Microbial contamination

How to avoid contamintion in regarding: (common sense)

1. Raw materials

2. Premises + environment

3. Processing

4. Personel

Raw material:

reputable suppliers with → store to prevent spoilage + degradation test for pathogens + other contaminant before use

Environment

• Maintaining cleanliness and hygiene in production

• regular sanitation of surfaces, controlling access to sensitive areas

• Synthetic product less bioburden as produced in under GMP, heat while simultaneously killing micro-organism compared to natural products

Processing:

• Apparatus should be sterile/ can reach terminal sterilisation

• Material is cleanable

routinely clean + with clear validation

Personel:

• slow +deliberate movement

if u think there is product is contaminated

1. do some testing - check contamination

what is sterility

COMPLETE absence of ORGANISM - not just microbes

Can a product be partially sterile

NO

Sterility is absolute

What is SAL?

Sterility assurance level

Does SAL have meaning in the context of aseptic processing ?

NO

What is the difference btw sterile and aseptic

sterile → product

Aseptic → procedure

Is aseptic processing a method of sterilisation

NO - aseptic processing is the most challenging

Sterile product should be ….

Terminally sterilised

What could be possible a reason for the lack of sterility ?

• faliicites is unprepreaperd

• Contamination

• Lack of validation

• Poor technique by the person

Where is sterility critical in bulk manufacturing?

Definition: Sterility is critical at all stages, from sourcing raw materials through to the final product,