Antineoplastics surface contamination

Connor, T.H. Anderson, R.W. Sessink, P.J. Broadfield, L. Power, L.A. Surface contamination with antineoplastic agents in six cancer treatment centers in Canada and the united states. AJHP 1999, 56 (14), 1427-1432. 

Categorisation of toxicity according to a REACH compatible approach as well according to NIOSH is dealt with. For categorisation of exposure the Advanced REACH Tool as well as a specific model for pharmacy preparation is discussed. Exposure via surface contamination is well researched for antineoplastic medicines with wipe tests. 

Corrosive substances are most feared because of their direct harmful effect on the skin. Antineoplastics are most feared with regard to absorption via the skin. The skin of operators may be primarily contaminated by the substance, but also secondarily via contaminated surfaces. Contamination of surfaces is very difficult to avoid, so potentially also contamination of skin of operators, cleaners and even staff who are working in adjoining areas (see further Sect. 26.5.4). 

The proposals for threshold values for surface contamination, especially directed at antineoplastics, have been discussed in Sect. 26.5.4. These levels very much depend on the method of sampling and analysis. The establishment of these threshold values are yet on the level of best practices, see also Sect. 26.8. 

The validation exercises should demonstrate that the method delivers conclusions with a high degree of confidence in relation to the intended use of the finished product. Therefore, each study protocol should have clear aims and relevance. For example, if the method for measurement of surface contamination with antineoplastics is found to have a limit of detection of 5 ng/cm, while the intended patient dose is 1,000 mg, one may expect the data generated to meet the purpose of the study. One may question whether a very sensitive and costly HPLC/MS method provides relevant information or that a threshold has to be proposed as part of an AV study. 

Exposure from antineoplastics in hospital pharmacies and wards during reconstitution of parenteral medicines is monitored and evaluated by assessing contamination levels in air, on surfaces or personnel (blood, urine). Publications originate from all over the world, for example in the Netherlands [33-37, 54], in Sweden [55], Germany [56-58], UK [59], Italy [60, 61], France [62-64], US and Canada [65, 66] and Japan [67]. 

When designing an analytical procedure one has to consider the major pharmaceutical objectives in (Quality Control, being methods for identity, purity and assay. Those objectives may require different approaches depending on dosage form or depending on how, where and when the method is applied. Examples which require different considerations include, assays used for a product release decision, in-process controls (IPC) stability testing or measuring contamination of surfaces with antineoplastics. 

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