. 

European Union Pharma Area Classification: European union guidelines provide pharmaceutical area classification as follows. Class A, Class B, Class C, Class D the European Union Guidelines also give emphasis on qualification of area both at working and at rest condition. Total particle counts of particles greater than or equal to 0.5 Micrometer and 5 microns is measured, both at working as well as at rest condition. 
Grade A is equal to Class 100 or ISO 5 Grade. For a Grade A Clean room to qualify it has to meet particle count limit of 3520 number of particles of size less than 0.5 micrometer both in operation and at rest condition. 
Grade B too is required to meet at working condition limit of particle count of particle size less than 0.5 micrometer to 3520 while at working condition it will go higher to 352000 no’s, also the limit of particles of size less than 5 microns is specified to NMT 2930 for working condition and for at rest limit for particles of size 5 micrometer or lesser is not specified, this has to be set by pharmaceutical manufacturer depending on the process and material handled. Refer below table for Grade C and Grade D.
European Union Pharma Area Class

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