This second edition(ISO 14644-1:2015) cancels and replaces the

first edition (ISO 14644-1:1999), which has been technically

revised throughout.
ISO 14644 consists of the following parts, under the general title
Cleanrooms and associated controlled
environments:
— Part 1: Classification of air cleanliness by particle concentration

— Part 2: Monitoring to provide evidence of cleanroom

performance related to air cleanliness by particle
concentration
— Part 3: Test methods

— Part 4: Design, construction and start-up

— Part 5: Operations

— Part 7: Separative devices (clean air hoods, gloveboxes, isolators

and mini-environments)
— Part 8: Classification of air cleanliness by chemical concentration
(ACC)
— Part 9: Classification of surface cleanliness by particle
concentration
— Part 10: Classification of surface cleanliness by chemical
concentration
Attention is also drawn to ISO 14698, Cleanrooms and associated
controlled environments —
Biocontamination control:
— Part 1: General principles and methods

— Part 2: Evaluation and interpretation of biocontamination data

— ISO14644-1 is one of the most used standards in Pharma and Electronics

controlled environments
  ISO 14644-1 specifies classes of air cleanliness in terms of the number of
particles expressed as a concentration in air volume.
 It also specifies the standard method of testing to determine cleanliness
class, including selection of sampling locations.
 Notable areas of change:
Number of Sample Locations
Particle Concentration Limit
Particle Counter Calibration
Table 4. Recommended Limits for Airborne Particle Concentration for
the Monitoring of non-Viable Contamination in the Annex 1 Draft(eu
gmp)

Recommended maximum Recommended maximum

limits limits
Grade for particles ≥ 0.5 μm/m3 for particles ≥ 5 μm/m3

In Operation At Rest In Operation At Rest

А 3 520 3 520 20 20

В 352 000 3 520 2 900 29

С 3 520 000 352 000 29 000 2 900

Set a limit Set a limit

based on based on
D 3 520 000 29 000
the risk the risk
assessment assessment

Table 7. Existing Grades and ISO Classes for air Cleanliness “in
Operation”

EU GMP

  FDA

Grade ISO Class

 Filling – Aseptic A ISO 4,8 ISO 5

Filling – Terminal Sterilization A ISO 4,8 -

Background for Grade A –

B ISO 7 ISO 7
Aseptic

Background for Grade A –

C ISO 8 -
Terminal Sterilization

No control,
Supporting Clean Areas D ISO 8
risk analysis

ISO 14644 IS ACCEPTED BY THE EU GMP IN 2003 FOR CLASSIFICATION

PURPOSE ONLY NOT FOR TESTING.