3 Tag Results for cross contamination

Definition - The contamination of a product by materials that are not part of the formulation, from another product. Requirements Changes in EU guidelines are setting quantifiable rules to guard against the risk of product cross contamination. The requirement is that the risks are formally assessed and periodic measurements taken to validate the assumptions made in the assessment. READ MORE.....
The EMA regulations require a risk assessment and also suggests a methodology to be followed. If you don't know what figures are required than you cannot design the facility or the operations. The figure is a total for the contamination by whatever route. Historically the only quantative approach was for cleaning validation. Whatever residues were left on equipment after cleaning were assummed to make their way into the next product that used the equipment. The maximum residues were set at 1/1000th of the minimum theraputic dose (of the contaminant) that was likely to be taken in a maximum does of the following product. READ MORE.....
Leaving aside mix up, where product A is mixed with product B, and mis-labelling where product A is labelled as product B to have cross contamination the active material in Product A has to get into Product B. Three routes for contamination to leave Product A and reach product B are examined and the degree of transfer quantified and evaluated. Obviously the numbers vary according to the scenario that is considered but the figures give an order of magnitude evaluation. READ MORE.....