CLEANROOM PACKAGE SOLUTIONS

2015年10月15日星期四

ISO14644-1 and FS209E Cleanroom Standards

ISO14644-1 and FS209E Cleanroom Standards
Anlaitech is the leading expert in the design and fabrication of critical-environment applications. We offer a complete range of clean room equipment, furnishing and supplies for cleanrooms and laboratories. Following are the rigorous standards to which Anlaitech adheres.

Before global cleanroom classifications and standards were adopted by the International Standards Organization (ISO), the U.S. General Service Administration’s standards (known as FS209E) were applied virtually worldwide. However, as the need for international standards grew, the ISO established a technical committee and several working groups to delineate its own set of standards.
FS209E contains six classes, while the ISO 14644-1 classification system adds two cleaner standards and one dirtier standard (see chart below). The "cleanest" cleanroom in FS209E is referred to as Class 1; the "dirtiest" cleanroom is a class 100,000. ISO cleanroom classifications are rated according to how much particulate of specific sizes exist per cubic meter (see second chart). The "cleanest" cleanroom is a class 1 and the "dirtiest" a class 9. ISO class 3 is approximately equal to FS209E class 1, while ISO class 8 approximately equals FS209E class 100,000.
By law, Federal Standard 209E can be superseded by new international standards. It is expected that 209E will be used in some industries over the next five years, but that eventually it will be replaced internationally by ISO 14644-1.
Airborne Particulate Cleanliness Class Comparison
ISO 14644-1
FEDERAL STANDARD 209E
ISO Class
English
Metric
ISO 1
ISO 2
ISO 3
1
M1.5
ISO 4
10
M2.5
ISO 5
100
M3.5
ISO 6
1,000
M4.5
ISO 7
10,000
M5.5
ISO 8
100,000
M6.5
ISO 9

Airborne Particulate Cleanliness Classes (by cubic meter):
CLASS
Number of Particles per Cubic Meter by Micrometer Size
0.1 micron
0.2 micron
0.3 micron
0.5 micron
1 micron
5 microns
ISO1
10
2
ISO2
100
24
10
4
ISO3
1,000
237
102
35
8
ISO4
10,000
2,370
1,020
352
83
ISO5
100,000
23,700
10,200
3,520
832
29
ISO6
1,000,000
237,000
102,000
35,200
8,320
293
ISO7
352,000
83,200
2,930
ISO8
3,520,000
832,000
29,300
ISO9
35,200,000
8,320,000
293,000
In cleanrooms, particulate concentration changes over time — from the construction and installation of equipment to its operational status. ISO delineates three cleanroom classification standards: as-built, at-rest and operational. As instruments and equipment are introduced and particulates rise, an "as-built" cleanroom becomes an "at-rest" cleanroom. When people are added to the matrix, particulate levels rise still further in the "operational" cleanroom.
ISO 14644-2 describes the type and frequency of testing required to conform to certain standards. The following tables indicate mandatory and optional tests.
Required Testing (ISO 14644-2)
Schedule of Tests to Demonstrate Continuing Compliance
Test Parameter
Class
Maximum Time Interval
Test Procedure
Particle Count Test
<= ISO 5
6 Months
ISO 14644-1 Annex A
> ISO 5
12 Months
Air Pressure Difference
All Classes
12 Months
ISO 14644-1 Annex B5
Airflow
All Classes
12 Months
ISO 14644-1 Annex B4

Optional Testing (ISO 14644-2)
Schedule of Additional Optional Tests
Test Parameter
Class
Maximum Time Interval
Test Procedure
Installed Filter Leakage
All Classes
24 Months
ISO 14644-1 Annex B6
Containment Leakage
All Classes
24 Months
ISO 14644-1 Annex B4
Recovery
All Classes
24 Months
ISO 14644-1 Annex B13
Airflow Visualization
All Classes
24 Months
ISO 14644-1 Annex B7
Today, in addition to ISO 14644-1 and ISO 14644-2, eight other cleanroom standards documents are being prepared. Many are in the final voting stage and can be legally used in the trade (see chart).
ISO Document
Title
ISO 14644-1
Classification of Air Cleanliness
ISO 14644-2
Cleanroom Testing for Compliance
ISO 14644-3
Methods for Evaluating and Measuring Cleanrooms and Associated Controlled Environments
ISO 14644-4
Cleanroom Design and Construction
ISO 14644-5
Cleanroom Operations
ISO 14644-6
Terms, Definitions and Units
ISO 14644-7
Enhanced Clean Devices
ISO 14644-8
Molecular Contamination
ISO 14698-1
Biocontamination: Control General Principles
ISO 14698-2
Biocontamination: Evaluation and Interpretation of Data
ISO 14698-3
Biocontamination: Methodology for Measuring Efficiency of Cleaning Inert Surfaces
The USA source for ISO documents is:
Institute of Environmental Sciences & Technology (IEST)

The source for FS209E documents at the General Services Administration is:
Naval Publications and Forms Center

ISO and Federal Air Change Rates for Cleanrooms
A critical factor in cleanroom design is controlling air-change per hour (ACH), also known as the air-change rate, or ACR. This refers to the number of times each hour that filtered outside air replaces the existing volume in a building or chamber. In a normal home, an air-conditioner changes room air 0.5 to 2 times per hour. In a cleanroom, depending on classification and usage, air change occurs anywhere from 10 to more than 600 times an hour.
ACR is a prime variable in determining ISO and Federal cleanliness standards. To meet optimal standards, ACR must be painstakingly measured and controlled. And there is some controversy. In an appendix to its ISO 14644-1 cleanliness standard, the International Standards Organization addressed applications for microelectronic facilities only. (ISO classes 6 to 8; Federal Standards 1,000, 10,000 and 100,000.) The appendix contained no ACR standards for pharmaceutical, healthcare or biotech applications, which may require higher ACR regulations.
According to current research, case studies and experiments, using an ACR range (rather than one set standard) is a better guideline for cleanliness classification. This is true because the optimal ACR varies from cleanroom to cleanroom, depending on factors such as internal equipment, staffing and operational purpose. Everything depends on the level of outside contaminants trying to enter the facility versus the level of contaminants being generated on the inside.
The breadth of these ranges reflects how dramatically people and processes affect cleanliness. Low-end figures within each contamination class generally indicate air velocity and air change requirements for an as-built or at-rest facility—where no people are present and no contaminating processes under way. When there are people and processes producing contaminants, more air changes are required to maintain optimal cleanliness standards. For instance, some manufacturers insist on as many as 720 air changes per hour to meet Class 10 standards.
Determining the appropriate number of air changes for a particular application requires careful evaluation of factors such as the number of personnel, effectiveness of garbing protocol, frequency of access, and cleanliness of process equipment.
Rajan Jaisinghani, in his paper "Energy Efficient Low Operating Cost Cleanroom Airflow Design," presented at ESTECH 2003, recommended the following ranges based on FS209E classifications:
FS Cleanroom Class
ISO Equivalent Class
Air Change Rate
1
ISO 3
360-540
10
ISO 4
300-540
100
ISO 5
240-480
1,000
ISO 6
150-240
10,000
ISO 7
60-90
100,000
ISO 8
5-48
Jaisinghani’s recommendations concur with other recent studies of ACR, which criticize some existing air rate standards (developed in the 1990s) as being unscientific because they are based on fans and filters inferior to today’s models. So when these older standards are applied, the resulting ACR is often too high. In fact, some studies have found that reducing the ACR (and its attendant air turbulence) can result in a cleaner atmosphere.
This was demonstrated in a study conducted by Pacific Gas and Electric (San Francisco) and the Lawrence Berkeley National Laboratory (Berkeley). The study measured air change rates in several ISO Class-5 cleanrooms and came to the conclusion that there is "no consistent design strategy for air change rate, even for cleanrooms of the same cleanliness classification."
ACR rates have critical design implications, especially when considering desired cleanliness, fan size and lower energy costs. The PG&E/Berkeley study caused many designers to reduce fan sizes. In short, a lower ACR often resulted in cleaner air.
The study revealed three abiding principles:
  • Lower air change rates result in smaller fans, which reduce both initial investment and construction cost.
  • Fan power is proportional to the cube of air change rates or airflow. A 30-percent reduction in air change rate results in a power reduction of approximately 66 percent.
  • By minimizing turbulence, lower airflow may improve cleanliness.
The study focused on Class-5 cleanrooms, concluding that an ACR range of from 250 to 700 air changes per hour is standard, but that "actual operating ACRs ranged from 90 to 625." It added that all of these optimized cleanrooms were certified and performing at ISO Class-5 conditions with these lower ACRs. Finally, the study concluded that rarely does a Class-5 facility require an ACR of more than 300.
The study also found that the "[b]est practice for ACRs is to design new facilities at the lower end of the recommended ACR range," with variable speed drives (VSDs) built in so that air flow adjustments can be made under actual operating conditions.
In his report "An examination of ACRs: An opportunity to reduce energy and construction costs," Peter Rumsey, PE, CEM, essentially concurred with the PG&E-commissioned study by Berkeley. Rumsey issued a caveat, then brushed it aside by citing research subsequent to Berkeley’s: "Air cleanliness is a critical component of any cleanroom, far outweighing energy saving priorities. Designers and operators need evidence from others who have tried similar strategies in order to address the perceived risks of lowering air change rates."
Rumsey then went on to cite studies done by International Sematech (Austin, Texas); the Massachusetts Institute of Technology (Cambridge, Mass.); Intel (Santa Clara, Calif.); and Sandia National Laboratories (Albuquerque, N.M.), which echoed the Berkeley study.
In summary, current research and thinking on air change rates indicate that some existing standards are too high and can be lowered while still meeting all ACR criteria.
Federal and ISO Ceiling Fan Coverage Specifications
Achieving the optimal air change rate requires proper ceiling fan coverage. The cleanest modular cleanroom incorporates filter/fan units (FFUs) in every 2’ x 4’ (610 mm x 1219 mm) ceiling bay. This near-100% coverage provides a laminar flow of filtered air to quickly remove contaminants from the room, thus meeting FS209E standards for Class 10 and ISO Class 1 standards.
Such coverage, especially in a large cleanroom, can lead to higher energy consumption, thus increasing costs for both initial construction and ongoing operation. In most cases, a smaller percentage of ceiling coverage produces adequate cleanliness.
This table illustrates the percentage of ceiling coverage recommended for each cleanliness class, again as a range:
Class
Ceiling Coverage (Percentage)
ISO 8 (Class 100,000)
5 – 15%
ISO 7 (Class 10,000)
15 – 20%
ISO 6 (Class 1,000)
25 – 40%
ISO 5 (Class 100)
35 – 70 %
ISO 4 (Class 10)
50 – 90%
ISO 3 (Class 1)
60 – 100%
ISO 1-2
80 – 100%
Federal and ISO Airflow Velocity Standards
In addition to ACR and ceiling coverage, the third factor integral to maintaining cleanliness is fan-generated air speed. Again, higher airflow velocity results in a "cleaner" cleanroom. The term "ventilation efficiency" refers to the speed of filtered air passing through the cleanroom in addition to the number of air changes per hour (ACH or ACR).
An earlier chart showed a range of recommended air change rates (ACRs) for different classes of cleanrooms. Ranges are given because as-built and at-rest facilities require a smaller ACR than an operational cleanroom, where both people and equipment are actively engaged. Non-operational cleanrooms are found in the lower range; operational cleanrooms higher.
Combining all three factors—ACR, ceiling coverage and airflow velocity—results in the following table:
Class ISO 146144-1 (Federal Standard 209E)
Average Airflow Velocity
m/s (ft/min)
Air Changes Per Hour
Ceiling Coverage
ISO 8 (Class 100,000)
0.005 – 0.041 (1 – 8)
5 – 48
5 – 15%
ISO 7 (Class 10,000)
0.051 – 0.076 (10 -15)
60 – 90
15 – 20%
ISO 6 (Class 1,000)
0.127 – 0.203 (25 – 40)
150 – 240
25 – 40%
ISO 5 (Class 100)
0.203 – 0.406 (40 – 80)
240 – 480
35 – 70%
ISO 4 (Class 10)
0.254 – 0.457 (50 – 90)
300 – 540
50 – 90%
ISO 3 (Class 1)
0.305 – 0.457 (60 – 90)
360 – 540
60 – 100%
ISO 1 – 2
0.305 – 0.508 (60 – 100)
360 – 600
80 – 100%
Before deciding on the appropriate velocity and air changes for your application, Terra Universal recommends careful evaluation of factors such as number of personnel, effectiveness of garbing protocol, access frequency and cleanliness of process equipment. Once the required air change figure is established, the number of required FFUs can be determined using this formula: No. of FFUs = (Air Changes/Hour ÷60) x (Cubic ft. in room÷ 650*)
*CFM output of a loaded FFU
Meeting Class 100 standards using the low-end air change recommendation (240/hour) inside a 12’ x 12’ x 7’ (3302 mm x 3302 mm x 2134 mm) cleanroom, with 1008 cu. ft. of volume, requires 6 FFUs. To meet the same standard using the high-end air change recommendation (480/hour) requires 12 FFUs.
Positive Pressure
Cleanrooms are designed to maintain positive pressure, preventing "unclean" (contaminated) air from flowing inside and less-clean air from flowing into clean areas. The idea is to ensure that filtered air always flows from cleanest to less-clean spaces. In a multi-chambered cleanroom, for instance, the cleanest room is kept at the highest pressure. Pressure levels are set so that the cleanest air flows into spaces with less-clean air. Thus, multiple pressure levels may need to be maintained.
A differential air pressure of 0.03 to 0.05 inches water gauge is recommended between spaces. In order to ensure that pressure differentials remain constant when doors are opened, or other events occur, control systems must be in place.
Laminar and Turbulent Air Flow
ISO 5 (Class 100) and cleaner facilities rely on unidirectional, or laminar, airflow. Laminar airflow means that filtered air is uniformly supplied in one direction (at a fixed velocity) in parallel streams, usually vertically. Air is generally recirculated from the base of the walls back up to the filtering system.

ISO 6 (Class 1,000) and above cleanrooms generally utilize a non-unidirectional, or turbulent, airflow. This means the air is not regulated for direction and speed. The advantage of laminar over turbulent airflow is that it provides a uniform environment and prevents air pockets where contaminants might congregate.



2015年7月1日星期三

Anlaitech Clean Room Air Shower Tunnel

Anlaitech Clean Room Air Shower Tunnel

company web: www.cleanroomffu.com
Alibaba shop: http://anlaitech.en.alibaba.com/

Clean Room Air Shower protects cleanroom environment from contamination.It can enhance cleanroom performance by removing surface contamination from clothing and garments of person.

Air Shower equipped with pre-filter and HEPA, by double-layers filtration system to ensure high air cleanness level.

Air shower is widely used in LCD and Optoelectronic Display, PCB, microelectronics, dust-free coating, aseptic packaging, medical care, Pharmacy,auto glass and precision parts.





Air Shower Room for GMP Standard  AL-AS-1300/P Series      

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Air Shower in producing:

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Economice material: epoxy powder coated steel outside and inside, stainless steel for base and door
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Best sold material: epoxy powder coated steel outside, stainless steel 304 inside, #304 stainless steel for doorDSCF7458 Pharmaceutical  Clean Room Air Shower as Airlock Room.jpg

Non-rust material: full stainless steel 304 made.
full Electrical Safety Proved Stainless Steel Air Shower.JPG

Air Shower Indication:
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Air shower control panel:LED Display Air Shower Control Panel.jpg












Air Shower door closer:
Door closer for air shower.jpg



Air shower air velocity testing
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Export packing:
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Factory testing (all the sets you ordered):  

All of equipment is individually factory tested for safety and performance in accordance with international Standards. Each unit is shipped with a documentation outlining the tests undertaken and the unit’s individual results for each unit.

Factory test include:

--appearance testing

--functional test and visual inspection

--electrical safety tests

--air velocity testing

--noise testing



Warranty:

Our equipment is warranty for 1 year excluding consumable parts and accessories.

All equipment is shipped with a comprehensive use’s manual complete with a report documenting all test procedures.

Additional IO/OQ/GMP document is available upon request.

Contact our sales representative for specific warranty details or document request.  



Consumable parts illustration:

1: Pre-filter: each one should be replacement in each 6 month, but it can refresh no more three times.

2: HEPA air filter: each one should be replacement in each half and one years. 



Standard export packing:

--Stretch film strapped whole cabinet,

--Foam inside protected,

--Plywood case solid fixed

--European standard bottom tray



What you can get from us?

  1. 1.    Immediately responses for your inquiry and response saving your time, update your project processing.
  2. 2.       Professional design team matches all your ideas;
  3. 3.       Over 10years cleanroom, laboratory furniture and air filters producing experience guarantee the quality;
  4. 4.       Strictly factory testing take out your troubles in advance;
  5. 5.       ISO, CE, UL,TUV, SGS testing Certificates helped your business;
  6. 6.       With 18monthes Warranty card service your business in good way;
  7. 7.       Own the CNC machine, class 10000 clean room workshop, spray booth, 1300*1300 non-gap Mini-plated HEPA filter producing machine as well with over 5years clean room producing experience workers keep well each your orders.
  8. 8.       Completed of set documents issued with final products help you easy with our products.



With many thanks for your support, factory price is waiting for your response.


2015年6月10日星期三

The difference between mini-pleat filter & separator filter

The two commonly used HEPA filter is Mini-pleat & separator. 

The mini-pleat HEPA filter mainly adopts thermal sol as filter divider, is advantageous for the mechanized production. At present, a lot of clean workshop need large quantities of this mini-pleat structure because of the small volume, light weight, easy installation, stable efficiency, and uniform wind speed. 

The separator HEPA filter, mainly adopts aluminum foil, paper to be folding shape as filter dividers, form the air channel. A separator is made of high quality craft paper, hot roll-press or adopted offset paper as partition plate. Currently, the use most is the double-sided adhesive coated paper for separator, main purpose is to prevent the partition affected by cold and hot dry wet contraction and emit particles. 
When temperature and humidity changes, the separator paper may have larger particles distribution, resulting the cleanliness test is unqualified for the cleanroom. 

So for the places with high cleanliness requirements, we should recommend customers to use Mini-pleat HEPA filter. The abroad price of Separator HEPA filter is higher than Mini-pleat HEPA filter, so the separator HEPA filter seldom used oversea. In addition, compared with the rectangular channel of separator HEPA filter, the V channel of mini-pleat HEPA filter further improve the uniformity of dust capacity and extend the service life. Ventilation mini-pleat HEPA filter can avoid the use of metal parts, easy to waste processing, in line with the increasingly stringent environmental requirements. Except some special occasions, like the high temperature resistant and high security requirements, the mini-pleat HEPA filter can replace the separator HEPA filter.





2015年6月9日星期二

The air cleanliness testing of cleanroom

The air cleanliness testing of cleanroom

The air cleanliness of cleanroom, should undertake the following tests:



A  Empty state & static testing
Empty state test: under the conditions of cleanroom has been completed & the purify air conditioning system has been in a state of normal operation, to do the test without process equipment and production personnel indoor.
Static test: under the conditions of cleanroom purify air conditioning system is in normal operation condition and process equipment has been installed, to do the test without production personnel indoor.

B  To do the dynamic testing cleanroom under the normal production.
Clean room air volume, wind speed, positive pressure, temperature, humidity, noise detection, can according to the relevant provisions of the general gm & air conditioning to execute.

Empty state, static testing
A   the preparation before the test
1. Response to the clean room clean air conditioning system to make a thorough clean.
2Using light scattering particle counter to do the leak detection test for HEPA filter. First determine the dust grain number of upper side of the HEPA air filter static pressure box (or air hose) particle size ≥0.5um should be ≥30000 / l. If not enough, smoke can be introduced, and then began to leak detection. Put the particle counter (or leak detection devices) about 2~3cm to the sampling port of the HEPA filter, can move at a speed of 2 ~ 4 cm/sec, to scan the whole section head at the glue and mounting frame. When the dust particles of particle counter?≥0.5um over 3 grain/min.l (or the penetration rate 0.01‰)that it has obvious leakage, must be prevented leak.

B  Test content
1. The total air supply volume, total return air volume, fresh air volume, exhaust air volume, etc.
2. Clean room pressure value.
3. The section air velocity and air flow of laminar flow cleanroom.
4. The cleanliness of clean work area.
5. Indoor temperature, humidity and the adjust test of control capabilities.
6. The indoor noise of cleanroom.

C  The test method for air cleanliness of the clean work area for the particle size ≥0.5um, it’s better to adopt a light scattering particle counting method. For the particle size ≥0.5um, it can also be used membrane microscope counting method.
Light scattering particle counting method
1
Light scattering particle counter sample volume for 100 rank: each time the sample volume ≥1 liter.
For 1,000~10,000 rank: each time the sample volume ≥0.3 liter.
For 100,000 rank: each time the sample volume ≥0.1 liter.
For the 100 rank cleanroom, it should be used to test by the large flow particle counter. If the conditions are not available, it can be used for each sample not less than 1 liter of particle counter.

2Sampling Notes
(1) The sampling tube must be clean, junction is strictly prohibited leakage.
(2) The length of sampling tube, should be based on allowable length of the instrument. If not has the specified, should be less than 1.5 meters.
(3) The sampling nozzle velocity, should close to the average wind speed of cleanroom section. The tester should at the downwind of sampling port.
(4) Sample order should be in accordance with the dust concentration from low to high.

3Monitoring point arrangement
(1) Testing should be proceed in the clean work area. When the production process without special requirements, sampling height appropriate for one meter from the ground.
(2) The total measuring point of laminar flow clean room not less than 20 points, each measuring point distance is from 0.5um to 2.0um. The number of dust particle size ≥ 0.5 microns allows more than one point. The measuring points of horizontal laminar flow clean room only arranged in the first clean workspace.
(3) Turbulence cleanroom according to clean area, if ≤ 50 square meters are arranged five measuring points (attached map 2). Each additional 20~50 square meters, add 3~5 measuring points.

4
Data processing
(1) Data processing of each measuring point should be three consecutive sampling under conditions of stable operation of test equipment, take the average value, is the point at which the measured value.
(2) For the number of dust particles ≥ 0.5um: laminar flow cleanroom to take each maximum measurement point, turbulence cleanroom averaged each measuring point.

D  Positive pressure measuring should adopt the micromanometers which the accuracy up to 0.01 mm water column.

Dynamic Testing. The operating position in the clean workspace choose a representative measuring point on the airflow wind direction, the test method is the same with empty state & static testing.

2015年5月6日星期三

How many Do you know about nozzles of industrial Cleanroom air shower?

How many Do you know about nozzles of industrial Cleanroom air shower?

Air shower room as dust removal equipment not less in industrial production, its use has been very extensive, but in today's article for you to some of the design and use of these air shower nozzle to introduce the basic situation, we have a look at today's vents.



1, air shower nozzle design materials

1.1, The materials of air shower nozzles must have the corrosion resistance, and easy molding;
1.2, When using aluminum to comply with the GB5237;
1.3, When using the steel to meet GB11253.


2, air shower nozzle design requirements

2.1, The decorative surface color to be consistent;
2.2, the blade pitch size deviation of not more than 1mm;
2.3, air decorative surface has no obvious scratch, indentation;
2.4, the curvature of the blade is 3/1000mm, the parallel degree is 4/1000mm;
2.5, determine the air in the standard test conditions rated air flow and a range of values;
2.6, air moving parts required to operate freely, not stuck, loose phenomenon;
2.7, the air in the neck of the speed is 6m/s, the total pressure loss of equipment can not exceed 100Pa;
2.8, air interface joint decoration on the surface of aluminium material should not exceed 0.15mm, other materials not exceeding 0.2mm.

3.The basic classification of the nozzle three, air shower room.

3.1, louver: square, rectangular, round;
3.2, the diffuser: circular, square, rectangular, circular etc.;
3.3: circular, rectangular, nozzle, spherical etc.;
3.4, the special air inlet, outlet, chair: lamps, grille and air outlet hole;
3.5, slot outlet: single slot, and a plurality of slots.

On the three aspects above we provide you a detailed analysis of the specifications and requirements of the air shower nozzle, these seemingly simple knowledge is in our actual operation process is very important, the general air shower nozzle quality will also affect the wind effect, because this is the understanding and very important to grasp this knowledge.

Anlaitech--We are professional in clean room air shower manufacturing,the standard nozzles of air shower specifications:
1. Stainless steel 304 made which is corrosion resistance, and easy molding.
2.Round type

WEB: WWW.CLEANROOMFFU.COM