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USP 1116 and ISO 14698

Many Life Science Industries base their EM programs on USP <1116> Microbiological Control and Monitoring of Aseptic Processing Environments or ISO 14698 Cleanrooms and associated controlled environments – Biocontamination control.

  • Alert and action Levels

    • Alert and Action Levels can be derived from various sources:

    USP <1116>:  Suggested Initial Contamination Recovery Rates

    Room
    Classification

    Active Air
    Samples (%)

    Settle Plate
    (%)

    Contact Plate
    or Swab (%)

    Glove or
    Garment (%)

    ISO 5

    > 1

    > 1

    > 1

    > 1

    ISO 6

    > 3

    > 3

    > 3

    > 3

    ISO 7

    > 5

    > 5

    > 5

    > 5

    ISO 8

    > 10

    > 10

    > 10

    > 10

    USP takes a percentage over all growth approach due to the variation in microbial counts and the vagueness of what a colony forming unit actually means (see USP <61>)

    Other sources offer an easier cfu/plate type limit:

    FDA Guidance for Industry:  Sterile Drug Products Produced by Aseptic Processing – cGMP

    ISO Designation

    Active Air Action
    Levels (cfu/m3)

    Surface Sample
    (cfu/plate)

    5

    1

    1

    6

    7

    3

    7

    10

    5

    8

    100

    50

European Union Annex 1: Manufacture of Sterile Medicinal Products

Grade

Air Sampler
(cfu/m3)

Settle Plates
(cfu/90 mm
plate/4 hours)

Contact Plates
(cfu/55 mm
plate)

Glove Print 5
Fingers
(cfu/glove)

A

> 1

> 1

> 1

> 1

B

10

5

5

5

C

100

50

25

_

D

200

100

50

_

Regardless, Action and Alert levels should be rational, justified, and continuously reassessed and improving.  FOCUS Laboratories can help determine rational Alert and Action levels based on previous historical trends. FOCUS Laboratories utilizes either a histogram approach or a standard deviation approach.  Contact us for more information.

  • Microbial Identification

It is important to know not just how many microbes are in the facility but what type of microbes as well.  FOCUS Laboratories characterizes each colony from a surface or air plate to groups such as Gram Negative rod like, Staphylococcus like, etc, so that the client has some idea of where the contamination is coming from and what the risk is. CLICK HERE for more on Microbial Identification.

However, to determine more precisely what the exact microbes are, FOCUS Laboratories will perform microbial identifications either by biochemical or genetic methods.