Monitoring Method for Surface Contamination
A method of evaluating surface contamination caused by selected antineoplastic agents was studied.
The antineoplastic agents tested were cyclophosphamide, ifosfamide, doxorubicin hydrochloride, fluorouracil, and paclitaxel. Each agent was reconstituted and prepared as a stock solution. A 0.1-mL portion of each solution was spread evenly over a 600-cm2 area of a stainless steel surface, a resin countertop surface, and a vinyl flooring surface. After drying, the surfaces were wiped with each of two types of commercially available wiping materials (Whatman no. 42 filters and Kimberly-Clark Kimwipes). A blend of methanol, acetonitrile, and buffered water was used both as the wetting agent for wiping the surfaces and as a desorbing solution. The desorbate was analyzed for drug concentration by reversephase high-performance liquid chromatography (HPLC).
Mean ± S.D. percent total recovery ranged from 72.4% ± 17.6% to 95.3% ± 2.9% for the vinyl surface wiped with filters, 91.5% ± 5.4% to 104.7% ± 0.8% for the resin surface wiped with filters, 73.9% ± 2.3% to 95.3% ± 1.7% for the stainless steel surface wiped with filters, and 18.2% ± 1.4% to 372.8% ± 8.0% for the stainless steel surface wiped with Kimwipes. Results were best for ifosfamide and cyclophosphamide. Kimwipes were deemed ineffective for this monitoring method because an ingredient interfered with the quantitive analytical tests.
A wipe-sampling, desorption, and HPLC method for monitoring surface contamination by selected antineoplastic agents was sufficiently accurate and sensitive to evaluate surfaces typically found in both the pharmacy and drug administration areas of oncology treatment facilities.
Biological evidence of absorption through the skin exists for several antineoplastic agents. For example, Hirst et al. detected cyclophosphamide in the urine of two nurses who handled the agent, thereby documenting absorption. Hirst et al. also documented skin absorption in human volunteers by using gas chromatography after topical application of the drug. It has been reported that dermal and ingestive routes of entry are more significant than inhalation for a number of these agents. Many are cytostatic drugs that have pharmacologic properties linked to potential genotoxic hazards. Because the mechanisms of interaction of these drugs frequently involve DNA, RNA, or protein synthesis, many have carcinogenic or mutagenic effects. Thus, when conducting a hazard analysis at work sites where antineoplastic agents are used, it is important to assess the presence of surface contaminants, just as it is to evaluate airborne contaminants.
Wipe sampling is a common method of evaluating surfaces for the presence of potentially hazardous agents. This method is also used to evaluate the effectiveness of personal protective equipment (PPE), housekeeping, and decontamination programs. Terms like "swipe sampling" and "smear sampling" are synonymous with wipe sampling, and they all describe the techniques used to assess surface contamination, whether it be on work surfaces, PPE surfaces, or skin.
The objective of this study was to identify an acceptable method of evaluating surfaces for contamination by certain antineoplastic agents. The method had to be able to identify an effective material for wiping surfaces of various types; have acceptable absorption and desorption capabilities, especially for cyclophosphamide (because it is a known carcinogen); and have sufficient sensitivity to detect the agent of interest at low concentrations.
A method of evaluating surface contamination caused by selected antineoplastic agents was studied.
The antineoplastic agents tested were cyclophosphamide, ifosfamide, doxorubicin hydrochloride, fluorouracil, and paclitaxel. Each agent was reconstituted and prepared as a stock solution. A 0.1-mL portion of each solution was spread evenly over a 600-cm2 area of a stainless steel surface, a resin countertop surface, and a vinyl flooring surface. After drying, the surfaces were wiped with each of two types of commercially available wiping materials (Whatman no. 42 filters and Kimberly-Clark Kimwipes). A blend of methanol, acetonitrile, and buffered water was used both as the wetting agent for wiping the surfaces and as a desorbing solution. The desorbate was analyzed for drug concentration by reversephase high-performance liquid chromatography (HPLC).
Mean ± S.D. percent total recovery ranged from 72.4% ± 17.6% to 95.3% ± 2.9% for the vinyl surface wiped with filters, 91.5% ± 5.4% to 104.7% ± 0.8% for the resin surface wiped with filters, 73.9% ± 2.3% to 95.3% ± 1.7% for the stainless steel surface wiped with filters, and 18.2% ± 1.4% to 372.8% ± 8.0% for the stainless steel surface wiped with Kimwipes. Results were best for ifosfamide and cyclophosphamide. Kimwipes were deemed ineffective for this monitoring method because an ingredient interfered with the quantitive analytical tests.
A wipe-sampling, desorption, and HPLC method for monitoring surface contamination by selected antineoplastic agents was sufficiently accurate and sensitive to evaluate surfaces typically found in both the pharmacy and drug administration areas of oncology treatment facilities.
Biological evidence of absorption through the skin exists for several antineoplastic agents. For example, Hirst et al. detected cyclophosphamide in the urine of two nurses who handled the agent, thereby documenting absorption. Hirst et al. also documented skin absorption in human volunteers by using gas chromatography after topical application of the drug. It has been reported that dermal and ingestive routes of entry are more significant than inhalation for a number of these agents. Many are cytostatic drugs that have pharmacologic properties linked to potential genotoxic hazards. Because the mechanisms of interaction of these drugs frequently involve DNA, RNA, or protein synthesis, many have carcinogenic or mutagenic effects. Thus, when conducting a hazard analysis at work sites where antineoplastic agents are used, it is important to assess the presence of surface contaminants, just as it is to evaluate airborne contaminants.
Wipe sampling is a common method of evaluating surfaces for the presence of potentially hazardous agents. This method is also used to evaluate the effectiveness of personal protective equipment (PPE), housekeeping, and decontamination programs. Terms like "swipe sampling" and "smear sampling" are synonymous with wipe sampling, and they all describe the techniques used to assess surface contamination, whether it be on work surfaces, PPE surfaces, or skin.
The objective of this study was to identify an acceptable method of evaluating surfaces for contamination by certain antineoplastic agents. The method had to be able to identify an effective material for wiping surfaces of various types; have acceptable absorption and desorption capabilities, especially for cyclophosphamide (because it is a known carcinogen); and have sufficient sensitivity to detect the agent of interest at low concentrations.