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PermaNet® Quality Manual - 2020 PermaNet® 2.0 PermaNet® 3.0 www.permanet.comEdition: November 2019

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1Quality Commitment PermaNet® is designed and produced to be “Fit for Purpose”. PermaNet® long-lasting insecticidal nets (LLINs) meet the customer needs whilst adhering to the established WHO product specifications.

Vestergaard promotes its delivery-with-precision value throughout its supply chain with the implementation of quality tools, control plans and management systems to ensure optimum alignment with the goal to fulfil customers’ requirements.

Vestergaard works towards high quality PermaNet® products with focus on continuous improvements, preventive actions and conformance to certified systems with adherence to relevant international standards.

Production sites and key raw material suppliers are ISO 9001 certified as a minimum requirement. Key laboratories engaged in insecticide analysis and textile testing for quality control are ISO IEC 17025:2017 accredited1. Shipments undergo an acceptance inspection and quality-assurance testing procedure in accordance with ISO 2859 / ISO3951 and WHO guidelines for procuring public health insecticide before they are submitted to the customer 2. Our two manufacturing facilities in Vietnam were inspected by the World Health Organization (WHO) PreQualification team. The facilities were deemed highly compliant against audit requirements. The Public inspection reports are available on the WHO website. https://www.who.int/pq-vector-control/resources/whopir/en/

2 Product Description PermaNet® 2.0 by Vestergaard is made of polyester fabric treated with WHO-approved deltamethrin, using the recognized PermaNet® coating technology. PermaNet® 2.0 was submitted for WHOPES evaluation in 2003, given a full recommendation for malaria prevention and control in 2009, and converted to WHO PreQualification listing in December 2017.

PermaNet® 3.0 PBO net is the world’s first new generation LLIN for use in areas with pyrethroid-resistant malaria vectors. The sides are made from polyester impregnated with WHO-approved deltamethrin using the approved PermaNet® coating technology. The roof is made from polyethylene with deltamethrin and the synergist piperonyl butoxide (PBO), using PermaNet® incorporation technology. PBO works by blocking the metabolic enzymes that mosquitoes use to break down the insecticide, allowing the deltamethrin to kill resistant mosquitoes that are affected by these mechanisms. PermaNet® 3.0 was given an interim recommendation for malaria prevention and control in 2008. In February 2014, the WHO’s Vector Control Advisory Group evaluated and supported the evidence for the product claim and recognized PermaNet® 3.0 as “first-in-class” in a new net category. The product’s WHOPES recommendation was converted to a WHO PreQualification listing in January 2018.

PermaNet® 2.0 and PermaNet® 3.0 are listed in the PreQualification Scheme for Vector Control by the WHO4 (http://www.who.int/pq-vector-control/prequalified-lists/PQT_VC_17July2018.pdf?ua=1; products 005-001 and 005-002).

Customers and suppliers sometimes differ in their definition of quality. Such differences are an invitation to trouble. To most customers, quality means those features of product or service that respond to customer needs. In addition, quality includes freedom from failures, plus good customer service if failures do occur. One comprehensive definition for the above is ‘Fitness for Purpose.’

Joseph M. Juran3

1 ISO IEC 17025 accreditation in Vestergaard Vector control Laboratories covers chemical analysis and textile testing. The accreditation status implies that the results provided from these laboratories are recognized under ILACMRA, accepted in the 36 member countries and economies, including Kenya and South Africa (http://www.ilac.org/members_contact_details.html).

2 Chapter 8. QUALITY CONTROL: PRE-SHIPMENT AND ARRIVAL INSPECTION in WHO Guidelines for procuring Public Health Insecticides.

3 Juran’s Quality Handbook 6 edition. McGraw Hill: Joseph Moses Juran was a 20th century management consultant wh is principally remembered as an “evangelist for quality and quality management”, having written several influential books on these subjects.

https://www.who.int/pq-vector-control/resources/whopir/en/ https://www.who.int/pq-vector-control/resources/whopir/en/ http://www.who.int/pq-vector-control/prequalified-lists/PQT_VC_17July2018.pdf?ua=1http://www.who.int/pq-vector-control/prequalified-lists/PQT_VC_17July2018.pdf?ua=1

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3Vestergaard Quality Management System 3.1 Quality steps in supplying PermaNet® LLINs

Incoming quality control of critical materials Yarn: Denier and tenacity Chemical purity Incoming materials

Extrusion (for Polyethylene roof)

Warping/knitting

Dyeing (for colored nets)

Coating

Cutting/sewing

End of line visual check

Outgoing products

Deltamethrin and PBO contents Yarn denier and tenacity Color shade

Defect number in grey fabric

Colour shade match test

Dimensional stability to washing Bursting strength Mesh count

Netting screened for holes and dirt marks Work in Progress (panel) dimension check

Visual and conformity inspection Dimension control

Quantity inspection Bale size control

Weight (GSM) Deltamethrin content Bioefficacy

MEANUFACTURING PROCESS QUALITY CONTROL

Figure 1. Quality control steps embedded in the PermaNet(r) LLINs manufacturing process

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Customer order is received

Order confirmation is issued

Production runs at ISO 9001 certified manufacturing facilities

Quality control inspection is done on batches of finished products

Meet product specifications?YES

Acceptance testing and inspection (ATI) is done on finished products per order in accordance with ISO2859/ISO3951 and

WHO guidelines for procuring public health pesticides

Meet ATI Criteria?YES

Certificate of conformity or certificate of analysis is issued

Third party quality inspection is done as mandated by the customer (optional)

Customer order is authorized to be shipped

Stuffing inspection by Cotecna

Figure 2. PermaNet® LLINs – Key quality checks from order to shipment

NO

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3.2 Acceptance testing and inspection on finished goods

Vestergaard applies the most widely accepted sampling system, ISO 2859 and ISO 3951, for controlling the quality of the shipment before submitting it to the customer or to a third-party inspection agency. The quality assurance sampling plan fully covers the range of critical characteristics of PermaNet® LLIN products.

Tests are conducted by ISO/IEC 17025:2017 accredited laboratories and/or by WHO collaborating centres.

Figure 3. Analysing deltamethrin content with High Performance Liquid Chromatograph in Vestergaard Vector Control Laboratory in Hanoi, Vietnam

Figure 4. Measuring denier of yarn in Vestergaard Vector Control Laboratory in Hanoi, Vietnam to ensure only the highest quality yarn is used for PermaNet® LLINs production

Figure 5. Measuring bursting strength of finished net in the Acceptance Testing and Inspection scheme

Figure 6. Testing PermaNet® under WHOPES Phase I scheme with Anopheles gambiae s.s. at Vestergaard - NMIMR Vector Labs in Accra, Ghana

Figure 7. Inspection for workmanship and appearance in the Acceptance Testing and Inspection scheme

3.3 Certificate of Conformity Vestergaard provides its customers with a Certificate of Conformity (COC) for each shipment with supporting facts and data provided in the Certificate of Analysis (COA) and the inspection report (IR). An example of a COC is provided in Annex 2.

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4Reference Sample Reference samples representative of every shipment are kept with their full history at the manufacturing unit for a period of its shelf life plus two years.

5 TraceabilityEvery PermaNet® by Vestergaard label bears a batch code that can trace the complete production history including raw material lots, processing history, and detailed quality control data as well as a reference sample.

Figure 8. Example of a PermaNet® Label (front and back)

6CustomerFeedback Vestergaard values customer feedback as an opportunity for improvement. Where justified, Supplier Corrective Action Response (SCAR) is implemented and its follow- up is communicated to customer. Feedback is provided within one week from receipt of a customer request.

Vestergaard handles customer feedback and complaints with responsiveness and values this as an opportunity for improvement to prevent any future occurrences.

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7PermaNet® Service Package A laboratory testing service is provided free of charge to customers under the PermaNet® service package, which covers an evaluation of insecticide content, bioavailability, and assessment of fabric integrity. PermaNet® LLIN products should be sent as a complete net with the original label showing a legible production code. The results of the analysis will be available within four weeks from the date of submission to the nearest Vestergaard office or laboratory.

PermaNet® by Vestergaard is designed to last at least 20 WHO standard washes and 3 years of field use; however, the lifetime largely depends on usage and local field conditions. Vestergaard does not stand liable for differences in the lifetime of PermaNet® with field use, the differences arising primarily due to potentially harsh washing conditions, exposure to UV rays, soiling, etc., under field conditions.

8Post-Market SurveillancePost market surveillance for health products aims to monitor and ensure safety and efficacy of the products in use.

Vestergaard operates a post market surveillance program which cover sampling and testing of LLINs after distribution in the field to monitor and assess the products insecticidal activity in real use conditions.

LLINs samples are collected from communities who received LLINs from distribution campaigns.

The sampling procedure used by Vestergaard to assess physical durability, net survivorship and user acceptability is identical to the one used in WHOPES Phase III study.

Post market surveillance of LLINs can provide chemical content, bioefficacy and other parameters on nets durability during two to three years of use.

9Continuous ImprovementsVestergaard develops long-term cooperation with its suppliers. Quality objectives, tools, environmental health and safety matters are discussed in various working forums such as regular meetings with related quality people, classroom training and on-site workshop trainings.

To engage all employees in the quality effort and to embrace a quality improvement drive, Vestergaard and its raw materials suppliers and manufacturing partners set mutual goals to provide higher value to customers by:

• Maintaining quality attributes and variables measurable, by focusing on process improvement, and taking preventative actions when required;

• Encouraging innovation at all levels of the supply chain.

Post-market surveillance • Net physical status • Net deltamethrin content • Net synergist content • Net bioefficacy

PermaNet ® LLINs distribution

PermaNet ® LLINs distribution

Figure 9. Schematic overview of post market surveillance activities

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10A Responsible Supply ChainVestergaard ensures its suppliers and manufacturing partners act as responsible and ethical companies in strict accordance with Vestergaard Code of Conduct.

Since 2017, Vestergaard manufacturing partners are certified SA8000® for their social accountability. The leading global certification ensures the highest quality standards of social compliance and fair treatment of workers.

Vestergaard also strives to find ways to produce with less usage of water, energy resources, and waste.

PermaNet® manufacturing site located in South Vietnam is accredited ISO14001:2015 since 2017. Vestergaard is also implementing a robust environmental management system at its PermaNet® manufacturing site located in North Vietnam with the goal to obtain the ISO 140001:2015 accreditation by the end of 2020.

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Annexes

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Annex 1: Standard PermaNet® 2.0 by Vestergaard. Product Specification

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Ref. No. P3-SP-01.5 (BU)

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Controlled document. Verify that this is the correct version before use CONFIDENTIAL and PROPRIETARY

PermaNet® 3.0 – Product Specification

No. Quality characteristics Requirement Standard method

Polyethylene roof (PE)

1 Yarn composition 100% polyethylene ISO 1833

2 Fabrication Warp knitted ISO 8388

3 Denier1 of yarn from unraveled fabric 100 D ISO 2060

4 Flammability

After removing the ignition source the following fire phenomena should not occur:

- ignition - propagation of the flame or glow - flaming debris - ignition of the filter paper EN 1102

5 Deltamethrin content Target 4.0 g/kg ± 25% CIPAC 333/LN/(M2)/3, CIPAC Handbook N, p.34, 2012

6 Piperonyl butoxide content Target 25.0 g/kg ± 25% CIPAC 33/LN/(M)/3, CIPAC Handbook N, p.111, 2012

7 Deltamethrin Wash Resistance Index 88% - 100% CIPAC MT 195

8 Piperonyl butoxide wash resistance index 81% - 100% CIPAC MT 195

9 Netting mesh size Min. 15.5 holes/cm2 or 100 holes/inch2 WHO specification 333/LN/1, Note 9

10 Dimension stability of netting to washing

Max. 10% shrinkage

Max. 5% expansion ISO 3759, ISO 6330, 8A / Flat drying, ISO 5077

11 Bursting strength – netting Min. 300 kPa ISO 13938-2, head area = 7.3 cm2

12 Weight 30.0 g/m2 ± 10% ISO 3801

Polyester side panel (PET)

13 Yarn composition 100% polyester ISO 1833

14 Fabrication Warp knitted ISO 8388

15 Denier2 of yarn from unraveled fabric 75D or 100D or 150 D ISO 2060

16 Flammability

After removing the ignition source the following fire phenomena should not occur:

- ignition - propagation of the flame or glow EN 1102

1 & 2 Denier measured on unravelled yarn is indicative value

Standard PermaNet® 3.0 by Vestergaard. Product Specification

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Ref. No. P3-SP-01.5 (BU)

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Controlled document. Verify that this is the correct version before use CONFIDENTIAL and PROPRIETARY

No. Quality characteristics Requirement Standard method

- flaming debris - ignition of the filter paper

17 Deltamethrin content

75D: 2.8 g/kg ± 25%

100D and 150D: 2.1 g/kg ± 25%

CIPAC 333/LN/M/2, CIPAC Handbook M, p 66, 2009

18 Deltamethrin wash resistance index 80% - 98% CIPAC MT195

19 Netting mesh size

75D and 100D: Mean. 24.0 holes/cm2 or 156 holes/inch2 Min. 24.0 holes/cm2 or 156 holes/inch2

150D: Mean. 12.4 holes/cm2 or 80 holes/inch2 Min. 10.6 holes/cm2 or 68 holes/inch2 WHO specification 333/LN/1, Note 9

20 Dimension stability of netting to washing

Max. 10% shrinkage

Max. 5% expansion ISO 3759, ISO 6330, 8A / Flat drying, ISO 5077

21 Bursting strength – netting

75D: Min. 250 kPa

100D: Min. 350 kPa

150D: Min. 380 kPa ISO 13938-2, head area = 7.3 cm2

22 Weight

75D: 30.0 g/m2 ± 10%

100D and 150D: 40.0 g/m2 ± 10% ISO 3801

Product (Bednet)

23 Storage stability

After storage the determined average Deltamethrin content (roof and side) and Piperonyl Butoxide content (roof) must not be lower than 95% of the average content found before storage and the netting shall continue to comply with the clauses for:

• Wash resistance index • Dimensional stability • Bursting strength

Storage condition as defined in MT46.3.4, CIPAC Handbook J.

• 54oC ± 2oC, 2 weeks for polyethylene roof

• 40oC ± 2oC, 8 weeks for polyester side

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Seam bursting strength/ seam connecting PE and PET

Not less than that of the weaker fabric of the two ISO 13938-2, head area = 7.3 cm2

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Ref. No. P3-SP-01.5 (BU)

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Controlled document. Verify that this is the correct version before use CONFIDENTIAL and PROPRIETARY

No. Quality characteristics Requirement Standard method

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Seam bursting strength/ seam connecting PET and PET Not less than the stated value for the fabric ISO 13938-2, head area = 7.3 cm2

26 Size of bednet Target size with ± 5% tolerance Flat measurement after relaxing and complete wrinkle removal

27 Workmanship and appearance

AQL = 2.5 for major

AQL = 4.0 for minor UNICEF defect classification3

3 AQL Levels and Defect classification for UNICEF and IDA Inspections of Long Lasting Insecticidal Net (LLIN)

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Annex 2: An example of PermaNet® by Vestergaard – Certificate Of Conformity

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Bag – The front side Bag – The back side

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Label – The front side

Label – The back side

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Annex 3: Quality Management System, ISO 9001:2015 certificates

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Annex 4: Social Accountability Standards, SA 8000:2014 certifications

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Annex 5: Environmental Management System, ISO 14001:2015

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Annex 6: Laboratory management, ISO/IEC 17025:2017 certification