The Interpretation of the relative Cytotoxic testing for gloves for the safety of the operator

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2 The Interpretation of the relative Cytotoxic testing for gloves for the safety of the operator Glove Selection factors Standards and guidelines for Gloves Cytotoxic testing

3 BioClean ISO Class 4 100kg Washer Dirty Side ISO5 Washer/Dryer Corridor ISO4 Packing ISO4 Printing

4 Glove Selection Cleanroom Under glove Double glove Isolator Preparation area Stores

5 Glove Properties Protection- Chemically and microbiologically Fit for Purpose Elasticity Material of Composition Tactility Hand Specific/Ambidextrous Colour Sizes Texture Finish Cost

6 Glove Materials Latex Polychloroprene/ Neoprene Exceptional elasticity and latex-like feel Nitrile Good elasticity, high level of chemical protection Vinyl Good ESD properties but poor levels of chemical protection

7 Nitritex - Certification and Standards REGULATORY CERTIFICATIONS ISO 9001 Quality Management ISO Quality for Medical EU Directive 89/686/EEC Article 11b Quality for PPE EU Directive 93/42/EEC MDD 89/686/EEC Article 10 Garments 89/686/EEC Article 10 Gloves UMBERELLA STANDARDS EN 455 Medical Gloves EN Protective clothing EN 420 PPE Gloves General Requirements DETAILED STANDARDS EN Type 5 Protective clothing EN Type 6 Protective clothing EN 374 Permeation and Penetration EN 388 Abrasion, Cut, Puncture and Tear Resistance EN Various Protective clothing type tests

8 EN 374 Permeation and Penetration EN 374 Permeation and Penetration - This standard specifies the capability of gloves to protect the user against chemicals and/or micro-organisms. (3 parts) EN 374-1: 2003 Protective gloves against chemicals and microorganisms Part 1: Terminology and performance requirements EN 374-2: 2003 Protective gloves against chemicals and microorganisms Part 2: Determination of resistance to penetration EN 374-3: 2003 Protective gloves against chemicals and microorganisms Part 3: Determination of resistance to permeation by chemicals

9 Definitions Permeation- is the process by which a chemical moves through a protective material on a molecular level Penetration is defined in EN374 as the movement of a chemical or micro-organism through porous materials, seams, pinholes or other imperfections in a protective glove material on a non-molecular level

10 Cleanroom Gloves Packing Standards Symbols

11 Protection against Chemotherapy Drugs EN 374-3: 2003 Protective gloves against chemicals and micro-organisms- Determination of resistance to permeation of chemicals ASTM D Standard practice for assessment of resistance of gloves to permeation by chemotherapy drugs

12 Differences between the Standards Difference EN 374-3:2003 ASTM D Consequence Thickness of the test specimens Sample has to be taken from the palm of the glove. Sample has to be taken from either the palm or the cuff, whichever is the thinner. The ASTM requirement ensures that the area of greatest risk is assessed. The cuff is usually the thinnest part of any glove, so gloves tested under EN 374 are not challenged as rigorously. Test temperature Test to be conducted at a temperature of 23º ±1ºC. Test to be conducted at a temperature of 35º ±2ºC. The ASTM standard specifies a test temperature that is 2ºC below body core temperature. This means that the gloves are tested at a temperature similar to that of a human hand. Test chemicals Permeation limit Test time A minimum of three chemicals must be used for the test. The chemicals are selected from a pre-defined list of 12. None of the predefined chemicals is a chemotherapy drug. Breakthrough of the test chemical is deemed to have occurred when the permeation rate has reached 1µg/cm 2 /min. The test time is defined (by EN 374-1) as 480 minutes. A minimum of nine chemotherapy drugs must be used for the test. Seven of them are predefined by the standard; the other two must be selected from a predefined list. Breakthrough of the test chemical is deemed to have occurred when the permeation rate has reached 0.01µg/cm 2 /min. The test time is defined as 240 minutes. The EN 374 list of chemicals will not give a representation of how the gloves will perform when challenged by chemotherapy drugs. Users purchasing these gloves for chemo use should be advised to have them tested for suitability. The ASTM test limit is set at 1 / 100 th of the EN 374 limit. This requirement is far more stringent and reflects the potential hazard presented by chemotherapy drugs.* The shorter test time required by ASTM is a relative weakness of the standard.* *Testing commissioned by Nitritex to ASTM D 6978 is routinely modified to extend the test time to 480 minutes and monitoring is continued beyond the 0.01µg/cm 2 /min limit to find the time at which the EN 374 limit of 1µg/cm 2 /min is reached.

13 ASTM D Summary Select 3 gloves for testing against each drug Measure the glove thickness at palm and cuff Take test samples from the thinnest part of the glove (identify the outer surface) Minimum number of test drugs is 9 for each glove type (27 glovesin total) 7 mandatory drugs plus 2 others (list provided) Samples must be tested per test method set out in ASTM F739-a (we extended test period from 4 to 8 hours) Test is completed when breakthrough occurs or at end of test period, whichever occurs first

14 Cytotoxic Permeation Performance Product Name: Product Code: BioClean Ultimate TM BUPS Permeation rate and breakthrough detection time (minutes) Specified limit 0.01 µg/cm 2 /Min 0.1 µg/cm 2 /Min 1.00 µg/cm 2 /Min Cisplatinum (Optional) ND ND ND Carmustine 2 38 ND Cyclophosphamide ND ND ND Doxorubicin Hydrochloride ND ND ND 5-Fluorouracil ND ND ND Methotrexate (Optional) ND ND ND Etoposide ND ND ND Paclitaxel ND ND ND Thio Tepa ND 1.Test method used is ASTM F739-a as required under ASTM D Specific limit 0.01µg/cm²/min is limit as defined under ASTM D Specific limit 1.00µg/cm²/min is limit as defined under EN 374-3: Test period under ASTM D is 4 hours (240 minutes). 5.Test period under EN 374-3: 2003 is 8 hours (480 minutes). 6.Test period extended to 8 hours (480 minutes) for all permeation rates. 7. ND = Denotes no permeation detected during the 480 minute test period.

15 BioClean P-Zero TM Chemical Permeation Performance against IPA based Biocide Product Name: Product Code: Specified limit Klercide BioCide* BioClean P-Zero TM BPZS EN 374-3: µg/cm 2 /Min Not Detected after 480 Minutes 1 EN 374-3:2003 Protective gloves against chemicals and micro organisms. Part three: Determination of resistance to permeation by chemicals * Market Leading Biocidal sterilisation agent

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

17 BioClean Double Gloving System Permeation Against Carmustine Product Name: Product Code: BioClean Ultimate TM & BioClean Emerald TM Double Gloving BUPS & BENS Permeation rate and breakthrough detection time (minutes) Specified limit 0.01 µg/cm 2 /Min 0.1 µg/cm 2 /Min 1.00 µg/cm 2 /Min Cisplatinum (Optional) ND ND ND Carmustine* ND ND ND Cyclophosphamide ND ND ND Doxorubicin Hydrochloride ND ND ND 5-Fluorouracil ND ND ND Methotrexate (Optional) ND ND ND Etoposide ND ND ND Paclitaxel ND ND ND Thio Tepa ND ND ND 1.Test method used is ASTM F739-a as required under ASTM D Specific limit 0.01µg/cm²/min is limit as defined under ASTM D Specific limit 1.00µg/cm²/min is limit as defined under EN 374-3: Test period under ASTM D is 4 hours (240 minutes). 5.Test period under EN 374-3: 2003 is 8 hours (480 minutes). 6.Test period extended to 8 hours (480 minutes) for all permeation rates. 7. ND = Denotes no permeation detected during the 480 minute test period.

18 Permeation Performance Comparison BioClean Ultimate TM Polychloroprene BioClean Emerald TM Nitrile BioClean P-Zero TM Polychloroprene Thick Latex**** Palm thickness (Typical) Test method EN 374-3:2003* EN 374-3:2003* EN 374-3:2003* EN 374-3:2003* Specified Limit*** 1.00 µg/cm²/min 1.00 µg/cm²/min 1.00 µg/cm²/min 1.00 µg/cm²/min Cisplatinum (Optional) >480Min (Class 6) >480Min (Class 6) >480Min (Class 6) > 180 Min (Class 4) Carmustine >480Min (Class 6) >480Min (Class 6) >480Min (Class 6) > 60 Min (Class 3) Cyclophosphamide >480Min (Class 6) >480Min (Class 6) >480Min (Class 6) > 120 Min (Class 4) Doxorubicin Hydrochloride >480Min (Class 6) >480Min (Class 6) >480Min (Class 6) > 180 Min (Class 4) 5-Fluorouracil >480Min (Class 6) >480Min (Class 6) >480Min (Class 6) > 180 Min (Class 4) Methotrexate (Optional) >480Min (Class 6) >480Min (Class 6) >480Min (Class 6) > 180 Min (Class 4) Etoposide >480Min (Class 6) >480Min (Class 6) >480Min (Class 6) Did Not Test Paclitaxel >480Min (Class 6) >480Min (Class 6) >480Min (Class 6) Did Not Test Thio Tepa >480Min (Class 6) >480Min (Class 6) >480Min (Class 6) Did Not Test Table shows the time in minutes, after exposure to the chemical,at which the permeation rate reaches 1.00 μg/cm 2 /Min Nitritex have tested gloves using ASTM ** which has identical methodology to EN374-3:2003 with the following exceptions: 1. ASTM D is developed specifically for the testing of Chemotherapy drugs. EN374-3:2003 is not. 2. ASTM D Tests at 35 degrees Celsius (±1) against 23 degrees Celsius (±1) for EN374-3:2003 giving more realistic in use permeation rate 3. ASTMD Tests chemicals on thinnest part of glove. EN374-3:2003 tests the palm, which is always thicker than the cuff area * EN374-3:2003. Definition: Protective gloves against chemicals and micro organisms. Determination of resistance to permeation by chemicals. ** ASTM D 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

19 Breakthrough detection time (minutes) as per ASTM D Chemo Drug Cisplatin (Optional) BUPS (Polychlo) BPZS (Polychlo) BENS (Nitrile) BUPS & BENS* (Double Gloving System) BNPS (Nitrile) S-BFAP (Polychlo) BNPLS (Nitrile) CleanTough Fabric ND ND ND ND ND NT ND ND Carmustine ND ND Cyclophosphamide ND ND ND ND ND NT ND ND Doxorubicin Hydrochloride ND ND ND ND ND NT ND ND 5-Fluorouracil ND ND ND ND ND NT ND ND Methotrexate (Optional) ND ND ND ND ND NT ND ND Etoposide ND ND ND ND ND NT ND ND Paclitaxel ND ND ND ND ND NT ND ND Thiotepa ND ND

20 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. Check gloves have the correct level of protection

21 Summary Understand the standards and how they impact on the operator for the choice of glove. Check the test results of glove for the application and area to be used. Ensure the Manufacturer conforms with the correct Quality System for the product manufactured.

22 Thank you for your kind attention. Any Questions?