contamination

Question 1

What are the main sources of contamination for pharmaceutical products?

Answer 1

Can people pay bills
1)
Physical – which enters via manufacturing/packaging process such as fibres materials.
2) Pyrogenic – microorganism that can cause fever.
3) Chemical – moisture, gas, vapour molecule contaminates sterile product
4) Biological – virus, bacteria, fungi can cause disease

Question 2

What is cross contamination and how can it arise?

Answer 2

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- When one product contaminates another, when a foreign substance is unintentionally transferred from one drug substance during manufacture to another drug substance.

Personnel
- people performing/supervising manufacturing and packaging processes to not the required standard. i.e lack of training , malpractices (eating)
Facility
- poor design and adequate space which leads to cross contamination and mix up. i.e improper ventilation, lighting, filtration systems.
Material
- Poor quality, handling and control of raw materials. I.e degradation of materials due to environmental conditions, improper handling and storages, using materials that does meet acceptable guidelines.
Manufacturing process
- lack of dedicated production facility for each product, such as the Lack of proper zoning to prevent mix-up and cross contamination.
- Not compliant with hygiene and cleanliness standards, due to insufficient cleaning and maintenance of equipments/materials.