MARKET BRIEF (CLEANROOM GLOVES) JULY 2016

Transcription

1 MALAYSIAN RUBBER EXPORT PROMOTION COUNCIL MARKET BRIEF (CLEANROOM GLOVES) JULY 2016 UNITED STATES OF AMERICA

2 CONTENTS Item Topic Page 1. COUNTRY PROFILE 2 2. MARKET INFORMATION 3 3. TRADE STATISTICS 6 4. TARIFF & NON TARIFF BARRIERS 13 5 TRANS PACIFIC PARTNERSHIP AGREEMENT FS209E and ISO CLEANROOM STANDARDS CLEANROOM PRODUCTS SUPPLIERS & DISTRIBUTORS IN USA USEFUL CONTACTS TRADE FAIRS 26 1

3 1.0 COUNTRY PROFILE Capital: Washington D.C, UNITED STATES OF AMERICA Population: million (UN, 2010) Area: 9.8 million sq km Official language: English Major religions: Christianity Life expectancy: 76 years (men), 81 years (women) Currency: US Dollar Main exports: Computers and electrical machinery, vehicles, chemical products, food and live animals, military equipment and aircraft Main imports: Agricultural products, industrial supplies (crude oil), capital goods (computers, telecommunications equipment, motor vehicle parts, office machines, electric power machinery), consumer goods (automobiles, clothing, medicines, furniture and toys). GDP per capita: $54,800 (2014 est.) GDP growth: 2.4% (2014 est.) International dialing code: +1 2

4 2.0 MARKET INFORMATION The U.S. Semiconductors Industry Semiconductors are a core component of electronics and vital inputs of products ranging from devices and systems (e.g. computers, cell phones and televisions) to solutions and services (e.g. internet providers, telecommunications and broadcasting services). The semiconductor and circuit manufacturing industry is one of the top export industries in the United States, and according to the Semiconductor Industry Association (SIA), indirectly provides jobs to over 250,000 Americans. Valued at US$54.2 billion, the industry has declined at an average annual rate of 9.0% over the five years to 2016, despite a 2.7% growth anticipated for However, this growth masks the significant year-over-year volatility that characterizes the industry. Demand for American-made semiconductors is being offset by international competition, aggressive import penetration and a stronger currency. Emerging countries, particularly in East Asia, have siphoned semiconductor manufacturing away from the United States through industrial policy, tax incentives and high-tech corridors with low-cost labor. Even as global demand for semiconductors rises, industry manufacturers are operating in a highly competitive global industry. Price reductions and production outsourcing have prevented the industry from achieving higher revenue and profit growth in the past five years, as well as lower demand in certain consumer electronic segments. These factors have also contributed to the industry's high revenue volatility, as industry performance has become more closely embedded into the globalized electronics value chain. In the five years to 2021, greater research and development efforts and broad-based economic growth will sustain the industry. Although operators will continue to face strong international competition, new opportunities in next-generation semiconductors and electronic inputs will encourage operators to invest in product development. For example, manufacturers will focus on producing wide bandgap semiconductors that are smaller, faster and more efficient than their silicon counterparts. Additionally, greater demand for industry products in smart grid technology and smart vehicles will spur revenue growth. In the five years to 2021, revenue is forecast to increase at an annualized rate of 0.9% to US$56.8 billion. Recent forecast summaries from the World Semiconductor Trade Statistics (WSTS) indicate that demand for semiconductor inputs slowed in almost all regions in 2016 (except in Asia Pacific). Growth in optoelectronics and sensors has offset declines in discrete, logic and memory products. Among the industry s downstream markets, automotive and communication are expected to grow at a faster rate than the total market, whereas consumer and computer products will remain flat. Manufacturers have faced the challenge of declining prices of industry products, which have prevented the industry from reaching higher revenue growth over the period. In the five years to 2016, IBISWorld estimates the price of semiconductor and electronic components will decline at an average annual rate of 1.1%. The US Bureau of Labor Statistics trade indices support this, with the import semiconductor price index falling 3

5 steadily over the past 10 years. Greater international competition and technological advances are responsible for driving down product prices in the past five years. Imports and Exports The US share of global semiconductor production has eroded in the five years to 2016, with foreign producers investing in fabrication facilities that can match those of domestic plants and are in proximity to upstream and downstream industries related to electronics production. In the past, US-based companies offshored the manufacturing of lower-value semiconductors to countries including Korea, Singapore, Taiwan and China. The contract manufacturers from these countries have expanded this role and now act as full-fledged semiconductor designers. Consequently, imports have gained increasing importance in the domestic market. Adding to this is the appreciation of the dollar, which has increased the purchasing power of American businesses and consumers over the past five years. During this time, the value of imports has increased at an annualized rate of 0.7% to US$43.6 billion. Malaysia (accounting for 29.9% of total import values), China (12.9%), Taiwan (10.7%) and Japan (7.4%) are the largest sources of imported semiconductors. Industry manufacturers have also faced falling exports in the five years to 2016 due to greater competition from Asian operators, as well as the dollar appreciation that has made American goods more expensive in the international market. In addition, the slowdown in emerging markets has lowered demand for certain consumer segments. Exports are expected to fall an annualized 3.6% to US$27.1 billion over the period; in 2016, exports are expected to generate 49.9% of industry revenue, demonstrating the importance of the export market. Cleanroon Industry Worldwide According to Transparency Market Research, a new market report titled, "Cleanroom Consumables Market - Global Industry Analysis, Size, Share, Growth, Trends, and Forecast : the global cleanroom consumables market was valued at US$ 7,638.6 Million in 2014 and is projected to expand at a CAGR of 4.4% from 2015 to 2023 to reach US$ 11,315.6 Million in Cleanrooms are controlled working environments, wherein contaminants such as dust, aerosol particles, airborne microbes, and chemical vapors are reduced to bare minimal levels. Cleanrooms are primarily used in every industry where small particles/contaminations can adversely affect the manufacturing/critical research activities. These vary in size and complexity, and used extensively in industries such as semiconductor manufacturing, pharmaceuticals, biotech, medical devices and life sciences, as well as critical process manufacturing common in aerospace, optics, military, and department of energy. Two international standards are used to classify cleanrooms: Federal Standard 209E, which is an old version, and TC 209 from the International Standards Organization, which is an updated form followed across the globe. 4

6 The cleanroom products can be further sub-classified into six categories: cleanroom apparels, cleaning products, cleanroom stationery, wipers, gloves, and adhesive mats. Cleanroom gloves of various materials are available in the market. Each of these types has merits and demerits. Nitrile gloves are most widely used in cleanrooms as these provide comfort and elasticity, have favorable static discharge properties, and provide effective barrier protection. Hence, these are ideally used in all major industries such as electronics, health care, aeronautical, defense, and automation. Major players profiled in the report include Berkshire Corporation, Cantel Medical, Contec, Inc., DuPont, Kimberly-Clark Corporation, KM Corporation, Micronclean (skegness) Ltd., Micronova Manufacturing, Inc., Nitritex Ltd., Texwipe, Thermo Fisher Scientific, and Valutek. Cleanroom Industry in the US In 2013, North America was the major market for cleanroom technology, with 38% share, followed by Europe, Asia-Pacific, and Rest of the World. A developed healthcare industry; significant presence of pharmaceutical, biotechnology, and medical device industries; and stringent healthcare regulations contributed to the large market shares of North America and Europe. But the majority of the growth in the cleanroom technology market is expected to come from the Asia- Pacific region during 2014 to 2019, where it is expected to grow at a CAGR of 8.2%, mainly owing to an increasing number of pharmaceutical and biotechnology production facilities, initiatives from governments for safety and efficacy of healthcare products, and rising demand for better quality healthcare products. China and India would be the fastest growing regions for healthcare cleanroom technology markets during the forecast period. 5

7 3.0 TRADE STATISTICS 3.1 MULTILATERAL TRADE a) Rubber and Rubber Products i) Top Ten Suppliers of Rubber and Rubber Products to United States United States Import Statistics Commodity: Rubber & Rubber Products Year To Date: January - December Rank Partner Country US$ Million % Share % Change /2014 World 56, , , China 23, , , Vietnam 3, , , Mexico 3, , , Canada 3, , , Indonesia 3, , , Japan 2, , , Thailand 2, , , South Korea 1, , , Malaysia 1, , , Germany 1, , , Source: World Trade Atlas ii) Leading Rubber & Rubber Products Imported by United States United States Import Statistics Commodity: Rubber & Rubber Products Year To Date: January - December Commodity Description US$ Million % Share % Change /2014 Rubber & Rubber Products 56, , , New Tires For Cars 7, , , Footwear, Outer Sole Rubber 6, , , Footwear, Outer Sole & Upper Rubber 4, , , Footwear, Out Sole Rubber & Upper 3, , , Leather New Tires For Buses Or Trucks 3, , , Source: World Trade Atlas 6

8 b) Rubber iii) Top Ten Suppliers of Rubber to United States Rank Partner Country United States Import Statistics Commodity: Rubber (Upstream) Year To Date: January - December US$ Million % Share % Change /2014 World 4, , , Indonesia 1, , Canada Thailand Japan South Korea Germany Mexico France Russia Malaysia Source: World Trade Atlas iv) Leading Rubber Commodity Imported by United States United States Import Statistics Commodity: Rubber (Upstream) Year To Date: January - December Commodity Description US$ Million % Share % Change /2014 Rubber (Upstream), , , , Natural Rubber 2, , , Synthetic 4002 Rubber 1, , , Compounded 4005 Rubber Reclaimed 4003 Rubber Unvulcanized 4006 Rubber Waste Of 4004 Rubber Source: World Trade Atlas 7

9 c) Rubber Products Rank v) Leading Suppliers of Rubber Products to United States Partner Country United States Import Statistics Commodity: Rubber Products CH40&NonCH40 Year To Date: January - December US$ Million % Share % Change /2014 World 51, , , China 23, , , Vietnam 3, , , Mexico 3, , , Canada 2, , , Japan 2, , , Indonesia 1, , , Thailand 1, , , Korea South 1, , , Malaysia 1, , , Germany 1, , , Source: World Trade Atlas MAJOR RUBBER PRODUCTS IMPORTED (vi) Rubber Gloves (Surgical & Non-Surgical Gloves) United States Import Statistics Commodity: Rubber Gloves Rank Partner US$ Million % Share % Change Country /2014 World 2, , , Malaysia 1, , , Thailand China Indonesia Sri Lanka Mexico Vietnam Guatemala Taiwan Singapore Source: World Trade Atlas 8

10 (vii) Surgical Gloves United States Import Statistics Commodity: , Surgical And Medical Gloves Rank Partner Country US$ Million % Share % Change /2014 World Malaysia Thailand Sri Lanka Indonesia Italy China India Austria Australia Mexico Source: World Trade Atlas (viii) Non-Surgical Gloves United States Import Statistics Commodity: , Gloves, Except Surgical And Medical Gloves, Of Vulcanized Rubber Rank US$ Million % Share % Change Partner 2015/201 Country World 1, , , Malaysia , Thailand China Indonesia Sri Lanka Mexico Vietnam Guatemala Taiwan Singapore Source: World Trade Atlas 9

11 3.2 BILATERAL TRADE (i) Malaysia s Trade with United States of America Rubber and Rubber Products Year Export Import Total Trade Trade Balance Value in RM Million , , , , , , , , , , , , , , ,113.0 Source: Department of Statistic a) Rubber Products (ii) Malaysia s Export of Rubber Products to USA (By Sector) Rubber Products (RM Million) Year Inner Latex Footwear GRG IRG Tires Total Tubes Goods , , , , , , , , , , Source: Department of Statistics, Malaysia (iii) Malaysia s Import of Rubber Products from USA (By Sector) Year Footwear GRG IRG Rubber Products (RM Million) Inner Tubes Latex Goods Tires Total Source: Department of Statistics, Malaysia 10

12 (iv) Malaysia s Export of Rubber Products in 2015 (By Destination) Rank Country Value (RM Million) % Share 1 USA 5, GERMANY 1, JAPAN 1, CHINA, UK AUSTRALIA BRAZIL SINGAPORE ITALY THAILAND ROW 6, Total: 17, Source: Department of Statistics, Malaysia (v) Latex Products Malaysia's Export of Latex Products To United States of America (RM Million) % SHARE 2015 CAGR % DESCRIPTION Non-Surgical Glove 3, , , , , Surgical Glove Catheters Other Articles Of Apparel And Clothing Accessories Condoms Other Hygienic And Pharmaceutical Rubber Articles Latex Thread Finger Stalls Teats And Soothers Foam Products Rubber Thread & Cord Total 3, , , , , Source: Department of Statistics, Malaysia 11

13 (vi) Malaysia s Export of Cleanroom Gloves in 2015 by Destination Rank Destination Value % Share (RM Million) 1 USA China Japan South Korea Vietnam Singapore Philippines Thailand North Korea Taiwan ROW T O T A L Source: GRE (vii) Cleanroom Gloves Malaysia's Export of Cleanroom Gloves To United States of America (RM Million) % SHARE 2015 CAGR % DESCRIPTION Cleanroom Gloves Source: GRE 12

14 4.0 TARIFF & NON TARIFF BARRIERS 4.1 Tariff Barriers Import Tax HS Code Description Import Duties Glove; Non-surgical gloves Free Glove; Seamless 3.0% Glove; Disposable & other 14.0% Gaskets, washers and other seals 2.5% VAT (Value Added Tax) VAT for Non-Medical Devices: Up to 3% (Cleanroom gloves, household gloves, etc.) 4.2 Non-tariff Barriers Premarket Notification 510(k) Each person who wants to market in the U.S., a Class I, II, and III device intended for human use, for which a Premarket Approval (PMA) is not required, must submit a 510(k) to FDA unless the device is exempt from 510(k) requirements of the Federal Food, Drug, and Cosmetic Act (the Act) and does not exceed the limitations of exemptions in.9 of the device classification regulation chapters (e.g., 21 CFR 862.9, 21 CFR 864.9). There is no 510(k) form, however, 21 CFR 807 Subpart E describes requirements for a 510(k) submission. Before marketing a device, each submitter must receive an order, in the form of a letter, from FDA which finds the device to be substantially equivalent (SE) and states that the device can be marketed in the U.S. This order "clears" the device for commercial distribution. A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device. The following four categories of parties must submit a 510(k) to the FDA: i. Domestic manufacturers introducing a device to the U.S. market ii. Specification developers introducing a device to the U.S. market iii. Repackers or relabelers who make labeling changes or whose operations significantly affect the device iv. Foreign manufacturers/exporters or U.S. representatives of foreign manufacturers/exporters introducing a device to the U.S. market. 13

15 4.2.2 Determining Admissibility/Customs Examination of Goods In simple cases involving small shipments, examination may be made on the docks, at container stations, cargo terminals, or the importer s premises. The merchandise may be retained by Customs for appraisal or classification purposes and the remainder of the shipment released. These sample packages will also be released to the importer after examination. Examination of goods is necessary to determine: i. The value of the goods for Customs purposes and their dutiable status. ii. Whether the goods are properly marked with the country of their origin. Generally, imported merchandise must be legibly marked in a conspicuous place and with the English name of the country of origin. iii. Whether the goods have been correctly invoiced. iv. Whether the shipment contains prohibited articles. v. Whether the requirements of other federal agencies have been met. vi. Whether the amount of goods listed on the invoice is correct, and no shortage or overage exists. If necessary, goods may be analyzed by a Customs laboratory to determine proper classification and appraisal, to determine that the goods meet safety requirements, or to ensure that they are not counterfeit or otherwise in violation of U.S. laws. 5.0 TRANS-PACIFIC PARTNERSHIP On 28 th January 2016, Dewan Negara has approved motion to allow Malaysia to participate in the Trans- Pacific Partnership (TPP) following Dewan Rakyat s endorsement on 27 th January TPPA was signed in Auckland, New Zealand on 4 th February 2016 by YB Dato Sri Mustapa Mohamed, Minister of Ministry of International Trade and Industry. On October 5, 2015, Ministers of the 12 Trans-Pacific Partnership (TPP) countries Australia, Brunei Darussalam, Canada, Chile, Japan, Malaysia, Mexico, New Zealand, Peru, Singapore, United States, and Vietnam announced conclusion of their negotiations. The result is a high-standard, ambitious, comprehensive, and balanced agreement that will promote economic growth; support the creation and retention of jobs; enhance innovation, productivity and competitiveness; raise living standards; reduce poverty in our countries; and promote transparency, good governance, and enhanced labor and environmental protections. We envision conclusion of this agreement, with its new and high standards for trade and investment in the Asia Pacific, as an important step toward our ultimate goal of open trade and regional integration across the region. Five defining features make the Trans-Pacific Partnership a landmark 21st-century agreement, setting a new standard for global trade while taking up next-generation issues. These features include: 14

16 Comprehensive market access. The TPP eliminates or reduces tariff and non-tariff barriers across substantially all trade in goods and services and covers the full spectrum of trade, including goods and services trade and investment, so as to create new opportunities and benefits for our businesses, workers, and consumers. Regional approach to commitments. The TPP facilitates the development of production and supply chains, and seamless trade, enhancing efficiency and supporting our goal of creating and supporting jobs, raising living standards, enhancing conservation efforts, and facilitating cross-border integration, as well as opening domestic markets. Addressing new trade challenges. The TPP promotes innovation, productivity, and competitiveness by addressing new issues, including the development of the digital economy, and the role of state-owned enterprises in the global economy. Inclusive trade. The TPP includes new elements that seek to ensure that economies at all levels of development and businesses of all sizes can benefit from trade. It includes commitments to help small- and medium-sized businesses understand the Agreement, take advantage of its opportunities, and bring their unique challenges to the attention of the TPP governments. It also includes specific commitments on development and trade capacity building, to ensure that all Parties are able to meet the commitments in the Agreement and take full advantage of its benefits. Platform for regional integration. The TPP is intended as a platform for regional economic integration and designed to include additional economies across the Asia-Pacific region. Main Export Items to Enjoy Immediate Import Duty Elimination under TPPA Source: MREPC seminar on TPPA: Benefits and Challenges to the Rubber Products Industry 15

17 Offered from USA under TPPA Source: MREPC seminar on TPPA: Benefits and Challenges to the Rubber Products Industry Impact on Malaysia s Key Exports to Major Markets in TPP Source: MREPC seminar on TPPA: Benefits and Challenges to the Rubber Products Industry 16

18 6.0 FS209E and ISO Cleanroom Standards 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 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 Airborne Particulate Cleanliness Class Comparison ISO FEDERAL STANDARD 209E ISO Class English Metric ISO 1 ISO 2 ISO 3 1 M1.5 ISO 4 10 M2.5 ISO 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 ISO ISO ISO3 1,

19 ISO4 10,000 2,370 1, ISO5 100,000 23,700 10,200 3, ISO6 1,000, , ,000 35,200 8, ISO7 352,000 83,200 2,930 ISO8 3,520, ,000 29,300 ISO9 35,200,000 8,320, ,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: asbuilt, 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 describes the type and frequency of testing required to conform to certain standards. The following tables indicate mandatory and optional tests. Required Testing (ISO ) Schedule of Tests to Demonstrate Continuing Compliance Test Parameter Class Maximum Time Interval Test Procedure Particle Count Test <= ISO 5 6 Months ISO Annex A > ISO 5 12 Months Air Pressure Difference All Classes 12 Months ISO Annex B5 Airflow All Classes 12 Months ISO Annex B4 Optional Testing (ISO ) Schedule of Additional Optional Tests Test Parameter Class Maximum Time Interval Test Procedure Installed Filter Leakage All Classes 24 Months ISO Annex B6 Containment Leakage All Classes 24 Months ISO Annex B4 Recovery All Classes 24 Months ISO Annex B13 Airflow Visualization All Classes 24 Months ISO Annex B7 Today, in addition to ISO and ISO , 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 ISO ISO ISO ISO Title Classification of Air Cleanliness Cleanroom Testing for Compliance Methods for Evaluating and Measuring Cleanrooms and Associated Controlled Environments Cleanroom Design and Construction 18

20 ISO ISO ISO ISO ISO ISO ISO Cleanroom Operations Terms, Definitions and Units Enhanced Clean Devices Molecular Contamination Biocontamination: Control General Principles Biocontamination: Evaluation and Interpretation of Data Biocontamination: Methodology for Measuring Efficiency of Cleaning Inert Surfaces The USA source for ISO documents is: Institute of Environmental Sciences & Technology (IEST) 5005 Newport Drive, Suite 506 Rolling Meadows, IL Phone: (847) Fax: (847) 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 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. 19

21 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. FS209E classifications: FS Cleanroom Class ISO Equivalent Class Air Change Rate 1 ISO ISO ISO ,000 ISO ,000 ISO ,000 ISO 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. 20

22 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) % ISO 4 (Class 10) 50 90% ISO 3 (Class 1) % ISO % Federal and ISO Airflow Velocity Standards In addition to ACR and ceiling coverage, the third factor integral to maintaining cleanliness is fangenerated 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 Average Airflow Velocity Air Changes Per Hour Ceiling Coverage (Federal Standard 209E) m/s (ft/min) ISO 8 (Class 100,000) (1 8) % ISO 7 (Class 10,000) (10-15) % ISO 6 (Class 1,000) (25 40) % ISO 5 (Class 100) (40 80) % ISO 4 (Class 10) (50 90) % ISO 3 (Class 1) (60 90) % ISO (60 100) % 21

23 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 lessclean 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. Source: 22

24 7.0 CLEANROOM PRODUCTS SUPPLIERS & DISTRIBUTORS IN USA No. Company Name Description 1. Cleanroom Connection Cleanroom Connection has over 25 years of experience working with cleanroom consumables. They work directly with trusted, USA-based manufacturers of cleanroom supplies, apparel and cleaning supplies that are USP and cgmp compliant. 2. NCI, Inc Innotech Products Inc offers a full line of cleanroom equipment and supplies. These products range from complete, sophisticated air filtration enclosures, to furniture, gloves, and swabs. 3. Kimberly-Clark Professional 4. American Cleanstat (ACS) 5. Terra Universal Innotech (now NCI) provides modular hardwall and softwall cleanrooms as well as the components for a stick built room and technical design assistance to determine what type of cleanroom is best for your specific application. Kimberly-Clark Professional helps to safeguard people all around the world in various industry. They provide full-service solutions that combine innovative products with industry expertise, to create healthier environments, safer and more productive. American Cleanstat (ACS) is a master distributor of essential production supplies used in controlled environment manufacturing and assembly applications. ACS specializes in expert technical support and sales of cleanroom consumables, facilities maintenance materials, handling equipment and cleanroom furniture. Combining this expertise with an in- depth line of products and brands to support product assembly, static control requirements, and other manufacturer requirements, ACS has successfully maintained a healthy position in the cleanroom consumables marketplace. Terra Universal is the leading manufacturing expert in critical environment applications, with over 40 years of design and fabrication experience in cleanroomand laboratory-based industries. Terra manufactures comprehensive lines of modular cleanrooms, pass-through chambers, glove boxes, laminar flow benches and furnishings. 23

25 8.0 USEFUL CONTACTS i. Embassy of Malaysia, Washington DC Address : Embassy of Malaysia 3516 International Court New Washington Washington DC Tel : Fax : malwashdc@kln.gov.my Contact Person : H.E. Datuk Dr. Awang Adek Hussin (The Ambassador) ii. Consulate General, Los Angeles Address : 777 South Figueroa St. Suite 600 Los Angeles California Tel : Fax : mwlosangeles@kln.gov.my Contact Person : Hon. YM Raja S. Ridzuwan Raja Kamaruddin(Consul General) iii. Malaysia External Trade Development Corporation (MATRADE Los Angeles) Address : Consulate General of Malaysia Commercial Section (MATRADE) 550 South Hope Street, Suite 400 Los Angeles CA USA Tel : Fax : losangeles@matrade.gov.my Contact Person : Rusiah Mohamed (Trade Commissioner) iv. Malaysian Rubber Export Promotion Council (MREPC) USA Address : Malaysian Rubber Export Promotion Council (MREPC) 3516, International Court, N.W. Washington D.C Tel : /9721 Fax : Mobile : esahsyip@mrepc.com Contact Person : Dr Esah Yip (Director, US Office) 24

26 v. Semiconductor Industry Association (SIA) Address : 1101 K Street NW Suite 450 Washington D.C Tel : Fax : ckazmierski@semiconductors.org Contact Person : Caroline Kazmierski (Director, Marketing and Communications) Website : 25

27 9.0 TRADE FAIRS No. Trade Fairs Description Website 1. SEMICON WEST International Exposition & Conference dedicated to Semiconductor Equipment, Materials & Services. SEMICON WEST is the premier event for the display of new products and technologies for microelectronics design & manufacturing 2. DESIGNCON Semiconductor and Electronic Design Engineering Expo & Conference 3. DESIGN & MANUFACTURING Design & Manufacturing Exhibition. Design & Manufacturing Midwest /expo/univ/chicago15/ - MIDWEST features leading suppliers of software, raw materials, manufacturing equipment, components, sub-assemblies & contract services used to design & produce finished OEM products & components 4. ELECTRONICS New England Leading Source for NEW ENGLAND Electronics Manufacturing Solutions 5. NANOTECH Nanotechnology Conference and Expo. Fabrication, Characterization & Tools, Advanced Materials, Electronics & Microsystems, Medical & Biotech, Energy & Environment, Ventures, Investment & Partnering. /World2016/ 26