Manufacturing and Sterilization for COVID-19

Design, development, prototyping, testing, and validation to help win the fight

N95 Masks

Contents

Need Exploration and Identification

Coronavirus disease 2019 (COVID-19) is an infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The disease was first identified in December 2019 in Wuhan, the capital of China’s Hubei province, and has since spread globally, resulting in the ongoing 2019–20 coronavirus pandemic. As of 14 April 2020, more than 1.94 million cases have been reported across 210 countries and territories, resulting in over 123,000 deaths (https://coronavirus.jhu.edu/map.html). The pandemic has resulted in travel restrictions and nationwide lockdowns in several countries.  With the sudden surges in patient volume during the COVID-19 outbreak, closing of borders and restrictions on international shipping, and temporary shutdown of manufacturers for medical supplies, personal protective equipment (PPE), ventilators and associated consumables, as well as many other medical supplies have become a scarce resource. 

What is an N95 respirator? 

  • N: This is a Respirator Rating Letter Class. It stands for “Non-Oil” meaning that if no oil-based particles are present, it can be used in a work environment.
  • 95: Masks ending in a 95, have a 95 percent filtering efficiency.
  • .3 microns: The size of .3 microns of particulates and large droplets won’t pass through the barrier as stated by the CDC.
  • Material: The filtration material on the mask is an electrostatic non-woven polypropylene fiber.
  • Regulation: Title 42 of the Code of Federal Regulations (CFR), Part 84 from National Institute for Occupational Safety and Health (NIOSH)  are the quality assurance standards that must be followed to manufacture and sell any respiratory device.  

What is a surgical N95 respirator?  

A surgical N95 respirator is NIOSH approved N95 respirator (adherent Title 42 of the Code of Federal Regulations (CFR) that has also been cleared by the Food and Drug Administration (FDA) as a surgical mask regulated under 21 CFR 878.4040. 

How do surgical masks differ from N95 respirators? 

This document details strategies to optimize supplies of N95 masks during this crisis:

Existing Solutions 

Current supply chains

 CDC Surgical N95 Respirators Trusted-Source Information includes manufacturer and instructions for use from every manufacturer.

Suppliers Link/Contact Info
3M  https://www.3m.com/

888-3M HELPS
Aero Pro Company, Ltd. http://www.aeropro.com.tw/zh-tw/

886-4-875-6141
Air Filtration Solutions, Ltd. http://www.airfiltrationsolutions.co.uk/

44 (0) 1772 790820 (UK)
Alpha Pro-Tech http://www.alphaprotech.com/

800-749-1363
AOK Tooling Limited http://www.toolingexpress.com/mask.aspx

86-755-84111912
Aswan International Corporation http://www.aswan-safety.com.tw/

866-2-8369-2525

603-929-6000
Champak Enterprise Company, Ltd. https://www.champak.com.tw/

886-3-3808818
Dentec Safety https://www.dentecsafety.com/

888-533-6832
Dobu Life Tech 314-743-6243

82-31-765-9311
Dräger Safety AG & Company https://www.draeger.com/en-us_us/Chemical-Industry/Productselector

800-858-1737
Ever Green Company, Ltd. 82-31-425-0596
Fido Industrial Safety Masks Manufacturer Company, Ltd. http://www.fidomasks.com.tw/

886-37-741471
Foss Manufacturing Company 603-929-6000
Global Safety First https://readimask.com/

610-240-0909
Guangzhou Harley Commodity Company, Ltd. https://harleymask.en.alibaba.com/

+86-20-36928707
GVS Filter Technology UK, Ltd. http://www.gvs.com/

44 1524 847600 ext 262 (UK)
Halyard Health https://www.halyardhealth.com/

800-331-4112
Honeywell Safety Products https://safety.honeywell.com/

800-430-5490

800-821-7236

800-343-3411
Industrias Saver S.A. 57-5-382-16-16
Jahan Company t/a IREMA Ireland https://www.irema.com/

+353 63 98544
Japan Vilene Company, Ltd.  http://www.vilene.co.jp/en/index.htm

81-3-3258-3355
Jiangyin Chang-hung Industrial Manufacturing Factory LLC of China (JCH) http://www.grandemask.com/

86-510-8691-3080
Jinfuyu Industrial Company, Ltd. http://www.jfymasks.com.tw/

886-2-2690-2271
JSP https://www.jspsafety.com/link/en/respiratory-protection/c/

44-0-1993-824000
Kimberly-Clark Corporation https://www.kimberly-clark.com/en/

800-524-3577

800-255-6401 (professional line)

Direct contact: Brad Frankle- West Team Leader (Brad.Frankel@kcc.com )
Koken, Ltd. http://www.koken-ltd.co.jp/english/top.htm

81-3-5276-1925
Louis M. Gerson Company, Inc. https://www.gersonco.com/

800-225-8623
MacoPharma http://www.macopharma.com/com/

33-3-59-03- 44-00
Magnum Medicare http://www.magnumohs.com/

0091-9820050482
Makrite Industries, Inc. 

  • Cardinal Health
  • CVS Pharmacy
  • First Aid Direct 
 http://www.makrite.com/

800-379-9929

617-964-1365

888-533-6832
Master and Frank Enterprise Co., Ltd. http://www.master-frank.com/

886-2-23255066
Mine Safety Appliances Company https://us.msasafety.com/detection?locale=en

800-672-2222
Moldex-Metric, Inc. https://www.moldex.com/

800-421-0668
MSA de Brasil Equipamentos e Instrumentos de Seguranca Ltd. https://br.msasafety.com/?locale=pt

55-11-4070-5999
NITTA Corporation, SA https://nitta.com.co/

770-497-0212
Prestige Ameritech

  • Cardinal Health
 https://www.prestigeameritech.com/

866-401-8972

817-427-2700

Direct contact: mike@prestigeam.com (Mike Bagley)
Profit Royal Pharmaceutical, Ltd. https://www.hktdc.com/manufacturers-suppliers/Profit-Royal-Pharmaceutical-Limited/en/1X0910PB/

+8520 2387 8926
Rizhao Sanqi Medical & Health Articles Company, Ltd. http://www.sanqicn.com/

86-633-8537378 x 2178
San Huei United Company, Ltd. https://www.sanhuei.com/

886-2-2683-0356

886-2-2683-5856
San M Package Company, Ltd. https://www.san-m.co.jp/english/

81-547-45-4125
Shanghai Dasheng Health Products Manufacture Company, Ltd.  http://www.dashengmask.com/

86-21-5778-3126
Shanghai Gangkai Purifying Products Company, Ltd. http://www.gangkai-mask.com/

86-21-5777-5401
Shigematsu Works Company, Ltd. http://www.sts-japan.com/

81-3-6903-7525
Shining Star Electronic Technology Company, Ltd. http://en.shiningstar-hz.com/

886 3 431 5486, 86 571 8618 1168
Shuenn Bao Shing Corporation http://www.aeropro.com.tw/zh-tw/

886-4-875-6141
Suzhou Fangtian Industries Co., Ltd. http://chinamasks.com/

+86 512 65586078 / 65586018
Suzhou Sanical Protective Product Manufacturing Company, Ltd. https://www.cemask.com/

86-512-66100068
Valmy SAS of France (DIV) http://www.valmy.eu/

1-450-844-3946
Venus Safety & Health http://www.venusohs.com/

91-022-2769-2646
Willson Dalloz Safety Products https://www.kimberly-clark.com/en/

800-345-4112
Xiantao Zhongyi Safety Protection Products https://xtzhongyi.en.alibaba.com/

+86-728-3257535 / 3257635

Alternative supply chains

How to identify fraudulent or counterfeit N95 masks based on NIOSH guidelines: https://www.cdc.gov/niosh/npptl/usernotices/counterfeitResp.html

Market Analysis 

  • As of 7th April 2020, the total numbers of infected people from COVID-19 are 1,352,173, and total deaths are 75,294 in the world
  • Due to the fear of COVID-19, there has been increased the purchase of N-95 mask across the globe → created a shortage for healthcare workers 
  • Key Players for Global N95 Grade Medical Protective Masks: 
    • 3M, Hakugen, Ansell, Sinotextiles, Shanghai Dasheng, Te Yin, Gerson, Honeywell, Vogmask, Kimberly-clark, Cardinal Health, KOWA, DACH, CM and among others
  • 3M is the biggest supplier of masks and is currently in short supply 
    • U.S. has 12 Million of N95 respirators and 30 million surgical masks stockpiled but would need significantly more in the event of an outbreak.
  • U.S. health officials have predicted a need for 300 Million facemasks in the incident of a domestic coronavirus outbreak
  • Due to the Coronavirus, the demand is up to 100 times higher than regular demand for N95 masks in the world. 
  • Many factories have shut down their production, which has created a massive shortage of masks, may hamper the growth of the market. 
  • Many countries have also banned the exports of face masks to fulfil the global demand, further hindering the market growth. 
  • Pennsylvania is also experiencing shortage of supplies. Summary of requested PPE from the  Federal Emergency Management Agency is as follows: 
Requested  Received Sent, Not yet Received  Shortfall/Surplus 
Coveralls 3990 480 0 -3510
Face Shields 110858 110880 62413 +62435
Face/Surgical Masks 582188 328500 287022 +33334
Gloves 690346 473725 0 -216621
N95 Masks  494392 112250 120900 -261242
Surgical Gowns 141761 86304 0 -55457

Table: Jonathan Tamari  Source: U.S. House Oversight and Reform Committee, FEMA (April 2nd, 2020)

Alternative Solutions

Operational

Novel Design

  • 3D printed masks – 
    • For information about 3D manufacturing of PPE that has been reviewed by the FDA : https://3dprint.nih.gov/collections/covid-19-response 
    • There are a variety of 3D printed masks, however many require sanding and other finishing. The Billings Clinic mask does not require finishing. According to the Billings Clinic, the mask takes ~2 hours to print and costs approximately $1. The mask has an insert for HEPA filter material (or a piece of surgical mask) and is rigid plastic so it can be disinfected. Due to the lack of seal, this may not qualify as an N95, but could work as a surgical mask option and could be a viable option to explore as we do have a 3D printer at HMC and likely additional at State College. 
  • Adaptation to readily available mask from alternative industry (i.e. scuba mask; firefighter mask) with similar level protective barriers required 
  • Alternative Materials for Construction of N95 

Concept Screening 

Clinical: 

  • Prevent oral nasal droplet transmission from human to human contact.
  • Bacterial Filtration Efficiency:  95 percent of 0.3 micron test particles filtered
  • Submicron Particle Filtration Efficiency: 99.9% filtered at 0.1 micron. 

Engineering

Regulatory

  • FDA Guidance on Face Masks and Respirators During COVID-19; FAQs on 3D Printing of Medical Devices, Accessories, Components, and Parts During the COVID-19 Pandemic
  •  Reach out to CDRH-COVID19-SurgicalMasks@fda.hhs.gov for assessing whether the device would be able to meet the EUA requirements
  • For current face mask and respirator manufacturers whose product(s) are not currently marketed in the US, FDA recommends providing the following information:
    •  General information such as your contact information, name and place of business, email address, and contact information for a U.S. agent (if any) in addition to general information about the device such as the proprietary or brand name, model number, and marketing authorization in your country (or region). 
    •  A copy of the product labeling. 
    • Whether the device currently has marketing authorization in another regulatory jurisdiction (including certification number, if available)
    • Whether the device is manufactured in compliance with 21 CFR Part 820 or ISO 13485: Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes or an equivalent quality system and the manufacturer or importer has documentation of such. 
    • Description of testing conducted on the device, including any standards met, such as liquid barrier protection, flammability, biocompatibility, and filtration performance, as appropriate. For surgical N95 respirators, FDA recommends including fluid resistance testing (liquid barrier performance). 
  • For any face mask or filtering facepiece respirator (including N95 respirators) issued an EUA, FDA will include appropriate conditions of authorization in accordance with section 564 of the FD&C Act. Although this is a case-by-case determination, based on current information and experience, we will likely include the following conditions: 
      • Appropriate conditions designed to ensure that health care professionals administering the device are informed
        • that FDA has authorized the emergency use of the device;
        • of the significant known and potential benefits and risks of the emergency use of the device, and of the extent to which such benefit and risks are unknown; 
        •  of the alternatives to the device that are available, and of their benefits and risks. 
      • Appropriate conditions designed to ensure that individuals to whom the device is administered are informed— 
        • that FDA has authorized the emergency use of the device;
        • of the significant known and potential benefits and risks of the emergency use of the device, and of the extent to which such benefit and risks are unknown; 
        •  of the option to accept or refuse administration of the device, of the consequence, if any, of refusing administration of the device, and of the alternatives to the device that are available and of their benefits and risks
      • Appropriate conditions for the monitoring and reporting of adverse events associated with the emergency use of the device. FDA intends to include conditions that are consistent with those promulgated under 21 CFR Part 803. 
      • For manufacturers of the device, appropriate conditions concerning recordkeeping and reporting, including records access by FDA, with respect to emergency use of the device.

Intellectual Property 

  • The FDA classifies medical devices based on the risks associated with the device and by evaluating the amount of regulation that provides a reasonable assurance of the device’s safety and effectiveness. Devices are classified into one of three regulatory classes: class I, class II, or class III. 
  • N95 masks fall within the Class II device category. This link provides more information on the specific requirements for each class. For additional guidance on how to classify a device, please see this resource. 
  • The following links provide relevant intellectual property around N95 masks in a filterable and searchable format.

 

Strategic Development 

Clinical

Regulatory

Research & Development

 

  • Material Design: N95 masks contain two layers. The top first layer is made of a mesh of synthetic polymer fibers that serve as a barrier for 95% of particles under 0.03 microns. For production, this layer utilizes a meltblown fabric technique requiring fine process management. The second inner layer is composed of a lining treated with copper and zinc ions with a positive charge which then interact with the negative charge of influenza viruses and cause them to denature. For this layer, ion charge, filtration efficacy and fit deterioration are the biggest barriers to utilizing N95 masks multiple times.
  • The biggest challenge for R&D and quality management is within the production of the first layer. The material needs to be made in regular time intervals to ensure the diameter of less than one micron to meet NIOSH’s standards  Obtaining appropriate machinery and equipment is a major challenge and requires extensive testing for fine particle sourcing. The following resource highlight the challenges: 

 

Testing

Quality Management

 

  • Regulatory – Any repurposing of products, de novo creation of air-purifying respirators should comply with: 

 

 

 

Intellectual Property

@CDCgov

@Surgeon_General

@PAHealthDept

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