WHO Basic Training Modules on Good Manufacturing Practices (GMP) - Basic Principles of GMP: Module 1 (Part 14): Sterile Pharmaceutical Products
(2006; 62 pages)
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Sterile Production

Sanitation (continued)

  • Limits of detection established

  • Alert and action, and monitoring trends of air quality

Table 1. Limits for microbial contamination (information only)

Grade

Air sample (CFU/m3)

Settle plates (90mm diameter) (CFU/4 hours)

Contact plates (55mm diameter) (CFU/plate)

Glove print (5 fingers) (CFU/glove)

A

< 3

< 3

< 3

< 3

B

10

5

5

5

C

100

50

25

-

D

200

100

50

-

The manufacturer should have alert and action limits, and should monitor the trends of results of air quality.

The table gives some guidance of limits of microbial contamination when samples are taken.

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Última actualización: le 3 mayo 2013