INTERPHEX  included a number of cleanroom displays

INTERPHEX 2013, the large trade event and conference program dedicated to the pharmaceutical manufacturing industry, was held April 23 - 25, 2013 at the Javits Center in New York City. With over 12,000 industry professionals present, show attendees numbered at over 8,100, a  20 percent increase over last year’s show.

Exhibitors included:

AES Clean

Bahnson,

Christ Aqua

Cleansesl Door

Dycem

Gemu Valve

Hach

HEPA

Howorth Air

Isolaton Systems

Laminar Flow

Lighthouse

Lymtech

Mettler Toledo

Meissner Filtraton

Nilfisk

Palbam Class

Particle Measuring Systems

Steris

Telstar

TSI

Uniclean

Vaisala

Walker Barrier

There were a number of papers of importance to the cleanroom industry. Here are abstracts of the two of them:

Effective Cleaning Procedure for Medical Devices Using Laboratory Studies #400

Speaker: Elizabeth Rivera

Description:
Designing an effective cleaning procedure is a critical part of a medical device site operation. Gain insight regarding laboratory studies that lead to the design of a successful cleaning procedure to be incorporated in the medical device manufacturing process. Review critical parameters, cleanliness acceptance criteria, and quality attributes to ensure that medical devices are successfully cleaned. Actual case studies will be used throughout to demonstrate critical points. In addition, the following topics will also be covered: residues typically associated with the manufacturing of medical devices and laboratory evaluation: why and how.

• Evaluate the use of laboratory test to develop cleaning procedures

·         Review critical factors affecting the cleaning of medical devices

• Cleanliness criteria based upon sampling method and pre-established limits

Design Aspects for a Bio Fill and Finish Facility #403

Speaker: Josef Trapl

Description:
Based on the design experience of an F&F (Fill and Finish) multi-use facility for bio products the basic engineering and design aspects for a lean facility design will be demonstrated. The project shows a new way for filling product in a BSL2 environment by using blow fill seal (BFS) technology for the primary packaging step. Based on a real case study the process integration, clean room aspects and operational requirements are discussed. Finally the methodology for the applied risk assessment to reduce potential contamination and operational risk will be explained. Based on a view risk assessment examples primary and secondary actions will be highlighted and the related activities which have to be considered during the design, construction and start-up.

Medtec U.K. was devoted to medical device manufacture and use

The conference and exhibition held May 1 – 2, 2013 at the Olympia in London covered medical devices. Exhibitors of cleanroom products included:

·         Connect 2 Cleanrooms

·         Guardtech

·          

World Cleanroom Space will Increase by 6 Million Square Feet This Year

By 2014 there will be 131 million ft² of cleanroom space in use across the world. This will be an increase of five percent over 2013. This is the latest forecast in Cleanrooms World Markets published by the McIlvaine Company.

Cleanroom Space in Use

(Million ft²)

This is net space in operation and reflects the retirements of older plants. The semiconductor industry generally builds new plants rather than renovating existing ones. This is due to contamination concerns.

Asia has surpassed the other regions due to its dominance in flat panel displays, hard disk drives, storage, and photovoltaics. China, Taiwan and South Korea are leading investors in semiconductor chip plants.

The semiconductor industry is the largest user of cleanrooms worldwide. The amount of cleanroom space is now at near record highs. Semiconductor sales for 2012 reached $291.6 billion, the industry’s third-highest yearly total ever, but a decrease of 2.7 percent from the record total of $299.5 billion set in 2011.

Some segments are in decline but are offset by growth in others; facing competition from tablets, smart phones, solid state drives (SSD), and global hard disk drives (HDD). Market revenue in 2013 will decline more than 10 percent this year. Revenue is set to drop to $32 billion in 2013.

The pharmaceutical industry continues to show steady growth. Much of the new growth is taking place outside the U.S. and Europe. The pharmaceutical industry in Russia has been witnessing a double-digit growth rate recently. According to the new regulations that will be enforced in Russia from 2014, it will be imperative for the pharmaceutical companies to pursue GMP-compliant production procedures.

Over the last decade the solar industry has had the highest percentage growth. Photovoltaic Module shipments in 2013 are forecast to exceed 34,000 MW, up 10 percent over 2012.

For more information on World Cleanroom Markets, click on: http://home.mcilvainecompany.com/index.php?option=com_content&view=article&id=73 

Asian Ultrapure Water Sales to Exceed $3 Billion in 2015

In the rapidly growing Asian market, sales of ultrapure water systems and consumables will exceed $3 billion for the first time ever in 2015. This is the conclusion reached in the McIlvaine on line report Ultrapure Water World Markets.

Industry Totals ($ Thousands)

 Asia is building more new coal-fired power plants than the rest of the world combined. The majority of these power plants are of the ultrasupercritical design. These power plants need the highest purity boiler feedwater. Contrary to public perception, the Chinese fleet is operating more efficiently than the U.S. counterpart. The reason being that most of the Chinese plants have been built since 2000. By contrast, the average coal-fired power plant in the U.S. is more than forty years old. Asia has been quick to embrace newer technologies such as electrodeionization (EDI) as a substitute for ion exchange.

Asia is proceeding with come nuclear power plants. These power plants require the highest quality water. Combined cycle gas turbine plants also require high quality water but their needs per megawatt are less than half of that of a coal-fired power plant.

Over 50 percent of the market is attributable to the electronics and flat panel segment. Asia has more electronics facilities using ultrapure water than the other continents combined. One of the bigger growth segments in China has been photovoltaic cells for the solar industry. These plants do require ultrapure water although not as pure as required for semiconductor manufacture.

The one application where Asia does not dominate is pharmaceuticals. Water for injection (WFI) needs to be ultrapure because it is mixed with substances which are then injected into humans. The bulk of the manufacturing of pharmaceuticals is still in the U.S. and Europe.

Special instrumentation which can measure dissolved oxygen and other constituents in parts per billion are required in ultrapure water systems. There are a series of filtration steps ending in treatment by reverse osmosis. Even after the water is ultrapure there is a concern about re-contamination in pumps and piping. Consequently, in a semiconductor plant, the water leaving the RO system passes through piping and then into an end point membrane cartridge filter before being used to wash the wafer.

For more information on Ultrapure Water World Markets: http://home.mcilvainecompany.com/index.php/component/content/article?id=71#n029

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rmcilvaine@mcilvainecompany.com

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