VALIDATION PACK

ansell.com

BioClean™ MTA, MTA210-1

ref: 1908/MTA/PI9

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TABLE OF CONTENT SMTA NON-STERILE FACEMASK PRODUCT DATASHEET . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

MTA210-1 STERILE FACEMASK PRODUCT DATASHEET . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

CERTIFICATE OF IRRADIATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

CERTIFICATE OF CONFORMITY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

CERTIFICATE OF ANALYSIS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

ANALYSIS SUMMARY CHART . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 1

STERILITY VALIDATION STATEMENT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

QUALITY STATEMENT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 3

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MTA NON-STERILE FACEMASK PRODUCT DATASHEET

BIOCLEANMTANon-sterile Tie-on Facemask

MTAAboutProviding high particle and bacterialfiltration efficiency, the BioClean™ MTACleanroom Tie-on Facemask ismanufactured from cleanroomcompatible materials to reducecontamination into the controlledenvironment and features tie-tapes for asecure fastening.

MaterialsINNER FACING LAYER:Non-woven polypropylene/polyethylene(hygroscopic)

FILTER LAYER:Meltblown polypropylene

OUTER FACING LAYER:Non-woven polypropylene/polyethylene(hydrophobic)

FASTENINGS:Non-woven polypropylene ties

NOSE-BAND:Plastic coated steel

FeaturesHigh bacterial & particle efficiencyfiltrationFully enclosed malleable nose-bandUltrasonically sealed edges

HIGH BFE & PFE

ISO CLASS 4 COMPATIBLE

LATEX-FREE

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Quality StandardsManufactured in a facility holding ISO 9001:2015Processed in an NEBB certified ISO Class 4 cleanroom environmentSampling and inspection in accordance with ISO 2859-3:1994Tested against standard ASTM F2101 for Bacterial Filtration Efficiency(BFE)

Shelf Life & StorageFive (5) years from date of manufacture.Store in a dry, cool place (<40°C) awayfrom direct sunlight and fluorescentlight.

MTA/1810/PDS25

Re-order codeRe-order code

MTA 210-0

MTA 210-2

TO ORDER

PackingPacking

MTA 210-0 (Bulk):

50 pieces per sealed inner PE bag; one inner bag per sealed outer PE bag; 16 outer bags per lined carton (800 pieces)

MTA 210-2 (Single):

One piece per sealed inner PE bag; 50 inner bags per sealed outer PE bag; 10 outer bags per lined carton (500 pieces)

Physical Properties

COLOUR White

STYLE Tie-on

LENGTH (± 5m m ) 210mm

WIDTH (± 5m m ) 95mm

Performance Information

COMPATIBILITY ISO Class 4

PARTICLE FILTRATION EFFICIENCY (PFE)@ 0.3 MICRON 98.8%

BACTERIAL FILTRATION EFFICIENCY (BFE) @ 3.0 MICRON 97%

DIFFERENTIAL PRESSURE (ΔP), m m H 20/cm 2 2.7

For additional information visit us at www.bioclean.com, or call us at:

Nitritex LtdMinton Enterprise ParkOaks DriveNewmarket, SuffolkCB8 7YYUnited Kingdom

Ansell US111 Wood Avenue SouthSuite 210Iselin, NJ 08830USA

Tel: +1 800 800 0444

Nitritex (M) Sdn.Bhd2 Jalan Jurunilai U1/20Seksyen U1, Hicom Glenmarie Industrial Park40150 Shah Alam, SelangorMalaysia

Tel: +603 5569 3857/3859Tel: +44 1638 663338

Neither this document nor any other statement made herein by or on behalf of Ansell should be construed as a warranty of merchantability or that any Ansell product is fit for a particular purpose.Ansell assumes no responsibility for the suitability or adequacy of an end user’s selection of disposable garments for a specific application.

Ansell, ® and TM are trademarks owned by Ansell Limited or one of its affiliates. © 2012 – 2019 Ansell Limited. All Rights Reserved.

MTA NON-STERILE FACEMASK PRODUCT DATASHEET

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BIOCLEANMTASterile Tie-on Facemask

MTA210-1AboutProviding high particle and bacterialfiltration efficiency, the BioClean MTACleanroom Tie-on Sterile Facemask ismanufactured from cleanroomcompatible materials to reducecontamination into the controlledenvironment and features tie-tapes for asecure fastening.

MaterialsINNER FACING LAYER:Non-woven polypropylene/polyethylene(hygroscopic)

FILTER LAYER:Meltblown polyester

OUTER FACING LAYER:Non-woven spunbonded polyester(hydrophobic)

FASTENINGS:Non-woven polypropylene ties

NOSE-BAND:Plastic coated steel

FeaturesHigh bacterial, viral & particleefficiency filtrationFully enclosed malleable nose-bandUltrasonically sealed edges

HIGH BFE & PFE

ISO CLASS 4 COMPATIBLE

LATEX-FREE

MTA210-1 STERILE FACEMASK PRODUCT DATASHEET

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Quality StandardsManufactured in a facility holding ISO 9001:2015Processed in an NEBB certified ISO Class 4 cleanroom environmentSampling and inspection in accordance with ISO 2859-3:1994Tested against standard ASTM F2101 for Bacterial Filtration Efficiency(BFE)

SterilizationMethod: Gamma irradiationMinimum Dose: 25kGy

Sterility Assurance Level: 10-6

Shelf Life & StorageFive (5) years from date of manufacture.Store in a dry, cool place (<40°C) awayfrom direct sunlight and fluorescentlight.

Re-order codeRe-order code

MTA 210-1

TO ORDER

PackingPacking

One piece per sealed inner PE bag; 50 inner bags per sealed outer PE bag; 10 outer bags per lined carton (500 pieces)

Physical Properties

COLOUR White

STYLE Tie-on

LENGTH (± 5m m ) 210mm

WIDTH (± 5m m ) 95mm

Performance Information

COMPATIBILITY ISO Class 4 & EU GMP Grade A

PARTICLE FILTRATION EFFICIENCY (PFE)@ 0.3 MICRON >97%

BACTERIAL FILTRATION EFFICIENCY (BFE) @ 3.0 MICRON >96.5%

VIRAL FILTRATION EFFICIENCY (VFE) 97.9%

DIFFERENTIAL PRESSURE (ΔP), m m H 20/cm 2 3.2

For additional information visit us at www.bioclean.com, or call us at:

Nitritex LtdMinton Enterprise ParkOaks DriveNewmarket, SuffolkCB8 7YYUnited Kingdom

Ansell US111 Wood Avenue SouthSuite 210Iselin, NJ 08830USA

Tel: +1 800 800 0444

Nitritex (M) Sdn.Bhd2 Jalan Jurunilai U1/20Seksyen U1, Hicom Glenmarie Industrial Park40150 Shah Alam, SelangorMalaysia

Tel: +603 5569 3857/3859Tel: +44 1638 663338

Neither this document nor any other statement made herein by or on behalf of Ansell should be construed as a warranty of merchantability or that any Ansell product is fit for a particular purpose.Ansell assumes no responsibility for the suitability or adequacy of an end user’s selection of disposable garments for a specific application.

Ansell, ® and TM are trademarks owned by Ansell Limited or one of its affiliates. © 2012 – 2019 Ansell Limited. All Rights Reserved.

MTA210-1/1804/PDS27

MTA210-1 STERILE FACEMASK PRODUCT DATASHEET

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CERTIFICATE OF IRRADIATION

SAMPLE

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CERTIFICATE OF IRRADIATION

SAMPLE

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CERTIFICATE OF CONFORMITY

COCCOCMTA210-1MTA210-1BioClean MTA™ SterileTie-on Facemask

Certi�cate of ConformityCerti�cate of Conformity

Size/TypeSize/Type N/A

Lot No.Lot No. 01904100

Manufacture DateManufacture Date 04/2019

Expiry DateExpiry Date 03/2024

SterilisationSterilisation COI Number: S1230041911

Certificate of Analysis resultCertificate of Analysis result Pass

Declaration of ConformityDeclaration of Conformity

The above product is hereby declared as conforming to;

all technical product specifications

all manufacturing control specifications

all applicable standards and regulations specified

all processing requirements as reported on the Certificate of Irradiation / Processing

all test parameter ranges as reported on the Certificate of Analysis

REACH Compliance

EMEA/410/01 Compliance – as it is declared that this product is free from any animal derived materials (TSE/BSE) and materials derived

from genetically modified organisms (GMO)

IssueIssue

This Certi�cate of Conformity is issued by the authorised signatories on behalf of the authorised supplier.This Certi�cate of Conformity is issued by the authorised signatories on behalf of the authorised supplier.

�eri�ed by:

�A O�cer

Current product datasheets and Certi�cates of Irradiaton may be downloaded from the BioClean website� Current product datasheets and Certi�cates of Irradiaton may be downloaded from the BioClean website� www.bioclean.comwww.bioclean.comSAMPLE

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CERTIFICATE OF ANALYSIS

COACOAMTA210-1MTA210-1BioClean MTA™ SterileTie-on Facemask

Certi�cate of AnalysisCerti�cate of Analysis

Size/TypeSize/Type N/A

Lot No.Lot No. 01904100

Batch No.Batch No. NA

SterilizationSterilization THESE PRODUCTS ARE SUPPLIED STERILE

Expiry DateExpiry Date 03/2024

Test Data - Test Data - Sampling Plan

StandardStandard

ISO 2859

PlanPlan

Inhouse

AQLAQL

Inhouse

TitleTitle

QSP/8.2.4/QA Inspection

Sample SizeSample Size

20 Bags

No. of DefectsNo. of Defects

0

QC ResultQC Result

Pass

N/A Inhouse Inhouse External Packing Conformity 20 Bags 0 Pass

Analysis ConclusionAnalysis Conclusion

This Certi�cate is based on the e�aluation of samples of the abo�e mentioned product and con�rms that the productThis Certi�cate is based on the e�aluation of samples of the abo�e mentioned product and con�rms that the product

conforms to the speci�cation re�uirements published by Nitritex Ltd.conforms to the speci�cation re�uirements published by Nitritex Ltd.

This Certi�cate of Analysis is issued by the authorised signatory below.This Certi�cate of Analysis is issued by the authorised signatory below.

�eri�ed by�

QA O�cer

Current product datasheets and Certi�cates of Irradiation may be downloaded from the BioClean website� Current product datasheets and Certi�cates of Irradiation may be downloaded from the BioClean website� www.bioclean.comwww.bioclean.comSAMPLE

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ANALYSIS SUMMARY CHART

Analysis Summary BioClean Facemasks

BioClean MTA Sterile Tie-on Facemask – MTA 210-1

Test Result Particle Filtration Efficiency (PFE)@ 0.3 micron >97% Bacterial Filtration Efficiency (BFE) @ 3.0 micron >96.5% Viral Filtration Efficiency (VFE) 97.9% Differential Pressure (ΔP), mm H20/cm2 3.2

BioClean MTA Non-sterile Tie-on Facemask – MTA 210-0 & MTA 210-2

Test Result Particle Filtration Efficiency (PFE)@ 0.3 micron 98.8% Bacterial Filtration Efficiency (BFE) @ 3.0 micron 97% Differential Pressure (ΔP), mm H20/cm2 2.7

Helmke Drum Test Results

BioClean MTA Non-sterile Tie-on Facemask – MTA 210-0 & MTA 210-2

Test Cycle Release Rate (particles/minute) ≥0.3µm ≥0.5µm ≥5.0µm 1 36 32 2 2 48 41 2 3 58 50 2 Average 47 41 2

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STERILITY VALIDATION STATEMENT

Sterility Validation Statement BioClean MTA 210-1 Sterile Tie-on Facemask

Herewith, I confirm that the BioClean MTA Sterile Tie-on Facemask – product code MTA 210-1 – has been sterilised using gamma irradiation to a Sterility Assurance Level (SAL) of SAL10ˉ⁶, validated using the VDmax²⁵ method as detailed in EN ISO 11137-2.

Sara Morgan Quality Specialist – Life Sciences

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QUALITY STATEMENT

Product Compliance Statement BioClean MTA Sterile Tie-on Facemask – MTA 210-1

BioClean MTA Non-sterile Tie-on Facemask – MTA 210-0

Herewith, I confirm that the BioClean MTA Sterile Tie-on Facemask and the BioClean MTA Non-sterile Tie-on Facemask – product codes MTA 210-1 and MTA 210-0/MTA 210-2 – are processed in a facility operating a Quality Management System compliant ISO 9001:2015, are processed in a NEBB certified ISO Class 4 cleanroom environment compliant with the requirements of ISO 14644 and are tested against standard ASTM F2101 for Bacterial Filtration Efficiency (BFE).

Sara Morgan Quality Specialist – Life Sciences

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Contact your Ansell representative for ordering or more information.North AmericaUS Tel: 800 952 9916CA Tel: 1-844-494-7854Email: info@ansell.com

Central & South AmericaTel: +52(442) 296 20 50Email: cslac@ansell.comBrazilTel: +55-11-3356-3100Email: luvas.medicas@ansell.com

Europe, Middle East & AfricaTel: +32 (0)2 528 74 00Email: info@ansell.eu

Asia PacificTel: +603 8310 6688Email: apac.medical@ansell.com

Australia & New ZealandTel: +61 3 9270 7270Email: protection@ap.ansell.com

ansell.comAnsell, ® and ™ are trademarks owned by Ansell Limited or one of its affiliates.© 2019 Ansell Limited. All Rights Reserved.

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