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Home , Carmustine, Cytarabine

Dynamic Permeation Device A Guide to Safe Handling of Drugs In order to ensure your maximum protection when In partnership with the Université Catholique de handling cytostatics, Ansell has invested in a totally Louvain, Brussels, Belgium, we have developed new permeation assessment protocol. a unique dynamic permeation device. After dynamic permeation simulation, aliquots of the collecting Because gloves are made to be used under dynamic medium are analysed by LC-MS/MS1 or HPLC-DAD2. physical conditions (stretching, tension, rubbing etc.) some of our products have been tested for cytostatic permeation under the same constraints.

Dynamic permeation device.

The Molecules Tested are the Following

LOD LOQ Analytical (Detection (Quantification Mol. Cytostatic Brand Name Company Method Concentration Limit) Limit) Weight Log P 1 Nutrimon BICNU Almirall-Prodesfarma HPLC-DAD 3.0mg/ml 59.02ng/ml 196.73ng/ml 214.0 1.50 2 Platinol Bristol-Myers Squibb HPLC-DAD 1.0mg/ml 49.70ng/ml 165.67ng/ml 300.1 -2,20 3 Cyclophosph- Endoxan AstaMedica LCMS/MS 20.0mg/ml 1.95ng/ml 31.60ng/ml 261.1 0.60 amide 4 Cytosar Pharmacia & UpJohn LCMS/MS 100.0mg/ml 0.97ng/ml 4.93ng/ml 243.2 -2.50 5 Taxotere Aventis Pharma LCMS/MS 10.0mg/ml 3.11ng/ml 17.32ng/ml 807.8 NA 6 Adriblastina Pharmacia LCMS/MS 2.0mg/ml 35.26ng/ml 55.10ng/ml 543.5 1.30 7 Vepesid Bristol-Myers Squibb HPLC-DAD 20.0mg/ml 63.06ng/ml 210.19ng/ml 588.5 0.60 8 5- Fluoroblastine Pharmacia & UpJohn HPLC-DAD 50.0mg/ml 37.47ng/ml 124.92ng/ml 130.1 -1.00 9 Holoxan AstaMedica LCMS/MS 100.0mg/ml 4.11ng/ml 45.11ng/ml 261.1 NA 10 Campto Aventis Pharma LCMS/MS 20.0mg/ml 16.32ng/ml 30.73ng/ml 586.6 NA 11 Ledertrexate Wyeth Lederle LCMS/MS 25.0mg/ml 1.41ng/ml 12.85ng/ml 454.4 -1.80 The results contained in this brochure are based on laboratory tests, and reflect the best judgement of Ansell at the time of preparation. As the conditions of ultimate use are beyond our control, and because we cannot run permeation tests in all possible environments, these results are advisory only. The data contained herein should not be Ansell invests for your protection and information 12 Ledertepa AstaMedica LCMS/MS 10.0mg/ml 3.06ng/ml 17.36ng/ml 189.2 0.50 construed as a representation or warranty of merchantability. 13 Navelbine Pierre Fabre LCMS/MS 10.0mg/ml 6.48ng/ml 43.72ng/ml 779.9 16.00 ACPP: Ansell Cytostatic Permeation Program 14 Mitomycin C Nycomed Belgium HPLC-DAD 0.4mg/ml 12.80ng/ml 42.50ng/ml 318.0 NA 15 Eloxatin Sanofi-Synthelabo HPLC-DAD 5.0mg/ml 19.00ng/ml 64.00ng/ml 397.3 NA 16 Taxol Bristol-Myers Squibb HPLC-DAD 6.0mg/ml 37.50ng/ml 125.00ng/ml 853.9 NA Ansell Limited 17 Ganciclovir3 Cymevene Roche LCMS/MS 50.0mg/ml 6.00ng/ml 20.00ng/ml 255.2 -1.60 Level 3, 678 Victoria Street Ansell, ® and ™ are trademarks Richmond, VIC 3121 Australia owned by Ansell Limited or one of its affliates. © 2011 Ansell Telephone 61 3 9270 7270 Limited. All rights reserved. 1. LC-MS/MS: Liquid Chromatography Tandem Mass Spectrometry. Facsimile 61 3 9270 7300 Caution: Some of the products featured in this brochure contain 2. HPLC – DAD: High Pressure Liquid Chromatography – Diode Array Detection. [email protected] natural rubber latex which may In partnership with the Université Catholique de Louvain

3. Anti-viral drug. MKTPRO419V1 www.medical.ansell.com.au cause allergic reactions. Brussels – Belgium Surgical Gloves Examination Gloves Dynamic permeation levels based on ACPP versus The ACPP those allowed by the existing norms Gammex® PF Gammex® PF Gammex® PF Encore® ® ® ® ™ ® ® ® ® One of the most frequently used treatments for cancer is chemotherapy. Unfortunately, it is well known that cytostatic Gammex PF Gammex PF HydraSoft Micro-Thin IsoDerm Orthopaedic Micro-Touch Micro-Touch Micro-Touch Practical example DermaPrene® (INRL) (NRL) (NRL) (PI) (NRL) DermaClean® Affinity® NitraTex® agents are potentially hazardous for healthcare professionals who are handling them. The Ansell Cytostatic Permeation Glove: Gammex PF latex powder free surgical glove. Program (ACPP) is an investment we make for your protection and information. Carmustine 4 6 3 6 3 6 2 6 3 Cytostatic drug: . Cisplatin 6 6 6 6 6 6 6 6 6 Permeation time: 30 minutes. Cyclophosphamide The ACPP is an internal program Ansell has developed in addition to standard tests with chemotherapy drugs in 6 6 6 5 6 6 6 5 6 Cytarabine accordance with the ASTM (the American Standard for Testing Materials) and D6978-05 standard (the Standard Practice 6 6 6 6 6 6 4 6 6 • Maximum permeation level allowed by EN374-3: 1μg/ for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs Methodology, which is a global Docetaxel 6 6 6 6 6 6 6 5 6 (cm2 X minutes). recognised standard for this measurement). Doxorubicin 6 6 6 5 6 6 4 6 6 • Dynamic permeation level according to ACPP testing Etoposide 6 6 6 6 6 6 4 6 6 procedure: 0,00009μg/(cm2 X minutes). 5-Fluorouracil 6 6 6 6 6 6 6 6 6 • Difference: 1,00000/0,00009 = 11.111. Ifosfamide 6 6 6 6 6 4 6 4 4 ACPP Project Goals Irinotecan 4 4 4 6 5 5 6 4 5 ACPP data show that Gammex PF’s permeation level

• To contribute to better protection for healthcare personnel handling cytostatics. 15 Minutes Methotrexate 6 6 6 6 6 6 6 6 6 to cyclophosphamide after 30 minutes is 11.111 times • To present results corresponding to real life conditions or, better still, to worst case scenarios (dynamic treatment Mitomycin C 6 5 6 5 6 6 inferior to the maximum level that European regulation and cytostatic concentration). Oxaliplatin 6 6 6 6 6 6 allows. • To be innovative and bring very practical answers to our customers. Paclitaxel 6 6 6 6 6 Thiotepa 6 6 5 4 6 6 4 4 6 Permeation levels allowed by the existing norms Vinorelbine 4 6 6 4 6 6 4 4 4 EN374-3: 2003 – non specific 6 6 6 6 6 Permeation: a very complex process • Protective gloves against chemicals and micro Carmustine 3 6 2 4 2 6 2 6 3 organisms. Part 3: Determination of resistance Permeation depends on many parameters and therefore the results obtained cannot be extended to any other material, Cisplatine 6 6 3 4 4 6 6 6 6 to permeation by chemicals. brand or competitive product. Cyclophosphamide 5 5 5 5 4 5 5 5 4 • Limit is 1μg (= 1.000ng)/(cm2 X minutes). Cytarabine 4 5 5 6 5 6 4 6 6 Docetaxel 5 5 5 5 5 5 5 5 5 ASTM F 739-99a (June 1999) – non specific Doxorubicin 6 6 6 5 6 6 4 6 6 • Standard test method for resistance of protective Etoposide 6 6 6 3 6 4 3 6 6 clothing materials to permeation by liquids or gases Glove Cytostatic 5-Fluorouracil 6 6 6 4 6 6 6 6 6 under conditions of continuous contact. Ifosfamide 4 5 4 4 4 4 3 4 4 • Limit is 0.1μg (= 100 ng)/(cm2 X minutes). characteristics characteristics Irinotecan 4 4 4 5 4 5 5 4 5

30 Minutes Methotrexate 5 6 6 5 6 6 6 5 5 ASTM D 6978-05 (April 2006) – specific Contact Time Mitomycin C 4 5 5 5 5 6 • Practice for Assessment of Resistance of Medical Oxaliplatin 6 4 4 5 4 6 Gloves to Permeation by Chemotherapy Drugs. Paclitaxel 4 6 4 4 4 • Limit is 0.01μg (= 10ng)/(cm2 X minutes). Thiotepa 5 4 4 4 5 6 4 4 6 Vinorelbine 4 6 6 4 6 6 4 4 4 Gaciclovir 5 6 5 5 5 Details about analytical conditions are available Room upon request. Exposure Permeation rate Carmustine 3 6 1 3 1 6 2 6 3 time parameters Cisplatine 6 6 3 3 3 6 6 6 6 Cyclophosphamide 5 5 4 4 4 5 4 4 3 Cytarabine 4 5 5 6 5 5 4 6 5 Docetaxel 5 4 5 5 5 5 4 5 5 Doxorubicin 6 5 4 5 5 5 4 6 6 Etoposide 4 3 4 3 4 3 2 6 6 5-Flurouracil 6 6 6 4 6 6 6 4 6 Ifosfamide 4 4 4 4 4 4 3 3 4 Irinotecan 4 4 4 4 4 5 3 4 5 Key

Other Worker 60 Minutes Methotrexate 5 6 5 5 6 5 6 5 5 Mitomycin C 4 5 5 4 5 6 Level 1: above to 10 times below detection limit as per European norm Level 2: 10 to 100 times below detection limit as per European norm Oxaliplatin 4 4 4 5 4 6 Level 3: 100 to 1,000 times below detection limit as per European norm Paclitaxel 4 6 4 4 4 Level 4: 1,000 to 10,000 times below detection limit as per European norm Thiotepa 5 5 4 4 4 6 4 4 5 Level 5: 10,000 to 100,000 times below detection limit as per European norm Vinorelbine 4 5 4 4 4 5 4 4 4 Level 6: >100,000 times below detection limit as per European or no Gaciclovir 4 5 5 5 5 permeation measured