LN Technical Standards, Durability and New products Technical Standards, Durability and New products...
Transcript of LN Technical Standards, Durability and New products Technical Standards, Durability and New products...
LN Technical Standards, Durability and
New products
Dr Rajpal Yadav
WHOPES
Dept. of Control of Neglected Tropical Diseases
Dr Abraham Mnzava Vector Control Unit
Global Malaria Programme
WHO definition of an LN
• An LN is a factory-treated mosquito net that is
expected to retain its biological activity for:
– a minimum number of standard washes under
laboratory conditions ( = 20)
– a minimum period of use under field
conditions (= 3 years)
– LLIN or LN?
Criteria for efficacy of an LN
• After 20 washes, the netting must
produce, in:
• Efficacy criteria cannot be used for quality
control
• Hence the use of physico-chemical criteria
Cone bioassays ≥ 80% mortality and/or ≥ 95% knockdown
Tunnel test ≥ 80% mortality and/or ≥ 90% blood-feeding inhibition
Specifications of an LN
• Denier
• Filament: mono-/multi-filament
• Polymer type: polyester, polyethylene, polypropylene, ...
• Treatment technology
– Coating onto filaments
– Incorporated into filaments
1. Product description
….. specifications of an LN
• Identity test – usually a CIPAC method
• AI Content
– Be from a WHO compliant source
– g AI/kg ±25% (tolerance at ± 20 0C)
mg AI/m2 dose to remain constant, irrespective of denier
– Isomer ratio (range), if required
– Retention/release index
• % values, within a range
• Varies for different polymer/treatment technologies
• Content of synergist (g/kg ±25%)
• Retention/release index of synergist
• Relevant impurities (of manufacture or storage)
2. Active ingredient
3. Physical properties
• Netting mesh size
– Average no. and lowest value of complete holes/cm2
• Dimensional stability of netting to washing
– Not >5% shrinkage/expansion in either
dimensions
• Bursting strength (fabric & seams)
– Minimum & average b.s. (in kPa)
….. specifications of an LN
4. Storage stability
• After storage at elevated temperature, LN shall
comply with:
– Dimensional stability
– Bursting strength
– Wash resistance index
– Isomer ratio, if required
– Any by-products (relevant impurities)
• Temperature conditions:
Temp ± 2 0C 54 50 45 40 35 30
Weeks 2 4 6 8 12 18
….. specifications of an LN
What tests are not part of the
specifications, yet important?
• Flammability test
– 16CFR part 1610 (450 slanted test)
• results to be presented on the package
– EN 1102 (vertical test)
• Mass of netting (GSM)
– Weight in g/m2
– Specify GSM range for quality control
LNs in pipeline
Type Phase Brand Manufacturer
LNs
I Aka Net LN Kuse Lace Co., Japan
Panda Net 2.0 Life Ideas Textiles, China
MiraNet LN A to Z Textile Mills, Tanzania
Olyset Duo LN Sumitomo Chemical, Japan
II Yahe LN Fujian Yamei Industry, China
III DawaPlus 2.0 LN Tana Netting, UAE
Duranet LN Shobikaa Impex, India
LifeNet LN Bayer CropScience, France
Netprotect LN Intelligent Insect Control, France
Olyset Plus LN Sumitomo Chemical, Japan
PermaNet 3.0 LN Vestergaard Frandsen,
Switzerland
Kit for long-lasting
treatment of
mosquito nets
ICON MAXX Syngenta, Switzerland
Durability & flammability • Textile tests
– Fabric weight per unit area (EN ISO 12127)
– Bursting strength (EN ISO 13938-2)
– Bursting strength on seams (EN ISO 13938-2)
– Tear strength, length and width (EN ISO 13937-1)
– Tensile strength, length and width, with and without
hooks (ISO 13934-2)
– Flammability 16 CFR part 1610 and EN 1102
• Survivorship in operational use
Manual on specifications
• Provides the standard process, unified requirements and procedures, harmonized definitions and nomenclature, technical guidelines and standards applicable to pesticides for use in agriculture and public health.
• Developed through the FAO/WHO Joint Meeting on Pesticide Specifications (JMPS) through an open consultative process, including national programmes and representation by industry at JMPS meetings.
Malaria Policy Advisory Committee (MPAC)
Provides independent strategic advice and technical input to WHO for the development of policies related to malaria control and elimination
Malaria Policy Advisory Committee Evidence
Review
Groups
MPAC
RBM: Secretariat,
WGs and SRNs
WHO malaria policy
recommendations and
guidelines
WHO DG MoH and
NMCPs SAGE
JTEG (with
IVB)
VCAG
(with
NTD)
Standing TEG
Chemotherapy
ERG a
ERG b
ERG c
WHO GMP
Secretariat
WHO ROs
WHO COs
Other WHO
departments
Standing TEG
Drug
Resistance &
Containment
Standing TEG
Malaria
Vector
Control
Standing TEG
Surveillance,
Monitoring &
Evaluation
Estimating functional survival of
long-lasting insecticidal nets from field data
Proportional Hole Index to classify
nets into servicable and RRR
(rapid replacement required )
Insecticide retention no need to be
included
Two 75 denier polyester nets, both 3 years old
one serviceable, one "Triple R"
(Photos - Albert Kilian)
LLIN Durability – Recognition by
VCTEG
• Measurement of LLIN durability in
operational conditions using standardized
methods is important
• Better anticipation of the replacement
timing of nets in the field
• Encourage innovation, leading ultimately
towards LLINs with a lower cost per year of
protection
Operationalization of LLIN durability data
• WHOPES to consider including durability
(estimating median survival of LLINs) in the
criteria for LN specifications
• Will be in line with the testing of nets for
insecticide retention and if possible be
integrated into Phase 1 testing.
• However, WHO guidance will be required on
how to handle currently approved products
• Might lead to some LLINs being removed
from the recommended list if they fail to
meet the proposed WHO specifications
Best buy list:
• WHOPES recommendations focus on minimum
acceptable criteria
• the VCTEG recommends the launching of a systematic
system of performance assessment similar to the
successful experience made with Rapid Diagnostic Test
kits (FIND/CDC/WHO testing)
• This would allow purchasers to make a comparative cost-
benefit analysis in their purchasing options
• Ultimately stimulating manufacturers to produce and offer
more durable products with option to periodically
evaluate their newer versions/ products
• Future performance criteria could include insecticide
resistance management properties of candidate LLIN
products.
Call to countries and partners
• Quality field monitoring studies are needed
to inform procurement decisions and timing
the replacement of nets
• Countries and partners therefore need to
mobilize resources for:
– routine monitoring of LLIN durability under
operational use
– implementation research including capacity to
validate such data.