Architects

Bernstein & Associates, Architects - Architecture firm specializing in healthcare and lab design with a subspecialty in pharmacy design, pharmacy planning, and pharmacy construction. The firm has designed over (20) pharmacies since 2005, across the United States. The pharmacy design work of the firm has been widely published. Pharmacists and pharmacy managers who need to design a pharmacy contact this architecture firm.

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

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

Analytical Testing

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 

Cleaning Products / Contamination Control

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

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  

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

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

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

Medical Specialties Distributors, LLC (MSD) - MSD is a market leading distributor offering a full line of USP 797 products from nations leading manufacturers.

• Alcohol – 70% IPA Alcohol Sterile and Filtered to 0.22 microns
• Biological Testing – Aseptic Technique, Product and Compounding Sterility Kits
• Chemo Safety Products – Collection Containers, Spill Kits and Waste/Transport Bags
• Contamination Control Products – Tacky Mats and Tacky Rollers
• Disinfectants – All Types
• Gloves – All Types, Sterile, Non-Sterile, Nitrile and Chemo rated
• Mops – Handles  Buckets and Mop Heads for Vertical and Floor Use
• Protective Apparel- Gowns, Lab Coats, Coveralls, Mask, Shoe Covers, and Goggles
• Wipers – Dry and Pre-Wetted 70% IPA Alcohol
• Shipping Containers – Cardboard Boxes General and Insulated

MSD is an authorized supplier for the following USP 797 product manufacturers: 3M, Becton Dickinson, Contec Inc, Connecticut Clean Room, Covidien (Kendall), Decon Laboratories, Kimberly Clark, ITW Texwipe and Thermo Safe, Valiteq-Lab Safety Corporation and many others.

Headquartered in Stoughton, Massachusetts, Medical Specialties Distributors ("MSD") was founded in 1984 as a distributor of home infusion therapy products. Today, it has become the leading supplier of healthcare products and biomedical equipment rentals and service to the home healthcare market. MSD offers its products and services through a national footprint of seven medical product distribution centers, seven medical equipment and repair centers, and thirty medical biomedical rental and service centers located throughout the United States. MSD's customers range in size from single site providers to national home healthcare companies and small to middle-size hospitals. MSD's primary focus is the alternate-site market, where they have secured long-term distribution agreements with many of healthcare's leading homecare providers. MSD's services include formulary development, online ordering, equipment management and tracking, patient direct delivery programs and a national field sales organization to drive and support customer initiatives.

Medical Specialties Distributors, LLC
Corporate Offices: 800 Technology Center Drive, Stoughton MA  02072
Ph: 800-967-6400 / Fx : 781-344-7244 / Email : customerservice@msdistributors.com
www.msdonline.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.

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:

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

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

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

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

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:

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

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 

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

usp797.org - usp797.org 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

Wireless Lighting:

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