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

Possible Issues

  • Autoclave - no pressure gauge

  • Autoclave - no temperature recorder

  • Autoclave - superheated steam

  • Clean room - pressure differentials

  • Exposure for settle plates

  • Interlocks turned off

  • Rusty Laminar airflow cabinets

  • HEPA filters not checked regularly

There are a number of areas where you might expect to find problems:

Autoclave - no pressure gauge

Autoclave - no temperature recorder

Autoclave - superheated steam

Clean room - pressure differentials

Exposure for settle plates

Interlocks turned off

Rusty Laminar airflow cabinets

HEPA filters not checked regularly

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Última actualización: le 3 mayo 2013