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Modular cleanrooms: An evolving industry
ISO 14644 and biopharma monitoring
Cleanrooms have a dirty little secret
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Controlled Environments July/August 2015Vol. 18 • No. 5
TABLE OF CONTENTS July/August 2015 • www.cemag.us4
7 The Implications of ISO/DIS 14644-1.2How does this standard affect biopharma monitoring of clean areas?
10 Modular Cleanroom Systems: An Evolving IndustryA discussion of the four main styles of modular cleanrooms.
12 The Cleanroom’s Dirty Little SecretProtection is a two-way street.
16 Personalized Medicine, Companion Diagnostics, and NGS Diagnostic TestsPersonalized medicine has the potential to be the biggest advance in health in many decades.
18 Particles Cling to der WaalsGeckos’ feet have something in common with particles and soils — force.
20 Benches and Enclosures Product Showcase
22 Cleanroom Training How to resource training for your cleanroom personnel.
14 Cleanroom Design and Environmental Control TechnologiesA look at the RFAB semiconductor facility of Texas Instruments.
7
18
12
TM
DEPARTMENTS 6 From the Editor24 How It Works
Texas Instruments’ Richardson Fabrication Facility (RFAB). Credit for this image and cover image: Texas Instruments
25 Trending on the Web 26 Cleanroom Tip and Index
20
Everything you need in one clean package...
Find current information on everything from pure materials through protective packaging, from state-of-the-art
facility construction through day-to-day cleaning, and control challenges affecting quality and yield.
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6 FROM THE EDITOR Controlled EnvironmentsVol. 18 • No. 5
TM
David A. Madonia, General [email protected] • 973-920-7048
Bea Riemschneider, Editorial [email protected]
MaryBeth DiDonna, [email protected]
Editorial Advisory Board Charles W. Berndt, C.W. Berndt Associates Ltd.
Adam Giandomenico, Particles Plus Inc. Scott Mackler, Cleanroom Consulting LLCGregg A. Mosley, Biotest Laboratories Inc.Robert Nightingale, Cleanroom Garments
Bipin Parekh, Ph.D., Entegris Inc.Michael Rataj, Aramark Cleanroom Services
Howard Siegerman, Ph.D., Siegerman and Associates LLCScott Sutton, Ph.D., Microbiology Network Inc.
Art Vellutato, Jr., Veltek Associates Inc. Bob Vermillion, CPP/Fellow, RMV Technology Group LLC
ADVERTISING/SALESNEW ENGLAND
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Phone: 973-920-7000; Fax: 973-920-7541www.cemag.us
July/August 2015 • www.cemag.us
STEM Education is Vital
The blogs section of the Controlled Environments website gives me a chance to write in-depth about timely topics, and to attach my personal voice to the subject matter at hand. A topic that’s become quite close to my heart
recently has been STEM (science, technology, engineering, and mathematics) education.
Back in May, I wrote about members of the CBS sitcom The Big Bang Theory sponsoring a STEM scholarship fund at UCLA. The school holds a special place in the hearts of many who work with the show … actress Mayim Bialik, who plays the quirky neuroscientist Amy Farrah Fowler, earned both her bachelor’s degree and her doctorate in neuroscience from UCLA. The show also employs a UCLA physics and astronomy professor as its science consultant. Caltech — home of NASA’s Jet Propulsion Laboratory, in whose cleanroom the Mars rover Curiosity was created — is another educational institution represented on the show, as many of the main characters are employed there as researchers. One episode even featured three of the characters working in a cleanroom, and hijinks ensued when a bird somehow found its way inside.
Another blog entry came about after Nobel laureate Tim Hunt made public remarks about working with women in the laboratory. “Three things happen when [girls] are in the lab: you fall in love with them, they fall in love with you, and when you criticize them they cry,” he told an audience gathered at the World Conference of Science Journalists in Korea. Hunt was quickly taken to task by social media, and offered a halfhearted apology via BBC 4 Radio. He later resigned his position with University College London, but in a joint newspaper interview with his wife (herself a University College London professor) the couple said that he had been unfairly targeted for his “joking” remarks.
I admit that it was a bit discouraging gathering sources for that blog entry — I searched for other examples of discrimination against women in STEM fields, and there was certain-ly no shortage. I picked a few to highlight, such as an article penned by a woman who was faced with crude remarks upon her admission to the prestigious Massachusetts Institute of Technology. Another photo, which was widely circulated around Twitter, showed a Target toy aisle that differentiated between “building sets” and “girls’ building sets.”
Speaking of Twitter … within a couple days of the Tim Hunt controversy, a retaliation of sorts sprang up on the social media platform. A feminist web magazine urged women scientists to tweet photos of themselves at work, using the hashtag #distractinglysexy in a tongue-in-cheek manner. The response was overwhelming. Women from all sorts of STEM-related fields — lab technicians, doctors and nurses, archaeologists, marine biolo-gists, and many more — used the hashtag to draw attention to their work and the inequali-ties they face. Also included in this movement were women who work in cleanrooms, and several of them graciously spoke with me about what they do in the clean lab, as well as their thoughts on STEM education.
I’m grateful for the blog feature on our website because it enables me to address things as they happen (and track the response from our readership in real time), rather than have to wait a few weeks for our print edition — as we all know, in our instant access society, even waiting a day or two can be too late. Visit cemag.us/blogs for more.
MaryBeth DiDonnaEditor
July/August 2015 • www.cemag.us 7
How does this standard aff ect biopharma monitoring of clean areas?
Jim Strachan, MBARandy GraterClimet Instruments T
he International Standards Organization (ISO) has published a Draft International Standard (DIS) for clean areas. Quality control manag-ers in the pharmaceutical and biotechnology
industries are curious about how this will impact their monitoring and compliance requirements.
Of foremost concern in the life science indus-try is the apparent removal of the > 5 μm particle concentration in ISO Class 5 clean areas when compared to the 1999 version. In the 1999 ver-
sion, the limit is 29 particles per cubic meter. This change to the ISO/DIS 14644 standard is a major concern for a number of reviewers.
The reasons for the de-emphasis on the 5 μm ISO Class 5 limit include:
Sampling and statistical limitations for particles in low concentrations make classification inap-propriate; and Sample collection limitations for both particles in low concentrations and sizes greater than 1 μm make classification at this particle size inap-propriate, due to potential particle losses in the sampling system.According to Farquharson (2012), “Once the
DIS standard is ratified, and assuming the concen-tration limit for the 5 μm column for ISO Class 5 is blank, then without further clarification this particle size cannot be used for classification in accordance with the ISO 14644-1.” He continues, “However, monitoring may be a different matter.”
In the life science industry, this change pres-ents a unique dilemma on how to support regula-tory requirements set out in the European Union Good Manufacturing Practice (EU GMP) Annex 1. It is even more sensitive due to the replication of the EU GMP Annex 1 requirements in the Pharmaceutical Inspection Co-operation Scheme (PIC/S) GMP Annex 1 No. 4, the World Health Organization (WHO) GMP for sterile pharmaceu-tical products Annex 6 No. 4.6.1, and the Chinese GMP regulations.
We know that in 2011 to 2012, experts were working on wording to be included in the stan-dard that would allow the pharmaceutical industry regulatory authorities to provide their own guid-ance outside the boundaries of the standard.
Regardless, the ISO/DIS 14644-1.2 has a third footnote that is often lost in the minutiae, and many erroneously presume that monitoring of the > 5 μm particle is no longer required. The DIS standard states (in footnote f):
“In order to undertake classification at this par-ticle size, use of the macro-particle descriptor M should be considered for > 5 μm.” The above references ISO/DIS 14644-1, Annex
C, entitled “Counting and sizing of airborne mac-roparticles.” Per ISO/DIS 14644-1.2 section C.1:
“In some situations, typically those related to specific process requirements, alternative levels of air cleanliness may be specified on the basis of particle populations that are not within the size range applicable to classification.” ISO14644-1 pertains to classification of clean-
rooms. Contrary to some claims, Annex C was strengthened in revision 1.2 of the draft standard, which was released in 2014. This new version of the ISO 14644-1.2 does not eliminate the 5 μm classification where there are specific process requirements. These are generally found in phar-
FACILITY MONITORING
The Implications of ISO/DIS 14644-1.2
Staphylococcus aureus
bacteria cluster > 5
μm. Credit: Centers for
Disease Control and
Prevention
8
maceutical, biotechnology, and life sciences.Quality control personnel need to know why
they are monitoring certain particle sizes. This is of paramount importance in the life science industry whose products affect public safety and therefore company reputations and business continuity. No doubt, environmental monitoring of clean areas in the life science industry is a mission critical appli-cation, and the one single activity that has the most impact on quality control.
The reason we monitor > 5 μm particles in the biopharma industry is twofold. First, to provide an early warning that a potential problem may be occurring. Indeed, most ISO Class 5 clean zones have counts of zero or one on the > 5 μm channel.
Moreover, viable microorganisms whose indi-vidual sizes are generally less than 1 μm tend to form in pairs, chains, and clusters. These colony forming units together often have a size greater than 5 μm. Therefore, a laser scattering aerosol particle counter (LSAPC) is metaphorically the
canary in a coal mine, because it provides an early warning of a potential problem.
This is confirmed in the EU GMP Annex 1, No. 13, which again provides the most common sense approach to monitoring in the Life Science indus-try:
“In Grade A [ISO Class 4.8] and B [ISO Class 5] zones, the monitoring of the > 5 μm particle con-centration count takes on particular significance as it is an important diagnostic tool for early detection of failure. The occasional indication of > 5 μm particle counts may be false counts due to electronics noise, stray light, coincidence, etc.
However, consecutive or regular counts due to low levels are an indicator of a possible contamina-tion event and should be investigated.”This clause in the EU GMP is supported in the
new draft ISO/DIS 14644-1.2 standard, Annex C, section C.2.1, which states:
“If contamination risks caused by particles larger than 5 μm are to be assessed, sampling devices and measurement procedures appropriate to the specific characteristics of such particles should be employed.The measurement of airborne particle concentra-tions with size distributions having a threshold size between 5 μm and 20 μm can be made in any of two defined occupancy states; at-rest and operational.” (Emphasis added.)Given the EU GMP provides a table for particle
counts in clean zones “at rest” and “in operation” (see Table 1), the statement above shows that ISO/DIS 14644-1.2 draft standard is in harmony with EU GMP Annex 1.
Additionally, 14644-1.2 section C.2.2 includes an example of how to describe a measurement of a particle count of 29 particles > 5.0 μm using a particle counter. This size limit of 29 particles > 5.0 μm is the current standard for an ISO Class 5 clean area, according to ISO 14644-1.
Therefore, contrary to what others may be sug-gesting, the > 5 μm particle size should continue to be an important element of risk assessment and monitoring in the life science industry.
Monitoring is about control. When we under-stand why we are monitoring, then it is clear that class limits in a table do not define all aspects of
Maximum permitted number of particles per m3 equal to
or greater than the tabulated size
EC GMP ISO At rest In operation
Grade Class 0.5 μm 5.0 μm 0.5 μm 5.0 μm
A 4.8 3,520 20 3,520 20
B 5 3,520 29 352,000 2,900
C 7 352,000 2,900 3,520,000 29,000
D 8 3,520,000 29,000 not defined not defined
Table 1: EU GMP:2008,
Annex 1, No. 4 and 5
July/August 2015 • www.cemag.us 9 FACILITY MONITORING
control and risk assessment. Class limits are an important measure of environmental control, but if the only concern is passing the location then there could still be exposure to unseen risk. And, in this case, a risk that directly correlates to product qual-ity and public safety.
Regardless of what changes may be made to ISO 14644-1, every indication is that it is unlikely EU GMP Annex 1 will follow suit. EU GMP Annex 1 was introduced to provide better guidelines for the life science industry and to address shortcomings of an ISO standard that focused on generic clean-room requirements. ISO/DIS 14644-1.2, Annex C recognizes needs beyond what is included in the standard, as it specifically addresses those process-es where particles greater than 5 μm (macropar-ticles) are important.
Certification and monitoring of the > 5 μm channel will continue to be an important element of control and risk assessment in the life science industry. This thesis is broadly supported among all international GMP standards that specifically relate to pharmaceutical and biotechnology sterile production. From a risk management perspective, is it prudent to give up a tool that focuses attention on changes in the environment that may serve to
alert personnel of a potential problem that could affect the quality or safety of the product? If using a conservative model when making a risk assess-ment, most will conclude, based on past experience and an understanding of microbiological organ-isms, that dispensing with 5 μm monitoring in the life science industry is simply imprudent and not worth the risk.
References• ISO 14644-1: 1999• ISO 14644-2: 1999• ISO/DIS 14644-1.2:2014• ISO/DIS 14644-1.2:2014• EU GMP Annex 1, Nos. 4, 5 (page 3), No. 13
(page 4) • Farquharson, Gordon J., “Revision of ISO
14644-1:1999 — A progress report and explana-tion of some of the key issues and principles,” June 2012.
Jim Strachan is the Sales and Marketing Manager and Randy Grater is the Technical Services Manager for Climet Instruments. The company manufactures airborne particle counters and microbial samplers for the life science indus-try and other markets. www.climet.com
10 CLEAN ENVIRONMENTS
Whether it’s because of advances in science and technology, growing regulation, or increased competi-tion, companies and organizations throughout the world continue to
face greater needs for controlled environments in their facilities. Oftentimes these needs arise very quickly and require solutions that can be implemented in a very timely manner. Such situations have spurred growth and innovation in the development of new modular cleanroom systems. Today’s facility operators can now choose from numerous modular systems to match their particular needs.
Regardless of which type of modular system one chooses, the benefits of these systems have remained relatively consistent over the years. They feature a quick and clean installation process, consistent product qual-ity, reduced construction time, certain tax advantages, and “green” benefits resulting from a reduced material waste. As the market evolves, however, new systems are being designed for specific applications and industries. The variety of panels and interchangeable components to choose from grows as well.
In today’s market, modular cleanroom systems can typically be categorized into four main styles: softwall cleanrooms, structural post and panel systems, specialty systems which include framing or partitioning, and aseptic systems. Each of these systems were designed by modular cleanroom manufacturers in order to satisfy the particular needs of an industry or application.
Softwall cleanroom systemsSoftwall cleanrooms provide an economical solution to applications requiring light environmental control. These cleanrooms are typically comprised of a metal framing system, flexible vinyl curtain walls, and a number of fan filter modules at the top of the structure to control particulate and air flow. Due to their basic design, softwall cleanrooms can be erected very quickly with minimized labor requirements, offering an ease of mobility that other structures do not provide.
Advances in mounting methods, closure, and fastening systems have made it easier to incorporate softwall cleanrooms into a variety of applications as well as within other cleanroom systems. They can be utilized within larger cleanroom environments as partitions to separate areas or to create cleaner inte-rior zones. As softwall systems continue to evolve, many manufacturers now offer transparent, tinted, opaque, and anti-static curtain options, furthering the list of applications for which these structures can be used.
Softwall cleanrooms offer a flexible and economi-cal solution for lower level classifications and basic environmental control pertaining to GMP rooms, inspection rooms, manufacturing areas, and machinery enclosures.
Structural post and panel systemsThe core product for many modular manufacturers and suppliers consists of an “all-purpose” system that can be utilized for a variety of applications from GMP rooms to specific ISO classes. These systems offer a high level of versatility and can be used to outfit existing facilities or to create larger freestanding envelope structures to house separate compartmentalized processes.
These cleanroom systems can offer further flex-ibility by incorporating a panel-post design. This type of configuration offers the integration of a variety of different wall panels and cores including aluminum honeycomb, polystyrene, stainless steel, fiberglass rein-forced plastic (FRP), and other selections based on the intended application and needs of the cleanroom.
All-purpose cleanroom systems are used in a variety of applications and ISO classifications including quality control enclosures or inspection rooms, medical device packaging areas, USP 797 compounding labs or equip-ment, and machinery enclosures.
Wayne McGeePortaFab Corp.
Modular Cleanroom Systems: A discussion of the four main styles of modular cleanrooms.
Bulkheading capabilities
for tools and equipment.
xx xx 11 July/August 2015 • www.cemag.us
An Evolving Industry Framing/partitioning systemsDue to the critical environmental conditions that are demanded in precision microelectronics manufacturing and nanotechnology applications, cleanrooms in these industries have typically required systems that integrated well with the equipment needed to run these operations. Framing systems tended to be the ideal solution for these types of cleanrooms. These systems feature both vertical and horizontal members that easily connect to each other to simplify bulkheading and create air tight seals around equipment and tooling. Plus, the non-progressive design allows for easy removal of the walls without the need to remove adjacent panels, framing studs, or ceiling grids.
One challenge is that cleanrooms in the microelec-tronics industry typically require anti-static wall panels that are also non-outgassing and non-shedding in order to completely eliminate the potential for contamination when working with electronic devices. The proven solu-tion is honeycomb aluminum panels — they perform well, but they are very expensive. A lot of innovation in the industry has been focused on developing more cost effective solutions. By analyzing the design of the clean-room, one can often find opportunities to integrate thinner wall panels and lighter weight frames that can significantly reduce the cost of the cleanroom without sacrificing performance or functionality.
Aseptic systemsDue to the unique needs and requirements found within the biomedical, life science, medical device, and pharma-ceutical industries, modular cleanroom manufacturers have developed systems exclusively for these markets.
Aseptic systems are designed to eliminate the poten-tial buildup of particles and other contaminants along cracks, seams, and crevices within the environment. To accomplish this, they utilize radius coving along all cor-ners of the room while incorporating flush windows, walls, ceilings, and floor systems to provide a com-pletely seamless interior. To further reduce contamina-tion, these systems feature durable and non-shedding wall panels consisting of uPVC coating and aluminum honeycomb cores which are designed to withstand the repeated cleaning and sanitization processes required by the pharmaceutical and medical industries.
In order to further meet specific regulations or requirements, many modular manufacturers now offer a variety of interchangeable window, floor, and ceiling styles that can integrate seamlessly within the aseptic cleanroom design.
Further advantages for facility ownersMost modular cleanroom manufac-turers design their systems so that that they integrate well together, offering end clients further advan-tages by mixing and matching varying systems and components to create customized solutions. This type of integration between varying modular prod-ucts allows facility managers to specify systems that are designed to meet the particular needs of their operation. For instance, a food manufacturer can be provided with a new laboratory, mixing operation, packaging line, and storage area, and still have these systems integrate together to form one cleanroom facility for increased throughput within the manu-facturing plant.
Even within these systems, modular manufacturers are continuously identifying cost-savings opportunities for their end clients. Many can offer thinner cleanroom wall panels to be used as cladding to skin existing walls or create side wall returns and mechanical chases quickly and more economically. Interior walls that do not require bulkheading can be constructed from more economical cleanroom partition systems, as opposed a more expensive cleanroom panel specifically designed for bulkheading and tooling needs. Load-bearing structures can also offer financial benefits by allowing the placement of air filtration equipment on top of the cleanroom. This arrangement eliminates the need to create bay and chase areas to surround the environ-ment, significantly reducing costs.
A continued evolutionFor those that have not considered utilizing modular cleanrooms in a while, it may be time to revisit them as an option. Newly designed modular systems and com-ponents are increasing in functionality and reducing overall costs as systems are becoming more application-specific and less “one-size-fits-all.” As a result, today’s facility managers have more and better options to choose from when comparing modular systems as the industry continues to evolve.
Wayne McGee is President and CEO of PortaFab Corp., a manufacturer of modular cleanrooms and environments, with over 25 years of modular design and construction expertise. PortaFab is headquartered in St Louis, Mo. www.portafab.com
Cleanroom showing par-
tition walls and custom
options including pass
through cut outs and
window glazing styles.
12
The Cleanroom’s Dirty Little SecretProtection is a two-way street.
CLEAN OPERATIONS
Hazards in cleanroom
environments require
special types of PPE,
such as the TouchNTuff
83-500 for chemical
protection.
Most of the time, the “protection” part
of hand protection is straightforward.
Gloves are designed specifically to pro-
tect the wearer’s hands from some type
of injury — cuts, spills, burns, or even repetitive
use injuries that only manifest over time. The
challenge is as straightforward as finding the right
glove for the job — balancing comfort, perfor-
mance, and protection.
In cleanroom environments, however, it isn’t so
simple. These are delicate ecosystems dedicated to
research and manufacturing that are sensitive to
even minute impurities, and 80 percent of those
impurities originate from people.1 Gloves and
other personal protective equipment must limit
the introduction of any particulates into the clean-
room, which means these special-use gloves are
designed to protect the products as much as the
wearer. Consider the potential cost of a contami-
nated pharmaceutical product; millions of dollars
could be conservative.
With that in mind, let’s take a closer look at
hand protection for cleanrooms from both per-
spectives — providing protection for the wearer
and for the product — and how glove technologies
and design practices are addressing both needs.
Protecting the productOf course, there are several types of cleanrooms. A
cleanroom designed for assembly of microchips for
electronics is different than one designed for medi-
cal research, and the level of cleanliness required in
the rooms is dependent on the activities taking place
inside. In the U.S., cleanrooms are designated Class
1; Class 10; Class 100; Class 1,000; Class 10,000; or
Class 100,000, corresponding to a certain acceptable
number of particulates per cubic foot. The lower the
number, the cleaner the room. In Europe, this desig-
nation follows ISO numbering guidelines (ISO 1 to
ISO 9), again with the lower number representing
the cleaner room. As you might expect, gloves and
other PPE designed for Class 1, Class 10, or Class 100
rooms — sometimes referred to as ultra-cleanrooms
— are more carefully manufactured, packed, and
shipped than those carrying less sensitive classifica-
tions.
It’s interesting to note that while there are
industry standards that establish the maximum
number of particulates allowed per cubic foot in
cleanrooms with different designations, there are
no standards or regulations around cleanroom
PPE or glove performance. When choosing gloves
for use in a cleanroom, buyers should therefore
carefully check that the particle count of the gloves
does not exceed the standards of the cleanroom
where they will be used. For example, gloves for
use in a Class 10 cleanroom should carry particle
counts no higher than 850 — that’s the number
of particles 0.5 microns or smaller. An acceptable
Don CronkAnsell
July/August 2015 • www.cemag.us 13
number for Class 100 is 3,000. Again, those num-
bers are recommended, not regulated.
Another concern is ionic content — the measure
of the amount of residual ions, either positive or neg-
ative — on the gloves. Non-volatile residue, or NVR,
is a potential contaminant with various implications
to products or activities. Silicone, for example, can’t
be present in aerospace manufacturing in a cleanroom
environment because it can impact the effectiveness
of some adhesives. Sodium ions can cause conduction
and low field breakdown in semiconductor manufac-
turing, while chlorides can trigger corrosion in disk
drive manufacturing.
Ionic residuals and the insulative properties
of the base glove material also dictate how well a
material behaves in terms of electrostatic discharge
(ESD) — another important consideration in the
cleanroom, especially in the electronics sector.
Since natural rubber latex is an excellent insula-
tor, it isn’t viable for ESD-sensitive applications.
Remember what happened when you rubbed a bal-
loon over your hair when you were a kid? Not what
you want in a cleanroom dedicated to the assembly
of sensitive electronics. A nitrile glove is by far the
better choice.
Protecting the personWhile preserving the sanctity of the cleanroom is
an important component of glove selection, it can’t
take precedence over the safety and protection of the
worker. Cleanroom hazards fall into three categories:
physical, biological, and chemical, each of which
requires unique characteristics from a glove.
Most physical hazards are what you might
expect — sharp or abrasive objects and surfaces
that can cut, scratch, or penetrate the skin. These
types of hazards can present a challenge in terms of
glove design. Innovations in materials are improv-
ing durability in cleanroom gloves, but today true
cut protection still requires wearing a cut-resistant
glove under the cleanroom glove.
Biological hazards are common in aseptic manu-
facturing and research and include risks associated
with handling potentially pathogenic materials.
Gloves for these tasks typically are thin, single-
use, disposable gloves designed to provide a reli-
able barrier between the biological agent and the
skin. They are similar to surgical gloves, although
cleanroom gloves — for any type of cleanroom
environment — are always powder-free, for obvi-
ous reasons. Barrier efficacy or integrity for this
type of product is evaluated by testing the gloves
for pinholes. As with any mass-produced product,
these gloves typically are held to a manufacturer-
determined acceptable quality level (AQL). This is
another metric informed decision-makers need to
know before choosing a glove, understanding that
the lower the AQL, the better quality the barrier.
Chemical hazards are different, because vari-
ous chemicals and chemical compounds can react
in different ways to materials used in gloves —
and to the skin beneath those gloves. Workers in
cleanrooms typically handle small quantities of
hazardous chemicals, and most cleanroom gloves
are designed appropriately, as single-use gloves
focusing primarily on splash-resistance. This means
the gloves are designed to provide initial protection
when a chemical splashes onto the hands, giving
the worker adequate time to remove and dispose of
the glove immediately and don a replacement.
Ensuring protection without compromiseThere was a time when serving these two distinct
needs — protecting the product and the person
— wasn’t possible to the standards we find accept-
able today. Fortunately, that no longer is the case.
Advanced materials and new design and cleaning
processes ensure the availability of a glove that can
provide adequate protection for the job without
compromising the purity of the cleanroom.
While cleanroom gloves start out as any other
typical single use glove they go through additional
manufacturing steps to ensure they meet the rigor-
ous requirements of cleanroom personal protective
equipment. Those steps include multiple washing
and leaching, or rinsing, cycles to remove produc-
tion chemicals and thoroughly clean the finished
gloves. The final laundering happens in a cleanroom
itself, and those gloves then are bagged (or double-
bagged) in vacuum-sealed plastic bags in yet another
cleanroom. Truly sterile gloves go through a steril-
ization process involving irradiation after cleaning
and packaging. It’s an expensive, time-consuming
process and some manufacturers may cut corners.
Responsible decision-makers should ask questions
about the cleaning and packaging processes used by
their cleanroom glove manufacturer.
Cleanroom gloves must protect not just the
person wearing the gloves, but the cleanroom envi-
ronment itself and the products within that envi-
ronment. Today’s technologies make it possible to
mitigate all of these risks.
References1. http://www.slideshare.net/HeidiTuomi/r3-naan-
tali
Don Cronk is the Regulatory Affairs & Technical Services Manager for Ansell’s Single Use Global Business Unit. www.ansell.com
14
Cleanroom Design and Environmental The RFAB semiconductor facility of Texas Instruments.
Ben WinsettTexas Instruments O
ne of the most recent semiconductor fabrica-tion facilities added to Texas Instruments’ lineup of 12 worldwide wafer fabs is located in Richardson, Texas. Aptly named RFAB for
short, the fab’s list of industry firsts and achievements in next-generation cleanroom design are much longer. RFAB is the world’s first LEED-Certified semiconduc-tor manufacturing facility, featuring several designed-in technologies that allow for more sustainable cleanroom operation and low cost environmental control.
The fab’s features include: • Well-insulated and airtight construction to maxi-
mize energy efficiency at the building envelope; • High-efficiency fan filter units (FFUs) to recircu-
late and remove particles from the cleanroom air stream;
• Run-around coils on the make-up air systems, which allow more efficient use of heat exchange sys-tems to minimize the reheating requirement when dehumidifying outdoor air;
• Extensive use of larger and straighter pipe and duc-twork to reduce inherent pressure loss/restriction, thereby enabling installation of smaller, lower cost, more efficient pumps and fans; and
• Gravity-driven waste streams achieved through proper layout and upfront planning. Theseeliminate the need for lift stations and reduce potential impact from airborne molecular contamination (AMC).The inception of RFAB and construction of the
LEED-Certified semiconductor manufacturing facil-ity began in 2004. Not only was focus on sustainability
paramount, the design team was tasked with building a factory at 30 percent lower cost than a similar 300mm wafer fab located just six miles away. Though construc-tion was completed in 2006, the first wafer was pro-duced from the site in 2010.
At a high-level, the fab consists of two-level fab construction; an open-floor, flow-through ballroom design (minimal columns, waffle slab, common plenums) spanning 284,000 sq. ft.; and cleanroom environmental control equipment including fan filter HEPA units at 25% coverage, mini-environment for all tools and sealed wafer carriers (FOUPs), makeup air systems to control dewpoint and pressure, cleanroom sensible cooling coils to control temperature, ionizers to mitigate static electricity in stockers, incoming, and wet chemical areas, UV sleeves for cleanroom lights in photolithography to filter wavelengths below 520nm, real-time airborne molecular contamination systems
Environmental control technologies and techniquesIt is easier to list the parameters and conditions that have no impact on the semiconductor manufactur-ing process than it is to detail those that do. However, all of these parameters fall into two general categories for cleanroom environmental control. The first are parameters with absolute control requirements such as cleanroom differential pressure, particle counts, static electricity, and exposure to UV light. The second are parameters with both absolute and rate-of-change/stability control requirements such as cleanroom tem-perature, dewpoint, and AMC.
Sustainability and cost efficiency were the funda-mental design criteria for RFAB; therefore, the basic configuration chosen was a ballroom concept to maximize space utilization. When it came to choosing the required cleanroom classification, the predomi-nant trend at the time had paced toward cleaner and cleaner classifications for the main cleanroom area. RFAB cleanroom design departed from that scheme, opting for a fully automated factory, sealed wafer car-riers, and tool mini-environments. If the wafers are only exposed to an air stream inside the manufacturing tools, there is no need to operate a cleanroom at Class 1 levels. Instead, each tool has a HEPA filtration system allowing it to achieve Class 1 capability while the ball-room can operate at Class 100 or higher. This change
CLEAN APPLICATIONS
RFAB includes a mini-
environment for all tools
and sealed wafer carriers
(FOUPs).
July/August 2015 • www.cemag.us 15
Completed cleanroom
(ballroom design) prior to
installation of production
equipment.
significantly reduced the recirculation air flow rate and number of FFU’s required to maintain cleanroom particle spec. The benefits do not stop there; reducing recirculation air flow rate reduces motor power, which in turn reduces sensible heat load, which significantly reduces the requirement for heat rejection equipment such as cooling towers and chillers. Furthermore, the ballroom design concept, coupled with FFUs, generates a negative plenum that further minimizes risk of particle contamination caused by ceiling penetrations and leaks in exterior seals. Particle contamination is arguably the largest concern in maintaining a controlled cleanroom environment; however, the choice does not have to be between improved control and reduced operating cost or equipment.
In addition to these technologies and techniques, several unique solutions were employed at RFAB to achieve improved environmental control and low-cost sustainable operation:• Split chiller plant concept where a smaller portion
of the chillers are designed for the cleanroom dehu-midification load, operating at a nominal 42 degrees F. The remaining chillers operate at higher discharge temperature better suited for sensible cooling and in a heat recovery configuration, significantly reduc-ing the requirement for natural gas fired boilers and water consumption at cooling towers.
• Adiabatic humidification systems eliminate the need for steam boilers or electric humidifiers, resulting in a simple, well controlled cleanroom humidification system that reduces water consumption and sensible cooling demand year-round.
• Full utilization of variable speed drives (VFDs) on all cleanroom control systems provides the ability to match demand as efficiently as possible while maintaining installed system capacity. VFDs are the primary means of controls for cleanroom pressure and air recirculation flow rate.
• Real-time AMC detection equipment allows fab per-sonnel to pinpoint components, systems, or outdoor conditions generating chemical vapors that can cause significant impact and corrosion to wafers being pro-cessed. Though it was not by design, allowing RFAB to remain empty for several years after construction permitted all the materials within the factory to off-gas completely and achieve the fastest initial product qualification period of any factory at TI. It is similar to a “new car smell” that is given the time to fade away.
• An extensive net-work of sensors integrated into a real-time data acquisition system with historical trending allows both the Facilities and Fab personnel to receive alerts on any adverse conditions so they can be corrected immediately. In addition, this system provides immediate feedback for setpoint changes and optimization opportuni-ties, enabling validation of expected results and data driven decisions for sustaining operations and envi-ronmental control.
Outlook for future cleanroom designBased on the advances at RFAB and progression in cleanroom design, concepts that will likely be pursued in future cleanroom designs include:• Further reduction in smocking requirements, which
would allow for more relaxed temperature, humidity, and particle specifications, thereby generating oppor-tunities for further utility reduction via recirculated air reduction and seasonal cleanroom temperature and dewpoint adjustments.
• Large-scale general exhaust or heat exhaust recov-ery either directly for fresh air makeup, or through technologies such as desiccant systems or enthalpy wheels.
• Full scale implementation of adiabatic humidifica-tion system offsetting sensible cooling load and pro-viding improved humidification control.
• Lighting upgrades to longer life, reliable LED prod-ucts, and responsive lighting systems. More automa-tion results in fewer personnel required to perform manual tasks on the cleanroom floor, which reduces the need for active lighting in many areas.
• Continued use of ballroom cleanrooms for long term operational flexibility and better space utiliza-tion.
• Adoption of inexpensive wireless sensors that could allow for better monitoring, control, and system optimization.
• Continued improvement in AMC control through continuously purged FOUPs (inert gas), further automation, and overall focus on wafer environment instead of cleanroom environment.
Control Technologies
continued on pg. 23
16
Personalized Medicine, Companion Diagnostics, and NGS Diagnostic Tests
Bikash ChatterjeePharmatech Associates
The field of personalized medicine has been evolv-ing ever since the Human Genome Project1 was completed in 2003. During that program researchers identified specific genes linked to
particular disease states such as the MSH2 gene with colon cancer, and variations in the FAD gene linked to Alzheimer’s disease. Personalized medicine looks to exploit this information by tailoring drug therapies to a patient’s gene mutation. To do this requires a diagnos-tic test for use by physicians to identify candidates for therapy and, specifically, what the proposed customized therapy should be. Termed Companion Diagnostics by FDA, the agency issued its first guidance2 in August 2014 to begin to define what constitutes a companion diagnostic and its regulatory path for filing.
FDA Companion Diagnostics GuidanceThe FDA guidance is intended to help companies identify the need for these tests during the earli-est stages of drug development and to plan for the development of a drug and a companion test at the same time. The guidance finalizes and takes into consideration public comments on the draft guid-ance that FDA issued in 2011.
The guidance makes several important clarifica-tions for in-vitro diagnostic (IVD) developers and drug developers. One point states that an IVD is considered a Companion Diagnostic when the IVD is essential to the safe and effective use of the therapeutic product. The key term in this definition is “Essential.” The notion of essential is defined in footnote 6 (emphasis is mine):
“When use of a diagnostic device is required in the labeling of a therapeutic product (e.g., for selec-tion of appropriate patients for therapy, or to select patients who should not use the product, or for moni-toring patients to achieve safety or effectiveness), use of the diagnostic device is considered ’essential’ for the purposes of this guidance. Uses of diagnostic devices that are suggested but not required in therapeutic product labeling are not considered ‘essential.’”
This definition answered some questions but raised others. Specifically, are personalized drug therapies that require a companion diagnostic considered a combination product in the eyes of the FDA? The guidance further addresses this question in footnote 5:
FDA expects that most therapeutic product and IVD companion diagnostic device pairs will not meet the definition of “combination product” under 21 CFR 3.2(e). It is not necessary to contact the Office of Combination Products about whether a therapeutic product and IVD companion diagnostic device pair is a combination product unless recommended by CDER, CBER, or CDRH. FDA intends to require separate marketing applications for a therapeutic product and an IVD companion diagnostic device intended for use with that therapeutic product regardless of whether the products could constitute a combination product.
So basically the agency is stating that if the drug and diagnostic requirement meet the definition of a combination product, they will require separate regulatory submissions. However, the FDA is will-ing to consider a single submission combination drug on a case by case basis.
The need for a companion diagnostic clouds the regulatory pathway for personal medicine innovators because the development timelines and skill sets are quite different for drug development and IVD devel-opment. It is quite possible that a novel drug therapy could be hung up waiting for the development of its companion diagnostic. Further confusing the issue is the FDA’s desire in most cases to have the diagnostic complete before the drug therapy, although they have indicated they are willing to discuss this expec-tation on a case by case basis.
Next generation sequencing diagnostics (NGS)Almost all current FDA-approved in-vitro diag-nostic tests (IVD) measure only a single or a limit-
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ed number of substances, such as DNA or proteins. Thus, it may require several patient samples and several tests to evaluate a patient’s clinical status or to determine the best therapy for the patient. In contrast to current approved IVDs, NGS diag-nostics can detect over three billion bases in the human genome and may identify almost three mil-lion genetic variants in a single test. It is possible that a single NGS test could identify multiple dis-ease states, making it difficult for the FDA to evalu-ate the suitability of the test. Because an NGS can analyze the whole genome, it is not nec-essary to know what variant you are looking for. The FDA has issued a white paper regard-ing NGS diagnostics and held a public work-shop in February 2015 to discuss the regula-tory paths forward. The FDA has approved one NGS system based upon demonstrating analytical capability and reliability in detect-ing a subset of variants in the genome. This approach is discussed in the white paper and is a possible way to prove reliability and capa-bility. In the white paper the FDA asked 10 basic questions to help frame the discussion at the workshop to obtain a clearer picture of what is a fair and reasonable regulatory requirement.
Drug advancesPersonalized medicine has the potential to be the biggest advance in health in many decades. To fully realize its promise will require shift-ing the paradigm as to how we define quality, efficacy, and safety, for both personalized drug therapies and their companion diagnostics. The FDA is continuing to refine its position on Companion Diagnostics and is working on more detailed guidance. But the agency must consider the broader implications to Laboratory Derived Tests (LDTs) within the guidance. Wall Street has bet heavily on this particular sector of biotech, creating some of the largest IPOs of 2014 and 2015. Whether the FDA and industry can navigate this com-plex relationship between performance, mea-surement, and safety will determine the likeli-hood of its realization.
References1. Human Genome Project: http://web.ornl.
gov/sci/techresources/Human_Genome/index.shtml
2. http://www.fda.gov/down-loads/MedicalDevices/
DeviceRegulationandGuidance/GuidanceDocuments/UCM262327.pdf
Bikash Chatterjee, President and Chief Science Officer of Pharmatech Associates, has been involved in the biopharmaceutical, pharmaceutical, medical device, and diagnostics industry for over 30 years. His expertise includes site selection, project management, design, and validation of facilities for U.S. and European regulatory requirements.
MEET TODAY’S
STANDARDS
WITH TOMORROW’S
18
Particles Cling to der WaalsCONTAMINATION CONTROL IN AND OUT OF THE CLEANROOM
Barbara Kanegsberg and Ed KanegsbergBFK Solutions LLC
Geckos appear to defy gravity as they run up a wall or across a ceil-ing. How can they do
that? It is not by exuding some sort of sticky goo. It is due to force, the same kind of force that causes a particle or soil to adhere to the surface of a com-ponent being manufactured or used, or to tooling, or to clean-room surfaces.
Three molecular forces — polar, hydrogen bonding, and dispersion — are associated with adherence as well as with solvency and cleaning.1 Geckos stick to walls by exploiting dispersion force.2 Dispersion force — sometimes referred to as a non-polar, Van der Waals, or London force — is the weakest of the three, but it may be the most fascinating as well as the most significant for particle adhesion and critical cleaning. Dispersion force is the mechanism by which non-polar compounds liquefy or solidify.
Subtle powerPolar and hydrogen bond-ing forces are associated with molecules that have dipoles, permanent positively and nega-tively charged sides. Dispersion forces, however, are a prop-erty of all molecules whether or not they have an inherent dipole. Because the electrons are always in motion, there can be a momentary fluctua-tion during which more of the electrons are on one side of the molecule than on the other. When this happens, the side with more electrons becomes
momentarily negatively charged and the other side becomes positively charged, creating a momentary dipole.
If another molecule comes very close to the molecule with the momentary dipole, the electrons on the approach-ing molecule will be induced to move. For example, if the momentary dipole has its positive side nearest the approaching molecule, elec-trons will be drawn towards that side creating a dipole in the second molecule. This sets up an attractive force between these two molecules. Sometimes, the two colliding molecules do not have enough energy to overcome this force and bounce back away; the molecules “stick” together. From this point, the dipoles are no longer momentary; they will last as long as the molecules are bound together. Moreover, this molecular duo is itself a dipole that can attract additional molecules, in somewhat of a chain reac-tion or domino effect.
Gecko feetThe feet of geckos have mil-lions of extremely tiny hairs. The ends of each hair sub-divide into many tiny pads or spatulae (about 0.2 µm diameter), each of which induces dipoles and associated attractive dispersion forces on molecules of the wall surface. Although dispersion forces are exceedingly small, the collec-tive sum from all the spatulae, or even those on a single toe, is sufficient to support the
gecko’s weight, even on a very smooth surface.
Particles and dried soils Dispersion force is also a pri-mary mechanism that causes contamination to stick. For dispersion forces to be attrac-tive or adhering, the molecules have to be very close, essentially within one atomic diameter of each other — just a few nano-meters. Small particles fit more easily into the pits and crevices of a surface (most surfaces are rather rough at a microscopic level even if they look smooth), just as gecko feet hairs do, so that more of the molecules of the particle are within the distance for attraction to the surface molecules. This is why small particles that stick to a surface are more difficult to remove than large ones.
A similar explanation elu-cidates why soil that is allowed to dry onto a surface is more difficult to remove. When a liquid that has soil molecules in suspension evaporates, the soil molecules become close enough to the surface for attractive dispersion forces to hold them there. Once the attractive bond between mol-ecules is made, it takes addi-tional force to overcome and break these bonds to allow the soil to be removed.
This is why we keep remind-ing you that deferring cleaning until the product wends its way through the supply chain over to your cleanroom is a terrible idea. Critical cleaning may need to happen early on in the build process.
July/August 2015 • www.cemag.us 19
Contamination controlWhen it comes to achieving, monitoring, and maintaining a clean surface, it is important to consider both the number and the size of particles.
The presence of many large particles might pose less of a problem than a few very small ones.
Large particles are easier to filter out of air or liquids. Also, because they will not adhere as strongly to a surface, they are also easier to remove during a cleaning process.
Small particles can be a big-ger challenge, both in terms of filtration and cleaning.
Because a molecule can be thought of as the ultimate small particle, airborne molecular contamination (AMC) deserves additional attention, both in cleanroom monitoring as well as control.3
References1. J. Burke, “Solvents and
Solubility,” Handbook for Critical Cleaning: Cleaning Agents and Systems; B. Kanegsberg and E. Kanegsberg, editors; CRC Press, 2011.
2. K. Autumn et. al. “Evidence for van der Waals adhesion in gecko setae.” Proceedings of the National Academy of Sciences of the USA, 2002, 99, 12252-12256. http://www.pnas.org/cgi/content/full/99/19/12252
3. B. Kanegsberg and E. Kanegsberg, “Airborne Molecular Contamination, Part 1: Silent Poison,” Controlled Environments Magazine, June 2009. http://www.cemag.us/articles/2009/06/airborne-molecular-contamination-part-1-silent-poison
Barbara Kanegsberg and Ed Kanegsberg (the Cleaning Lady and the Rocket Scientist) are expe-rienced consultants and educators in critical and precision cleaning, surface preparation, and con-tamination control. Their diverse projects include medical device manufacturing, microelectronics, optics, and [email protected]
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BENCHES AND ENCLOSURES20
Swing-Over BenchRPA Cleanroom Products off ers Palbam Class Cleanroom Gowning Sys-tems and Swing-Over Bench. The system provides a seating surface and a raised platform to assist with putting on booties or shoe covers. A protective barrier exists between the controlled and uncontrolled sides of the gowning area. Modular components that can be arranged in linear or angular confi gurations. The unit features elec-tropolished stainless steel construction.www.rpaproducts.com
Laminar Airfl ow Isolator
The Esco General Processing Platform Isolator is suitable for aseptic handling processes, including compound-ing and fi ltration, fi lling/stoppering/crimping, sterility testing, weighing and dispensing, and other processes that require an ISO Class 5 (Grade A) aseptic environment. The control system allows the operator to select positive or negative chamber pressure as well as single pass or recirculating airfl ow. It also features supply and return ULPA fi lter safe change capa-bilities. www.escopharma.com
Clean Benches and Workstations The clean bench and workstation models available through Clean Rooms International incorporate either HEPA or ULPA air fi ltration systems. Table top, stand-up, and sit-down versions are off ered, in a variety of vertical and horizontal fl ow combinations. Products are designed to accommodate the most stringent cleanroom condi-tions as well as systems engineered for applications requiring a lower level of cleanliness.www.cleanroomsint.com
Enclosures for Robotics and Laboratory AutomationHEMCO Enclosures are designed to enclose robots and other lab automated processes by providing exhaust air systems or HEPA fi ltered clean workstations. Enclosures are built to protect robotic processes from contamination and per-sonnel from hazardous fumes. A selection of standard sizes in vented or HEPA fi ltered models is available. www.hemcocorp.com
July/August 2015 • www.cemag.us 21
LiquidWorkstationLEWA Process Technologies Inc. off ers its Bulk Liquid Bottling Station, a single pass laminar fl ow cleanroom work station. The unit minimizes operator involvement, and provides an isolated fi lling environment that smoothly fi lls containers from the bottom up. The fi lling operation is controlled using an automated arm and scale system. A free-standing vertical laminar air fl ow hood isolates the fi lling environment from the cleanroom and the operator.www.lewapt.com
Vertical Flow BenchHutchins & Hutchins Inc. distributes Cleanroom International’s E Series Verti-cal Flow Clean Benches. The
self-contained SAM Fan Filter Unit provides Class 100 HEPA fi ltered air, fl owing in a vertical laminar pattern. The work surfaces are solid core with a white, high pressure laminate fi nish. The HEPA fi lters are 99.99% effi cient at 0.3 micron or larger with anod-ized aluminum frame.www.yourcleanroomsupplier.com
Aseptic Containment Isolator Comecer’s aseptic containment isolator is suitable for anti-blastic and chemo-therapic compound-ing. It is comprised of a compact air lock chamber and a 4-glove process chamber (2 or 3 gloves also available).
The system is equipped with a unidirectional airfl ow with positive/negative pressure with respect to the lab environment. The airlock is equipped with turbulent airfl ow for fl ash bio-decontamination.www.comecer.com
Wet Bench
The Two Process Wet Bench from Leatherwood Plastics features a sloped sump area with drain, hinged clear PVC eye shield, and rear side exhaust connection with adjustable slot openings to maintain a fume controlled work area. Other features include a purged control enclosure, removable work deck sections, adjust-able levelling legs for a balanced and stable set up, and low profi le casters.www.leatherwood.com
Ductless Fume HoodAir Science off ers the Purair ECO line of Energy-Saving Ductless Fume Hoods designed for both chemical and particulate protection. The units are available with a choice of controllers including touchpad control with color display interface. An optional BACnet network interface connects all cabi-net control, monitoring, and alarm functions to an open-source facility monitoring system. www.airscience.com
22
Cleanroom Training
Jan EudyCleanroom/Con-tamination Control Consultant
We built an ISO Class 7 cleanroom to serve our customers in the aerospace industry. We’ve hired engineers and operators to work in the cleanroom.
Where can we resource training for our clean-room personnel?
There are several independent cleanroom and contamination control consultants and trade industry conferences that you may contact to provide the required training. However, the cleanroom and controlled environment indus-tries rely on two main sources for standards and best practices in cleanroom and contami-nation control management: the Institute of Environmental Sciences and Technology (IEST) for training best practices, and the International Organization for Standardization (ISO) for global standards.
The ISO 14644 global cleanroom standards established airborne particulate cleanliness classes for particle sizes ranging from 0.1 µm to 5 µm as well as design, construction, and operation of cleanrooms, minienvironments, and separative devices. Eight of these inter-national standards are currently designated by the American National Standards Institute (ANSI) as American national standards. IEST is Secretariat of ISO/TC 209 and Administrator of the ANSI-accredited U.S. Technical Advisory Group (TAG) to ISO/TC 209. IEST is a not-for-profit organization that provides cleanroom and contamination control training to promote education and best practices. For more than 15 years, IEST has provided one-day courses on the ISO 14644 series of cleanroom standards dur-ing the annual technical meeting (ESTECH) in the spring; the Fall Conference; at IEST head-quarters in the northwest suburbs of Chicago; and custom training at locations in the U.S. and other countries.
IEST also develops Recommended Practices (RPs) for the nanotechnology; contamina-tion control; design, test, and evaluation; and product reliability industries. IEST is an ANSI-accredited standards developer and all the edu-cational programs are peer-reviewed. The senior faculty members of the Education Advisory Council are industry subject matter experts who
have contributed information to the current IEST recommended practices and ISO 14644 series of standards. IEST also offers educational training on recently published recommended practices in the disciplines listed previously.
The ISO standards provide the information as to “what to do” and the IEST recommended practices provide the information as to “how to do it.” Together, these non-profit organizations contribute a vast amount of knowledge and resources to the cleanroom and controlled envi-ronments industries.
Internationally, IEST (www.iest.org) is also a founding member of the International Confederation of Contamination Control Societies (ICCCS) (www.icccs.net). The ICCCS was formed in 1974 and consists of 20 countries as part of 17 member societies. The objectives of the ICCCS are to promote best practices through the international exchange of knowl-edge and the coordination and promotion of standards.
At the core of ICCCS is education, and the ICCCS encourages the promotion of education and training through coordination with mem-ber societies such as IEST. The International Cleanroom Education Board (ICEB) is the education arm of the ICCCS and prepares guidelines for contamination control courses for international harmonization through accredi-tation. IEST is considering providing hosting within the U.S. of ICCCS accreditation courses to expand global harmonization of contamina-tion control education.
The ICEB program operates under a num-ber of guiding fundamental principles. One is the principle of “personal certification through examination,” meaning the emphasis is on the student and not the company. Another principle is the 75/25 rule, stating that a minimum of 75 percent must be based on an ISO cleanroom standard (which is the same across the world) and 25 percent can be localized to suit differ-ent industries to allow flexibility. Since the ISO standard is the same everywhere in the world, the goal is to train people applying the standard to have the same competency skills and expecta-tions.
ASK JAN
23 July/August 2015 • www.cemag.us
Yet, there are specific needs — such as within the aerospace community — that require flex-ibility in providing application-specific train-ing. The longer term objective of IEST and the ICEB is to create common training programs to improve professional skills with globally accept-ed accreditation based on recognized standards.
The author acknowledges and thanks IEST staff and Conor Murray for their contribution to this article. Conor Murray is a principal in his own com-pany, 3dimension Cleanrooms, and is a subject matter expert on cleanrooms and contamination control. He is Chairman of the Irish Cleanroom Society and Head of Delegation for Ireland at TC 209. He is a past Chairman of the ICCCS and the inaugural chair of the ICEB.
Jan Eudy is a Cleanroom/Contamination Control Consultant as well as a Fellow and Past President, Institute of Environmental Sciences and Technology. She is located in Carolina Beach, N.C. and can be reached at [email protected].
July/August 2015 • www.cemag.us 17
SummarySemiconductor manufacturing requires significant energy, resources, and monitoring to ensure prod-uct quality and personnel safety. Turning a normal environment, where everything is a risk to the wafer, into a highly controlled, stable, continuously operat-ing environment is a unique challenge. However, that challenge can be met without sacrificing cost or environmentally sustainable operation. RFAB is a testament to bringing the best of both worlds together to achieve the world’s first LEED-Certified semiconductor manufacturing facility.
Ben Winsett is the Facilities Engineering Manager of Texas Instruments, headquartered in Dallas.www.ti.com
Cleanroom Design and Environmental Control Technologies
continued from pg. 15
23
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Problem: Within the phar-maceutical, biomedical, microelec-tronics, and similar industries, it is imperative that exposure to micro-bial contaminants and electrostatic discharge (ESD) are minimized at every turn of the manufacturing process. To maintain an exceptional-ly “clean” environment, tabletops and other hard surfaces must be regularly wiped down with cleanroom wipes.Normally, cleanroom wipes are sup-plied in flat sheets and placed on a table or in trays within a clean-room. Because the facility person-nel is required to wear gloves, it is very difficult to select one wipe at a time. Consequently, sometimes three or more wipes are selected — resulting in wasteful usage and the possibility of cross-contamina-tion.
Solution: Modifying the process of selecting a cleanroom wipe is often not the top priority of cleanroom personnel. Yet, as waste continues and valuable counter space is taken up by a messy stack of wipes, that modifi cation might be worth a second look. Similar to the benefi ts a napkin dispenser off ers a busy fast food restaurant, the Grab-EEZ from High-Tech Conversions provides these same benefi ts to a cleanroom. Unlike a napkin dispenser used in a fast food restaurant, a well-designed cleanroom wipe dispenser has to be carefully engineered us-ing advanced nonwoven folding technology and cleanroom compatible materials.At the heart of the Grab-EEZ design are its uniquely folded wipes. Each wipe is uniquely folded in a double “C” shape. The wipe contains an upper and lower leg, wherein the lower leg of each cleanroom wipe abuts the upper leg of an adjacent wipe. Each cleanroom wipe is stacked with the v-fold seam exposed in the opening of the unit, leaving the
next wipe in the stack untouched and exposed enough to easily pull from the dispenser.The Grab-EEZ is an ESD-safe, wall-mountable or table top cleanroom wipe dispenser. Its rectangular shape features a compartment for storing wipes protected from chemicals and other outside contaminants found in cleanroom settings. A viewing slot along a substantial portion of the dispenser is present so that a user may visually determine when the wipes within the compartment become depleted.The outer housing of the wipe dispenser is comprised of an ESD-resistant material. One particular issue with ESD-safe cleanroom wipes when they are pulled from the bag, although the wipe itself may be ESD-safe, the
bag can contain static electricity which is harmful to a cleanroom
that produces microelectronics. This method of distribution prevents cross contamination by removing the option to select more than one wipe at a time. In addition, the efficient delivery eliminates the need
to “fan” through a stack of wipes and saves time — resulting in reduced cost of consumables and operating cost. Each dispenser is prepared and cleaned in a clean-room and double bagged before it is fi rst intro-duced into the controlled environment where it will be used. The Grab-EEZ is made from the highest grade ESD-safe plastics and is suitable for use in ISO Class 5 (Class 100) cleanrooms and higher.Cleanroom facilities that incorporate the Grab-EEZ Wipe Dispenser will notice improved organization and reduced cross contamination, as well as cost sav-ings as a result of less waste.
More information is available at www.high-techconversions.com.
Each cleanroom wipe is stacked with the v-fold seam exposed in the opening of the unit, leaving the next wipe in the stack untouched and exposed enough to easily pull from the dispenser.
Cleanroom Wipe Dispenser Improves Process in Controlled Environments
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High quality dispensers for gloves, wipers, apparel, safety glasses, face masks, bouffant caps, etc. for your controlled environment. See all dispenser options at www.s-curve.com
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CLEANROOM TIP & INDEX 26
CLEANROOM
The cleanroom industry has embraced the tactic of includ-ing controls to allow the end user to manage the facil-ity’s energy consumptions. This includes set back hours
for non-critical hours of operation to save energy, as well as adjusting the facility’s air changes per hour (ACH) for the times that they might go out of specifications.
Some of the most common adjustments are made by tying in the facility’s fan filter units to be monitored and controlled by stand-alone control systems and, more commonly, the building management system (BMS). This is dependent upon the facility’s GMP and the critical environmental issues in the process.
USP 797, 798, and 800 call for these controls:• interlocking doors• lighting systems • particle counters• temperature sensors• pressure sensors• humidity sensors • closed loop operation of the listed equipment
This cleanroom tip is courtesy of Les Goldsmith of Envirco Corp. in Sanford, N.C. www.envirco-hvac.com
ManagingEnergyConsumption
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Arizona Polymer Flooring ...................... 25 ........................................ www.apfepoxy.com
Berkshire Corporation ........................... 27 ........................................ www.berkshire.com
Clean Air Products ................................. 19 ............ www.cleanairproducts.com/resources
Contec, Inc. ............................................ 28 ........................................www.contecinc.com
Geerpres ................................................. 9 .......................................... www.geerpres.com
Mar Cor Purification .............................. 23 .............................................www.mcpur.com
Masy BioServices .................................... 2 ............................................... www.masy.com
Monroe Electronics ................................ 25 ........................www.monroe-electronics.com
S-Curve Technologies ............................ 25 ........................................... www.s-curve.com
Simplex Strip Doors, Inc. ....................... 19 .............. www.simplexisolationsyystems.com
TSI, Inc. ................................................. 17 ................................. www.tsi.com/lifescience
Veltek Associates, Inc. ............................ 3 ..............................................www.sterile.com
July/August 2015 • www.cemag.us
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• Effectively and efficiently cleans both sides of a curtain strip in a single pass.
• Perfect for 4” - 12” (10 - 30cm) curtain strips.
• Microfiber cover removes and traps dust and other visible contaminants. For more critical environments, a Quiltec® knit polyester cover is available.
• Electropolished frame is resistant to most chemicals and disinfectants and can be sterilized.
• Tension on the curtain strip is easily controlled.
There are two sides to every story.
But with Contec’s DualClean™ Softwall Strip Cleaner, there is only one ending - happily ever after.
Clean both sides of a softwall strip at the same time!R
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To make your softwall cleaning and disinfecting more effective and efficient, choose DualClean from Contec. Learn more by visiting our web site: www.contecinc.com.
Patent Pending
