| USP 797 Vendors
Architects
Bernstein
& Associates, Architects
- Architecture firm Specializing in Healthcare and lab
design with a subspecialty in USP 797 consulting, USP
797 compliance action plans, and USP 797 architectural
and engineering plans.
Bernstein & Assoc., Architects, PLLC
59 West 19th Street - 6A,
New York, NY 10011
Ph : 212-463-8200 / Fx : 212-463-9898 /
info@bernarch.com
www.bernarch.com
Analytical Testing
Aemtek, Inc. -
Aemtek was
founded and is operated by dedicated Ph.D. mycologists and
microbiologists. We share our passion for and commitment
to the advancement of microbial science and technologies.
Coming from an academic research background, we are
accustomed to laboratory bench work, problem solving,
in-depth investigation, critical reading of references,
and data gathering and analysis. Because of our life-long
interests in microorganisms, we feel extremely fortunate
to be paid for doing what we truly enjoy. Being able to
contribute to the industry and help our clients adds even
more to our career satisfaction.
We
provide laboratory testing services and product
development in the fields of applied and environmental
microbiology. Our analysts combine academic expertise with
advanced analytical techniques to generate scientifically
sound and legally defensible data for our clients. Each
project is treated with technical expertise, and every
sample is analyzed with utmost care.
Aemtek, Inc.
46309 Warm Springs Blvd., Fremont, CA 94539
Ph: 510-979-1979 / Fx: 510-668-1980 /
info@aemtek.com
www.aemtek.com
Aerobiology Laboratory Associates
-
Aerobiology Laboratory Associates is a full service AIHA
EMLAP accredited environmental microbiology laboratory
with locations in Washington, DC area, Atlanta, Georgia,
and Denver, Colorado. It was founded by Suzanne Blevins
in 1997 and supported by an excellent, dedicated staff of
advanced degreed bacteriologists and mycologists. Suzanne
can be contacted to consult on USP 797 sampling
implementation and laboratory support.
suzanne@aerobiology.net
Aerobiology Laboratory Associates focus has remained
constant: dedication to the highest quality scientific
standards and a passion for our clients. At Aerobiology
Laboratory Associates, our success is measured by the
success of our customers; therefore, we are dedicated to
quality service, quick and accurate delivery of results
and consultative support by experienced experts.
Our experienced staff is available 24 hours to offer
assistance.
Aerobiology Laboratory Associates, Inc.
43760 Trade Center Place, Dulles, VA. 20166
Ph: 877 648 9150 / Fx: 703 648 3919
suzanne@aerobiology.net
Burgh & Schoenenberger Associates, Inc.:
Since 1972, Schoenenberger
Associates Certification, Inc. has been offering leading
service in airflow testing, repairs, and decontamination
procedures for laminar flow hoods, biosafety cabinets,
clean rooms, glove boxes, Biosafety Level 3 (BSL3)
environments, animal cages, barrier isolators, fume hoods,
ceiling units, scrubbers, and incubators. To obtain USP
<797> compliance we determine total particle counts in
addition to offering viable particle sampling and
environmental monitoring. We provide our services to an
assortment of facilities including pharmacies, drug
manufacturers and re-packagers, hospitals, research
facilities, crime labs, hematology and oncology clinics,
animal facilities, doctors’ offices, and industrial
applications. Our highly qualified staff includes NSF and
IAFCA accredited technicians who adhere to the highest
standards of customer service. If you're looking for a
company who will deliver friendly, timely, affordable and
accurate service, please contact us.
Schoenenberger Associates Certification, Inc.
7070 Telephone Road, Pavilion, NY 14525
Ph: 585-584-3768/ Fax: 585-584-3322/ email:
certifications@burghschoenenberger.com
www.burghschoenenberger.com
EDLab:
The
Environmental Diagnostics Laboratory (EDLab) at Pure Air
Control Services (PACS) offers complete and
comprehensive environmental microbiological analytical
testing which include: microbiology, aerobiology,
allergen assays and microscopy designed to meet all your
indoor air needs. We serve all 50 states as well as
international clientele. The EDLab supports IEQ
investigations by assisting with strategic sampling plan
development and supplying media collection equipment
while performing a wide range of environmental
analyses. EDLab has analyzed over 100,000 samples since
1992. All of our analysts hold college degrees and
participate in ongoing, industry-leading quality
assurance and training programs. EDLab at Pure Air
Control Services (EMLAP# 102795) is an American
Industrial Hygiene Association Accredited ISO/IEC 17025
compliant Environmental Microbiology Laboratory. It
maintains proficiency both internal and external (third
party) proficiency testing.
EDLab –
Environmental Diagnostics Laboratory
4911 Creekside Dr., Clearwater, FL. 33760
Ph : 800-422-7873 ext 802 / Fx: 1727-572-5859 / email:
iaq@pureaircontrols.com
www.EDLab.org
EM Lab P&K
- EMLab P&K is a privately held corporation with over 40
service and drop-off locations throughout the United
States. We specialize in analyzing air and surface
samples for fungi, asbestos, and bacteria. EMLab P&K has
helped pioneer today’s IAQ industry by developing the
tools for precise data interpretation, including
MoldRange™ and MoldScore™. All of our analysts hold
college degrees and participate in ongoing,
industry-leading quality assurance and training
programs. Most have advanced degrees and are certified
by the Pan American Aerobiology Certification Board (PAACB).
We are committed to providing our customers with
outstanding service, quality, and support.
EMLab P&K
1150 Bayhill Dr., Suite 100
San Bruno, CA 94066
Ph : 866-888-6653 / Fx: 650-829-5852 /
info@emlabpk.com
www.EMLabPK.com
EMSL Analytical Inc.
-
EMSL Analytical Inc. is a
nationwide network of 25 laboratories established in
1981 that provides sampling products and analysis to the
pharmaceutical industry. Our Products Division offers
bacterial air sampling equipment, particle counters,
settle plates, and temperature/relative humidity
meters. Our Laboratory Services Division offers
Endotoxin Testing, Microbial Limits Testing, Bacterial
and Fungal Testing and identification, Particulate
Matter Testing, and chemical contaminant identification
following USP methods and monographs. We are ISO 17025
compliant and are AIHA EMLAP accredited. Our Materials
Lab is FDA/GMP complaint. Our Microbiology and Organic
Chemistry Labs are pursuing advanced accreditation in
the form of FDA/GMP. For more information please
contact:
EMSL Analytical Inc.
107 Haddon Ave.
Westmont, NJ 08018
800-220-3675
www.emsl.com
PathCon Laboratories - Pathcon
provides custom sampling protocols, microbiological
sampling media, air sampler rental, microbial counts and
identifications, and data interpretation to assist
pharmaceutical compounding facilities in evaluating
microbial bioburden as described in USP 797.
PathCon Laboratories offers microbiological laboratory
and consulting services in air quality issues. We
analyze air, water, and environmental samples for fungi,
bacteria, and other microbes, including Legionella,
Mycobacterium and Norovirus. For rapid turnaround,
PathCon offers custom assays using
Express ID™.
Since 1986, PathCon has been an industry leader in
indoor air microbiology with an outstanding and proven
track record and long-standing clients. PathCon
Laboratories is accredited by the American Industrial
Hygiene Association (AIHA) in the EMLAP program for
culturable fungi and bacteria from air, bulk and surface
samples. AIHA accreditation complies with ISO/IEC
Standard 17025 requirements.
PathCon Laboratories
270 Scientific Drive, Suite 3 Norcross, GA 30092
Ph : (770) 446-0540 or 1-866-PathCon
www.pathcon.com
Cleanroom
Products / Contamination Control
Acute Care
Pharmaceuticals
recently introduced their Pharma®
Brand line of USP<797> Compliant Cleanroom Disposables.
Acute Care provides unparalleled convenience by offering
Pharma® Brand Product Availability and GPO Contract
Pricing through AmerisourceBergen, Cardinal and
McKesson. For Pharma® Brand product descriptions and
Wholesaler Item Numbers,
click here. Contact
Acute Care to receive your GPO Contract Pricing.
Email
797@acutecareonline.com
for FREE electronic copies of Pharma® Brand Product Fact
Sheets. When you are searching for sterile alcohol,
wipers, mop covers, cleaning solutions, tacky mats,
cleanroom apparel, test kits or other USP<797> items, our
mission is to be your trusted, sole source for USP<797>
Compliant Cleanroom Disposables.
Acute
Care Pharmaceuticals
12225 World Trade Drive - Suite F, San Diego, CA 92128
Ph : 888-909-7700 / Fx : 858-675-9380 /
797@acutecareonline.com
www.acutecareonline.com
Attentus Medical Sales, Inc.
–
Wholesale distributor of cleanroom, medical and packaging
products specializing in the Home Infusion and Pharmacy
Markets. We stock an array of products that will assist
your organization in achieving USP <797> Compliance
Standards. These products include dry and pre-saturated
low lint wipers, sterile and non-sterile IPA, mops,
contamination control tacky mats, shoe covers, masks,
disposable isolation gowns and lab coats, gloves, bouffant
caps, and cleaning solutions to name a few. Call us to
set up an account. Mention you saw us on this website and
receive 5% off your first order.
Attentus
Medical Sales, Inc.
Headquartered in Houston, Texas
Ph : 866-456-3929 /
jjodway@attentusmedical.com
www.attentusmedical.com
Berkshire Corporation
- Berkshire is the global leader in the engineering and
manufacturing of contamination control products for
cleanrooms and critical environments worldwide. Global
technical specialists assess specific process needs and
bring qualified solutions to the most critical
application. We bring the products, the knowledge and
the integrity critical to your success.
Berkshire Corporation
21 River Street Great Barrington Massachusetts 01230
Ph : 800.242.7000 / Fx : 336.446.0156 / E-mail:
csr@berkshire.com
www.berkshire.com
Blue Thunder Technologies, Inc.
- is a manufacturer of wiping products for use in Class
1 cleanrooms and higher. These wipes are extremely low
in particle generation, and non-volatile residue.
Virtually any size, shape, and packaging is available.
These wiping products are made from highly engineered
fabrics that include, nonwovens, interlocking
monofilament knits, and mercerized cotton. Blue Thunder
Technologies also provides custom made products, and a
complete list of consumable items used in any clean
environment. Blue Thunder Technologies also provides a
suggested items list to help achieve USP 797 Compliance
and an optional Starter Kit.
Blue Thunder Technologies, Inc.
11B Pasco Dr, East Windsor, CT 06088
Ph : 860-370-9828 / Fx : 860-627-8370 /
info@bluethundertechnologies.com
www.bluethundertechnologies.com
Cleanroom Supply
Connection.com -
Distributor of cleanroom supplies, sterile cleanroom
supplies and USP 797 supplies from brand names including
DuPont, Kimberly Clark, Veltek Associates, QRP Gloves,
CT International, Cardinal, Micronova as well as other
reputable cleanroom supply manufacturers. We offer a
hand picked selection of disposable and launderable
cleanroom coveralls, hoods, shoe covers and face masks.
We also offer lintless cleanroom wipers, gloves, paper,
swabs, finger cots, anti-microbial tacky floor mats,
tacky roller mops and everything else you need to keep
your Class 1 – Class 10,000 cleanroom in top shape. Our
customers include the nation’s most well respected
pharmaceutical, electronics, medical,
educational,biotechnology & research facilities. Special
pricing agreements granted for large volume orders.
Charlotte Safety | CleanroomSupplyConnection.com
116 Franklin Blvd – Long Beach NY 11561
Ph : 516-596-8781 / Fx : 516-596–8619 Email /
Sales@CleanroomSupplyConnection.com
www.CleanroomSupplyConnection.com
Connecticut Clean Room Corporation
-
Connecticut Clean Room Corporation offers special
products that meet all
critical manufacturing, industrial and sanitary
standards. CCRC is your single source for all of your
USP 797 products including mats, mops, buckets, mopping
systems, wipers, cleaning agents, gloves and apparel. We
also manufacture PolyTack Entrance Mats and Roll Mops
and convert nonwoven material into wipers of all sizes.
CCRC is a master distributor for: Roll-O-Matic®,
Rubbermaid®, Perfex, Kimberly Clark, Contec, Milliken,
ITW Texwipe, Micronova and many more. Our Customer Care
Team has over 30 years of industry experience and is
here to assist you in finding the right product for the
right application. Manufacturing, converting and
distributing critical products since 1979.
Connecticut Clean Room Corporation
Bristol, CT
www.ctcleanroom.com
Contec, Inc.
- Contec, Inc. has over 20 years of experience providing
simple solutions for complex problems of contamination
and infection control in critical environments,
including pharmaceutical and hospital cleanrooms. Our
expert technical support team will advise you on a
complete cleaning and disinfection program for your
sterile and non-sterile environments. Contec’s product
line includes specialty wipes, sterile alcohol, mopping
systems, isolator cleaning tools, disinfectants and
swabs, available in a wide variety of formats that meet
the requirements of USP <797>. Contec is committed to
providing total customer satisfaction through developing
and manufacturing innovative cleaning and contamination
control products which exceed the expectations of our
clients.
Contec,
Inc.
525 Locust Grove, Spartanburg SC 29303
Ph: 864-503-8333, 1-800-289-5762
www.contecinc.com
CT
International
– has been a
leading manufacturer of high quality latex and non-latex
gloves for over 20 years. One of the true vertically
integrated glove manufacturer’s in the market today, CT
International has recently been awarded the ISO 14001, ISO
17025, and ISO 13485 to go along with the ISO 9001
certification! We offer the USP797 Market the finest
assortment of nitrile and latex gloves available today. We
also provide shoe covers, bouffant caps, and beard covers
as well as Cleanroom paper.
CT International
4340 Old Santa Fe Rd. , San Luis Obispo, Ca
93401
Ph : 800-755-7575 /
sburr@ctint.org
and
juhran@ctint.org
www.ctint.org
Decon Labs Inc.
- is the market leading manufacturer/supplier of
disinfectants and cleaners made specifically for
cleanrooms and compounding areas. Our wide range of
sterile alcohol, sterile disinfectants, antimicrobial
handcare products, pre-sat wipes, and cleaners will help
you achieve USP 797 compliance. Our national
distribution network makes our products readily
available in local proximity to your compounding
facilities. Decon’s trained staff will help you choose
the proper product for your application making
contamination control simple and easy. Call us or visit
our website (www.deconlabs.com)
to find out how we can help you
Decon
Laboratories, Inc.
460 Glennie Circle,
King of
Prussia, PA 19406
Ph : 610-755-0800 /
Contact:
Mike Dunne
mdunne@deconlabs.com
www.deconlabs.com.
Dycem's CleanZone
- Dycem's CleanZone, Contamination Control floor mats,
provide a simple, highly effective, low cost solution,
designed specifically to meet your concerns about foot
and wheelborne contamination (particulate and bacteria)
in your Critical Environment, Compounding Pharmacy,
Sterile and Aseptic areas to comply with USP 797
requirements. The CleanZone mats will remove 99% of all
viable and non-viable particulates, bio-burden levels
will be reduced and cross contamination can be
eliminated by simply placing the floor mats in your
personnel and cart traffic areas at critical entrances
and exits. Full 3 Year Warranty.
.Dycem's Protectamat - loose laid contamination
control/anti-fatigue mat will remove and hold
particulate and bacteria from foot traffic. The thick,
cushioned polymer Protectamat is ideal for placing in
front of Chemo Hoods, Isolators and Laminar Flow Hoods.
All Dycem Mat products are maintained using your
approved disinfectants and established SOP's.
Dycem Ltd.
83 Gilbane Street, Warwick, RI 02886
Ph: 800-458-0060 / Fx: 401-739-9634 /
info@dycemusa.com
www.dycem.com
FHP LP
- FHP LP is a world-wide leading manufacturer of
innovative cleaning and disinfecting tools within
controlled and professional environments. The brand
new Advanced Technology portfolio includes four, six,
seven and twelve foot Stainless Steel and Aluminum
Extendable Roll-O-Matic® handle options for hard to reach
walls and ceilings. The new Aluminum Extendable Roll-O-Matic®
Mop handles are ergonomic, color coded, lightweight, and
fully autoclaveable. This mop is offered in a straight or
angled head to ensure versatility and flexibility for
various cleaning applications.
The
new Advanced Technology Roll-O-Matic® Refills are fully
autoclaveable, individually packaged, lot traceable and
resistant to common disinfectants. Four refill styles are
offered for use in Absorbing Spills, Applying
Disinfectant, and Deep Cleaning for floors, walls and
ceilings.
Advanced Technology products are manufactured in the
U.S.A. and distributed world-wide. Do not settle for
substitutes. Request FHP Roll-O-Matic® products by name!
FHP
505 N. Railroad Ave.
Northlake, IL 60164
Phone: 708-452-4100 / email:
salesce@fhp-ww.com
www.rollomatic.com
Lymtech Scientific -
is a
manufacturer and global provider of a complete line of
cleanroom wipers and disposable contamination control
products. Our cleanroom wiper products are a specialized
economic solution allowing flexibility to optimize and
customize to your exact specifications.
Industrial
Wipes, C-Wipes, Purity Wipes, Extreme Clean Wipes,
Specialty Wipes, LymSat PreSaturated Wipes, Gamma
Irradiated Wipes, Validated Sterile Wipes, LymWrite
Cleanroom Paper, Swabs &Applicators, Custom Roll Goods,
Wall &Ceiling Mopping Systems.
Lymtech’s
cleanroom wiper products are Dry or PreSaturated,
Lint-Free, Non-Woven or Knitted, Knife Edge Cut or Laser
Sealed Edge, Durable, Fast Absorbing, Perforated or
Non-Perforated, Non-Abrasive, and Exceptionally Strong
with Superior Wet Strength. Lymtech is truly your partner
to reduce total supply chain costs with unparalleled
capabilities such as customization, contract converting,
specialty products, business flexibility, price stability,
managed in-stock inventories, quick response and
controlled lead-times. Our experienced team of Global
Sales Managers and Customer Service Staff provide
specialized solutions, training, and technical support for
product compliance to meet with today’s demanding end-user
requirements.
Ask about
our new Fully Compliant USP 797 Start-Up Cleaning Kit.
Lymtech
Scientific
60 Depot Street, PO Box 157, Chicopee, MA 01014
Ph : 800-628-8606
www.lymtech.com
Micronova Manufacturing Inc. -
was established in Torrance, California in 1984.
Recognizing the need for tools to address critical
cleaning in aerospace and military installations, the
company developed a range of cleanroom mops, wipers and
detergents to serve the emerging cleanroom industry. With
its CR100PC tape, the company was the first to develop
specially processed cleanroom tape for controlled
environments. In recent years the company has broadened
its product range to meet the needs of pharmaceutical and
biotechnology sites as well as research facilities and
compounding pharmacies. Standard-line products include the
touch-free dispenser with a comprehensive range of soaps
and lotions, cleanroom mops and corresponding hardware,
cleanroom tape, sponges and wipes, and detergents and
cleaners. All manufacturing is carried out at the Torrance
facility and Micronova's products are distributed and sold
into cleanroom facilities worldwide.
Micronova
Manufacturing Inc.
3431 W. Lomita Boulevard, Torrance, CA 90505-5010
Ph : (310) 784-6990 / Fx : (310) 784-6980 / email :
info@micronova-mfg.com
www.micronova-mfg.com
Techniglove International
- is a
leading manufacture and supplier of Cleanroom Nitrile
Gloves to the Semiconductor, Electronic, Pharmaceutical
and USP 797 Market. Our products include Class 10, Class
100 and Class 1000 Nitrile gloves. In addition we offer
the USP 797 Market a Sterile Class 100 Nitrile pair pack,
one pair per wallet. This ambidextrous glove is offered in
6 sizes and provides the comfort, fit and feel of nitrile
with a significant cost savings over hand specific
versions. For the non-sterile user we offer a Class 100
nitrile glove packed in our exclusive PVC dispenser box
for Cleanroom use. All Techniglove products are available
thru our network of distributors and should you need
samples or technical information you can email Techniglove
at customer-service@techniglove.com
Techniglove International
1280 Graphite Drive,
Corona, CA.
92881
Ph : 951-582-0890 /
Carl@Techniglove.com
www.techniglove.com
Cleanroom Design/Build Companies:
Clean Room Technologies, Corp.
–
Clean Room Technologies, Corp is a growing service
company. These services include the sale and installation
of clean rooms for the Pharmaceutical and Biotechnological
industries. It also includes the installation of rigid
vinyl sheets for clean room environment such as Rap Wall,
FRP and Kydex.
Clean Room Technologies, Corp will offer skilled and
trained technical personnel, who are fully certified to
install all types of heated welded floor, wall and ceiling
systems. Our technical background will help to identify
potential opportunities and/or milestones ahead of the
installation phases in order to minimize excessive
designs, installation change orders, installation costs
and maximizing the job quality.
Clean Room
Technologies, Corp.
PMB 330,
425 Carr. 693, Dorado PR, 00646
Ph :
787-403-1956 / Fx :787-269-1557
www.crt-pr.com
Connecticut Clean Room Corporation
-
Connecticut Clean Room Corporation offers special
products that meet all
critical manufacturing, industrial and sanitary
standards. CCRC is your single source for all of your
USP 797 products including mats, mops, buckets, mopping
systems, wipers, cleaning agents, gloves and apparel. We
also manufacture PolyTack Entrance Mats and Roll Mops
and convert nonwoven material into wipers of all sizes.
CCRC is a master distributor for: Roll-O-Matic®,
Rubbermaid®, Perfex, Kimberly Clark, Contec, Milliken,
ITW Texwipe, Micronova and many more. Our Customer Care
Team has over 30 years of industry experience and is
here to assist you in finding the right product for the
right application. Manufacturing, converting and
distributing critical products since 1979.
Connecticut Clean Room Corporation
Bristol, CT
www.ctcleanroom.com
TAC Americas
-
TAC
Americas is a full service design/build company for
precision controlled cleanrooms and laboratories.
With more than 20 years of experience, TAC offers
clients a turn-key solution by providing
the design-engineering, construction, certification, and
service for ISO 1 through ISO 8 pharmacy cleanrooms.
From concept through validation, our team of experts
minimizes customers' overall project risk by delivering
projects that are validatable, on-time, and guaranteed
to meet the performance criteria of USP <797> -- all
within budget. For more information, please
contact Thomas Perazzo at the information listed below,
or visit our website
www.tac.com/pe.
TAC
Americas
1770 Mason
Morrow Rd.
Lebanon,
OH 45036
TCA -
TCA, Inc consults, designs, builds and installs
modular acrylic and aluminum cleanrooms for medical
applications.
TCA also
manufactures a portable, affordable fiberglass T-MOD and
T-POD for smaller volume pharmacies or satellites.
We are the only cleanroom company to guarantee our
cleanrooms in writing to meet USP <797> standards and
offer an extended
warranty
for your peace of mind.
TCA, Inc.
131 12th St. SW
Loveland, CO 80537
Phone: 970.203.0516 / Fax: 970.461.1388 / Email:
info@travisca.com
www.travisca.com
Compliance
Action Plans
Clinical
IQ, LLC -
Clinical
IQ, LLC aims to serve as the trusted source for
pharmacy information services and product solutions for
all our customers who range from local start-up
operations to established national companies in the
hospital, home care, and specialty compounding
industries. With this aim, Clinical IQ creates
software, classroom training, web based training, audit
tools, and many
other informational products to make sterile
compounding and related areas of pharmacy safer. Our
mission is about improving patient safety through
better standards-setting in sterile compounding and
other practice areas is not our only goal, though it is
the highest goal. Another goal is to improve the
professional life of
pharmacists and technicians as we carry out our craft
with the comforting knowledge of reduced probability of
causing harm. You see, Clinical IQ and our partners are
practitioners. We have real on-the-floor experience. We
are aware of how the rigors and pressures of daily work
and work habits impact quality beyond textbook
formulas. Clinical IQ and our partners are on a mission
to change pharmacy for the better and our work is never
done. We hope you will join us.
Clinical IQ, LLC
184 Columbia Turnpike, #282, Florham Park, NJ 07932
Ph : 973-765-9393 / Fx : 866-538-4783 /
moreinfo@clinicaliq.com
/
www.clinicaliq.com
Global Quality Alliance, LLC
-
GQA
is able to provide Compounding Pharmacies with services
such as Gap Assessment of current facilities, procedures
and systems with respect to <797> and all other USP
requirements, create or update procedures required for
compliance to <797>, assess the USP Risk Levels for
current products, and provide on-site training for staff
members on aseptic technique, environmental monitoring
and other USP <797> requirements. Whether you are
looking to become PCAB accredited, or simply desire to
improve quality and compliance to offer greater
assurance of patient safety, GQAs extensive experience
in the pharmaceutical industry has provided an excellent
evolution into the sterile compounding industry where we
continue to provide expert service and advice.
Global
Quality Alliance, LLC
300 Center Drive, Suite G, #310, Superior, Colorado 80027
In Colorado Ph: 303-459-2382 /
Outside
Colorado Ph : 866-216-2815 /
Fx :
Fax: 303-459-2382 /
info@gqaconsulting.com
www.gqaconsulting.com
Lasco
Services
- We’ll
evaluate your space to design a new clean environment or
renovate your existing compounding area. All work is done
quickly, with minimal disturbance, with less expense than
you might think and USP <797> compliant...guaranteed.
Learn how Lasco Services can make it easy for you to be
USP <797> compliant.
Lasco
Services
601 Compton Irving, TX. 75061
Ph : 800-815-2726 / Fx : 972-513-1877 /
info@lascoservices.com
www.lascoservices.com
Quality Solutions, LLC
- is a turn-key solutions provider offering USP 797
compliance in a cost-effective manner. Drawing from its
compliance, validation and technical services background
in the highly regulated Biotech/Pharma industry, Quality
Solutions, LLC can assist your pharmacy in performing a
GAP analysis, assess risk levels, create the supporting
Quality Assurance plans, and execute all required
testing. Furthermore, all HEPA and Laminar Flow
Certifications are conducted using NSF certified
engineers.
Quality Solutions, LLC
Baltimore, MD 21286
Phone : 443-416-6102 / Fx: 410-823-5226 /
Usp797@qualsolve.net
www.qualsolve.net
RJ Lee Group, Inc.
offers a wide variety of USP 797 compliance and consulting
services with the understanding that each institution may
face unique challenges when working toward compliance.
Our scientific and technical staff coupled with consulting
pharmacists offers years of experience with USP
797 related projects to help you formulate a compliance
action plan that will fit your individual needs and
budget.
RJ Lee
Group, Inc.
350 Fifth Avenue, Suite 5820 New York, New York 10118
Ph :
212-613-2700 / Fx: 212-613-2701 / email:
info@rjlg.com
www.rjlg.com
Contamination Control
Building Remediation Sciences -
Provides a complete topical disinfecting, mold
remediation, HVAC System cleaning, chamber cleaning,
contents cleaning program to help you achieve USP 797
compliance. Treated buildings are monitored with an
optional indoor air quality maintenance agreement to
ensure a healthy indoor environment for the future.
Treated buildings can be monitored with an optional indoor
air quality maintenance agreement to ensure a healthy
environment for the future. As an industry leader,
Building Remediation Sciences with over 600 million square
feet of building experience provides professional
remediation services for healthcare, pharmaceutical,
commercial, industrial and institutional facilities. These
services are performed under USP 797 compliance and under
the direction of an Industrial Hygienist, Building
Scientist, Environmental Chemist, Microbiologist and/or
CIAQP's.
Building Remediation Sciences
4911 Creekside Dr., Clearwater, FL. 33760
Ph : 800-422-7873 ext 802 / Fx: 1727-572-5859 / email:
iaq@pureaircontrols.com
www.brsciences.com
Environmental Monitoring
AES-Chemunex, Inc. -
Achieve USP <797> compliance with Sampl’air – this ISO
14698 Validated air sampler provides optimal collection
efficiency for microorganisms. Sampl’air provides fast
and accurate, active microbial air sampling. This is
critical for quality assurance, especially for
pharmaceuticals, personal care products and companies
that need to comply with USP <797> regulations. You can
have complete confidence in the results because the International
Organization for Standardization (ISO) (Health
Protection Agency) recently tested our Sampl’air™ Lite
model and gave it ISO 14698 Validation. “The Sampl’air
Lite sampler was found to be efficient (115.9-138.5%)
for collecting particles containing bacterial cells in
the size range of 2.5-12.5 microns compared to membrane
filters.” (ISO HPA 2007) Efficiencies were 60.5-66.2%
for lower particle sizes of 0.8-1.3 microns. This
suggests the d50 is 0.5 microns. (d50 is the particle
diameter at which sampler efficiency drops below 50%).
“The percentage of microbiological particles found in
indoor environments at this particle size is very low
and therefore this sampler should be capable of
collecting over 99% of particles occurring in this
environment.” Whyte et al 2007, ISO HPA 2007.
View our
FREE Air Sampling Webinars on
www.aeschemunex.com.
Learn more about Sampl’air on
www.samplair.com.
AES-Chemunex,
Inc.
301 North Harrison St., Suite 109, Princeton, NJ 08540
Ph: 609-497-0166 /
p.yvon@us.aeschemunex.com
www.aeschemunex.com
Biotest - To
meet <797> requirements, Biotest offers a complete
solution for both active air sampling and total particle
count evaluations. The RCS High Flow microbial air
sampler, APC handheld airborne particle counter, and
contact slides for surface sampling are simple and
reliable for compliance. Our environmental monitoring
system is validated and supported by an experienced
staff and comprehensive microbiology lab to cover all
<797> contamination control and needs.
Biotest Diagnostics Corporation
400 Commons Way, Suite F / Rockaway, NJ / 07866
Ph: 800.522,0090 / Fx: 973.625.9454 /
CustomerService@BiotestUSA.com
www.BiotestUSA.com
Building Health Check/Pure Air Control Services, Inc.
- The scientists at Building Health Check (BHC, LLC)
have the experience of evaluating over 10,000 facilities
covering over 600 million square feet of indoor building
environments. We serve the healthcare and
pharmaceutical industry with a subspecialty in USP 797
compliance. The scientific and technical staff at BHC,
LLC has extensive experience providing affordable,
microbial environmental monitoring for pharmacies in the
hospital, home care, and research facilities. Our USP
797 environmental monitoring services can include
program design, environmental sampling (both a-biogenic
and biogenic), data interpretation and management, along
with recommendations for corrective actions.
Pure Air
Control Services, Inc.
4911 Creekside Dr., Clearwater, FL. 33760
Ph: 800-422-7873 ext 802 / Fx: 1727-572-5859 / email:
iaq@pureaircontrols.com·
www.pureaircontrols.com
Controlled Environment Testing
Association
- The Controlled Environment
Testing Association (CETA) is devoted to promoting and
developing quality assurance within the controlled
environment testing industry.
Controlled Environment Testing
Association
1500
Sunday Drive, Suite 102, Raleigh, NC 27607
Ph: 919-861-5576 / Fx : 919-787-4916 /
info@cetainternational.org
www.cetainternational.org
ENV
Services, Inc. -
ENV Services, Inc. is the nationwide pioneer in the
Calibration, Certification, and Decontamination of
Controlled Containment Equipment, and Facilities. Today
ENV continues to be the recognized leader in providing
these services to the pharmaceutical, biotechnology,
chemical, academic, healthcare, aerospace, defense,
validation, medical device, food, packaging, and various
other service industries. Our USP <797> services
including viable samples, certification for rooms and
equipment are preformed by a staff that includes NSF
Biosafety Cabinet Certifiers, and a Clean Room Supervisor
that is NEBB certified. We are an ISO 17025 Accredited
company that is committed to providing the highest levels
of customer service, attention to detail, and quality to
help you keep your products and business moving, no matter
where you are located in the USA.
ENV
Services, Inc.
Corporate: 2880 Bergey Rd, Suite K Hatfield, PA 19440
Ph: 1-800-345-6094 / Fax: 215-997-5088 / email:
info@envservices.com
www.envservices.com
Lighthouse Worldwide Solutions -
Lighthouse particle counters and facility monitoring
systems process data recorded to meet requirements of
regulatory agencies such as USP 797 and 21 CFR Part 11 in
manufacturing of aseptic products. Contamination
compromises product integrity in the aseptic manufacture
of pharmaceuticals and medical devices. International
regulatory organizations require particle counting and a
comprehensive environmental monitoring program. Portable
and fixed particle sensors are used for an effective
environmental monitoring programs. Visit
www.golighthouse.com for
a complete line of products and services for air, liquid,
and gas applications.
Lighthouse Worldwide Solutions
46501 Landing Parkway, Fremont, CA 94538
Ph: 510.438.0500 / Fx: 510.438.3840 /
info@golighthouse.com
http://www.golighthouse.com/products-pharmaceutical.asp
RJ Lee
Group, Inc’s
scientific
and technical staff has extensive experience providing
affordable, worry-free USP 797 microbial environmental
monitoring for pharmacies in the hospital, home care, and
research settings. Our USP 797 environmental monitoring
services include program design, microbial environmental
sampling, data interpretation and management, and
recommendations for corrective actions. We also provide
monitoring for hazardous drugs (anti-neoplastics) on
environmental surfaces.
RJ Lee
Group, Inc.
350 Fifth Avenue, Suite 5820 New York, New York 10118
Ph :
212-613-2700 / Fx: 212-613-2701 / email:
info@rjlg.com
www.rjlg.com
Technical Safety Services, Inc.
- TSS
is your single source service provider specializing in
USP<797> compliance. From environmental monitoring to
complete cleanroom testing and ongoing certification, our
knowledgeable staff of engineers and technicians will make
USP<797> compliance simple. With over 38 years of
experience and nationwide locations to serve you, TSS is
the only call you need to make. Let TSS focus on the
standards while you focus on the science - put the
nation's largest staff of NSF certified technicians to
work for you today.
Technical Safety Services, Inc.
Corporate Headquarters - 620 Hearst Avenue, Berkeley, CA
94710
Toll Free: 1.800.877.7742 / Fax: 510.845.5595 / Email:
customerservice@techsafety.com
www.techsafety.com
Equipment Planning
Equipment Planning, Inc.
: is NYC-based company that provides equipment planning
services to the hospital, healthcare and lab industries.
The company is owned and operated by experienced,
licensed, equipment planners.
Equipment Planning, Inc.
59 West 19th Street - 6A, New York, NY 10011
Ph : 212-463-0800 / Fx : 212-463-9898 /
info@equipmentplanning.org
www.equipmentplanning.org
Healthcare Design and Construction Resources:
Cardiology Business -
Cardiology Business is a comprehensive source for finding
products and services for designing, building, equipping, and
managing cardiology facilities. We offer insight into the
process and help selecting qualified experts in the field of
cardiology design.
What you will find on Cardiology Business: Cardiology Planning
Services, Facility Design Services, Facility Construction
Services, Cardiology Project Management Services, Cardiology
Products, Cardiology Equipment, Cardiology Suite Furniture and
Cardiology Software.
Cardiology
Business
59 West 19th St. - 6A, NY, NY 10011
Telephone : 212-463-0800
Fax: 212-463-9898
Email:
info@cardiologybusiness.org
www.cardiologybusiness.org
EnergyAudit.org
- is an authoritative source for information on the Energy
Audit. An Energy Audit is an analysis of a single building
or campus, which indicates how and where that building or
campus can reduce energy consumption and save energy
costs. An energy audit can be performed on any type of
building. This site --- Energy Audit.org --- is a
comprehensive resource for all information, news, products
and services related to an Energy Audit. On this site you
will find a comprehensive listing of all information on
Energy Audit news, Energy Audit products, Energy Audit
software, and Energy Audit vendors.
EnergyAudit.org
59 West 19th Street - 6A, New York, NY 10011
Ph : 212-463-0800 / Fx : 212-463-9898 /
info@energyaudit.org
www.energyaudit.org
Hospital
Safety
- This is the world's
most comprehensive Hospital Safety resource. What you will
find on HospitalSafety.com: Hospital Safety regulations,
Hospital Safety Vendors, Hospital Safety Products,
Hospital Safety Articles, Hospital Safety Software, and
How Safe is Your Hospital.
hospitalsafety.com
59 West 19th Street - 6A, New York, NY 10011
Ph : 212-463-0800 / Fx : 212-463-9898 /
info@hospitalsafety.org
HospitalSafety.org
WirelessLighting.com
- is a comprehensive resource for all information, news,
products and services related to Wireless Lighting. On
this site you will find a comprehensive listing of all
information on wireless and cordless lighting technology,
wireless and cordless lighting news, wireless and cordless
lighting products, and wireless and cordless lighting
vendors. Amongst the products covered:
Wireless or Cordless Lamps,
Wireless or Cordless Lighting,
Wireless or Cordless Table Lamps,
Wireless or Cordless Switches,
Wireless or Cordless Bulbs,
Wireless or Cordless Dimmers,
Wireless or Cordless Light Controls,
and
Wireless or Cordless Light Dimmers.
wirelesslighting.com
59 West 19th Street - 6A, New York, NY 10011
Ph : 212-463-0800 / Fx : 212-463-9898 /
info@wirelesslighting.com
www.wirelesslighting.com
Pharmacy Design:
is a
comprehensive new pharmacy website that is now online.
Pharmacy Design is a comprehensive source for pharmacy
owners, or managers, looking to upgrade their facility to
a state-of-the-art pharmacy environment.
Pharmacy Design offers facility managers, pharmacy
managers, pharmacy purchasing agents, and pharmacy owners
a comprehensive directory for all products and services
needed to design, build, equip, and manage a
state-of-the-art pharmacy.
What you fill find on Pharmacy Design: Pharmacy Planning
and Pharmacy Design Services, Pharmacy Construction
Service, Pharmacy Project Management Services, Pharmacy
Products, Pharmacy Equipment, Pharmacy Furniture, and
Pharmacy Software.
PharmacyDesign.org
59 West 19th Street - 6A, New York, NY 10011
Ph : 212-463-0800 / Fx : 212-463-9898 /
info@pharmacydesign.org
www.pharmacydesign.org
Safest
Hospital
-
SafestHospital.org is a privately-owned resource developed
to help increase safety in the design, construction and
operation of hospitals. It was founded to provide
information and resources related to the The Safest
Hospital Alliance, which was formed to combat the growing
epidemic of medical errors in hospitals by developing the
first comprehensive approach to patient safety. What you
will find on SafestHospital.org : Safest Hospital
regulations - Safest Hospital Vendors - Safest Hospital
Products - Safest Hospital Articles - Safest Hospital
software.
Safest Hospital
59 West 19th Street - 6A, New York, NY 10011
Ph : 212-463-0800 / Fx : 212-463-9898 /
info@safesthospital.org
www.safesthospital.org
rx3d.com
-
Rx3D is a comprehensive directory for all products and
services needed to design build and equip healthcare and
laboratory facilities.
What you will find on Rx3D: Healthcare and lab regulations
– Healthcare and lab vendors – Healthcare and lab products
– Healthcare and lab articles.
rx3d.com
59 West 19th Street - 6A, New York, NY 10011
Ph : 212-463-0800 / Fx : 212-463-9898 /
info@rx3d.com
www.rx3d.com
National USP 797 Testing Provider
Medical Technology Associates, Inc.-
Medical
Technology Associates, Inc. (MTA) offers a Single Source
USP 797 Clean room Compliancy Testing & Certification
Program. Our program is designed to be very cost
effective. Presently, we are under contract to
semi-annually certify all the clean rooms for numerous
national infusion companies. Our program is designed to
lower the customer’s cost of certifying their Clean Room,
while still providing a high quality and accuracy of
testing, a high quality written report with strong
documentation value, and a high level of over all service.
MTA is a
national, independent, third party healthcare compliancy
testing and equipment company whose certifiers and
consultants have been serving the healthcare community for
twenty five years. MTA’s expertise is in numerous
healthcare disciplines which includes Pharmacy clean rooms
and BSC certification. MTA is also a modular clean room
partner of TCA modular clean rooms and Front Line
Laboratory. We have regional offices located in Florida,
Texas, Arizona, and Kansas City. All of our certifiers are
strategically based throughout the United States, allowing
them the ability to comfortably service customers almost
anywhere within the United States.
Medical Technology Associates, Inc.
Ph : 727-535-3007 / Fx :
727-535-3049 /
ZachW@MTAIus.com
www.MTAIus.com
Pharmacy Staffing
Healthcare Consultants Pharmacy
Staffing
- Healthcare Consultants Pharmacy Staffing is one of the
fastest growing firms in the nation. We are the leading
placement service in the United States. HCC now serves
Florida, Georgia, Alabama, Tennessee, South Carolina and
North Carolina, Kentucky, Mississippi, Louisiana and
Texas.
Healthcare Consultants Pharmacy Staffing was established
in 1989. We specialize in placing Pharmacists and
Technicians (technicians in Florida only). HCC has a
consultant pharmacist on staff to assist with any
information you require. We carefully screen our personnel
and all of our pharmacists comply with HIPPA requirements.
Our state of the art computer matching and scheduling
allows us to find the right candidate with the right
capabilities. You can reach us 24 hours a day, 7 days a
week, 365 days per year. Our permanent placement service
recruits, screens and guarantees our personnel. Healthcare
Consultants Pharmacy Staffing requires that our
pharmacists maintain professional liability insurance.
Healthcare Consultants Pharmacy Staffing
P.O. Box 915726 Longwood, FL 32791
Ph :
800-642-1652 /
Fx : 800-439-4160 /
info@pharmacy-staffing.com
www.pharmacy-staffing.com
Project
Management
Empire Projects, Inc.
- Project management company serving the heathcare
industry, with a subspecialty in pharamacy design,
pharmacy construction and USP 797 compliance. Consulting
team includes architects, engineers, construction
managers and pharmacy operations consultants.
Empire Projects, Inc.
59 West 19th Street - 6A, New York, NY 10011
Ph : 212-463-0800 / Fx : 212-463-9898 /
info@EmpireProjects.com
www.EmpireProjects.com
Building Health Check, LLC
- The scientists at Building Health Check (BHC, LLC)
have the experience of evaluating over 10,000 facilities
covering over 600 million square feet of indoor building
environments. We serve the healthcare and
pharmaceutical industry with a subspecialty in USP 797
compliance. The scientific and technical staff at BHC,
LLC has extensive experience providing affordable,
microbial environmental monitoring for pharmacies in the
hospital, home care, and research facilities. Our USP
797 environmental monitoring services can include
program design, environmental sampling (both a-biogenic
and biogenic), data interpretation and management, along
with recommendations for corrective actions.
Building
Health Check, LLC
4911 Creekside Dr., Clearwater, FL. 33760
Ph : 800-422-7873 ext 802 / Fx: 1727-572-5859 / email:
iaq@pureaircontrols.com
·
www.buildinghealthcheck.com
Software
Simplifi
797
-
The first and only web-based system with integrated expert
rules of Eric S. Kastango, RPh, MBA, FASHP that simplifies
all of the ongoing quality requirements of USP Chapter
<797>. Simplifi 797 automatically keeps quality managers
aware of "who did what, when they did it, and when things
fall out of line" without active involvement. It also
provides expert guidance and resources on dealing with
exceptions. Simplifi 797 is the easiest and least
expensive way to implement an expert-based quality system
to meet USP 797 requirements. Each application is
customized to provide surveillance, benchmarking, and
review of quality systems specific to your pharmacy
compounding sites. Content and expert rules, including
expert-based, well-tested policies and procedures, are
provided and maintained by Eric S. Kastango, RPh, MBA,
FASHP.
Pharmacy OneSource, Inc.
3535 Factoria Blvd SE #440, Bellevue, WA 98006
Ph: 800-654-8395 / Fx: 608-829-7301 / e-mail
sales@pharmacyonesource.com
www.simplifi797.com
Testing & Certification
Certco, Inc.
- Certco, Inc., established in 1989, is a completely
independent firm specializing in certification of
cleanrooms and laboratory hoods. We can provide all
aspects of USP 797 compliance from protocol development,
training programs, viable and airborne particulate
monitoring, cleanroom and hood certification. We
have NSF accredited certifiers on staff, and our
technician's average over 12 years of hands on experience.
This experience can prove invaluable in rectifying
potential performance problems uncovered in the compliance
program. We can also assist in implementing an
internal monitoring program to provide cost-effective
ongoing compliance.
Certco,
Inc.
16 Upton Drive, Suite #1, Wilmington, MA 01887
Ph: 978-657-7777 / Fx: Fax 978-657-4111 / e-mail:
k.norwood@certco-us.com
www.certco-us.com
ENV Services, Inc. -
ENV Services, Inc. is the nationwide pioneer in the
Calibration, Certification, and Decontamination of
Controlled Containment Equipment, and Facilities. Today
ENV continues to be the recognized leader in providing
these services to the pharmaceutical, biotechnology,
chemical, academic, healthcare, aerospace, defense,
validation, medical device, food, packaging, and various
other service industries. Our USP <797> services
including viable samples, certification for rooms and
equipment are preformed by a staff that includes NSF
Biosafety Cabinet Certifiers, and a Clean Room Supervisor
that is NEBB certified. We are an ISO 17025 Accredited
company that is committed to providing the highest levels
of customer service, attention to detail, and quality to
help you keep your products and business moving, no matter
where you are located in the USA.
ENV
Services, Inc.
Corporate: 2880 Bergey Rd, Suite K Hatfield, PA 19440
Ph: 1-800-345-6094 / Fax: 215-997-5088 / email:
info@envservices.com
www.envservices.com
Pure Air Control Services, Inc.
- The
scientists at Building Health Check have studied over
10,000 facilities covering over 600 million square feet of
indoor building environments. We serve the design and
construction industries with a subspecialty in USP 797
compliance. The scientific and technical staff at Pure Air
Control Services has extensive experience providing
affordable, worry-free USP 797 microbial environmental
monitoring for pharmacies in the hospital, home care, and
research settings. Our USP 797 environmental monitoring
services include program design, microbial environmental
sampling, data interpretation and management, and
recommendations for corrective actions.
Pure Air Control Services, Inc.
4911 Creekside Dr., Clearwater, FL. 33760
Ph: 800-422-7873 ext 802 / Fx: 727-572-5859 / email:
iaq@pureaircontrols.com
www.pureaircontrols.com
Technical Safety Services, Inc.
- TSS
is your single source service provider specializing in
USP<797> compliance. From environmental monitoring to
complete cleanroom testing and ongoing certification, our
knowledgeable staff of engineers and technicians will make
USP<797> compliance simple. With over 38 years of
experience and nationwide locations to serve you, TSS is
the only call you need to make. Let TSS focus on the
standards while you focus on the science - put the
nation's largest staff of NSF certified technicians to
work for you today.
Technical Safety Services, Inc.
Corporate Headquarters - 620 Hearst Avenue, Berkeley, CA
94710
Toll Free: 1.800.877.7742 / Fax: 510.845.5595 / Email:
customerservice@techsafety.com
www.techsafety.com
Therapeutic Environments:
Therapeutic Environment which
can be found at
www.therapeutucenvironment.com is
an authoritative source for information on therapeutic
environments. Therapeutic Environment offers
administrators, clinicians, and patients a comprehensive
directory of all goods and services related to the
therapeutic environment.
Therapeutic Environment
59 West 19th Street - 6A, New York, NY 10011
Ph : 212-463-0800 / Fx : 212-463-9898 /
info@therapeuticenvironment.com
www.therapeuticenvironment.com
USP
797 Related Products:
CriticalPoint, LLC - offers a
series of interactive web based training for compounding
sterile preparation to assist in meeting your overall
quality assurance program. Some of the modules we offer
are Environmental Monitoring and Maintenance, Cleaning
and Disinfection, and the Principals of Primary and
Secondary Engineering Controls. The value of this type
of
training is in the confidence that you are receiving
quality information and every employee gets the same
consistent message with every lesson. With every one of
our modules, we use only the top industry leading experts
to write our courses. These experts not only talk about
these principals but have also put these practiced
principals to use while working in their own cleanroom
environments. Another major benefit of taking our online
courses is that you can take your training when and where
you want allowing you to continue to meet the daily
demands of your job while educating yourself.
CriticalPoint, LLC also offers a full line of project
management services to assist you in creating your own
line of web-based and software applications. With
more than 10 years of experience in creating pharmacy
based training and educational products for the Web, CD,
or Video/DVD, CriticalPoint, LLC can help your take your
idea and make them come alive.
CriticalPoint, LLC
12154 Darnestown Road, # 360, Gaithersburg, MD 20878
Ph: 240-238-4352 / Fx: 866-538-4783 /
moreinfo@criticalpoint.info
http://www.criticalpoint.info
EMSL Analytical Inc.
-
EMSL Analytical Inc. is a
nationwide network of 25 laboratories established in 1981
that provides sampling products and analysis to the
pharmaceutical industry. Our Products Division offers
bacterial air sampling equipment, particle counters,
settle plates, and temperature/relative humidity meters.
Our Laboratory Services Division offers Endotoxin Testing,
Microbial Limits Testing, Bacterial and Fungal Testing and
identification, Particulate Matter Testing, and chemical
contaminant identification following USP methods and
monographs. We are ISO 17025 compliant and are AIHA EMLAP
accredited. Our Materials Lab is FDA/GMP complaint. Our
Microbiology and Organic Chemistry Labs are pursuing
advanced accreditation in the form of FDA/GMP. For more
information please contact:
EMSL Analytical Inc.
107 Haddon Ave.
Westmont, NJ 08018
800-220-3675
www.emsl.com
EM Lab P&K
- EMLab P&K is a privately held corporation with over 40
service and drop-off locations throughout the United
States. We specialize in analyzing air and surface
samples for fungi, asbestos, and bacteria. EMLab P&K has
helped pioneer today’s IAQ industry by developing the
tools for precise data interpretation, including
MoldRange™ and MoldScore™. All of our analysts hold
college degrees and participate in ongoing,
industry-leading quality assurance and training
programs. Most have advanced degrees and are certified
by the Pan American Aerobiology Certification Board (PAACB).
We are committed to providing our customers with
outstanding service, quality, and support.
EMLab P&K
1150 Bayhill Dr., Suite 100
San Bruno, CA 94066
Ph : 866-888-6653 / Fx: 650-829-5852 /
info@emlabpk.com
www.EMLabPK.com
Esco Technologies -
Esco is recognized as a global leader in containment,
clean air and laboratory equipment technology. We are
highly oriented towards the international marketplace,
with distribution in more than 100 countries and a direct
presence in 10 of the key global markets. Esco represents
innovation and forward-thinking design, coupled with a
tradition of quality since 1978.
Esco
pharmacy products include a complete range of barrier
isolators, NSF listed biological safety cabinets and clean
benches. Only Esco offers:
-
Superior product and operator protection. ULPA filters
tested to a typical efficiency of >99.999% for 0.1 to
0.3 micron particles. ULPA filters last as long as
conventional HEPA filters and have similar replacement
costs.
-
Built in microbial protection. ISOCIDE™ antimicrobial
coating on all powder coated surfaces eliminates 99.9%
of surface bacteria within 24 hours of exposure.
-
Quality, easy-to-clean construction. Barrier isolators
and biological safety cabinets utilize stainless steel
interiors with coved corners.
-
Continuous monitoring for peace of mind. Barrier
isolators feature built-in digital airflow and pressure
displays.
Esco
directs a highly efficient research, product development,
manufacturing and customer service program. We are the
only company in our market that is completely configured
to export most of what we manufacture. And because of our
worldwide presence, and because we listen carefully to our
customers and our distributors, you can have confidence
that Esco products represent the best thinking in the
world.
A nationwide
network of manufacturer's representatives and distributors
ensures fast local response and support. We supply the
highest quality products backed by US central warehousing,
spares, customer service and nationwide on-site technical
support.
Esco
Technologies, Inc.
2940 Turnpike Dr, Units 15-16, Hatboro, PA 19040
Ph: 215-441-9661 / Fx: 215-441-9660
http://us.escoglobal.com/
Germfree Laboratories
Incorporated
- GERMFREE specializes in the production of all-stainless
steel unidirectional (laminar) flow equipment for
hospital, pharmacy, and oncology use. GERMFREE
manufactures a full line of USP <797> and NIOSH compliant
Compounding Aseptic Isolators (CAI), Compounding Aseptic
Containment Isolators (CACI) as well as horizontal and
vertical laminar airflow hoods and chemo hoods. With over
45 years in the industry, GERMFREE has the experience to
provide the best protection for patients, personnel and
products.
GERMFREE
Laboratories Incorporated
11 Aviator Way Ormond Beach, FL 32174
Ph: 800-888-5357 /
info@germfree.com
www.germfree.com
Isotech Design
is a leading
designer and manufacturer of turnkey barrier isolators,
glove boxes, microenvironments and clean air environments
solutions for the biopharma, pharmacies and research
centers. Our solutions allows high level of sterility
assurance, microorganisms and particle contamination
controls, containment management to meet USP 797 and cGMP
requirements for the pharmacy sterile compounding and the
biopharma aseptic processing.
IsoTech Design Inc.
5778 Thimens Blvd - Montreal, QC, H4R 2K9, Canada
T/F: 1 800 476-2010 / Tel: 514 956-1602 / Fax: 514
956-1032 /
info@isotechdesign.com
www.isotechdesign.com
RJ Lee Group,
Inc. offers a wide variety of USP 797 consulting services
that will help your institution meet compliance.
Our scientific and technical staff is knowledgeable in the
requirements of USP 797 regarding pharmacy clean room
design and operation. Our consulting services will help
ensure compliance with USP 797 in all phases of design and
construction. We will audit existing facilities,
help your team design a new pharmacy clean room,
and ensure compliance to USP 797 and adherence to design
specifications during the build-out phase. We also
provide required microbial environmental sampling
and recommended monitoring for hazardous drugs on
environmental surfaces.
RJ Lee
Group, Inc.
350 Fifth Avenue, Suite 5820 New York, New York 10118
Ph :
212-613-2700 / Fx: 212-613-2701 / email:
info@rjlg.com
www.rjlg.com
Trion,
Inc. Air Purification Systems
- Since
1947, Trion has provided quality products for the
commercial, industrial, residential, and military markets,
engineered specifically to provide a clean, safe and
comfortable indoor air environment. Dependable
performance, superior product quality and excellent
customer service are essential to our long-term success.
Trion has developed a level of technical expertise that
allows us to create innovative products and cost effective
solutions to serve our customer's air cleaning problems
worldwide. Our products can be found in homes, offices,
factories, pubs, clubs, hospitals and sea vessels.
Headquartered in Sanford, North Carolina, Trion
manufactures products in a dedicated 263,000 square foot
plant. Trion UK's European, Middle and Far East operations
are based in Winnall Close, Winchester in the United
Kingdom. Trion Deutsehland GmbH was formed in 1984 and is
responsible for Central and Eastern Europe. Our goal is to
provide environmentally sound solutions for all our
customers.
Trion,
Inc.
101 McNeil Road, Sanford, NC 27330
Ph : 800-884-0002 / Fx : 919-777-6399 /
customerservice@trioninc.com
www.trioninc.com
USP 797 Related Organizations:
American Society of Health System Pharmacists
-
ASHP is the 30,000-member national professional
association that represents pharmacists who practice in
hospitals, health maintenance organizations, long-term
care facilities, home care, and other components of health
care systems.
American Society of Health-System Pharmacists
7272 Wisconsin Avenue, Bethesda, MD 20814
ph : 301–657-3000 /
ahfs@ashp.org
www.ashp.org
United States
Pharmacopeia (USP)
-
The
United States Pharmacopeia (USP) is an official public
standards–setting authority for all prescription and
over–the–counter medicines and other health care products
manufactured or sold in the United States. USP also sets
widely recognized standards for food ingredients and
dietary supplements. USP sets standards for the quality,
purity, strength, and consistency of these
products–critical to the public health. USP's standards
are recognized and used in more than 130 countries around
the globe. These standards have helped to ensure public
health throughout the world for close to 200 years.
USP
is a non-governmental, not-for-profit public health
organization whose independent, volunteer experts work
under strict conflict–of–interest rules to set its
scientific standards. USP's contributions to public health
are enriched by the participation and oversight of
volunteers representing pharmacy, medicine, and other
health care professions as well as academia, government,
the pharmaceutical and food industries, health plans, and
consumer organizations.
United States Pharmacopeia (USP)
12601 Twinbrook Parkway,
Rockville, Maryland 20852–1790
Ph : 800–227–8772 / Fx : 301–816–8148 /
custsvc@usp.org
http://www.usp.org/
usp797.org
-
usp797.org, inc. is a privately-owned resource developed to aid
public understanding of the USP 797 regulation developed
by U.S. Pharmacopoeia, and its JCAHO-mandated schedule for
implementation. What you will find on USP797.org : USP 797
regulations – USP 797 vendors – USP 797 products – USP 797
articles – USP 797 cleanrooms – USP 797 barrier isolators
- USP 797 software.
usp797.org
59 West 19th Street - 6A, New York, NY 10011
Ph : 212-463-0800 / Fx : 212-463-9898 /
info@usp797.org
www.usp797.org
|