USP 797 & Clean Room & JCAHO
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

Project Management

Empire Projects, Inc. - Project management company serving the design and construction industries with a subspecialty in USP 797 compliance, USP 797 regulations, USP 797 construction, and USP 797 project management.

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

Analytical Testing

Aerobiology Laboratory Associates, Inc. – AIHA EMLAP Accredited - established in 1997 to meet the specific needs of indoor air quality specialists, healthcare engineers, risk managers and industrial hygienists. Our staff, consisting of degreed and advanced degreed Clinical & Environmental Bacteriologists and Mycologists, recognizes the organisms that compromise the cleanliness or air quality in the critical Health Care arena. We offer Health Care Specific Protocols and Consultation for the design of a plan to minimize microbial contamination risk levels.

Aerobiology Laboratory Associates, Inc.
43760 Trade Center Place, Suite 100
Dulles, Virginia  20166
Ph: 877 648 9150 / Fx: 703 648 3919
www.aerobiology.net

Front Range Labs, Inc. – is an analytical testing laboratory, able to perform your end product testing needs compliant with USP 797. We perform the following analysis: Sterility Testing (USP 71), Endotoxin Testing (USP 85), Potency Testing (USP 621 & 851), Particulate Matter Testing (USP 788/789), Microbial Limits Testing (USP 61) and Fungal Testing. Whether you are in need of a single analysis or a long term stability study, we have the capabilities to assist you. Our laboratory is able to carry out analysis on low, medium and high risk products. Having served the Compounding Pharmacy Community since 1997; we pride ourselves on offering minimal turn-around times, therefore allowing you to bring your product to market quickly. Our staff is well trained and ready to assist you with all you analytical end product testing needs.

Front Range Labs, Inc.
131 12th Street S.W.– Loveland, CO 80537
Ph: 970-593-0171 / Fx: 970-593-9044
www.frontrangelabs.com 

Cleaning Products for Controlled Environments

Acute Care Pharmaceuticals - provides single source convenience and full-line distribution for multiple manufacturers of USP<797> Cleanroom Disposables to Hospital, Home Infusion and Alternate Site pharmacies throughout the USA.  We are full-line Authorized Distributors for all of the major manufacturers and several specialty manufacturers of USP<797> products.   We are a USP<797> Contracted Provider for multiple GPO’s.  Contact us for a FREE printed or electronic 797 catalog, a Rapid Order Form and a 5% discount off of your initial order.  Whether you are searching for wipers, mops, cleaning solutions, tacky mats, cleanroom apparel, test kits or other 797 items, our mission is to be your trusted, sole source for multiple manufacturers of USP<797> Cleanroom Disposables.  

Acute Care Pharmaceuticals
12225 World Trade Drive - Suite F, San Diego, CA 92128
Toll Free: 1-888-909-7700 / Fax : 858-675-9380 / email: 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

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 RESULTS Inc. - Our distribution division has “Same-day-shipment” of cleanroom supplies such as disposable bouffant caps, masks, beard covers, cleanroom coats and coveralls, shoe covers, contamination control mats, sterile alcohol, sterile gloves and Nitrile cleanroom gloves, glove liners, wipes, etc. We also stock HEPA filters, cleanroom lights, gasketed ceiling grid and cleanroom ceiling tile, residue-free cleanroom cleaning solutions and disinfectants, HEPA and ULPA vacuum cleaners, and mop systems. Our equipment division can provide same-day leasing rates or quotes for biological safety cabinets, laminar-flow clean benches, fume hoods, cleanroom and laboratory furniture, gowning benches, garment racks, cleanroom chairs and stools, and related laboratory equipment. Our construction division designs and builds site-specific cleanrooms and laboratories, and we also sell and LEASE modular and relocatable cleanrooms.

Cleanroom Results Inc.
P.O. Box 1316 , Wexford, PA 15090-1316
Ph : 724-934-3396 / Fx : 724-934-3831  / sales@cleanroomresults.com
www.cleanroomresults.com / www.nerakinc.com

ITW Texwipe - ITW Texwipe is the leader in supplying consumables for contamination control in critical environments. Our product line includes a complete array of sterile
products, wipers, swabs, mops, cleaning solutions and stationery for use in
controlled and cleanroom environments. We also offer training and intuitive tools on
how to achieve and maintain controlled environments.

ITW Texwipe
Ph : 201-684-1800
www.texwipe.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

SOSCLEANROOM.com - is an industry leader in the distribution of clean room supplies used in commercial and industrial applications based in Dallas, Texas. For over 25 years, SOS companies has been providing best in class service to customers involved in semiconductor and electronics manufacturing, pharmaceutical, and other health care industries. SOS has been distributing to clean rooms since 1990, and is proud to have been designated as the Texwipe Master Distributor for the South West Region of the United States. SOS offers our customers a single source for wipers - dry or pre-saturated, sterile or non-sterile, low lent to totally lent free class 1; IPA – non-sterile or sterile; moping systems; TOC cleaning validation kits; ALMA anti-bacterial contamination control tacky mats; swabs; cleanroom stationary; safety glasses; face masks; bouffant caps; shoe covers; lab coats; gloves - powdered, powder free or sterile and shatter proof light bulbs. When you need help today, call or visit www.SOSCleanroom.com.

Specialty Optical Systems - SOSCleanroom.com
10210 Forest Lane, Dallas, TX 75243
Ph: 800-443-7101 / Fx: 214-340-5723 / sales@soscleanroom.com
www.soscleanroom.com, www.soslightbulbs.com

Cleanroom Design/Build Companies:

Haddad-Wylie-Industries, LLC- HWI has taken the USP797 by storm.  Completing some of high profile hospital facilities around the nation, they are proven to be the experts.  HWI provides full turn-key packages.  Meaning we will design, build, and certify your facility.  You will be left with a state of the art facility with high aseptic standards.  All of our certified USP 797 clean rooms have passed occupancy testing from the DOH and JCAHO with flying colors.  Visit our website to learn more and to schedule your no obligation job proposal.

Haddad-Wylie-Industries, LLC
4143 Brownsville Rd., Suite 6, Pittsburgh, PA 15227
Ph:412-884-3028 / fx:412-884-3029 / cell:412-378-3334
www.hwicleanrooms.com

Midwest Cleanroom Associates - is a full-service design/build firm that specializes in planning, design, construction and certification of clean and controlled environments. Our team of experts will help you assess your needs and develop a plan to implement and comply with the USP 797 guidelines.

Midwest Cleanroom Associates
2350 Oak Industrial Dr NE Suite B, Grand Rapids MI 49505
Ph : 616-458-8533 / Fx: 616-458-0797 / e-mail mch@mcacleanrooms.com www.mcacleanrooms.com

Technovation - Technovation design/builds highly functional and energy efficient cleanrooms compliant to USP 797 (both current guidelines and proposed 2005 revisions - expected to be put into practice in late 2006 or early 2007).

Technovation
13511 East Boundery Rd, Suite D/E
Midlothian, VA 23112-3941
ph : 804-744-0604 / fx : 804-744-0677 / sales@technovation.org
http://www.cleanroomsys.com/usp_797_pharmacies.htm

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 

Cleanroom Retrofit

Abatement Technologies HEPA-Care (r) systems can help you economically meet USP797 air quality requirements (ISO Class 7) with minimum disruption to your facility.  Our systems purify 100% of the air through high-performance HEPA filters while they provide a positive pressure environment and maintain 30 ACH, if desired.  Our ceiling models are mounted on the HVAC Ducting and provide easy, room-side filter replacement.  We also have portable freestanding models.  Each HEPA-CARE system is an FDA Class II medical device and is designed to run 24/7.  Additionally, we have germicidal UV modules, room pressure monitors and laser particle counters for your convenience.

Abatement Technologoes, Inc.
605 Satellite Boulevard, Suite 300
Suwanee, GA 30024
Ph: 800-634-9091 / Fx: 800-358-2394 / iaqinfo@abatement.com
www.hepacareusp.com and www.hepacare.com

Cleanroom Filters & Supplies – provides solutions to USP797 by offering a variety of equipment needs. We carry hepafilters for any biological safety cabinet, laminar flow hood, or air handler. We also carry softwall clean rooms, air showers, fan powered modules, and all the components for your clean room. In addition, we have automatic shoe brush cleaners, HEPA vacuums, Tacky mats, adhesive mats, cleanroom garments, and other products for your daily business operations. It is our goal to accompany your every cleanroom or HEPA filtration need.

Cleanroom Filters & Supplies
P.O. Box 20905 – Lehigh Valley, PA 18002
Phone: 800-334-9142 / Fax: 610-289-2666 / Email: info@hepafilters.com
www.hepafilters.com

Compliance Action Plans

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

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 

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


Environmental Monitoring

Biotest - To meet 797 requirements, Biotest offers the HYCON System - one complete solution for both active air sampling and total particle count evaluations. The HYCON System includes an extensive line of microbial air samplers, airborne particle counters, and contact slides for surface sampling. It is a fully validated system supported by an experienced staff and comprehensive microbiology lab to cover all 797 contamination control needs.

Biotest Diagnostics Corporation
66 Ford Road, Suite 220, Denville, NJ 07834
Ph: 800.522,0090 / Fx: 973.625.9454 / CustomerService@BiotestUSA.com
www.BiotestUSA.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

Kanomax USA, Inc. - Kanomax USA, Inc. introduced our new Handheld Particle Counter model 3887, which can be used to monitor from mini-environments, portable or small scale clean rooms, to full sized clean rooms and complies with ISO classes 5 thru 8 and meets the USP797 requirements.  Features include 3 Simultaneous Measurement Channels, Data logging, RS232/RS485 Output, Network Capable and much more.  Also included are AC Adapter, 4 x AA NiMH, Battery Charger, Operation Manual, Zero Filter, Windows Software, Communication Cable, and NIST Certificate.

Kanomax USA, Inc.
219 Route 206  PO Box 372, Andover, NJ 07821
Ph: 800.247.8887 / Fx: 973.786.7586 / info@kanomax-usa.com
www.kanomax-usa.com

PharmMicro Assurance - a division of Microbiology Specialists Incorporated can provide a wide variety of consulting and testing services for USP<797>, as well as other environmental microbiology testing for infection control and risk management.  Our services include baseline surveillance, assistance with facility design with regard to USP<797> compliance; environmental monitoring of cleanroom, anteroom, and hood(s); sterility testing of compounded end product and media fill competency testing of personnel.  We are able to trend the number and type of microorganism(s) from sampling period to sampling period on a secure website.  Training and continuing education are also available on-site as is help with sampling plans or other procedures.  We are accredited by the Centers for Medicare & Medicaid Service s (CLIA), The College of American Pathologists (CAP), the New York State Department of Health (NYSDOH), and the American industrial Hygiene Association (AIHA).  We are also members of the American Society for Microbiology (ASM) and the American Society of Health System Pharmacists (ASHP)

PharmMicro Assurance, a division of Microbiology Specialists Incorporated
8911 Interchange Drive
Houston, Texas  77054
Ph: 713-663-6888 / Fx: 713-663-7722 / pma@microbiologyspecialists.com
www.microbiologyspecialists.com

Particle Measuring Systems – We offer a comprehensive line of particle counters and monitors to meet your contamination monitoring needs. Our knowledgeable staff will assist you in choosing the best particle counter to meet the USP 797 environmental monitoring requirements. We also offer 21CFR11-compliant software, parenteral and in-line liquids particle counters, parts cleanliness testing, turnkey project management, and educational seminars.

Particle Measuring Systems
5475 Airport Boulevard- Boulder, CO80301
Ph: 303.443.7100 / Fx : 303.546.7331 / marketing@pmeasuring.com
www.pmeasuring.com/moreinfo/USP797

Gap Analysis

MicroTest Laboratories - MicroTest Laboratories provides complimentary Gap-Analysis compliance audits, certification and routine Environmental Microbiology monitoring [including viable/nonviable air and surface testing] of hoods and clean-rooms, on-site personnel training to USP<797>compliance [contamination control/aseptic technique], development of client-specific USP related SOP documentation and Low/Medium/High risk media-fill test programs. In addition, we offer end-product testing for sterility, endotoxin, purity and other analytical testing. MicroTest Laboratories is an FDA and DEA registered contract testing and manufacturing facility.

MicroTest Laboratories, Inc.
104 Gold Street, Agawam, MA 01001
Ph : 413-786-1680 / Fx : 413-789-4334 / e-mail Info@microtestlabs.com  www.microtestlabs.com

Environmental Microbiology Laboratory, Inc. - We specialize in the analysis of air and surface samples for fungi, mold, bacteria, and allergens.

Environmental Microbiology Laboratory, Inc.
1150 Bayhill Dr, #100, San Bruno, CA 94066
Ph : (866) 888-6653.
www.emlab.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

Micro-Clean, Inc. and Cleanroom Filters & Supplies – are two companies offering one convenient solution. Micro-Clean, Inc. has been performing clean air testing and certification services for over 30 years, while Cleanroom Filters & Supplies has all of your cleanroom products and equipment needs. Our dedicated staff provides the most extensive training program, developed and maintained by known industry experts. Micro-Clean, Inc. and Cleanroom Filters & Supplies have the solutions to all of your USP 797 needs: BSC testing per NSF 49, Laminar Flow Clean Benches, Compounding Aseptic Isolators, Cleanroom Certification, Viable Monitoring Programs, Facility Qualification, Cleanroom Design, Consultation & Installation Services, and Garments and Cleanroom Supplies.

Micro-Clean, Inc.
P.O. Box 21806 – Lehigh Valley, PA 18002-1806
Phone: 800-523-9852 / Fax: 610-954-7803 / Email: sales@microcln.com
www.microcln.com

USP 797 Related Products:

The Baker Company - The Baker Company is the recognized world leader in the design and manufacture of biological safety cabinets, clean benches and fume hoods. For over five decades The Baker Company has been at the forefront of engineering, testing and production of reliable laboratory contamination control equipment.

The Baker Company
P.O. Drawer E, 161 Gatehouse Road, Sanford, Maine 04073 USA
ph : 800-992-2537 / fx : 207-324-3869 / bakerco@bakerco.com
www.bakerco.com

Central Admixture Pharmacy Services - CAPS® pioneered in 1991 to deliver high quality admixture services and solutions to a dynamic and challenging pharmacy environment.

Central Admixture Pharmacy Services (B.Braun Medical Inc.)
824 Twelfth Ave, Bethlehem, PA 18018
ph: 800-853-6498
www.capspharmacy.com

Containment Technologies, Inc. - Mobile isolation chambers that have revolutionized the industry

Containment Technologies, Inc.
10329 Vandergriff Road, Indianapolis, IN 46239
ph : 317.862.5945 / fx : 317.862.9135
www.mic4.com

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

Healthcare Marketplace - The Online Store for Healthcare Management Professionals

Healthcare Marketplace (HCPro, Inc. )
200 Hoods Lane, Marblehead, MA 01945 USA
ph : 877/727-1728 / Fx : 800/639-8511 / webmaster@hcmarketplace.com
www.hcmarketplace.com

High-Tech Conversions, 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.  High-Tech Conversions also provides custom made products, and a complete list of consumable items used in any clean environment.  High-Tech Conversions also provides a suggested items list to help achieve USP 797 Compliance and an optional Starter Kit.

High-Tech Conversions, Inc.
11A Pasco Dr, East Windsor, CT 06088
Ph : 860-370-9828 / Fx : 860-627-8370 / info@high-techconversions.com
www.high-techconversions.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

Liberty Industries, Inc. - We design and build Cleanooms, Laminar Flow Benches, Fume Hoods, Pass Thru's and carry a full line of Barrier Isolators. What sets us a part from others is that we also carry a full line of accessories to maintain a clean environment including our registered Tacky Mats®.

Liberty Industries, Inc.
133 Commerce Street, East Berlin, CT 06023
ph : 800.828.5656 / Fx : 860.828.8879 / libind@liberty-ind.com
www.liberty-ind.com

NuAire, Inc. - NuAire’s PharmaGard Barrier Isolators are your Single Source Solution to assure compliance with USP Chapter <797> for the proper preparation of compounding sterile products [CSP]. NuAire offers three PharmaGard Barrier Isolators, the NU-PR797 Positive Pressure, NU-NR797 Negative Pressure Re-circulating and the NU-NTE797 Negative Pressure Total Exhaust. NuAire’s Barrier Isolators are constructed of Stainless Steel with seamless interiors and exteriors, centrally located control centers, interior stainless steel IV bars, large glove ports, and are designed with the ergonomic needs of the user in mind. For more information please contact NuAire at 1-800-328-3352 or visit our website at http://www.nuaire.com/pharmacy_products.htm

NuAire, Inc.
2100 Fernbrook Lane, Plymouth, MN 55447 USA
Ph: 1-800-328-3352 / Fx: 763-553-0459 / nuaire@nuaire.com
http://www.nuaire.com/pharmacy_products.htm

OmniAire HEPA and OmniAire PAC Portable Air Cleaners combine the best technologies for scrubbing air of finest dust, odors and biological contaminants. In healthcare facilities our portable machines are used to provide required air changes, clean room environment, patients isolation room and to control any contaminants during maintenance and restoration projects. Our equipment can provide positive or negative room pressure using HEPA 99.99% efficiency filters combined with high intensity UVGI germicidal lights to sterilize the air.

Omnitec Design, Inc.
2125 196th St. SW, Suite 115, Lynnwood, WA 98036
Ph : 888.528.0058 Fax : 425.774.4983 / www.omnitecdesign.com

Pharmacy Isolators - The A2 Pharmacy Isolator is the ultimate alternative to a clean room. It offers the same level of air quality, yet requires much less space, cost and maintenance to operate. The A2 Pharmacy Isolator is a more efficient and sensible option, especially for smaller scale packaging runs.

Pharmacy Isolators (Innovative Technology, Inc.)
2 New Pasture Road, Newburyport, MA  01950
Ph : 978 462-4415 / Fx : 978 462-3338 / info@gloveboxes.com
www.pharmacyisolators.com

R.C. Smith Company - Since 1965, R.C. Smith Company has installed its line of modular casework (modular furniture) in over 3,000 healthcare facilities worldwide. Our products include specialized modular casework for hospital and clinic pharmacies, workstations for medical laboratories, millwork for nurses stations and casework for dental clinics.

R.C. Smith Company
14200 Southcross Drive, Burnsville, Minnesota 55306
ph : 952-854-0711 / Fx : 952-854-8160 / info@rcsmith.com
www.rcsmith.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


making the world a better place
What is USP 797?

Endorsed by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) has an aggressive compliance schedule, USP 797 has received great attention from hospital administrative, clinical and pharmacy staff.

USP 797's requirements also extend to architectural and environmental areas. Hospital design, construction and operations professionals need to be familiar USP 797.

USP 797 is a far-reaching regulation that governs a wide range of pharmacy policies and procedures. It is designed both to cut down on infections transmitted to patients through pharmaceutical products and to better protect staff working in pharmacies in the course of their exposure to pharmaceuticals.

Issued by U.S. Pharmacopoeia (USP), the regulation governs any pharmacy that prepares "compounded sterile preparations" (CSPs). Many pharmacies fit this description. Moreover, many large hospitals have several pharmacies--a main one and several satellite pharmacies--that will be affected.
JCAHO clarifies expectations and timelines in compliance with USP797.
At the summer meeting of the American Society of Health-System Pharmacists (ASHP) held in June 2004, Darryl S. Rich, Pharm.D., M.B.A., FASHP presented on the legal and JCAHO implications of USP/NF chapter 797. In the presentation, Dr. Rich identifies that JCAHO's approach to compliance with the facilities and equipment requirements of USP <797> are similar to their approach to Life Safety Code compliance issues:
•Assess gaps in compliance
•Establish action plan with leadership commitments for funding and completion date
•Implement interim steps to mitigate the impact of noncompliance until the work is completed.
JCAHO expects that by:
•1/1/05 - organizations have performed a risk assessment/gap analysis to identify facility and equipment areas of non-compliance, established a written action plan with specific timeframes and funding approval for achieving compliance.
•7/1/05 - organizations have implemented any interim steps to mitigate the impact of non-compliance and assure sterility in compounding.
•1/1/08 - organizations have completed their action plans and are in full compliance.
Dr. Rich explained specific circumstances, such as construction and occupancy of a new facility may extend the definition of "realistic timeframe" beyond the 1/1/08 deadline. The specific circumstances should be documented and approved by the organization's leadership. The timelines listed above are specific to compliance with facilities requirements. JCAHO anticipates a providing a table of USP requirements and implementation dates in a future issue of Perspectives.
JCAHO to Enforce New USP 797
The April 2004 JOINT COMMISSION PERSPECTIVES identifies that starting July 1, 2004, JCAHO surveyors will begin surveying compliance with a new chapter in the 2004 United States Pharmacopoeia—National Formulary (USP-NF) entitled “USP Tests and Assays Chapter 797, Pharmaceutical Compounding, Sterile Preparations.” This new chapter deals with new requirements for the compounding, preparation, and labeling of sterile drug preparations and applies to health care institutions, pharmacies, physician practices, and other facilities that prepare or compound sterile preparations (for example, intravenous solutions, eye drops).
JCAHO reports that although surveyed in the pharmacy, these new requirements will be judged in the following EC standards
•Environment design of drug preparation rooms (EC.8.10)
•Air quality testing and environmental monitoring of compounding environment (EC.7.10 testing), (EC.9.10 monitoring)
•Temperature testing of drug storage areas (EC.6.10)
•Automated compounding device—verification of accuracy, calibration and maintenance (EC.6.10)
In Perspectives, JCAHO recommends “To comply with these requirements, organizations should immediately evaluate their current practices in the light of the new USP-NF chapter and make appropriate changes.”
ASHE Guidance
•Contact your pharmacy(s) to determine if they are preparing or compounding sterile preparations
•If so, determine the USP Risk Level
•Review the following built environmental requirements
Built Environment Requirements[1]
USP Risk Level: Low & Medium Risk
•Must provide an ante area but need not be separated from the controlled area with a physical wall
•Air quality of ISO class 8*
•A certified constant running ISO class 5 laminar air flow work bench for IV prep with visible pressure gauge*
•Cytotoxic and other hazardous products should be prepared in a vented class II biological safety cabinet or barrier isolator
•Trash can should be below the level of the laminar air flow work bench and should be removed from the controlled area before being emptied
•Positive pressure to adjacent areas
•Walls floors fixtures and ceilings should be smooth and free of cracks, crevices and be of non-shedding materials
•Surfaces should be resistant to damage from sanitizing agents
•Shelving should be of a low particulate material
•Storage in the controlled area should be limited to items in constant use
•Junctures of ceilings and walls should be coved and caulked
•If ceilings consist of inlaid panels, the panels should be impregnated with a polymer to render them impervious ands hydrophobic and the should be caulked around each perimeter to seal them to the support frame
•Walls may be panels locked together and sealed or epoxy coated gypsum board
•Floors should be overlaid with sheet vinyl flooring with heat-sealed seams and coving at the sidewall
•The buffer or ante areas should contain no sinks or floor drains
USP Risk Level: High Risk
•Same as low risk and: The ante area must be a separate room
American Society of Health-System Pharmacists guidance on assessment and compliance with USP 797

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