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ISO Classifications for Sterile Areas

This document provides information on ISO classifications for sterile environments used in pharmaceutical manufacturing. It lists the particle limits and microbiological limits for ISO grades 5 through 8 according to standards set by the US FDA, EU, and PIC/S. The document also includes legacy classifications from previous editions of the ISPE Sterile Product Baseline Guide.

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atif ali
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29 views2 pages

ISO Classifications for Sterile Areas

This document provides information on ISO classifications for sterile environments used in pharmaceutical manufacturing. It lists the particle limits and microbiological limits for ISO grades 5 through 8 according to standards set by the US FDA, EU, and PIC/S. The document also includes legacy classifications from previous editions of the ISPE Sterile Product Baseline Guide.

Uploaded by

atif ali
Copyright
© All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as XLSX, PDF, TXT or read online on Scribd

ISPE Sterile

Product
ISO 5/ ISO 7/
Baseline® Harmonized Designations ISO 6
Grade A Grade B
Guide (Third
Edition)
US FDA [3] ISO Designation
ISO 5 ISO 6 ISO 7
In Operation Maximum no. 0.5 µm
particles particle/ft3 100 1,000 10,000
permitted ≥ the
0.5 µm
stated size
particle/m3 3,520 35,200 352,000
EU [1] and Descriptive Grade
PIC/S [9] Grade A N/A (Note 4) Grade B
In Operation Maximum no. 0.5 µm
particles particle/ft3 3,520 35,200 352,000
permitted ≥ the
0.5 µm
stated size
particle/m3 20 (Note 3) Not Defined 2,900
In Rest Maximum no. 0.5 µm
particles particle/ft3 3,520 Not Defined 3,520
permitted ≥ the
0.5 µm
stated size
particle/m3 20 (Note 3) Not Defined 29
US FDA [3], In Operation Microbiological Active Air <1 7 10
EU [1], and Action Limits, CFU/m3 (Note
PIC/S [9] 5)

ISPE Sterile Legacy ISPE Suggested Classifications Grade 5 Grade 6 Grade 7


Product
Baseline®
Guide (Second
Edition)
ISO 8/ Grade CNC
Grade D
C (Note 1)

N/A (Note
ISO 8 2) N/A
Not
100,000 Not Defined Defined
Not
3,520,000 Not Defined Defined

Grade C Grade D Grade D


Not
3,520,000 Not Defined Defined
Not
29,000 Not Defined Defined
Not
352,000 3,520,000 Defined
Not
2,900 29,000 Defined
100 200 Not
Defined

Grade 8 CNC (with CNC


local
monitoring)
or CNC+

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