Detmold Medical - QRC COVID-19 information
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Detmold Medical 1 | Detmoldmedical.com
Committed to Quality.
Connected Globally. Resourced Locally.
Engineered with Passion. Driven by Collaboration.
Safeguarding fellow Australians.
2 | Detmoldmedical.com
Our Story
The Detmold Group
The Detmold Group is a privately owned
family company, established in 1948. The
Group, specialists in packaging solutions,
employing over 2,500 people globally with
manufacturing in 7 countries – Australia,
Indonesia, Vietnam, Philippines, China,
India & South Africa.
2020
Detmold Medical
Detmold Medical was founded in March 2020, in response to an
urgent community need during the COVID-19 health crisis.
Localising manufacturing of PPE is vital to secure supply ensuring
the health and safety of Australian medical professionals.
The Detmold Medical manufacturing facility was rapidly
established to deliver local PPE capability in South Australia,
leveraging existing expertise, networks, systems and knowledge
from the Detmold Group.
1948
3 | Detmoldmedical.com
Our Brands
Manufacture and supply of Non-food premium packaging Design, manufacture, and supply the Manufacturing arm of the Detmold
PPE products to professionals solutions offering the largest range of FMCG, grocery and food service Group in 7 countries, producing over
in the healthcare and the recyclable retail packaging in Australia industry with world-class sustainable 22,000 different food and retail
general community. and New Zealand. paper and cardboard packaging packaging products.
solutions.
4 | Detmoldmedical.com
Localising the Supply Chain
Connected Globally. Resourced Locally.
▪ Detmold Medical provide a local manufacturing solution, while
maximising expertise of our global network including China, Indonesia,
South Africa, Vietnam, India and the Philippines
▪ Our local manufacturing solution protects supply in times of major
business disruption, like the COVID-19 health crisis
▪ Access to a global procurement team ensures efficient sourcing from
reputable suppliers, backed by an agile and responsive supply chain to
react to demand and customer need
▪ Supported by LaunchPad, the Group’s rapid innovation centre, Detmold
Medical utilises local and international expertise, knowledge and
networks in research and development to provide effective solutions.
Delivered in Collaboration.
▪ Uniquely positioned to leverage existing networks, Detmold Medical has Brisbane
partnered with SA Health and industry to facilitate Australia’s first PPE
Perth
testing facility to fast-track product compliance. Adelaide Sydney
▪ Department of Industry & Skills have partnered with the University of SA
and Flinders University to establish independent testing capability.
Detmold Group Melbourne
Manufacturing & Sales
Detmold Group
Sales
5 | Detmoldmedical.com
Quality & Compliance
Committed to Quality.
Quality is our priority, and our packaging facilities are accredited to ISO
MANUFACTURING COMFORMITY
9001 standards. Accreditation for ISO 13485 Medical Devices Quality
Management planned for completion 2021
Adhering to guidelines established by the Therapeutic Goods
TGA REGISTERED
Association of Australia (TGA), we prioritise responsible material
supply and manufacturing practices
QUALITY YOU CAN COUNT ON Detmold Medical maintains formal procedures for the
registering, handling and resolving of quality issues
All products packaging feature information to promote
TRACEABILITY
traceability to the exact production batch for quality control and
efficiency of problem resolution
Manufactured products are tested to meet Australian Standards in
PRODUCT COMPLIANCE
collaboration with the University of South Australia, Flinders University,
Vic Labs, CSIRO, TestSafe NSW & international laboratories
6 | Detmoldmedical.com
Real Responsibility
Safeguarding our Communities.
Detmold Medical is deeply committed to environmental & social responsibility. Launched during the COVID-19 health crisis, the health and safety of
Australian medical professionals propelled the development of Detmold Medical. For us, this means supporting our people and sustaining our future.
Sustainability Making A Difference
We are committed to We choose to positively impact
sustainable manufacturing our local communities around
practices, including; reputable the world. We sponsor
raw material sourcing, regular numerous charities, initiatives
supplier auditing, re-use and and events throughout the year
recycling of materials, and waste in the regions in which we
minimisation. Real operate. Some of our recent
Responsibility initiatives include: South
Australian Health and Medical
Research Institute (SAHMRI),
Ethical Jodi Lee Foundation, Clean up
We are an ethical employer who Australia, Fred’s Van and White
contributes to the communities Ribbon Australia/New Zealand.
in which we operate, with
regular audits of OHS and
employment practices and a
focus on fair hiring and safe Ethical
working conditions in all sites.
7 | Detmoldmedical.com
Detmold LaunchPad
Engineered with Passion. Delivered in Collaboration.
▪ LaunchPad is the Detmold Group’s centre for research and development
▪ Utilising local and global experts allows LaunchPad to have the ability to produce designs
that cater specifically to local requirements.
▪ LaunchPad incorporates areas of graphic and product design, print expertise, materials
evaluation, product testing, rapid prototyping as well as industry networks and knowledge -
all in one facility
▪ With an end to end understanding of the product journey from ideation to production,
LaunchPad encompasses entrepreneurial spirit with rapid execution
▪ Access to LaunchPad unlocks industry partnerships, product expertise and material
knowledge uniquely positioning Detmold Medical, to provide effective solutions to the
healthcare industry
Problem or idea We collaborate with Product prototype Adjustments are Products are made
is briefed to our our network of is rapidly designed made to suit in our world class
Launchpad team experts & partners market feedback manufacturing
facilities
8 | Detmoldmedical.com
Our Journey So Far and Next Steps
Feb Establishment of Detmold Medical.
2020 In February 2020, the Detmold Group was approached by SA Health and the Commonwealth to localise
mask manufacturing in Australia, supplying fit-for-purpose L3 and P2 masks in the shortest lead-time.
Subsequently:
▪ P2 mask specification evolved into a P2 L3 Surgical Respirator Mask to ensure protection against
aerosol infection
▪ Mask machines with Earloop designs offered the shortest lead-time and contracts for 145M masks
were executed based on this design
▪ Detmold Medical workforce established with 200 new jobs in SA
20 machines to be commissioned by end of June (14 x L3 and 6 x N95) manufacturing +20M masks per
month. Detmold Medical will have internal testing capability to support rapid product and material
validation by July.
July
2020
Challenges Met and Overcome. We are Seeking Your Help.
▪ No domestic testing capability against the Australian standards ▪ We have been conducting regular fit testing in collaboration the Lyell
McEwin Hospital with 10 perfect fits achieved 2nd June.
▪ No domestic raw material supply chain
▪ 500-1000 Masks will be manufactured in preparation for larger scale fit
▪ Global material shortages and sovereign export restrictions
testing on Tuesday
▪ Securing air-freight to secure material and machines
▪ We expect to have TGA Registration before Thursday 11th June and
▪ Counterfeit mask imports creating distrust request your endorsement for the release of the D95+ mask.
▪ COVID-19 restrictions
9 | Detmoldmedical.com
Laboratories Engaged
The TGA has acknowledged that given there is no current capability to test to the Australian standards, they do not object to corroborated results from two
independent labs to achieve testing requirement.
There is an exemption in place for Federal supply of masks.
The TGA will recognize testing from international laboratories against the testing standards.
Laboratories engaged for testing to AS/NZS1716:2012 + AS4381:2015 or international equivalent
AS/NZS 1716:2012 AS4381:2015
Laboratories Status
or equivalent or equivalent
Uni SA Set up and testing ✓
Flinders University Set up and testing ✓ ✓
Vic Labs Test Results Received (passed) ✓
Test Safe NSW Testing ✓
CSIRO Awaiting Accreditation ✓
GTTC Test Results Received (passed) ✓ ✓
Nelson Laboratories 60-day turnaround time – yet to submit ✓
Eurolab, Turkey Engaged – 1st Preference ✓ ✓
Rise Research Institute, Sweden Engaged – 2nd Preference ✓ ✓
Eurofins, France, Spain & Shanghai Engaged – 3rd Preference ✓ ✓
Centexbel, Belgium Contacted - Long turnaround & limited capability ✓
Dekra, Germany Contacted – unable to conduct all testing
Hohenstein, Germany Contacted – unable to conduct all testing
10 | Detmoldmedical.comGTTC – Credentials
Lab certifications:
▪ CNAS: China National Accreditation Service for Conformity
Assessment - Uniformly responsible for the accreditation of
certification bodies, laboratories, inspection bodies and
other relevant institutions. CNAS is the one who approve
certificate of ISO 17025 in China. Through (International
Laboratory Accreditation Cooperation (ILAC), GTTC'S report
is recognized by over 100 countries and regions.
▪ CMA : China Inspection Body and Laboratory Mandatory
Approval, is a domestic approval to lab or inspection body
which is base in China mainland, only with this approval,
the report is accepted with legal effect.
Company History:
▪ GTTC is formerly known as GTT, which is establish in 1964.
GTTC is now become a comprehensive lab specialising in
garment and textiles (including industrial), food,
environmental protection. GTTC owns 3 national centers
relating to garment, leather products and food.
▪ Over 800 employees with 3 labs - 2 is in Guangzhou and in
Shanghai
Customer Base:
GTTC has over 1000 contracted clients, many of them are
international medical clients including: Kimberly-Clark, 3M and
Cardinal Health.
11 | Detmoldmedical.comLevel 3 Surgical Mask 12 | Detmoldmedical.com
Product Overview – Level 3 Surgical Mask
Product Description
The Level 3 Surgical Mask is a single-use face mask for use in healthcare where a person is at risk of blood or
fluid splash. Designed to meet Australian Standard AS/NZ 4381:2014, the mask limits the passage of blood or
body fluids through the mask layers. Featuring multiple layers of lightweight material, the mask provides
comfort and breathability with two ear loops to hold the mask in place.
▪ Designed to meet AS/NZS 4381:2015 Surgical Face Masks
▪ Bacterial Filtration Efficiency (BFE) ≥ 98%
▪ Differential pressure, mmH2O/cm < 5.0
▪ Resistance to penetration by synthetic blood to 160mmHg
▪ Planned for inclusion within the TGA Australian Register of
Therapeutic Goods (ARTG) from June 2020
▪ Non-sterile and Latex Free
▪ Ear loop design
▪ Detmold Medical are currently working on a head-tie
solution for the Level 3 Surgical Mask
13 | Detmoldmedical.comProduct Specification – Level 3 Surgical Mask
Item Number Item Description Size Width Height Ear Loop Length Inner Qty Carton Qty
W138M Level 3 Surgical Face Mask One Size 175mm ± 2mm 95mm ± 2mm 165mm ± 5mm 50 pieces 1200 pieces
14 | Detmoldmedical.comMaterial Specification for Manufacturing – Level 3 Surgical Mask
Material Outer Layer Inside Outer Layer Middle Layer Inner Layer Ear Loop Nose Wire
Description Spunbond PP Meltblown PP Spunbond PP Spunbond PP 3mm latex free elastic 3mm aluminum
Treatment Hydrophobic 3% Electret Hydrophobic Hydrophilic n/a n/a
Material GSM Typically 50gsm Typically 25gsm Typically 25gsm Typically 25gsm n/a n/a
MSDS Available^ ✓ ✓ ✓ ✓ ✓ n/a
Biocompatibility of material+ ✓ ✓ ✓ ✓ ✓ n/a
Material Swatch test to AS4381 GTTC CSIRO
✓
BFE (Appendix B) n/a ✓ n/a n/a n/a n/a
Extrapolation
Pressure Differential (Appendix C) ✓ ✓
Soft and comfortable, the
Hydrophobic (repellent) layer
^ Available on request Designed to capture the inner hydrophilic (absorbent)
+ Completed by Professor Raina McIntyre UNSW to protect from the passage of Provides additional comfort
wearer’s bacteria and protect layer captures droplets from
blood splash or body fluids and fluid barrier.
from external bacteria. the wearer e.g. sneezes and
outside the mask.
coughs
1 2 3 4
15 | Detmoldmedical.comMask Performance Testing – Level 3 Surgical Mask
Meeting requirements of AS4381:2015 or international equivalents
Australian Test Facilities International Test Facilities
Flinders
Uni SA CSIRO GTTC Eurolab
University
Currently, there are no testing
International Laboratory facilities in Australia that are
Internationally recognized certification: No No In development Accreditation ISO/IEC 17025:2017 capable of testing to
Cooperation AS4381:2015 which are
Internationally certified.
Bacterial Filtration Efficiency % (BFE) - Appendix B; 98%
Local testing capability in
Extrapolated development
Indicative Extrapolation Guide
Reference test
testing complete
method
ASTM F2101-14 In development In development
EN 14683:2014 ✓ Min ETA - 4 weeks
Resistance to penetration by synthetic blood; 160 mmHg
Reference
ISO 22609 ✓ Min ETA - 4 weeks
method
test
ASTM F1862/F1862M-13 ✓
Differential pressure, mmH2O/cm2 - Appendix CMask Testing – Level 3 Requirements
Meeting AS4381:2015 Mask material selection and
construction based on a
• BFE: ≥ 98% comprehensive testing program
• Differential Pressure: < 5.0 mm H2O/cm2
• Blood Penetration: 160mmHg
Stage 1: Initial Material Testing Stage 2: Laboratory Constructed Mask Testing
CSIRO "indicative extrapolation" GTTC Testing University Testing
Differential Blood Blood
Filters BFE Proceed? Filters Construction BFE ∆P Proceed? Filters Construction BFE ∆P Proceed?
Pressure (∆P) Penetration Penetration
4 layer 4 layer
Passed Passed Passed Yes
finished mask finished mask
Melt Blown
Melt Blown Melt Blown
Filtration Passed Passed Yes Awaiting Passed Passed Yes
Filtration Layer A Filtration Layer A
Layer A 3 layer 3 layer
Passed Passed Passed Yes
finished mask finished mask
Melt Blown
Filtration Failed Failed Stopped
Layer B
Melt Blown finished mask
Awaiting Passed Passed Review
Melt Blown Melt Blown Filtration Layer C single filter
Development 4 layer
Filtration Within 10% Passed Filtration Layer Testing Underway
review finished mask
Layer C C Melt Blown finished mask
Awaiting Failed Passed Stopped
Filtration Layer C double filter
Melt Blown Melt Blown
Filtration Failed Passed Stopped Filtration Material Swatch Failed Passed N/A Stopped
Layer D Layer D
17 | Detmoldmedical.comD95+ Surgical Respirator Mask 18 | Detmoldmedical.com
Product Overview – D95+ Surgical Respirator Mask
Product Description
The D95+ is a single-use surgical respirator mask for use in healthcare. The mask is designed to filter out non-
oil based airborne particles and offers bacterial filtration and fluid resistance. Featuring a lightweight flat fold
design, the mask expands into a convex-shaped device with two ear loops to hold the mask in place.
Head band solution under development:
▪ Designed to meet AS/NZS 1716:2012 Respiratory Protective
Devices Appendix E, G, I
▪ Particulate Filtration Efficiency (PFE) > 95% at 0.3μm
particulate size
▪ Bacterial Filtration Efficiency (BFE) ≥ 98%
▪ Resistance to penetration by synthetic blood to 160mmHg
▪ Included on the TGA Australian Register of Therapeutic Goods
(ARTG) – from June 2020
▪ Non-sterile & Latex Free with ear loops
19 | Detmoldmedical.comProduct Specification – D95+ Surgical Respirator Mask
Item Number Item Description Size Width Height Ear Loop Length Inner Qty Carton Qty
W619M D95+ Surgical Respirator Mask Regular 117 ± 1mm 157 ± 1mm 175mm 30 pieces 720 pieces
W290M D95+ Surgical Respirator Mask Large 120 ± 1mm 162 ± 1mm 175mm 30 pieces 720 pieces
ComfortClip - Ear Loop Extender One Size 237 ± 1mm 88 ± 1mm N/A 100 pieces 1000 pieces
Optional ComfortClip for improved comfort & mask fit
ComfortClip provides flexibility in the securing of respirator masks.
Designed* for easy application with a D95+ Medical Respirator, the
ComfortClip pulls ear loops securely onto an adjustable band worn
on the head. The ComfortClip alleviates pressure from the mask on
the ears and provides comfort with three adjustments levels to
ensure an adequate seal.
*Final Design of the ComfortClip may be subject to change to suit requirements.
20 | Detmoldmedical.comMaterial Specification for Manufacturing – D95+ Surgical Respirator Mask
Material Outer Layer Inside Outer Layer Middle Layer Inner Layer Ear Loop Nose Wire
Description Spunbond PP Meltblown PP Spunbond PP Spunbond PP 5mm latex free elastic 0.9mm flat aluminum
Treatment Hydrophobic 3% Electret Hydrophobic Hydrophobic n/a n/a
Material GSM Typically 50gsm Typically 25gsm Typically 25gsm Typically 25gsm n/a n/a
MSDS Available^ ✓ ✓ ✓ ✓ ✓ n/a
Biocompatibility of material+ ✓ ✓ ✓ ✓ ✓ n/a
The inner hydrophobic layer
Hydrophobic (repellent) layer The meltblown filtration layer is convex-shaped to create a
to protect from the passage of is designed to capture Provides additional comfort seal around the mouth and
blood splash or body fluids external bacteria and/or and fluid barrier. nose to prevent any
outside the mask. particulates. particulates from passing
through the mask.
^ Available on request
+ Completed by Professor Raina McIntyre UNSW
1 2 3 4
21 | Detmoldmedical.comTesting Standards for D95+ Surgical Respirator
Particulate Testing
USA/NIOSH (N95) European (FFP2) Australian (P2)
42C FR84 EN149-2001 AS1716:2012
D95 +
Additional Surgical Testing
Resistance to
BFE
Blood Penetration L3 Mask Standard
AS4381:2015
ASTM F2101-14 ASTM F1862/F1862M-13
or or
EN14683:2014 App B ISO 22609
D95+ Surgical Respirator
Suite of Testing
AS1716:2012 + AS4381:2015
22 | Detmoldmedical.comMask Performance Testing – D95+ Surgical Respirator Mask
Australian Test Facilities International Test Facilities
Lyell McEwin Uni SA Flinders CSIRO Vic Labs TestSafe NSW GTTC Eurolab Nelson
FDA Registered
Internationally recognized certification: No No No NATA (underway) NATA (underway) ISO 9001 ILAC ISO/IEC 17025:2017
ISO 17025
Facial Fit – Appendix B & Appendix D
Fit Testing ✓
Test method
Unavailable
AS1716:2012 – Clause 2.2 To be conducted
due to COVID-19 Final D95+
NIOSH – 42C FR84 60 Days Production
EN 149 - 2001 Min ETA - 4 weeks
specification has
passed all required
AS1716:2012 or Equivalent
Simulated Wear – Appendix E
testing.
AS1716:2012 – Clause 4.3.3 ✓ ✓ ✓
Test method
NIOSH – 42C FR84 60 Days
EN 149 - 2001 Min ETA - 4 weeks
D95
Inhalation Resistance – Appendix G
AS1716:2012 – Clause 4.3.4 ✓ ✓ ✓ Currently, there are
Test method
NIOSH – 42C FR84 60 Days no testing facilities
EN 149 - 2001 ✓ in Australia that are
NATA certified to
EN 149 - 2001 Min ETA - 4 weeks
testing to
Particle Fltration Efficiency % (PFE) – Appendix I AS4381:2015 or
AS1716:2012 – Clause 4.3.5 In development ✓ ✓ AS/NZS1716:2012
Test method
NIOSH – 42C FR84 60 Days
Local testing
ISO22609:2014 ✓
capability in
EN 149 - 2001 Min ETA - 4 weeks development
Bacterial Filtration Efficiency % (BFE) - Appendix B; 98%
Additional Surgical
Indicative Extrapolation Guide Extrapolated (≠NATA)
International testing
requirements
Test method
AS4381:2015
being pursued
ASTM F2101-14 (Proceeding CSIRO) In development
where viable.
EN 14683:2014 ✓ Min ETA - 4 weeks 60 Days
Resistance to penetration by synthetic blood; 160 mmHg
✓
method
ISO 22609 Min ETA - 4 weeks 60 Days
Test
23 | Detmoldmedical.com ASTM F1862/F1862M-13 ✓ In developmentContact
Ron Tremaine
Group General Manager - Global Brands, Business Development & New Markets
+61 414 725 821
ron.tremaine@detpak.com
24 | Detmoldmedical.comYou can also read
