Summary
Summary Microbiological validation
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Industrial pharmacy - 1st semester Includes bullet points, key diagrams and images
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Microbiological Validation Action of proving (in principles of GMP) that any procedure, process, equipment,
material, activity or system actually and consistently leads to the expected
results
Can apply to manufacturing methods and equipment, operators, cleaning.
Methods, computer systems and analytical techniques
Applied to: manufacture of sterile products, operator techniques in aseptic
preparation, surface sanitation techniques and cleaning methods
Validation
For the manufacturing process and operator technique a sterile liquid broth
media is used
The suggested technique is then applied an the broth incubated to determine
whether it has been contaminated
For sanitation and cleaning processes samples are taken from the surface and
incubated
For cleaning there must be a reduction in the number to a suitable level
For sanitation there must be a complete removal of microbes
Media and Incubation Conditions
Growth media is usually Agar or Tryptone Soya Broth (TSA)
14 day incubation
Incubated at 20-25 or 30-35oC
Efficacy of Disinfectants
Disinfectants- substances applied to non-living objects to destroy microbes
Antiseptics – substances applied to tissue to reduce the chance of infection
European Standard for Fungicidal and Bactericidal Activity- after 5 minutes of
exposure there must be a log 4 (fungi)/log 5 (bacteria) reduction
Process Validation
Statistical using Pr (x>0)=1-(1-P)N
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