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

BioClean ISO Class 4100kg Washer “Dirty Side”

ISO4 Packing

ISO5 Washer/Dryer Corridor

ISO4 Printing

Glove Selection

• Cleanroom

– Under glove

– Double glove• Isolator

• Preparation area

• Stores

Glove Properties

• Protection- Chemically and microbiologically

• Fit for Purpose

• Elasticity• Material of Composition

• Tactility

• Hand Specific/Ambidextrous• Colour

• Sizes

• Texture Finish• Cost

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

Nitritex - Certification and Standards

ISO 9001

Quality

Management

ISO 9001

Quality

Management

ISO 13485

Quality for

Medical

ISO 13485

Quality for

Medical

EU Directive

93/42/EEC

MDD

EU Directive

93/42/EEC

MDD

EU Directive

89/686/EEC

Article 11b

Quality for PPE

EU Directive

89/686/EEC

Article 11b

Quality for PPE

89/686/EEC

Article 10

Gloves

89/686/EEC

Article 10

Gloves

89/686/EEC

Article 10

Garments

89/686/EEC

Article 10

Garments

EN 455

Medical Gloves

EN 455

Medical Gloves

EN 420

PPE Gloves

General

Requirements

EN 420

PPE Gloves

General

Requirements

EN 374

Permeation

and

Penetration

EN 374

Permeation

and

Penetration

EN 388

Abrasion, Cut,

Puncture and

Tear Resistance

EN 388

Abrasion, Cut,

Puncture and

Tear Resistance

EN 14325

Protective

clothing

EN 14325

Protective

clothing

EN 13982-1

Type 5

Protective

clothing

EN 13982-1

Type 5

Protective

clothing

EN 13034

Type 6

Protective

clothing

EN 13034

Type 6

Protective

clothing

REGULATORY

CERTIFICATIONS

REGULATORY

CERTIFICATIONS

UMBERELLA

STANDARDS

UMBERELLA

STANDARDS

DETAILED

STANDARDS

DETAILED

STANDARDS

EN Various

Protective

clothing type

tests

EN Various

Protective

clothing type

tests

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

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

Cleanroom Gloves

Packing

Symbols

Standards

Protection against Chemotherapy Drugs

• EN 374-3: 2003 Protective gloves against chemicals and micro-organisms- Determination of resistance to permeation of chemicals

• ASTM D 6978-05 Standard practice for assessment of resistance of gloves to permeation by chemotherapy drugs

Difference EN 374-3:2003 ASTM D 6978-05 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 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.

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.

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.

Permeation limit Breakthrough of the test chemical is deemed to have occurred when the permeation rate has reached 1µg/cm2/min.

Breakthrough of the test chemical is deemed to have occurred when the permeation rate has reached 0.01µg/cm2/min.

The ASTM test limit is set at 1/100th of the EN 374

limit. This requirement is far more stringent and reflects the potential hazard presented by chemotherapy drugs.*

Test time The test time is defined (by EN 374-1) as 480 minutes.

The test time is defined as 240 minutes.

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/cm2/min limit to find the time at which the EN 374 limit of 1µg/cm2/min is reached.

Differences between the Standards

Select 3 gloves for testing against each drugSelect 3 gloves for testing against each drug

Measure the glove thickness at palm and cuffMeasure the glove thickness at palm and cuff

Take test samples from the thinnest part of the glove (identify the outer

surface)

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 gloves in total)Minimum number of test drugs is 9 for each glove type (27 gloves in total)

7 mandatory drugs plus 2 others (list provided)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)

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

Test is completed when breakthrough occurs or at end of test period,

whichever occurs first

ASTM D 6978-05 Summary

Permeation rate and breakthrough detection time (minutes)

Specified limit 0.01 µg/cm2/Min 0.1 µg/cm2/Min 1.00 µg/cm2/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 47.7 55.6 ND

Cytotoxic Permeation Performance

Product Name: BioClean UltimateTM

Product Code: BUPS

1. Test method used is ASTM F739-a as required under ASTM D 6978-05

2. Specific limit 0.01µg/cm²/min is limit as defined under ASTM D 6978-05

3. Specific limit 1.00µg/cm²/min is limit as defined under EN 374-3:2003

4. Test period under ASTM D6978-05 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.

BioClean P-ZeroTM

Chemical Permeation Performance against

IPA based Biocide

EN 374-3:2003 1

Specified limit 1.0 µg/cm2/Min

Klercide BioCide* Not Detected after 480 Minutes

Product Name: BioClean P-ZeroTM

Product Code: BPZS

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

BioClean Double Gloving System

BioClean UltimateTM

& BioClean EmeraldTM

BioClean EmeraldTM - inner glove

• 100% Accelerator-free & Latex-free

• Easy double donning facilitated by smooth outer surface

• Distinctive green colour

BioClean UltimateTM - outer glove

• Provides excellent tactility and sensitivity

• Performs well against chemotherapy drugs

• 100% Latex-free

Product Name: BioClean UltimateTM

& BioClean EmeraldTM

Double Gloving

Product Code: BUPS & BENS

BioClean Double Gloving System

Permeation Against Carmustine

Permeation rate and breakthrough detection time (minutes)

Specified limit 0.01 µg/cm2/Min 0.1 µg/cm2/Min 1.00 µg/cm2/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 6978-05

2. Specific limit 0.01µg/cm²/min is limit as defined under ASTM D 6978-05

3. Specific limit 1.00µg/cm²/min is limit as defined under EN 374-3:2003

4. Test period under ASTM D6978-05 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.

BioClean UltimateTM

Polychloroprene

BioClean EmeraldTM

Nitrile

BioClean P-ZeroTM

Polychloroprene

Thick Latex****

Palm thickness (Typical) 0.14 0.12 0.17 0.41

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

Permeation Performance Comparison

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, 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 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

Breakthrough detection time (minutes) as per ASTM D 6978-

05Chemo Drug BUPS

(Polychlo)

BPZS

(Polychlo)

BENS

(Nitrile)

BUPS &

BENS*

(Double

Gloving

System)

BNPS

(Nitrile)

S-BFAP

(Polychlo)

BNPLS

(Nitrile)

CleanTough™

Fabric

Cisplatin

(Optional)

ND ND ND ND ND NT ND ND

Carmustine 2 50.3 12.4 ND 2.5 89.7 1.70 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 47.7 107.7 30.5 ND 111 5.84 0.52 ND

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

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.

Thank you for your

kind attention.

Any Questions?