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March 2010 • Vol. 16 No.

New York Society of Cosmetic Chemists www.nyscc.org

CHAIR
Bill Woods Process Analytical Technology (PAT)–
(201) 655-4155
wbwoods@optonline.net Not Just for Pharmaceuticals! …Edward Malawer
CHAIR-ELECT

S
cienceDirect is one of the largest online
Brian Hom collections of published scientific research in
(973) 345-8600 x3430
b.hom@lipochemicals.com the world. Produced by Elsevier, it contains
over 9.6 million articles from over 2,500 journals,
TREASURER including titles such as The Lancet and Cell, and over
John Zamorski
(908) 272-0491 6,000 e-books, reference works, book series, and
jzamorski@essentialingredients.com handbooks. Placement of the search term “process

TREASURER-ELECT
analytical” into ScienceDirect’s search engine at present
Erich Bodnar
produces more than 1,500 relevant publication hits.
(732) 728-9235 Perusing the hundreds of titles and abstracts, it is
superm131@verizon.net easy to draw some general conclusions regarding
SECRETARY
the current level of utilization of process analytical
Rey Ordiales technology (PAT) as a function of industry. The
(973) 630-1674 pharmaceutical industry has, by far, the greatest
rey_ordiales@colpal.com
share of publications describing applications of process
ADVISOR analytical technology despite the high degree of
Joe Albanese concern in this industry for control of trade secrets
(908) 456-2968
j.albanese@3vusa.com
and a required high level of regulatory compliance.
The activity of the chemical, food, and electronics
HOUSE industries is also evident, albeit each to a significantly
Alison Griffin
lesser degree. What is most striking is the lack
(215) 320-1581
agriffin@inolex.com of process analytical technology citations by the enforceable regulation, the issuance of this document
has had a very cathartic effect upon the pharmaceutical
MEMBERSHIP
personal care/cosmetics industry. Assuming the same
degree of concern in that industry over publication industry as a whole, resulting in a paradigm shift in
Amy Marshall
(908) 806-4664 of potential trade secrets as in the drug product PAT implementation. In citing the rationale for
amy.marshall@altana.com business, one can immediately conclude that there process analytical technology deployment in drug
PROGRAM CHAIR
is simply a lack of acceptance of PAT in personal product manufacturing, the FDA guidance states,
Nava Dayan care operations. “Today significant opportunities exist for improving
(201) 206-7341 The preponderance of PAT activity in the pharmaceutical development, manufacturing, and
n.dayan@lipochemicals.com quality assurance through innovation in product and
pharmaceutical field has not always been the case.
SPECIAL EVENTS In fact, the petrochemical industry was probably the process development, process analysis, and process
Phil Klepak first industry sector to embrace the use of on-line, control. Unfortunately, the pharmaceutical industry
(973) 265-2869 in-process testing in refineries. This was followed by generally has been hesitant to introduce innovative
pklepak@summitresearchlabs.com
the commodity and specialty chemicals sectors. The systems into the manufacturing sector for a number
COSMETISCOPE EDITOR explosion of process analytical applications in the of reasons. One reason often cited is regulatory
Roger McMullen pharmaceutical industry was clearly set off by the uncertainty, which may result from the perception that
(973) 872-4391
roger.mcmullen@gmail.com publication in 2004 by the Food and Drug our existing regulatory system is rigid and unfavorable
Administration (FDA) entitled, “Guidance for Industry: to the introduction of innovative systems.”
COSMETISCOPE ADVERTISING PAT—A Framework for Innovative Pharmaceutical In this regard, the desired state of pharmaceutical
Douglas Krysiak
(917) 509-6462 Development, Manufacturing, and Quality Assurance.”1 (product) manufacturing and regulation (by the FDA)
doug.krysiak@dowcorning.com Despite being “only a guidance” and not an

NYSCC CHAPTER MEETING • MARCH 3


(Continued on Page 6)

COSMETISCOPE EMPLOYMENT

SEASONS WESTWOOD • WASHINGTON TOWNSHIP, NEW JERSEY


Tim Gillece
tgillece@yahoo.com
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La Presse Écrite …Roger L. McMullen

I
t is already March and we should finally be able to see temperature is also dictated by weather conditions. Our eccrine
the light at the end of the tunnel (hopefully, not from glands, which are located throughout the entire integument, are
an oncoming train) as winter ends. As usual, winter capable of initiating a process known as evaporative cooling
inspired me to ponder a bit about meteorology. I considered (perspiration) in which an aqueous substance (sweat) is
both how our bodies respond to seasonal weather changes produced by the gland and distributed on the surface of the
and the effects of variable ambient conditions on scientific skin. During dry conditions, evaporative cooling usually works
research. pretty efficiently. However, when humidity strikes, it is more
Like many regions of the United States, the New York difficult for the body to cool because sweat remains on the
City area has a continental climate, which typically surface, becomes hot, and new sweat is unable to surpass
means cold, dry winters and hot, humid previous secretions. Thus, cooling becomes extremely
summers. In winter, on the occasional cold challenging. It certainly does not help that sweat, like water,
day in January or February, the temperature has a very high heat capacity.
could easily fall to -8 °C (17.6 °F). Extremely Likewise, human hair is certainly not exempt from
dry conditions, with relative humidity Mother Nature’s wrath. As is the case with skin, we tend
dropping to 10-15%, often accompany to think about the effects of humidity on hair or cosmetic
these frigid temperatures. In contrast, treatments intended for hair. Anyone with
summer temperatures can reach 35 °C borderline frizzy hair will tell you that his
(95 °F) and be accompanied by relative or her worst bad-hair days occur during
humidity levels of up to 80%. the dog days of summer, when the relative
Since we work in many facets humidity soars. On the other hand, there are
of cosmetic science, we find that those who complain about dry hair syndrome,
weather affects not only the which usually starts in December and lasts
substrates (skin, hair, nails, until sometime in March. There is often a
etc.) we are interested in, but great deal of confusion, at least among
also the molecules used to treat them. Therefore, scientists and consumers, about what dry hair really connotes.
in the laboratory, it is imperative that we consider Scientists are always quick to point out that what the consumer
the atmospheric conditions that each season really senses is rough, not dry, hair. We should, of course,
bequeaths us. Any experiments we conduct not forget to consider the effects of humidity on hair surface
in the laboratory must consider the time of roughness.
year when performed. Oftentimes, it is sound Besides temperature and humidity we may also want to
scientific practice to run our evaluations under contemplate some other elements of weather that may be
tightly controlled environmental conditions. equally important. We rarely discuss dew point temperature—
For skin, there are countless examples the temperature to which a substance is cooled where the gas
of the influence of weather factors on its phase (vapor) condenses to become a liquid (dew). Dew point
condition. The most prevalent is the dreadful temperature correlates with relative humidity. At 100% RH, the
winter itch, which is a form of dry skin, or dew point temperature is equal to the current temperature—
xerosis, and is caused by extremely cold, dry the air is at its maximum saturation point. As in the case with
conditions. Due to this type of environmental high relative humidity, high dew point temperatures will also
insult, the stratum corneum loses its structural wreak havoc on our experiments. Other environmental factors
water, which leads to compromised barrier we certainly should heed are temperature and, possibly,
function. Our body’s ability to regulate barometric pressure.

Contact Information
D
on't miss out on all the news from the NYSCC chapter.
Please update your contact information immediately by
calling or e-mailing:

Amy Marshall at (908) 806-4664


or at amy.marshall@altana.com.

March 2010
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Genomics and Cosmetics …Nava Dayan

T
he human genome project (HGP) that was expose our body to a peptide or protein that is
competed in 2003 identified 20,000 to produced naturally, the system will get a “message”
25,000 genes in humans, which means that that this compound is produced in excess, which will naturalbynature
every one of us is born with this number of genes lead to downregulation of the gene that encoded
this compound. The reverse
response will occur in the case of
High quality Brazilian plant actives
reduced levels of the compound— Marine derived actives
Botanical extracts & blends
upregulation will occur. Moreover, Certified Organic Essential Oils and Butters
we say, “We are what we eat.” But,
97 785 TAOS (8267)
973
are we also what our parents and www.taosinc.info
grandparents ate? Is it possible that
their life style affected the creation
of our genes?
If we apply this concept to
cosmetics, could it be that by
repetitive application of compounds
that are absorbed into the skin we
are affecting controlled mechanisms
in this tissue that can change its
appearance? We already know that
environmental factors affect gene
expression in skin. An example is
photo-damaged skin. Skin that is
that are translated into amino acids to form peptides constantly exposed to UV stress expresses enzymes
and proteins. We tend to believe that our genes and and proteins such as metalloproteinases that
their expression are set in stone at the precise moment contribute to accelerated aging by destructing the
of our conception. While these genes dictate our fiber network in the dermis, ultimately leading to
physical and mental being, can we possibly control the creation of wrinkles. Although we are at the
their expression and change our health, behavior, or very tip of the iceberg with the investigation of gene
destiny? The fact that we were able to significantly expression and the capacity to control it, this area
postpone our death age is a hint to the answer. In is fascinating for human kind. Our meeting this
biological systems there are feedback and control month is an introduction to the field of genomics
mechanisms of compensation. If, for example, we along with possibilities it brings to our industry.

NYSCC Scholarship Program


Applications for the NYSCC Scholarship Program
will be accepted until March 15, 2010.

T
he scholarship program was founded in honor of Sal Gimelli,
Professor Emeritus at Fairleigh Dickinson University. Professor Gimelli
was one of the founders of the Fairleigh Dickinson University Master’s
program in Cosmetic Science, and for many years, acted as a consistent contributor
to the better understanding and knowledge of the cosmetic sciences as well as to the NYSCC.
This year, the NYSCC Board has expanded the scholarship program, and will be selecting three winners:
• The Sal Gimelli Scholarship winner will receive $2,500 per year.
• The Henry Maso Scholarship winner will receive $1,500 per year.
• The NYSCC Scholarship winner will receive $1,000 per year.
If you are an NYSCC member with a son or daughter, who is currently a high school senior, and wishes
to participate in the scholarship program, please contact the NYSCC Scholarship Chair at scholarship@nyscc.org.
Applications are available on the NYSCC web site (www.nyscc.org) and will be accepted until March 15, 2010
(postmarked). Final decisions will be determined by May 12, 2010.

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NYSCC March Educational Hour…


Speaker… Anna Jelaso Langerveld, Ph.D.
Topic… Application of Genomics Tools
for Personal Care Product Development
March 3, 2010 • Seasons Westwood, Washington Township, NJ
Abstract:

B
reakthroughs in genomics offer new opportunities for developing highly efficacious
products that target specific skin concerns (i.e. aging, redness, etc.). The human genome
project produced two major technologies for measuring what genes are “turned on or
off” in a given situation: DNA microarrays and quantitative real time PCR (qRT-PCR). These tools are being utilized in all
areas of medicine to define “healthy versus disease” states, and are rapidly being incorporated into personal care product
development. This presentation will provide an overview of basic genomics principles, the predominant technologies, and
how they are being applied to the personal care industry. The use of genomics methods will improve product development
and market share for companies that want to demonstrate that their products are the best on the market.
Biography:

P
resident and CEO of Genemarkers LLC, Anna has more than ten years of experience with state-of-the-art
genomics methods. The former director of the Western Michigan University Environmental Institute Genomics
Facility (2000-2005), Anna played an instrumental role in carrying out Affymetrix and Taqman qRT-PCR analyses
for neurobiological, environmental, and animal health applications. Anna founded Genemarkers LLC in 2007 and has
been carrying out contract-based genomics research for a myriad of clients, ranging from small organic skin care
companies and university researchers to large companies, such as Pfizer and NuSkin. Her gene expression work has
been published in numerous peer-reviewed journals, cited in the Wall Street Journal, and recently featured in
Cosmetics & Toiletries (May, 2009). Anna received her B.A. from SUNY Binghamton and her Ph.D. from the
Interdisciplinary Program in Neurosciences at Tulane University (1998).

Monthly Meeting Registration…3 Ways to Register!


Students and Emeritus Members are FREE…and now CREDIT CARD registration is here!
1 REGISTER WITH A CREDIT CARD The New York Society of Cosmetic Chemists will now accept monthly meeting registration
by credit card. Credit cards will be accepted during pre-registration and registration at the door. To pre-register and for more
information, go to www.nyscc.org.

2 PAY AT THE DOOR Pre-registration with the option to pay at the door will remain. As in the past, go to our website (www.nyscc.org)
to register and bring your check to the meeting. Contact Courtney Kawula (courtney.kawula@symrise.com, 201-462-2960) if you have
questions regarding registration.

3 REGISTER BY MAIL** If you must register by mail, please mail a completed copy of this page together with a check payable to
“NYSCC.” Please Note: Reservations will not be honored without payment and must be received no later than noon the Friday before
the meeting. There will be a surcharge at the door for those without reservations.
** If paying by check, your payment and pre-registration information must be RECEIVED by the arrangements chair, Courtney Kawula, BEFORE the
day of the meeting. If it is not, your original check will be returned and you will be required to pay the door fee upon arrival at the meeting. Please
mail a completed copy of this page together with check to:

YES, I will be attending the March 2010 Meeting. I have enclosed a check for (please indicate applicable status)
Courtney Kawula, 300 North Street, Teterboro, NJ 07608 • Tel: (201) 462-2960 • E-mail: courtney.kawula@symrise.com

 $25 (each SCC member) or  $35 (each non-member) made payable to “NYSCC.”

Name(s) _______________________________________________________ Company __________________________________________________________

Address ________________________________________________________________________________________________________________________ City _______________________________________________________________________ State __________________ Zip ___________________________

Phone _____________________________________________________________________________________________ Fax ________________________________________________________________________________________ Number attending _____________________________________________

March 2010
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NYSCC March Meeting…


Speaker… Helen Knaggs, Ph.D.
Topic… Aging and Genes–The Link with Skin
March 3, 2010 • Seasons Westwood, Washington Township, NJ
Educational Hour Starts: 4:30 PM • Cocktail Reception: 5:30 PM
Pre-registered SCC members: $25 • Pre-registered non-SCC members: $35 • Register at the Door: $40

Abstract:

T
he advent of the Human Genome project, the understanding the effect of antiaging
development of better methodology for probing actives (e.g. retinoic acid) or clinical interventions
genetic material, and the improvement in accessibility (laser therapies, microdermabrasion) which are
of these methods has collectively resulted in the generation known to improve aged skin appearance, and could
of a large amount of scientific data describing individual act as a positive control to understand and develop
genes, as well as families of genes. Application of these new ways to treat aging. Clearly, the challenge facing
methods to skin tissue has been no exception, with much the Personal Care industry is to be able to use this
of the available data coming from a variety of different abundance of scientific data and interpret it into
techniques as methods have evolved and newer methods meaningful information and marketing concepts,
have become available, thus making it difficult to compare thereby delivering a consumer-compelling story.
across studies and determine consistent findings. Additionally,
the complexity of the skin tissue, which contains multiple Biography:

D
cell types and many different proposed mechanisms for aging, r. Knaggs has more than fifteen years of experience
makes it hard for clear data interpretation. This presentation in product research and development. Her
will review and summarize current genetic findings associated expertise in skin and hair biology has helped
with skin aging. Review of these papers indicates that there produce numerous patents, presentations, and publications.
is a substantial body of work published on changes in skin in Prior to joining Nu Skin Enterprises, Dr. Knaggs worked for
both intrinsic and extrinsic aging. Data has been collected Unilever in both the United States and Asia. In addition, she
from different sources including human skin biopsies, tissue spent several years as a research biochemist in the dermatology
culture of aged and young fibroblasts, and keratinocytes. department of Leeds General Infirmary in England where her
One way authors are dealing with the overwhelming work involved clinical and laboratory research, interpretation
amount of data generated is by attributing these genes to of trial results, and data reporting to corporate and scientific
families of genes or gene ‘themes’ defined by the Genetic communities. Dr. Knaggs earned bachelor’s degrees in biochemistry
Ontology (GO) library of gene pathways, then looking for and pharmacology, and a doctorate degree from the Department
changes in pathways which can be related to the different of Biochemistry and Molecular Biology at the University of
mechanisms of skin aging. Other groups are focused on Leeds.

Directions to the Seasons Westwood, Washington Township, NJ


• From Teaneck: Follow Route 4 West to Route 17 North then to Garden State Parkway North. Go through the toll (.35 or
EZ-Pass) and take Exit 168 (Washington Township). Go up the ramp and bear right at the intersection (Washington Avenue). Go
approximately ½ mile to SEASONS at the first light. The driveway is located about 100 feet on the right side before the light. If you
go to the light, make a right turn and go in the first driveway on Pascack Road about 125 feet south of Washington Avenue.
• Alternate: Same as above to Route 17 North. Go past the Garden State Parkway entrance to the Linwood Avenue exit in Paramus (about ½ mile
after Fashion Center). Take the Linwood Avenue exit, bear right onto Linwood Avenue, and go about ¾ mile to a “T” in the road, which is the
intersection of Pascack Road, AKA Woodland Avenue. Make a left on Pascack Road (Woodland Avenue), then go north about 1 ½ miles past the
shopping center on your right to SEASONS (on left) at the light. The driveway into SEASONS is about 125 feet before the light.
• From NYC: Take the George Washington Bridge to Route 4 West, then follow the instructions from Teaneck.
• From Closter: Take Closter Dock Road West to Closter, then turn left at the blinker (just before Closter town center) onto High Street. Continue
west on High Street across Schralenburgh Road. High Street now becomes Old Hook Road. Go west on Old Hook Road past the reservoir,
hospital, and across Kinderkamack Road into Westwood. Bear right onto Broadway before the railroad tracks and continue until Washington
Avenue on the left at the railroad station. Turn left on Washington Avenue and follow for 1½ to 2 miles until you reach the intersection of
Pascack Road (light). SEASONS is located at the intersection on the left side.
• From Rockland: Take the Garden State Parkway South to Exit 166. Turn right after the exit. The road ends at Linwood Avenue. Turn right on
Linwood Avenue. Linwood Avenue ends at Pascack Road. Turn left at Pascack Road. SEASONS is 1 ½ miles on the left, on the corner of
Pascack Road and Washington Avenue.

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Process Analytical Technology (PAT) (Continued from Page 1)

may be characterized as follows: use of process analytical technology to monitor


• Product quality and performance are ensured and control (through feed-back and feed-forward
through the design of effective and efficient information communication with distributed control
manufacturing processes. systems (DCS) used in manufacturing operations).
• Product and process specifications are based on This is what the FDA expects to see in connection
a mechanistic understanding of how formulation with 21st century pharmaceutical GMP practices,
and process factors affect product performance. such as “Quality by Design” (QbD).8 The goal of PAT
• Continuous real time quality assurance. is to understand and control the manufacturing
Cosmetics are regulated by the Center for Food process, which is consistent with our current drug
Safety and Applied Nutrition, the same branch of the quality system: quality cannot be tested into products;
FDA that regulates food. It is well known that the it should be built-in or should be by design. The
FDA has the right to inspect cosmetics firms (as ultimate goal is for firms to have such precise quality
well as those producing drug ingredients/products, control over their manufacturing schemes that real-
nutritional supplements, and foods) under the Food, time product release is possible using only on-line
Drug, and Cosmetic Act of 1938. Its primary concern analyzer data. This is not expected to eliminate the
in this connection is to ensure that the cosmetics need for off-line, laboratory-based product release
firms are not producing either adulterated (containing but should tremendously reduce the testing burden
poisonous or putrid substances rendering the material of these laboratories (and their associated operating
injurious to users) or misbranded (using false, costs).
misleading, or inadequate labeling) products. The The PAT framework focuses on the design and
aforementioned is the basis for the very limited development of processes that can consistently ensure
cosmetic Current Good Manufacturing Practices a predefined quality at the end of the manufacturing
(cGMP). This would seem to allow for a very wide operation. Such procedures would be consistent
degree of variation of cosmetic product composition, with the basic tenet of quality by design and could
which would not be objectionable to the FDA. reduce risks to quality and regulatory concerns while
Despite this, a large number of personal care improving efficiency. Gains in quality, safety, and/or
companies make products which, depending upon efficiency will vary depending on the product and
their label claims, are regarded as over-the-counter are likely to come from: 1) reducing production cycle
(OTC) drug products as well as cosmetics and thereby times by using on-, in-, and/or at-line measurements
come under the highest level of FDA scrutiny. For and controls; 2) preventing rejects, scrap, and
such products, the PAT guidance to industry clearly re-processing through improved product consistency
applies. Let us first consider toothpaste. If it only has and quality; 3) real-time release; 4) increasing
cleaning claims on the product label, the toothpaste automation to improve operator safety and reduce
is a cosmetic. However, if it makes an anticaries human error; 5) facilitating continuous processing to
claim, it is treated as an OTC drug product.2 Another improve efficiency and manage variability using
prominent example would be a deodorant. If it is small-scale equipment (to eliminate certain scale-up
said to address body odor, the product is a cosmetic. issues) and dedicated manufacturing facilities,
If, however, it is also claimed to control perspiration, improving energy and material use, and increasing
it is treated as a drug product.3 A shampoo is a capacity. (Note that “in-line” means that the analyzer
cosmetic because its intended use is to cleanse the probe is directly in contact with the manufacturing
hair. An antidandruff treatment shampoo is a drug process, “on-line” denotes that the probe contacts
because its intended use is to treat dandruff.4 the process through a slip stream or recycle loop,
Similarly, a moisturizer is a cosmetic while one while at-line refers to an “off-line” process sample
which also claims to be a skin protectant is a drug analysis made at an isolated instrument located in
product.5 Finally, a sunscreen product is considered the immediate vicinity of the sampling point.) Other
by the FDA to be a drug.6 The prime consideration potential benefits of process analyzers include
for designation as a drug is whether a product is reduced raw material use and chemical waste,
claimed to cure, treat, or prevent disease or to affect reduction of energy usage, reduction of pollution and
the structure or any function of the human body.7 carbon footprint, improved process sustainability,
It follows that such personal care/cosmetic firms and reduction of laboratory testing (as mentioned
ought to be very interested, from both a regulatory previously).
as well as a financial savings standpoint, in making These analyzers could be, and most frequently

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are, simple temperature and pressure transducers as and light reflectance (giving size information about
well as flow meters, since such devices are required to particles counted sequentially, albeit rapidly). The
follow the most basic engineering control parameters latter type is particularly adept at monitoring
of virtually any chemical process. For example, a changes in aspect ratios of particles within the
flow meter would be able to provide the amount of process. Particle size analyzers are very applicable to
a given liquid chemical flowing into a reactor or processes producing compositions such as emulsions,
which consist of discrete liquid particles in a different,
(a) continuous liquid phase. The size range and
concentration of the discontinuous phase droplets in
an emulsion are key to its behavior and performance
and can be accomplished using light scattering9 or
reflectance10 instruments. The same can be said for
particles in a colloidal suspension. Analyzers based
upon the reflectance principle are also capable of
providing percent solids information for a slurry.
The most interesting, and useful, classes of process
analyzers are those which provide chemical or
compositional information. The best of these can
perform this function in close to real time allowing
(b) for the potential of direct process control. This reduces
the product variation encountered in one batch versus
the next when an operator has to wait for an off-line,
in-process laboratory test results subjecting a key
unit operation to variable hold times typically at
elevated temperature. Such analyzers generally fall
into one of two analytical instrumental classifications,
namely chromatographs or spectro-photometers/
spectrometers.
Process gas, liquid, and ion chromatographs have
found utility in specific industrial market niches. For
example, process gas chromatographs (GCs) are
prevalent in the petrochemical industry especially
Figure 1: In (a) the left portion of the instrument in the separation of lights (low molecular weight
enclosure is the NMR analyzer while the right hand components). Separations can be as rapid as five
portion contains the microprocessor and electronic
to ten minutes for complex systems if parallel
controller. In (b) the two enclosures represent the
aforementioned instrument enclosure as well as the chromatography is deployed. Process GCs require
sample conditioning system. (Courtesy of Process complex sample handling systems to bring the
NMR Associates LLC, Danbury, CT) analyte stream of interest to the analyzer. In temperate
and cold climate facilities, sample lines frequently
mixing vessel (such as a raw material) or flowing out must be heat-traced to avoid liquification and/or
of such units (such as the product or a waste stream). solidification of gas or liquid streams. Process liquid
More sophisticated mass flow meters, particularly chromatography is of particular interest in the
those based upon the Coriolis Principle, are capable pharmaceutical sector where it is important to monitor
of providing additional information such as density, active pharmaceutical ingredients along with impurities
specific gravity, volume flow, and percent solids. The and degradants. Very rapid separations are possible
aforementioned all provide physical information for both on-line liquid and ion chromatographs using
about material in a process. small stationary phase particle (ca. 2 µm) technology.
An additional, albeit significantly more complex The latter technique finds use in the inorganic
analyzer type, which provides key physical property chemicals industry. Its main competition is process
information about solid or mixed phase process titration technology. If the composition of a process
streams, is the particle size distribution analyzer. The of interest, requiring both monitoring and control,
most important classes of these are based upon light changes slowly (over the course of many minutes or
scattering (giving information about an ensemble of even an hour or more), then a form of process
particles through analysis of light scattering patterns) (Continued on Page 8)

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Process Analytical Technology (PAT) (Continued from Page 7)

chromatography may be a good choice given the containing O-H, N-H, and C-H functionalities and is
amount of analyte information it provides. especially useful in following water content, such as
On the other hand, if the process of interest in pharmaceutical drying operations. It is also possible
changes rapidly and/or if a complex sampling system to deploy a near-IR analyzer in the convenient location
is impractical, a process spectrophotometer or of a control room by connecting it to a probe
spectrometer may be a better choice. Spectrophoto-
meters involve the use of light of some convenient
energy range; the most common process spectro-
photometer analyzer types are UV, mid-IR, near-IR,
and Raman. Spectrometers do not employ the use of
light; examples are mass spectrometers (MS), ion
mobility spectrometers (IMS) (similar to time-of-flight
MS), and nuclear magnetic resonance (NMR)
spectrometers. Proton NMR analyzers compete
successfully with process GCs in the petrochemical
arena. Figure 1 shows an installed process NMR
analyzer in a petrochemicals plant used to monitor
(a)
and control a refining operation. While they do not
Figure 2: In (a) a receiving clerk records the barcode
perform physical separations of molecular species, of an incoming raw material drum using a hand-held
process NMRs do provide a great deal of compositional Raman analyzer. In (b) the individual obtains a Raman
information based upon hydrocarbon type. Process spectrum through the polyethylene bag liner in
NMRs, like chromatographs, do require a piping order to confirm the identity of the material without
exposing it to the air using an internally-stored,
system to bring the (conditioned) sample stream to
spectral library of compounds. (Courtesy of Ahura
the analyzer. They are applicable to most types of Scientific, Inc., Wilmington, DE)
organic liquid streams including those which are
(b)
opaque. Process MS analyzers also compete with
process GCs in a similar fashion but are restricted to
lower molecular weight analytes. Common application
areas include environmental monitoring and
control, metals processing, fermentation (headspace)
monitoring, and pharmaceutical solvent drying. IMS
units are primarily used in the pharmaceutical
industry for cleaning validation/verification (where
the primary competitive technologies are total organic
carbon analyzers and liquid chromatographs) and
for ensuring process water quality. UV analyzers can
be quite useful and sensitive for simple systems where
the analyte of interest possesses a UV chromophore immersed directly into the process stream via a long
and there is only one such analyte within the fiber optic cable. Several scans (data acquisitions) may
system. be required to build adequate signal-to-noise ratio
Near-IR spectroscopy is very likely the most for an individual process reading but this typically
common and popular type of compositional, on-line requires only thirty seconds to two minutes, nearly
analyzer technology. This is due to the fact that it has real time. The traditional mid-IR technology (exhibiting
access to spectral signature information similar to sharp peaks relating to fundamental structural
that in the mid-IR (molecular vibration) range except information) is extremely useful in following chemical
that the information is expressed as overtone and reactions and does not generally require chemometric
combination bands. Furthermore, the typical near-IR data treatment, but the analyzer must be located
spectrum consists of “wavy lines” as opposed to very close to the reaction vessel. Sample probes are
sharp peaks and, as a result, absolutely requires typically the attenuated total reflectance (ATR) type.
the use of multivariate data treatment methods On-line Raman spectroscopy has experienced rapid
(chemometrics) in order to extract needed chemical growth in recent years. Like mid-IR, it provides
information. It is very useful for following species fundamental spectral information relating to molecular

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vibrations but has the advantage of fiber optic cable identification. Depending upon the natures of the
connected probes as in near-IR. Unlike near-IR, it is material and the analyzer, the sample would be
rather insensitive to water, an advantage in some inserted into the instrument’s sample compartment
cases. Since it is a light scattering technique and not or interrogated within the drum using a wand-type
based on light absorption, sample probes can be probe. The instruments’ microprocessors are trained
located outside process sight glasses while the to recognize the spectral signatures of expected raw
probe’s optics are focused to interrogate the process materials with a high degree of acceptance accuracy.
medium within a vessel. Raman spectroscopy is Receiving clerks need not have any chemistry or
prone to fluorescence interference in certain samples spectroscopy training. Advances in the miniaturization
primarily due to certain impurities. of spectrophotometer footprint and weight have led
Even a brief overview of the PAT field such as to the introduction of hand-held Raman and mid-
this one would be incomplete without mentioning FT-IR analyzers from several vendors allowing the
the importance of at-line analysis. In the opinion of analyzer to be brought directly to incoming pallets of
the author, the most critical area of importance for raw materials. An example of the use of a hand-held
at-line analysis is in the identification of key incoming Raman analyzer is shown in Figure 2.
raw material ingredients. For a number of years When selecting the optimum technology for an
all three of the spectral techniques discussed in the on-line analysis and control project there is no
preceding paragraph have been used in this absolutely right or wrong choice. There are many
connection. The typical configuration would be an excellent process analytical technologies available,
analyzer or instrument mounted on a rolling cart or each having many established and proven applications.
located on a bench in the vicinity of the receiving One should choose the technology that solves the
location in the plant. Samples from incoming analysis problem at hand while being readily
drums could be brought to the analyzer for rapid accommodated by the organization as a whole.

REFERENCES
1. FDA/CDER “Guidance for Industry: PAT—A Framework for Innovative Pharmaceutical Development, Manufacturing,
and Quality Assurance,” September 2004.
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070305.pdf.
2. Code of Federal Regulations, Title 21, Part 355 “Anticaries Drug Products for Over-the-Counter Human Use.”
3. Code of Federal Regulations, Title 21, Part 350 “Antiperspirant Drug Products for Over-the-Counter Human Use.”
4. Code of Federal Regulations, Title 21, Part 358 “Miscellaneous External Drug Products for Over-the-Counter Human
Use,” Subpart H—Drug Products for the Control of Dandruff, Seborrheic Dermatitis, and Psoriasis.
5. Code of Federal Regulations, Title 21, Part 347 “Skin Protectant Drug Products for Over-the-Counter Human Use.”
6. Code of Federal Regulations, Title 21, Part 352 “Sunscreen Drug Products for Over-the-Counter Human Use.”
7. FDA/CDER “Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?)”
http://www.fda.gov/Cosmetics/GuidanceComplianceRegulatoryInformation/ucm074201.htm.
8. FDA/CDER “Guidance for Industry: Q8(R1) Pharmaceutical Development, Revision 1,” http://www.fda.gov/down
loads/RegulatoryInformation/Guidances/ucm128005.pdf.
9. J.F. Ge, F.J. Lu, and W. Ding, Chin. Chem. Lett., 13(10), 993-996 (2002).
10. S. Rimpler and R. Daniels, Pharmaceutical Technology Europe, October 1996, 72-80.
11. “Process Analytical Chemistry” (in annual reviews edition) Anal. Chem., 79, 4345-4364 (2007).
JPAD LO1 11/29/07 8:54 PM

About the Author…Edward Malawer, Ph.D.


Custom Toll Processing

D
r. Edward Malawer received his Ph.D. in physical chemistry from New
York University. He has over thirty years of industrial analytical chemistry
experience and until 2007 served as Vice President in charge of analytical
R&D, quality assurance, product stewardship, and technical information services
at International Specialty Products (ISP). Ed currently operates a consulting Dry Powder Size Reduction
firm, Malawer & Associates Consulting, LLC (www.malawerconsulting.com), High Purity & Inert
specializing in laboratory and process analytical measurement solutions as well Jet Milling Technology
as cGMP pharmaceutical auditing and quality system improvements. He has Test Grinding Services
developed and currently teaches a short course for the American Chemical FDA Registered cGMP
Society entitled, “Introduction to Process Analytical Technology,” which is ISO 9001: 2000 Registered
directly supported by many key analyzer vendors. He can be contacted at The Jet Pulverizer Co., Inc.
emalawer@optonline.net. (800) 670-9695
toll@jetpul.com
March 2010 ® www.jetpul.com
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NYSCC Spring Seminar…


Nanotechnology—The Good, The Frightful, and The Mysterious
April 21, 2010 • Pleasantdale Château, West Orange, NJ

T
he word nano comes to us from Greek and can be translated, literally, as dwarf or little old man. In more modern times, it
has been utilized as a prefix for the International System of Units that indicates that something is 10-9 units in magnitude,
e.g. one nanometer is one-billionth of a meter. In most recent history, nano has
been defined as an entity having a size of 100 nm or smaller and gave birth to the field
of nanotechnology. In our everyday lives, we are exposed to a variety of nano-sized
particles, such as polymer-surfactant aggregates, microemulsions, hydrogels,
liposomes, micellar structures, and tiny particles that are used as sunscreens.
In fact, colloids fall under the umbrella of nanotechnology even though colloid
science was born long ago—in the mid-18th century.
In the past two decades, probably due to new research findings and
improved instrumentation sensitivities, voices of controversy have been raised in
regard to human exposure to nanotechnology. While this technology may bring
forth great promise for novelty, it may also carry a potential risk…or does it?
Our Spring Seminar this year will provide an overview addressing the
following topics:
• Do nanoscale particles penetrate the skin, and under which conditions?
• Are nanoparticles toxic to living cells?  An example of a supramolecular
assembly reported by Atwood and
• Examples of great technologies that were developed and launched with the
coworkers in Science, 309, 2037 (2005).
use of nanotechnology. Image from www.Wikipedia.org.
• What is the opinion and action taken by different regulatory authorities?
• Do nano-entities “obey” rules that are different from the rules in chemistry and physics that are more familiar to us?
SEMINAR SCHEDULE
8:00–8:45 a.m. Registration
8:45–9:00 a.m. Introduction -– Nava Dayan
9:00–9:45 a.m. John Bailey – An update on Nanotechnology and Personal Care Products
9:45–10:30 a.m. Srikanth Nadadur – NIEHS Research Efforts in Health Implications
of Nanotechnology
10:30–11:15 a.m. Coffee Break
11:15 a.m.–12:00 p.m. Amy Madl – Considering Physicochemical Characteristics of Nanomaterials
Under A Risk Assessment Paradigm
12:00–1:15 p.m. Lunch Break
1:15–2:00 p.m. Phil Wertz – Pathways Across the Stratum Corneum—Compositions and Dimensions
2:00–2:45 p.m. Tamara Minko – Nanotechnology Strategies to Overcome Limitations in
Drug Delivery: Opportunities and Challenges
2:45–3:45 p.m. Keynote Speaker: John Crowley – Utilizing Nanotechnology in Drug Development—
A Personal Story
3:45 – 4:00 p.m. Concluding remarks and book signing by John Crowley

 COST (Breaks and Lunch Included):


• Members – $50 • Non-members – $100 • Faculty – $25 • Students – $10 • Unemployed – No charge
 NYSCC SPRING SEMINAR REGISTRATION:
• Online: www.nyscc.org
• Mail: Kristen Presti, c/o Scent & Care Division, Symrise Inc., 300 North Street, Teterboro, NJ 07608
 CO-CHAIRS of the NYSCC SPRING SEMINAR:
• Nava Dayan: (201) 206-7341 • Anna Gripp: (973) 628-3637

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Employment Opportunities
Employment ads should be sent to…Tim Gillece • E-mail: tgillece@yahoo.com
You may contact National SCC at (212) 668-1500 for a list of employment opportunities.
Employment listings published in the Cosmetiscope are abridged due to space limitations.
Received 01-21-10 regulatory requirements; providing critical
 STAFF COSMETICS FORMULATION CHEMIST review for regulatory compliance of the
ENGLEWOOD LAB, a Cosmetics Contract Manufacturer in content and format of labeling and promo-
Englewood, NJ, is looking for a cosmetics development chemist tional materials; compiling product formula,
(skincare formulation experience a plus). support, and safety data documentation files;
Please send résumé to: info@englewoodlab.com. assembling regulatory submission to government
______________________________________________________________________________________________________ agencies; internal documentation; and inter-
Received 01-08-10 acting with government agencies and trade
 SCIENTISTS AND ENGINEERS associations on assigned projects.
AVON PRODUCTS, INC. is seeking several experienced Requirements include: a B.S. in a scientific
professionals to join our dynamic Global Research & Development discipline and at least five years experience in a
facility located in Suffern, NY. regulatory affairs function, or experience in a
We currently have Chemist positions available in our Fragrance, closely related scientific function (e.g. QA, QC,
Hair Care, Innovation, and Productivity departments. We are also research, etc.) related to products similar to those
seeking Research Scientists, Engineers, Toxicologists, and Consumer of the company.
Science professionals. To apply, please send résumé and salary
Please visit our Career Website to find your next exciting career: requirements to:
www.avoncareers.com. gary.kokesh@churchdwight.com.
______________________________________________________________________________________________________ ________________________________________________________________________________
Received 12-30-09 Received 11-17-2009
 SENIOR CHEMIST – PERSONAL CARE  MARKETING SPECIALIST – COSMETIC ACTIVES
NEWAYS INC., located in Salem, Utah, is seeking a Personal EMD CHEMICALS is looking for a Marketing
Care Chemist. Specialist.
Responsibilities include: Performing a variety of duties to bring Responsibilities include: Coordinating and managing
new technology and innovation to the formulation of new products all cosmetic and biological actives sales collateral,
and in the maintenance of current products; reviewing current including drafting global brochures and conversion of
products, formulas, and processes for regulatory compliance, GMP product technical presentations to short presentations;
compliance, and technical updates; formulating products; developing designing, scheduling, and executing product training for
methods and procedures; and leading projects. distributors; designing, managing, and maintaining CRM and
Requirements include: A B.S. in Chemistry or Biology; and at off-line Excel databases; presenting technical product data;
least ten years experience in a personal care product development and coordinating and participating in lab-scale preparation and
environment. filling of finished product samples for use at trade shows.
Please send résumé and contact information to: Requirements include a B.S. in Chemistry, Biology, or
employment@neways.com. Marketing and 3-5 years experience in a laboratory position with
______________________________________________________________________________________________________ a cosmetic customer, ingredient supplier, or direct customer role.
Received 12-29-09 Experience with CRM systems, knowledge of the cosmetic
 REGULATORY AFFAIRS SPECIALIST industry, and bench-level cosmetic formulating is preferred.
CHURCH & DWIGHT has an opening for a Regulatory Affairs Send résumé to:
Specialist at their Princeton, NJ headquarters. lita.tatum@emdchemicals.com.
Responsibilities include: Maintaining up-to-date knowledge of

Upcoming 2010 SCC Events Calendar


• For updated NYSCC information, visit us on the web at: www.nyscc.org
• For National SCC information: www.scconline.org
April 21 NYSCC Spring Seminar, Pleasantdale Château, West Orange, NJ
May 11 Suppliers’ Day, Raritan Center, Edison, NJ
July 30 NYSCC Golf Outing, Crystal Springs, Hamburg, NJ
September 15 Chapter Meeting, The Manor, West Orange, NJ
September 23 Culinary Event, TBD
October 6 Chapter Meeting, Seasons Westwood, Washington Township, NJ
October 20 Cosmetic Technology Transfer Conference, Woodbridge Hilton, Woodbridge, NJ

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January 6th NYSCC Chapter Meeting


Bridgewater Manor • Bridgewater, New Jersey

March 2010