Contaminants can gain entry into a production process stream from several sources such as, personnel, poor facility design, incoming ventilation air, machinery and other equipment for production, raw material and semi-finished material, packaging material, Utilities, Different media used in the production process as well as for cleaning and Cleanroom clothing.
This can leads to a whole host of cross contamination risks.
Modes of Cross-Contamination
Product mix up refers to the contamination at unsafe levels of one product with another via inadequate plant and process design or human error. An example of a mix up is a wrong label on a product.
Product carryover refers to the inheritance of the material on product contact surfaces from one product to another in the same equipment used in a sequential or campaign manner. With shared equipment that is cleaned between different materials, material retained in equipment could be carried over into the next product, resulting in cross-contamination.
Physical Transfer
Physical transfer refers to the transfer of material from contaminated non-product contact surfaces into the product. Physical transfer occurs mostly through the movement of personnel with contaminated gowning, contaminated material transfer trolley etc.
Airborne Transfer
Airborne transfer refers to the generation and subsequent movement of a stable aerosol to another area where it is deposited in unsafe quantities on another exposed product. Airborne transfer generally occurs through the air-handling system.
Controls must be set to prevent cross-contamination through any of these routes.
