close
HSE Science and Research Centre places cookies on your computer to improve our website. These cookies don't collect information that identifies a visitor and are all anonymous. They are used to measure its performance and to provide enhancements to you while using the site.
Mobile Nav Mobile Basket

You are not logged in

Free email notifications

Cytotoxic Drugs

HSE Science and Research Centre are able to offer an analysis service for biological monitoring and surface wipe sampling for cytotoxic drugs.  We have also publsihed a number of papers on the topic. (all are freely available from the links provided).

Mason HJ, Blair S, Sams C, Jones K, Garfitt SJ, Cuschieri MJ, Baxter PJ.  Exposure to antineoplastic drugs in two UK hospital pharmacy units. Ann Occup Hyg. 2005 Oct;49(7):603-10.

Mason HJ, Morton J, Garfitt SJ, Iqbal S, Jones K. Cytotoxic drug contamination on the outside of vials delivered to a hospital pharmacy. Ann Occup Hyg. 2003 Nov;47(8):681-5.

Ziegler E, Mason HJ, Baxter PJ. Occupational exposure to cytotoxic drugs in two UK oncology wards. Occup Environ Med. 2002 Sep;59(9):608-12.

In addition to hospital pharmacies and exposures in healthcare, there is increasing use of cytotoxic drugs in the veterinary sector.  The European College of Veterinary Internal Medicine - Companion Animals (ECVIM-CA) has produced guidelines for preventing occupational and environmental exposure to cytotoxic drugs in veterinary medicine.  Surface wipe testing and biological monitoring may also have roles to play here in assessing the adequacy of control.

Surface wipe testing

Surface wipe testing is a practical means of testing the level of contamination external to enclosures, such as isolators or safety cabinets.  Any such contamination is a possible source of exposure to staff.  A monitoring strategy based on surface wipe testing can help benchmark the combined effectiveness of containment work practices, operating and cleaning procedures in reducing the risk to staff. Any monitoring may be carried out annually or six-monthly using an identical procedure. It can also be used to identify the effect of any implemented changes.

This note details a procedure for determining cytotoxic drug contamination on surfaces.  It is based on monitoring of one or more "marker" drugs that may be used as surrogates of the general level of contamination.   Recently we have reduced the number of high sensitivity analytical methods for cytotoxic drugs due to limited demand.  We now offer platinum for the platino-coordinated drugs such as cis-platin and carboplatin (Pt), cyclophosphamide (CP) and ifosfamide (Ifos).   Analysis of the drugs uses high sensitivity ICP-MS or LC-MS techniques, and the methods were specifically developed for low levels that may be found outside laminar flow cabinets, microbiological safety cabinets or isolators, rather than the level of contamination that may be found inside such enclosures.  Methods for these specific marker drugs have been developed as they are widely used in anti-neoplastics/cytotoxic pharmaceuticals.  The choice of one or more marker drugs to be monitored will depend on the amounts of cytotoxics being routinely used and any specific work practices. It is not necessary to measure all marker drugs.

We recommend wipe testing of defined, measured areas. Any repeat testing should ideally test the same defined area.  Results are expressed as levels of contamination per wipe, which can then be converted to contamination per sq. centimetre or sq. metre.  Details of wipe testing are shown below.

We have an increasing amount of information from various cytotoxic sampling exercises that allow interpretation of the results. Biological monitoring measurements based on urine samples to quantify any absorption are also available for these marker drugs.

Surface samples may be taken from the floor, and other surfaces such as workbenches, desks, fittings etc.  Where samples are taken from will depend largely on the reason for the sampling, and the size and layout of the facility. An appropriate general sampling strategy may be to take samples from two distinct floor areas and one work surface such as desk or bench, depending on layout.  One of the defined floor areas may be directly under the glove ports of an isolator or the front of a safety cabinet.  Other areas such as shelving and areas of pharmacy stores may be tested in some circumstances.

We recommend that sampling is carried out at the end of a working day before any cleaning is carried out and that a note of the amount of marker drug(s) formulated that day is recorded.

We can supply the necessary sampling kits (our standard kit includes 10cm x 10cm template, solvent, wipe, screw-cap bottle, disposable gloves to be worn while sampling and labelling for return of samples to the laboratory). The table below details the procedure. One area may be sampled and the wipe sample tested for various cytotoxic drug combinations - see table below. One blank sample per batch should also be submitted for analysis.  We will include an extra wipe kit with the kits you request - this should be left unopened and submitted with your samples and labelled "blank".  We recommend you contact the laboratory to discuss any aspect of a cytotoxic surface monitoring strategy.

If samples are sent to the laboratory directly after being collected, no special storage conditions are required and samples should be sent by first class post or courier.  If storing samples for up to five days before sending to the laboratory then samples should be refrigerated during storage.  If storing for longer than five days, samples should be frozen prior to despatch although it is not necessary to transport to the laboratory as frozen or refrigerated. It is useful if details of the areas wiped accompany the samples.

Surface

Method for sampling.  Remember to wear disposable gloves while carrying out wipe testing and dispose of gloves appropriately.

 

Floor (large area)

Measure and mark out an area 70cm x 70cm square.  Pour 10ml of the appropriate wetting solvent* in the middle of the area and wipe thoroughly with two of the wipes folded. Wipe the whole area firmly and thoroughly until dry, a third or fourth wipe may be needed to fully dry and clean off the area. Place all the wipes into the screw cap bottle; label accordingly including area wiped

 

Bench/desk/

Floor small area

Measure and mark out an area of 10cm x 10cm (or use template).   Pour 0.5 ml of the appropriate wetting solvent* in the middle of the area or wet a folded wipe with 0.5 ml and wipe thoroughly until the surface appears dry. A second wipe may be needed. Place the wipes into the screw cap bottle and label accordingly, including area wiped.

 

Small surfaces

If possible measure a 4cm x 4cm area. Wet one end of cotton bud with appropriate wetting solvent* and squeeze off any excess. Use to wipe over the identified area. Use dry end of cotton bud to remove any remaining solvent on the surface. Place cotton bud in screw cap bottle and label accordingly

* This is either 10mM bicarbonate or 50% methanol, see table below for test combinations and appropriate wetting solvent for wiping.

Drug measurements - compatible combinations from a single area wipe and solvent to be used:

Wipe solvent supplied

Pt

CP/Ifos

10mM bicarbonate

Yes

Yes

50% methanol

No

Yes

 

Analytical method details:

Parameter

Method

Detection Limit

(ng per wipe)

Precision

Cyclophosphamide

LC-MS/MS

5

17%

Ifosfamide

LC-MS/MS

5

10%

Platins (total)

ICP-MS

0.1

5%

Back to the top