Contamination and Cross Contamination are two different things needs to be controlled in pharmaceuticals .
- Contamination is Spoilage of product with unknown Contaminant
- Cross contamination/Mix up means the product is contaminated with known contaminant like paracetamol is contaminated with aspirin .
In Pharmaceuticals Contamination and Cross Contamination can bring great danger to the life of patients so, Appropriate measures must be taken to prevent contamination and documented evidence must be there to ensure there is no contamination in manufacturing facility
SOURCES OF CONTAMINATION ARE
Contamination
- Manufacturing Equipment
- Cleaning issues
- Airflow issues
- Personnel
- Facility Design
SOURCES OF CROSS CONTAMINATION ARE
- Lack of Training.
- Inappropriate segregation .
- Space limitation
- Proper labeling not done
- Lack of Attention.
Manufacturing facilities should be designed in appropriate way to maintain flow of materials during manufacturing and walls should be free from cracks .
Cross Contamination
Equipment should have non reactive and absorptive surface and in case the equipment is hard to clean it should be Dedicated for particular product like Finger bags of Fluidised bed dryer.
Airborne contaminants like microorganisms could be controlled by using appropriate airlock systems and proper validation of Air handling units .
Training should be imparted on routine basis to all the employees working in area about activity they had to perform.
Cleaning is major contamination factor and should be frequently overlooked proper training should be given to the persons and standard operating procedure of cleaning should be notified to all persons involved in manufacturing activity.
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