Chemo Gloves For Cytotoxic Drug Preparation & Handling

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Presentation transcript:

Chemo Gloves For Cytotoxic Drug Preparation & Handling Code: BUPS Chemo Gloves For Cytotoxic Drug Preparation & Handling Features Proprietary Co-Polymer 300mm Textured Ideal for double gloving Sterile / Hand Specific Excellent chemical Protection ISO Class 4, EU GMP Class A Latex-free to avoid Type 1 allergies Applications Cleanroom Ideal for Isolator Cuffs Chemotherapy drug preparation Sterile environments Great dexterity

Cytotoxic Permeation Performance Product Name: BioClean UltimateTM Synthetic Product Code: BUPS ASTM D 6978-05 1 ASTM F 739-a 2 EN 374-3:2003 3 Specified limit 0.01 µg/cm2/Min 0.1 µg/cm2/Min 1.00 µg/cm2/Min Cisplatinum (Optional) ND Carmustine 2 38 Cyclophosphamide Doxorubicin Hydrochloride Fluorouracil Methotrexate (Optional) Etoposide Paclitaxel Thio Tepa 47.7 55.6 1 ASTM D 6978-05 – Standard practice for assessment of resistance of medical gloves to permeation by chemotherapy drugs 2 ASTM F 739 – 99a – Standard test method for resistance of protective clothing materials to permeation by liquids or gases under conditions of continuous contact 3 EN 374-3:2003 – Protective gloves against chemicals and micro organisms. Part three: Determination of resistance to permeation by chemicals ND = Permeation not detected during the 480 minute test period.

Chemo Gloves for Cytotoxic Drug Preparation & Handling Code: BENS Chemo Gloves for Cytotoxic Drug Preparation & Handling Features Nitrile 300mm Textured Ideal for double gloving Hand Specific / Sterile Ultra sensitive ISO Class 4, EU GMP Class A Latex and accelerator free to avoid Type 1 & Type 4 allergies Applications Cleanroom Pharmaceutical / Biotec Ideal as an under glove Ideal for delicate work Chemotherapy drug preparation

Cytotoxic Permeation Performance Product Name: BioClean EmeraldTM Nitrile Product Code: BENS ASTM 6978-05 1 ASTM F 739 2 EN 374 3 Specified limit 0.01 µg/cm2/Min 0.1 µg/cm2/Min 1.00 µg/cm2/Min Cisplatinum (Optional) ND Carmustine 12.4 39.2 Cyclophosphamide Doxorubicin Hydrochloride Fluorouracil Methotrexate (Optional) Etoposide Paclitaxel Thio Tepa 30.5 35.2 1 ASTM D 6978-05 – Standard practice for assessment of resistance of medical gloves to permeation by chemotherapy drugs 2 ASTM F 739 – 99a – Standard test method for resistance of protective clothing materials to permeation by liquids or gases under conditions of continuous contact 3 EN 374-3:2003 – Protective gloves against chemicals and micro organisms. Part three: Determination of resistance to permeation by chemicals ND = Permeation not detected during the 480 minute test period.

Double Gloving System. BioClean UltimateTM & BioClean EmeraldTM BioClean Emerald - inner glove 100% Accelerator free & Latex Free Easy double donning facilitated by smooth outer surface Distinctive green colour BioClean Ultimate - outer glove Provides excellent tactility and sensitivity Performs well against chemotherapy drugs 100% Latex free

Permeation Against Carmustine Currently Under Testing Double Gloving System Permeation Against Carmustine Product Name: BioClean UltimateTM & BioCleanTM Emerald Double Gloving Product Code: BUPS & BENS ASTM D 6978-051 ASTM F 739-a 2 EN 374-3:2003 3 Specified limit 0.01 µg/cm2/Min 0.1 µg/cm2/Min 1.00 µg/cm2/Min Cisplatinum (Optional) ND Carmustine* Cyclophosphamide Doxorubicin Hydrochloride Fluorouracil Methotrexate (Optional) Etoposide Paclitaxel Thio Tepa Currently Under Testing 1 ASTM D 6978-05 – Standard practice for assessment of resistance of medical gloves to permeation by chemotherapy drugs 2 ASTM F 739 – 99a – Standard test method for resistance of protective clothing materials to permeation by liquids or gases under conditions of continuous contact 3 EN 374-3:2003 – Protective gloves against chemicals and micro organisms. Part three: Determination of resistance to permeation by chemicals ND = Permeation not detected during the 480 minute test period.

BioClean Emerald & Ultimate (Double Gloving System) Permeation Against Carmustine 5 20 30 35 40 60 70 80 90 240 Time Mins Permeation Rate At 0.01/0.10/1.0 µ/cm2/min ND after 240 Mins Permeation Rate - ND

Berners Cytotoxic Permeation Performance Comparison   BioClean Ultimate BioClean Emerald Berner**** EN 374-3:2003* Specified Limit*** 1.00 µ/cm²/Min Cisplatinum (Optional) >480Min (Class 6) > 180 Min (Class 4) Carmustine > 60 Min (Class 3) Cyclophosphamide > 120 Min (Class 4) Doxorubicin Hydrochloride Fluorouracil Methotrexate (Optional) Etoposide Did Not Test Paclitaxel Thio Tepa Table shows the time in minutes, after exposure to the chemical, at which the permeation rate reaches 1.00 μg/cm2/Min Nitritex have tested gloves using ASTM6978-05** which has identical methodology to EN374-3:2003 with the following exceptions: 1. ASTM D 6978-05 is developed specifically for the testing of Chemotherapy drugs. EN374-3:2003 is not. 2. ASTM D 6978-05 Tests at 35 degrees Celsius (± 1) against 23 degrees Celsius (± 1) for EN374-3:2003 giving more realistic in use permeation rate 3. ASTMD 6978-05 Tests chemicals on thinnest part of glove. EN374-3:2003 tests the palm. * EN374-3:2003. Definition: Protective gloves against chemicals and micro organisms. Determination of resistance to permeation by chemicals. ** ASTM D 6978-05. Definition: Standard practice for assessment of resistance of medical gloves to permeation by chemotherapy drugs *** Nitritex have also conducted testing at 0.1μg/cm2/Min and 0.01 μg/cm2/Min. results can be furnished on request **** Source: Berner. www.berner-international.de. Document: 08th September 2006

Glove Use Outside The Pharmacy Contact with cytotoxic drugs also occurs outside the pharmacy. Primarily: A) when being transported to point of use. B) at point of use. In both instances there is no requirement for sterile gloves, but there remains a requirement for protection against exposure to cytotoxic drugs. For safe handling and administration of cytotoxic drugs outside the pharmacy we can recommend 2 latex-free gloves. These gloves are either: Omega NeoTechTM 240mm length ambidextrous Polychloroprene glove Or Omega NeoTech XPTM 300mm length ambidextrous Polychloroprene glove.

Omega Neotech Features Applications 240mm Textured Ambidextrous Code: ONB Omega Neotech 240mm Textured Ambidextrous 100% Latex free Superior formulation Features Applications Pharmaceutical / Biotec Chemotherapy drug preparation Excellent chemical protection

Omega Neotech XP Features Applications 300mm Textured Ambidextrous Code: ONBXP Omega Neotech XP 300mm Textured Ambidextrous 100% Latex free Superior formulation Features Applications Pharmaceutical / Biotec Chemotherapy drug preparation Excellent chemical protection