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