Prevention of Cross-contamination in Production

1. Contamination of a starting material or of a product by another material or product must be avoided. This risk of accidental cross-contamination arises from the uncontrolled release of dust, gases, vapours, sprays or organisms from materials and products in process, from residues on equipment, and from operators’ clothing. The significance of this risk varies with the type of contaminant and of product being contaminated. Amongst the most hazardous contaminants are highly sensitising materials, biological preparations containing living organisms, certain hormones, cytotoxics and other highly active materials. Products in which contamination is likely to be most significant are those administered by injection, those given in large doses and/or over a long time.

2. Cross-contamination should be avoided by appropriate technical or organisational measures, for example:
(a) production in segregated areas (required for products such as penicillins, live vaccines, live bacterial preparations and some other biologicals), or by campaign (separation in time) followed by appropriate cleaning;
(b) providing appropriate air-locks and air extraction;
(c) minimising the risk of contamination caused by recirculation or re-entry of untreated or insufficiently treated air;
(d) keeping protective clothing inside areas where products with special risk of cross-contamination are processed;
(e) using cleaning and decontamination procedures of known effectiveness, as ineffective cleaning of equipment is a common source of crosscontamination;
(f) using “closed systems” of production;
(g) testing for residues and use of cleaning status labels on equipment.

3. Measures to prevent cross-contamination and their effectiveness should be checked periodically according to set procedures

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