Mask Production Line: The Complete Guide

This is a list of all the questions and answers about mask production line construction. They will help you to understand the construction qualification, quality management, production process, costing of the mask production line, etc. So, before you build a mask production line, read this guide.

• Mask production line construction qualification
• Mask production line construction type / face mask classification
• Mask production line workshop construction planning
• The basic performance inspection requirements of face mask raw materials
• The use performance inspection requirements of face mask
• The process of the mask production line
• The equipment of the mask production line
• The costing of the mask production line

♦ Mask production line construction qualification

Different countries and regions must comply with the relevant local policies and regulations for the construction of the mask production line. The following briefly introduces the entry requirements and certification for face mask production qualification in the EU and USA. For other regions, please refer to local official agencies.

The access requirements of the EU for face mask supplies

According to the use, the EU classifies masks into two categories: medical masks and personal protective masks.

Medical masks need to be labeled with the CE mark in accordance with the EU Medical Device Directive 93/42/EEC (MDD) or the EU Medical Device Regulation EU2017/745 (MDR), which corresponds to the standard EN 14683. Depending on the sterile or non-sterile state of the mask product, the conformity assessment mode is different.

For sterile medical masks, CE certification must be carried out by an authorized notified body. For non-sterile medical masks, companies only need to make CE self declaration of conformity and do not need to be certified by the notified body. After preparing the corresponding documents and test reports and other information, you can complete the declaration of conformity on your own.

Personal protective masks: Personal protective masks do not belong to medical devices, but need to meet the requirements of the EU Personal Protective Equipment Regulation EU 2016/425 (PPE), CE certification and issuance of certificates by authorized notified bodies, corresponding to the standard EN 149.

EU announcement agency address

1 The address of the announcement agency authorized by EU Medical Device Directive 93/42/EEC (MDD).
https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=13

2 The address of the announcement agency authorized by EU Medical Device Regulation EU 2017/745 (MDD).
https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=34

3 The address of the announcement agency authorized by EU Personal Protective Equipment Regulation EU 2016/425 (PPE)
https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=155501

The access requirements of the U.S. for mask supplies

The United States also distinguishes between medical masks and protective masks, with medical masks managed by the U.S. Food and Drug Administration (FDA) and personal protective masks managed by the National Institute for Occupational Safety and Health (NIOSH).

Medical masks: medical masks need to be registered through the FDA, companies apply directly to the FDA official website and submit relevant materials. In addition, there are two other ways.

1 N95 masks that have already obtained NIOSH registration can be exempted from product listing registration (510K) and directly undergo FDA factory registration and medical device listing if the product biology test, flame retardant test and blood penetration test are passed.

2 If authorized by the manufacturer holding the 510K, the 510K approval number can be used as its substitute factory for business registration and device listing.

Personal protective masks: protective masks need to be registered through NIOSH, companies apply directly on the NIOSH website.

♦ Mask production line construction type / face mask classification

Before the construction of the mask production, we need to have a comprehensive understanding of what kinds of masks are available and what occasions they are used for. Only by figuring out the people who use the masks we produce can we know where the market demand is.

Type	Labour protective masks	Medical Masks
Standards	EU, EN149: 2001+A1 USA, NIOSH Standards, (Title 42 CFR Part 84) China, GB 2626	EU: EN 14683 Type Ia, Type II, Type IIR USA: ASTM F2100 Level 1, level 2, level 3 China: YY/T 0969, YY 0469, GB19083
Level	EU: FFP1, FFP2, FFP3 USA: N, R, P series China: KN, KP series	Each of the three Chinese standards represents three levels, and Europe and the United States are writing the three levels into one standard. Different levels are used for different risk levels.
Application	Used in construction, industry and other polluting industries to filter particulate matter.	Used in the medical industry to prevent liquid penetration and filter bacteria.
Remarks	Washable and sterilizable	No expiration valves, no cleaning.

In terms of this epidemic, the demand for medical masks has increased greatly. Medical masks mainly include three kinds: general medical masks, medical surgical masks, and medical protective masks. For different countries and regions, the main differences between these three types of masks are as follows.

EU and USA standards:

Main performance indicators	EN 14683	ASTM F2100
Particulate filtration efficiency	Unspecified	Unspecified
Bacterial filtration efficiency	Type Ia ≥95% Type II ≥98% Type IIR ≥98%	Low ≥95% Moderate ≥98% High ≥98%
blood penetration	Type Ia , Type II, not required Type IIR, 120mmHg	Low, 80mmHg Moderate, 120mmHg High, 160mmHg

Chinese standards:

Main performance indicators	General medical masks	Medical-surgical masks	Medical protective masks
Standards	YY/T 0969	YY 0469	GB 19083
Particulate filtration efficiency	Unspecified	≥30%	Level 1 ≥95% Level 2 ≥99% Level 3 ≥99.97%
Bacterial filtration efficiency	Not less than 95%	Not less than 95%	Unspecified
blood penetration	Not required	120mmHg	80mmHg
Note: Bacterial filtration is to prevent bacteria from infecting the patient and blood penetration is to keep the patient’s blood from splashing.	Wear it in a general medical setting to block the exhalation or ejection of contaminants from the mouth or nose.	It is worn by clinical operators during invasive operations, etc., to prevent spattering of blood or infection of patients.	In a medical work environment, filters particulate matter in the air and blocks droplets, blood, body fluids, secretions, etc.

Note: [Unspecified], means that the absence of a direct reference to this indicator in the corresponding criterion does not imply a complete lack of protective capacity in this case.

Different standards have different requirements for the performance of masks, if you want to know more detailed mask standards. This article has compiled the most complete introduction to mask standards. Global Standards for Face Masks: Fullest Version Update

♦ Quality management of mask production line

Quality management of mask production line is the key point of building mask factory. How to ensure the quality and speed of mask production line and how to effectively reduce the defective products in mask production are the key points to focus on in building mask factory. Here will be explained from the following three aspects.

Mask production line workshop construction planning

1. Medical device purification engineering – Specification reference for aseptic cleanroom engineering design.
2. International standard: ISO/DIS 14644
3. Medical device packaging workshop cleanroom plant specification: GMP-97
4. Quality management standard for pharmaceutical production: GMP-98
5. Cleanroom construction and acceptance specification: JGJ 71-90
6. U.S. Federal Standard: FS209E-92
7. Clean room plant design specification: GB50073-2001

According to the relevant specifications, the construction of cleanrooms conforming to the relevant standards is required for sterile medical device production workshops, pharmaceutical production workshops, etc. In the construction or reconstruction of cleanroom, we cannot guarantee the quality of cleanroom only according to the acceptance, we must strictly check from the design and equipment selection stage, strictly check and supervise the main key points in the whole process of construction, and regularly monitor in the actual use to ensure the cleanroom can reach the design index and use requirements.

Medical mask production line purification project construction needs to consider the following issues.

1. The purification materials needed for packaging workshop cleanroom project of medical mask production line.
2. Comprehensive services such as design, installation, commissioning and maintenance for plant clean room and packaging workshop cleanroom project of the medical mask production line.
3. The air conditioning purification part for packaging workshop cleanroom project of medical mask production line.

Temperature and relative humidity: Usually requires a temperature of 18℃~28℃ and humidity of 45%-65%.

As temperature, relative humidity, wind speed, air change times, static pressure difference together constitute the cleanroom microclimate, is an important indicator of cleanroom maintenance normal or not. In order to ensure the scientific and accurate data of cleanroom performance monitoring, the testing department should conduct the test of temperature, relative humidity, number of air changes, static pressure difference and other prerequisites at the same time when the key items of suspended particles and microorganisms are tested.

Product quality is not detected but produced by strict process control, and environmental control is a key part of the production process control. The environmental control of the mask production line includes space design, cleanroom monitoring, management protocols, personnel training and other aspects.

The basic performance inspection requirements for the raw materials of mask production line

A mask from raw materials into the factory, intermediate process control, to the final product factory inspection, a total of more than a dozen testing projects, using a variety of testing equipment of about twenty kinds.

Generally speaking, the quality control of the mask is mainly divided into two parts: one is the basic performance inspection of the raw materials of the mask, and the other is the inspection of the use performance of the mask. Here we introduce the basic inspection of the raw materials of the mask, such as appearance, odor, size, etc.

Sampling

Inspection of the same species, the same specification of the material. Sampling of the appearance quality inspection: according to the provisions of the table, the corresponding number of volumes randomly selected from a batch of products, at least 5m from the head end of the place to cut samples.

Volumes	Volumes Sampled
≤25	2
26~150	3
>150	5

Inspection requirements of meltblown nonwoven (mask filter layer)

Item	Technical indicators	Test method
Appearance	No foreign objects (insects, hair, etc.)	Visual inspection
Odor	Shall not have pungent odor	Sniffing
Appearance	No damage, stain and color difference	Visual inspection
Width / cm	17.5±0.2	Straightedge measurement
Grammage (g/㎡)	22±2，30±2，33±2	Electronic Balance / Fabric Scale

Inspection requirements of spunbond nonwoven fabric (mask inner and outer layers, wrapping layer)

Item	Technical indicators	Test method
Appearance	No foreign objects (insects, hair, etc.)	Visual inspection
Odor	Shall not have pungent odor	Sniffing
Appearance	No damage, stain and color difference	Visual inspection
Width / cm	Out layer fabric: 17.8±0.2 Inner layer fabric: 19.8±0.2 Wrapping fabric: 33.0±0.5	Straightedge measurement
Grammage (g/㎡)	22±2, 30±2, 33±2	Electronic Balance / Fabric Scale

Inspection requirements of nose bridge strip for mask (PP strip or metal strip)

Item	Technical indicators	Test method
Appearance	Flat, flat, no oil stain, no foreign matter, no color change, no burr, no sharp edge.	Visual inspection
Odor	No oil smell, no odor	Sniffing
PP strip weight	3.3±0.2	Electronic Balance
PP strip width	3.0±0.2	Straightedge measurement
Metal strip weight	4.0±0.2	Electronic Balance
Metal strip width	2.9±0.2	Straightedge measurement

Quality deviation requirement

Item	Specification
	≤20	≤50	≤100
Width deviation / mm	-1 ~ +3
Mass deviation rate per unit area / %	±8	±7	±5
Coefficient of variation of mass per unit area / %	≤7		≤6
Transverse breaking strength	≥2	≥6	≥10
Longitudinal breaking strength	≥4	≥9	≥15
Longitudinal/transverse elongation at break / %	≥20

 

Item		Requirement
Hole		not allowed
Pinhole	Not Obvious	≤10/100cm²
	Obvious	not allowed
crystallizing Point	Area < 1nm²	≤10/100cm²
	Area ≥ 1nm²	not allowed
Flying		not allowed
Foreign Objects		not allowed
Note: 1 Crystallizing Point are dotted polymer particles present on the fabric surface. 2 Flying refers to the presence of solidified fiber blocks or fiber strips on the surface of the cloth, with a sense of raised surface. 3 Meltblown fabric does not allow pinholes and crystallizing points with particle filter efficeiency ≥95%.

The test results of all samples as the batch of fabric quality indicators, the indicators meet the requirements, the batch of products of qualified quality. If there are unqualified items, resampling according to the provisions, retest the non-conforming items. If the retest results meet the requirements, the quality of the batch of products qualified, if the retest results still do not meet the requirements, the batch of product quality failed.

Use performance inspection requirements of mask

The nonwoven fabrics used for mask production are mainly spunbond nonwoven fabrics and meltblown nonwoven fabrics, which determine the use performance of masks, of which meltblown fabrics are the main deciding factor.

The production and sales of masks are inseparable from the standards, and only masks that meet the standards can meet the use of performance. Different national standards, performance requirements are not the same, only familiar with the relevant mask standards, in order to correctly test the use of the mask performance is qualified.

Common mask standards as shown above, through the analysis of mask standards can be found, regardless of which standard or type of mask, the main use of performance tests mainly include the following: mask ear strap break strength test, differential pressure test, synthetic blood penetration test, bacterial filtration efficiency test, etc.

Bacterial filtration efficiency test

Bacterial filtration efficiency is a key indicator of the quality assessment of the mask, which is also one of the important quality standards for nonwoven fabrics. Referring to the relevant standards, we recommend that the bacterial filtration efficiency of the mask nonwoven fabric should be not less than 95%.

For meltblown fabric, after checking the filtration efficiency, the meltblown fabric of the mask can be classified as 80%, 90%, 95%, 100% according to the filtration efficiency. It is convenient for subsequent use.

Differential pressure test / Breathing resistance

Differential pressure is the degree of smoothness that hinders breathing when people wear the mask. The breathing resistance of the mask non-woven fabric determines the breathing comfort when wearing the mask, here we recommend the indicator of inspiratory resistance should be ≤ 350Pa, exhalation resistance should be ≤ 250Pa.

Synthetic blood penetration test

Synthetic blood penetration test, by spraying a small volume of synthetic blood horizontally to assess the resistance of medical masks to blood penetration and splash resistance characteristics. This test is suitable for evaluating the resistance of medical surgical masks, disposable masks and other masks to synthetic blood penetration.

Earloop breaking strength test of mask

Use the appropriate fixture to fix the mask earloop and mask body respectively, start the TU001 medical textile tensile testing machine pull the mask strap off, if it is a disposable medical mask, see whether its breaking strength ≥ 10N; if it is a daily protective mask, see whether its breaking strength ≥ 20N.

Hygiene indicator

Hygiene indicator is another key index of mask nonwoven. Here we recommend the testing items are mainly initial contamination bacteria, total bacterial colony, coliform, pathogenic septic bacteria, total fungal colony, E. coli, golden staphylococcus, Candida albicans, ethylene oxide residue, etc.

In the above tests, the filtration efficiency of the non-woven fabric of the mask is the most important of these test indicators. Specific testing methods can refer to the standards: EN 149, NIOSH Standards – Title 42 CFR Part 84, GB 2626. where the filtration efficiency performance comparison is as follows.

Filtration efficiency test conditions and requirements	GB 2626	EN 149	NIOSH Standards – Title 42 CFR Part 84
Non-oily particulate matter (NaCl)	KN90≥90% KN95≥95% KN100≥99.97%	FFP1≥80% FFP2≥94% FFP3≥99%	N95/P95/R95≥95% N99/P99/R99≥99% N100/P100/R100≥99.97%
Oily particulate matter (DOP or paraffin oil)	KP90≥90% KP95≥95% KP100≥99.97%	FFP1≥80% FFP2≥94% FFP3≥99%	P95/R95≥95% P99/R99≥99% P100/R100≥99.97%
Remarks	NaCl concentration is (10±2) mg/m³, oil particulate concentration is (20~30) mg/m³	Referring to BS EN13274, the concentration of particulate matter is (4~12) mg/m³	NaCl particles, oily DOP or paraffin oil, test flow rate 85L/Min

If you want to learn more about the performance test standards for mask use, you can refer to these articles below.

• Global Standard for Face Masks: Fullest Version Update
• Protective Face Masks, GB 2626-2019 and EN 149: 2001 + A1: 2009, Standards Comparison
• How to Distinguish Between KN95 and N95 Masks: Standard Full Comparison
• Antiviral Face Mask for Filtering 2019-nCoV: Full Analysis of Nine Standards
• Quality Detection and Specification for Use of Medical Masks or N95 Masks – for the Novel Coronavirus

Note: meltblown fabric is the key to the quality of the mask. Compared with spunbond nonwoven fabric, the characteristics of meltblown fabric are as follows.

Spunbond nonwoven fabric is not easy to tear and will not stain your hands due to static electricity. Qualified meltblown nonwoven fabric is obviously good to tear and will be stained by static electricity.

Spunbond nonwoven and meltblown nonwoven are both polypropylene products, and the burning difference is not significant.

♦ The process of the mask production line

The process of the whole mask production line is still relatively large, we take medical surgical masks as an example to illustrate the production process of mask manufacturing machine, other protective masks, such as N95, KF94, etc., the production process is similar to that of flat masks, only the type of mask manufacturing machine used is different to facilitate the production of different shapes of masks.

To understand the process of mask production line, let’s start with the composition structure of the mask itself. Common medical masks are mainly composed of three layers of non-woven fabric, the inner layer is ordinary non-woven fabric, the outer layer is a non-woven fabric with waterproof treatment, which is mainly used to isolate the liquid sprayed by the patient, and the middle layer is the main filter material, commonly used polypropylene meltblown fabric material. In addition, other materials used in the production of masks include, metal strips (for nose clips), elastic materials (for mask earloop), etc.

Whether it is a flat mask manufacturing machine, or N95 mask manufacturing machine, KF94 mask manufacturing machine, from the process point of view, the production process of mask manufacturing machine is mainly divided into four parts: incoming material part, mask body part, earloop welding part and disinfection packaging part. The total includes 12 small steps.

Incoming material inspection→loading material→mask body forming→ear loop welding→folding ear loop→ear loop inspection→finished mask inspection→mask packaging→logo printing→UV sterilization→mask boxing→mask packing

Incoming material part

The incoming material part mainly refers to the incoming material inspection (see the basic performance inspection of masks above) and the selection of the corresponding specifications of nonwoven fabrics and nose bridge strip for the specifications of masks to be produced.

Mask body part

The mask body forming part is a more important step of the mask production line, the focus is to ensure that the mask is folded into shape, the position of the nose bridge strip is adjusted, and the mask wrap edge is flat.

Earloop welding part

The difficulty of earloop welding is how to ensure the accuracy of the welding position, the solidity of the welding, and the flatness of the ear loop folding for packaging. After the ear loop welding, the earloop needs to be tested for breaking strength to check the solidity of the ear loop welding. At this point, the finished product is already a mask, and the first finished mask needs to be tested comprehensively and spot-checked in the later process of the mask production line.

UV sterilization and packaging

This is the last part of the mask production line and the preparation work before mask boxing. It mainly refers to the printing of mask logo, individual packaging of individual masks, UV sterilization, mask boxing, mask crating and so on, which can be selected according to the requirements.

Note: The contents of each package identification should include the manufacturer’s name and address, product name, executive mark number, production batch number, product specifications (unit area quality, width, volume length, etc.), production date, volume weight, volume number, as well as other enterprises that should be necessary to mark the content. Product packaging should ensure that product quality is not easily damaged, not easily contaminated, no damage caused by storage and transportation, and easy to transport.

What are the equipments of the mask production line?

The equipment of the mask production line mainly refers to mask manufacturing machine, and disinfection packaging equipment, etc. A good mask manufacturing machine has the characteristics of full automaticity, high output, high stability, easy maintenance, etc.

From the classification of masks, there are now three main types of common mask manufacturing machines: flat mask manufacturing machine / medical surgical mask manufacturing machine, N95 mask manufacturing machine, and KF94 mask manufacturing machine.

1 flat mask manufacturing machine / medical surgical mask manufacturing machine

Medical surgical mask manufacturing machine, used to produce disposable medical face masks or surgical face masks in mass production. It is constructed with 3 major parts, they are automatic mask bodies forming machine, automatic earloop welding machine, and the conveyor (when automatic mask packing machine being chosen, the conveyor is not must).

2 N95 mask manufacturing machine

N95 mask manufacturing machine used to produce n95 masks, kn95 masks, or other foled-type masks in mass production. N95 mask manufacturing machine is an easy set-up solution to produce N95 folded masks, a total 3 manufacturing process, first automatically forming N95 mask bodies, and then be welded the earloop on, finally mask bodies be folded with the two edges sealed to output the final folded N95 masks.

3 KF94 mask manufacturing machine

KF94 mask manufacturing machine, fish design mask manufacturing machine, a fully automatic mask manufacturing machine for KF94 standard or DS2 standard mask production, which can produce different standards of masks depending on the raw materials used.

From the process of the mask production line, mask production equipment mainly includes incoming materials frame, mask body forming, mask earloop welding, mask UV disinfection, mask logo printing, mask packaging and other equipment.

For excellent manufacturers of mask manufacturing machine, the equipment of these production processes should be modularized and standardized, so as to enhance the stability of the mask production process, and these modules can be interconnected to achieve fully automated production of masks.

In addition, if the production of sterile medical masks involves a sterilization process. At present, the vast majority of enterprises choose ethylene oxide (EO) sterilization equipment.

The masks sterilized by ethylene oxide need to be analyzed. Because after the sterilization of ethylene oxide, there will be residual ethylene oxide on the mask, and ethylene oxide is a toxic carcinogenic substance, long-term inhalation of ethylene oxide, not only to stimulate the respiratory tract, but also the possibility of cancer.

Therefore, the medical masks sterilized by ethylene oxide must be analyzed to release the residual ethylene oxide on the masks and be tested and qualified before they can be marketed. The verified ethylene oxide analysis time is about 14 days, which can ensure that the residual ethylene oxide content in the mask is lower than the safety standard of 10ug/g.

Equipment procurement advice of mask production line

To make the mask production line smoothly built and put into production, we must pay attention to the equipment purchase of mask production line, whether it is mask manufacturing machine or testing equipment, we have to go from delivery, output, price, after-sales service, stability, compliance with regulations and other aspects of a comprehensive measure to purchase the right mask production line.

Compliance with regulations: CE marking for machinery and equipment is a safety certification mark that is regarded as a passport for manufacturers to enter the European market. All products with the “CE” mark can be sold in each member state of the European Union without having to meet the requirements of each member state, thus achieving the free flow of goods within the EU member states.

• Delivery time: Time is money, and it is obvious that a fast delivery time of mask manufacturing machine means a fast entry into production.
• Output speed: High output of the mask manufacturing machine means more masks are produced in the same amount of time, and the efficiency is naturally higher.
• Stability: Stability is a prerequisite, and only with fewer failures of mask manufacturing machine can we maximize the continuity of production.
• After-sales service: After purchasing the mask manufacturing machine, whether the mask machine manufacturer can provide timely and professional after-sales service is very important.
• Cost-effectiveness: cost effectiveness needs to be considered according to your own circumstances, after all, a penny is worth a penny.

♦ Costing for a mask production line

Whether the global epidemic is over or not, if we want to build a mask production line, we’d better learn to do a preliminary costing of whether we need to build a mask production line from an input-output perspective.

Taking the disposable medical masks as an example, how to calculate the return on its input by buying a mask manufacturing machine and mask raw material?

One-time input cost M

Production equipment such as mask manufacturing machine	Clean Workshop	Testing Equipment
Subject to actual purchase	Refer to the local labor price rent	Can be tested by third-party testing organizations

Ongoing input costs N

Goods and materials	24H inputs	24H costs
Raw materials	0.1ton meltblown nonwoven fabric, 0.2ton spunbond nonwoven fabric, Ear loop, nose bridge strip	Subject to actual purchase
Manpower	six people, 8H each, full-day production	Reference labor cost at production site

Note: According to 30g/m² of the mask material (non-woven fabric), the size of the mask is about 18cm*18cm, the output of a mask manufacturing machine is about 100K masks one day, it can be calculated that consume 0.1ton melt-blown fabric and 0.2ton spunbond non-woven fabric per 24H.

Mask income P

For different regions, the price of masks will vary due to different prices, here the price of masks on top of Amazon is used as a reference.

The one-time input M is used as a fixed asset, so as long as the income P from the sale of masks can be greater than the ongoing input cost N, theoretically, the return on the mask production line will be higher as long as the longer the life of the mask manufacturing machine is, the greater the (P-N).

Finally, in the new year of 2022, TESTEX wishes everyone a happy new year, and we will continue to contribute to the world, wishing that the worldwide epidemic will end sooner.