Cross-Contamination

Cross-Contamination

The term cross-contamination refers to product-to-product contamination. It can be through careless sharing of the manufacturing equipment and utensils, sharing of space without proper cleaning, poor production planning and particularly inadequate dust control. It is known that contamination by some potent drugs, even at a very minute level, can cause hyper-sensitivity reaction like anaphylaxis which may even risk the life of the patient under certain clinical circumstances. In the current GMP approach the possibility of cross-contamination with penicillin, steroids and some highly sensitive drugs has become a great concern to all. For instance a very small fraction of population may get severe allergic reaction to penicillin called anaphylactic shock with nominal amounts of penicillin i.e. as low as 0.01 IU with parenteral dosage. In case of oral administration the tolerance limit is higher.

While dealing with a highly sensitive product likes penicillin the recommended approach il having a dedicated manufacturing facilities where the objective is totally isolating such

How can cross-contamination prevent?

Cross-contamination should be avoided by taking appropriate technical or organizational measures, for example:

(a) Carrying out production in dedicated and self-contained areas (which may be required for products such as penicillin's, live vaccines, live bacterial preparations and certain other biological s);

(b) Conducting campaign production (separation in time) followed by appropriate cleaning in accordance with a validated cleaning procedure;

(c) Providing appropriately designed airlocks, pressure differentials, and air supply and extraction systems;

(d) Minimizing the risk of contamination caused by re-circulation or re-entry of untreated or insufficiently treated air;

 (e) Wearing protective clothing where products or materials are handled;

(f) Using cleaning and decontamination procedures of known effectiveness;

(g) Using a “closed system” in production;

(h) Testing for residues;

(i) Using cleanliness status labels on equipment.