Gloves & Gloving –

Properties &

Selection,

Wednesday 28th

September A SHIELD Scientific Education Program

Introduction

Wearing disposable gloves in the workplace is now common practice

In the last 10 years, the consumption of disposable gloves has increased significantly (e.g. from 1 to 20 billion gloves in US)

Why are gloves used in the pharmacy?o Protect pharmaceutical preparations from

human borne contaminationo Protect pharmacy staff o Protect process and pharmacy staff

The Regulations for

protecting you….(1)

BUT …

o HOW SIGNIFICANT ARE THE PICTOGRAMS DISPLAYED ON THE PRODUCTS?

o DO YOU HAVE ANY IDEA ABOUT THE DIFFERENT REGULATIONS?

o DO YOUR COLLEAGUES HAVE THE RIGHT LEVEL OF PROTECTION?

EN420

EN374-1

EN388

EN374-2

EN374-3

The Regulations for

protecting you….(2)

PPE at Work Regulations, 1992 (relating to PPE at Wo rk Directive 89/656/EEC) + COSHH for hazardous substan ceso Employers obliged to undertake risk assessment of hazards to

employeesPersonal Protective Equipment Regulations, 2002 (re lating to PPE Directive 89/686/EEC) o Manufacturer’s obligations � Protect the wearer

Regulations relating to Directive 93/42/EEC on Medical Devices (MDD).o Manufacturer obligations � Protect the patient

If the principle intended purpose is personal protection, then gloves that are registered according to the PPE

Regulations should be used.

EN455

EN374:2003

How to identify PPE Gloves?

As noted earlier, gloves worn in the pharmacy should be PPE products

o PPE Products must protect the wearer!

PPE Products are classified according to 3 categories of risk

o Category I: Simple Designo Category II: Intermediate design

(products which do not fit into cat 1 or 2)

o Category III: Complex design

How to identify PPE Gloves

How does a category III PPE glove meet the needs for pharmacy staff? o Category III PPE gloves

o Displays a specific CE-Mark with four digits underneath CE mark, identifying Notified Body

o Notified Body audits the production and quality system used by the manufacturer

o For irreversible and mortal risko Cat III disposable gloves typically designed for

protection against chemicals & micro-organismsIf in doubt request supplier to provide Declaration of

Conformity

How to identify PPE Gloves

Category III PPE disposable gloves (Cont.)

o Are tested against the following PPE norms:

o EN420: Protective gloves - General requirements and test methods

o EN388: Protective gloves against Mechanical Risks

o EN374-2: Protective gloves against chemicals and micro-organisms – Part 2: Determination of resistance to penetration

o EN374-3: Protective gloves against chemicals and micro-organisms – Part 3: Determination of resistance to permeation by chemicals

o EN374-1: Protective gloves against chemicals and micro-organisms – Part 1: Terminology and performance requirements

Penetration vs. Permeation

PENETRATION “Penetration refers to the flow of a chemical agent through seams, porous materials, pinholes and other imperfections in the protective glove” (*HSE).

PERMEATION “Chemical permeation is the process by which chemicals flow through the glove material at the molecular level” (*HSE). A breakthrough takes place when the chemical is detected on the other side of the sample.

Penetration as defined by

EN374-2:2003

Based on an inspection levels defined in ISO 2859), manufacturers have to test a defined number of gloves per lot to measure the AQL level for porosityAn AQL 0.65 is better than an

AQL 4.0For PPE Cat. III, the

minimum AQL is 1.5

Level 2 on the pictogram means AQL <1.5

EN374-2

Level 2

EN374-2

INTERPRETATION OF EU

REGULATIONS

EN374-2:2003 is the reference standard for personal protection from microbiological hazardso Based on the water leak or air leak procedure to

demonstrate that gloves offer an effective barrier o NB: EN374-1:2003 Article 3.2 explains that the micro-

organism resistance definition extends only to bacteria and fungi. The test does NOT apply to protection against viruses.

PROTECTION AGAINST VIRUSES

THE VIRUS PENETRATION TEST (ASTM F1671) COULD BE THE RIGHT SOLUTION

PROTECTION AGAINST VIRUSES

Viral Penetration Test

0 50 100 150

Pol io virusHepatitis B

HIVHerpes

PhiX174

Average size in nm

Test Method: ASTM F1671-07 “Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Blood-Borne Pathogens” using the non-hazardous Phi-X174 Bacteriophage as a penetration test systemLimits: No viruses should go throughIndustry standard method: YesTesting: Required for every new glove or glove formulation, and tests are doneon as needed basis. Performed at an outside laboratory such as Nelson Laboratories

Permeation as defined by

EN374-3:2003

EN374 – 3: Determination of resistance to permeation by ChemicalsAssessed by measuring the time for a chemical to breakthrough glove materialTo carry chemical pictogram glovemust meet level 2 on at least3 chemicals from defined listLetters below symbol denotechemicals testedGloves not meeting requirementsbut which pass EN 374 – 2 havethis symbol

ASTM 6978 -05 vs. EN374-3:2003– Which standard

is more appropriate when handling cytotoxics? (1)

Comparison ASTM 6978-05 EN374-3:2003

Test Temperature 35 º Celsius (+/- 2º C) 23 º Celsius (+/-1º C)

Permeation rate0,01 µg/cm²/Min (Test method as

per F 739) 1,0 µg/cm²/Min

ScopeResistance against cytotoxic

drugsResistance against chemicals in

general

Chemicals that need to be tested

9 cytotoxic drugs - 7 are definedand 2 additional chemicals to be selected by test house

12 standard chemicals detailed inEN374-1:2003, with no mention ofcytotoxic drugs. Thus no specificguidance is given on the selectionof cytotoxic drugs.

Area of glove that needs to be tested

Palm or cuff whichever is thethinnest part of the glove & outerside of glove (i.e. that which is incontact with chemical)

Palm area for gloves of homogenous design. Outer surfaceto be in contact with chemical.

ASTM 6978 -05 vs. EN374-3:2003– Which standard is

more appropriate when handling cytotoxics? (2)

240 Min test of Cytotoxic drugs permeation

SHIELDskin™ ORANGE NITRILE™300 sterile

Permeation rate0,01 µg/cm²/Min ASTM6978-05Breakthrough detection time: 240 min

Permeation rate1,00 µg/cm²/Min EN374-3 Breakthrough detection time: 240 min.

Carmustine XBreakthrough after 2 mins

No detection

Dacarbazine X No detection No detection

Doxorubicin HCI X No detection No detection

Cyclophosphamide (Cytotan) X

No detection No detection

Paclitaxel (Taxol) X No detection No detection

Etoposide X No detection No detection

5-Flourouracil X No detection No detection

Thio-Tepa XBreakthrough after 57 mins No detection

Cisplatin X No detection No detection

Dermal Reactions

Irritant Contact Dermatitis (also known as irritation, irritant dermatitis or dermatitis)

Allergic Contact Dermatitis (also known as Type IV, Delayed Hypersensitivity or Chemical Allergy)

Natural Rubber Latex Allergy (also known as Immediate Type Hypersensitivity, Protein Allergy or Type I)

Dermal Reactions

TYPE OF DERMAL REACTION INCIDENCE OF OCCURRENCE

Irritant contact dermatitis

40%-60%**Owenby, 1998

Allergic contact dermatitis

12%**Gibbon, 2001

Natural rubber latex allergy

0.8%-7%** Lebenbom-Mansour, 1997

wears high allergen glove

wears low allergen glove

Theoretical Career Exposure

protein allergen exposure level

20 40 60Age

hives, rhinitis, watery eyes

Retirement

Threshold for Clinical Symptoms – Natural

Rubber Latex Allergy

Glove materials - Elongation and

Tensile Strength (1)

Glove barrier issues – Focus

on vinyl Up to 60% in-use failure rate (Rego & Roley,1999)

Poor chemical resistance propertiesDEHP is a reprotoxin o Carcinogenico Mutagenico Reduces reproductiono PVC medical devices

must be labelled “Containing phthalates”

Nitrile – pros & cons

PROS Good ergonomicsHigh tensile strength Low particle releaseExcellent abrasion resistance Broad chemical resistanceNo latex proteins Static dissipative

CONSPetroleum based – non replenishableHigh modulus Premium materialNot compatible with isolators under negative pressure -prone to tearing at cuff

Latex – pros & cons

PROS Elastic properties (excellent ergonomics) High tensile strength Cost effective Replenishable source Good barrier propertiesLow modulus Thicker versions suitable for isolator use

CONSLatex allergiesPoor ESD properties Low abrasion resistanceTacky natural surface High particle release

Selecting the right glove

1) What is the principal intended purpose: o Personal Protectiono Process Protectiono Patient Protection

2) What is the risko Minimal Risk => PPE Cat I i.e. easily reversibleo Irreversible / mortal risk => PPE CATEGORY III

3) How do I protect my hand from the wearing of gloveso Glove associated irritationo Glove associated Type IV reactionso Glove associated Type I reactions

4) Which material do I select – vinyl, nitrile or latex? o Long cuff preferred for more critical applications o Ensure proper fit