USP 797 Vendors

USP 797 vendors in the following categories: USP 797 Architects, USP 797 Analytical Testing, USP 797 Cleanroom Products, USP 797 Cleanroom Design/Build Companies, USP 797 Equipment Planning, USP 797 Project Management, and USP 797 Testing & Certification.

Architects

Bernstein & Associates, Architects

Bernstein & Associates Architects has a national reputation in the areas of pharmacy design for hospital pharmacies, compounding pharmacies and retail pharmacies. Additional pharmacy design specialties include USP 797 compliant pharmacy design, pharmacy equipment consulting and planning, USP 797 engineering, and USP 797 construction project management. Founded in 1990, Bernstein & Associates, Architects creates state-of-the-art, efficient, compliant, and appealing pharmacies for pharmacy clients who demand the best.

Bernstein & Assoc., Architects, PLLC
1201 Broadway – 803, New York, NY 10001
Ph : 212-463-8200
www.bernarch.com
New York – Princeton – Charlottesville – Los Angeles     
                                                     

Analytical Testing

Aerobiology Laboratory Associates

Aerobiology Laboratory Associates was incorporated in 1997 to assist Indoor Air Quality professionals in all aspects of work-related environmental microbiology. Our laboratory facilities in Washington, D.C., Atlanta, GA, Cherry Hill, NJ, Denver, CO, Phoenix, AZ, and Los Angeles, CA serve a nation-wide client base. Our services include a complete range of sampling and analysis of indoor environments for bioaerosols, and the identification of biological sources of IAQ problems. In addition to a full range of microbial culture analysis, our microbial services include:
• Non-viable spore trap analysis from Burkard in support of standard culture methods for mold assessment and decontamination programs
• Air-O-Cells *Site Note: Need additional info like above
• Allergenco Impactors
• Testing for antigens to dust mites, cat dander, and cockroaches.
• Analysis of air, water, wipes, and bulk samples for bacteria and fungi (both molds and yeasts).
• Food Microbiology
• Product Validation as well as Research and Development
We also provide on-site mold Analysis services, as well as assistance in the development, at the request of an industrial hygienist, of abatement strategies, abatement monitoring, and final clearance documentation.

Aerobiology Laboratory Associates
43760 Trade Center Place, Suite 100
Dulles, Virginia
P: (877) 648-9150
F: (877) 598-0946
www.aerobiology.net

Analytics Corporation

Analytics Corp was founded in 1977 as an industrial hygiene laboratory and we received our AIHA-LAP, LLC accreditation in 1981. Based on the needs of our IH clients, Analytics began testing environmental samples in the late 90s and received our NELAC certification in 2000. In addition, we are now participating and proficient in the Pharmaceutical Round Robin PT program.

By combining scientific expertise, state-of-the-art instrumentation and leading edge information management systems, Analytics Corp is committed to delivering the highest quality analytical laboratory services to our clients. See our full comprehensive directory of services and sampling media by clicking the directory below.

Analytics Corporation
10329 Stony Run Lane, Ashland, VA 23005
Phone: 804-365-3000/ 800-888-8061
Fax: 804-365-3002 / Email: info@analyticscorp.com
www.analyticscorp.com

Associates of Cape Cod, Inc.

Associates of Cape Cod, Inc. (ACC), is one of the world’s largest manufacturers of products developed to detect and quantify gram-negative bacterial endotoxins and (1→3)-ß-D-glucans. Our products are used worldwide by leading pharmaceutical and medical device companies to ensure the safety of their parenteral drugs, biological products and medical devices. Our goal is to provide the best products and services, as well as the best technical support and customer service, in our industry to enhance the productivity and efficiency of all our customers. We are ISO 13485: 2003 certified, our laboratories are FDA Inspected and DEA Licensed and our Beacon Diagnostics ® laboratory is CLIA certified.

Our corporate headquarters are located in East Falmouth, Massachusetts with offices in the UK and Germany. Founded in 1974 by Dr. Stanley Watson, our company was the first to be licensed by the FDA to manufacture LAL for use as a quality control test for endotoxin detection in the pharmaceutical and medical device markets. Over the years, we have grown to be an internationally recognized leader in endotoxin detection, with over 150 employees and a distribution network servicing 80 countries.

Associates of Cape Cod, Inc.
Falmouth Technology Park
124 Bernard E. Saint Jean Drive
East Falmouth, MA 02536-4445
(T) (888) 395-2221
(T) (508) 540-3444
(F) (508) 540-8680
(E) info@acciusa.com
www.acciusa.com

Atlantic Technical Systems

ATS is known for providing cleanroom solutions in mission-critical environments where there is simply no room for error. We combine engineering excellence with contamination control expertise to create cleanroom solutions for pharmaceutical, biotech, semiconductor, micro-electronic organizations and more. The driving force behind our approach is ATS president and founder Brian Flynn. A mechanical engineer by training, Brian spent nearly 15 years overhauling and refueling nuclear submarines, using engineering-based problem solving skills to resolve issues including preventing radiation contamination. It was in these highly sensitive environments that Brian honed his expertise in the identification and elimination of dangerous contaminants of all kinds. And it was there that he learned how important credentials, professionalism and commitment are to the process. He founded ATS with these priorities in mind. Today, all ATS technicians have engineering training and strong analytical skills. Most importantly, ATS technicians understand both the big-picture implications of cleanroom management and detailed interactions within controlled environments. As a result, they excel at troubleshooting and problem solving.

ATS offers services that support everything from cleanroom design to construction and final qualification. For example, ATS can:
– Analyze facilities, advise clients on contaminant control, and certify their facilities
– Capture airborne contaminants and analyze them
– Collect and grow contact samples to determine bacterial and fungal levels
– Investigate air flows, airborne contamination, HEPA filter integrity, room pressurization, temperature, and humidity to optimize operating parameters
– Issue certification reports that assess the health of a facility
– Create sterile environments

Atlantic Technical Systems (ATS)
P.O. Box 249 Annapolis, MD 21404
Phone: 410.507.2779
sales@atscert.com 443.223.5110

EMSL Analytical, Inc.

EMSL Analytical, Inc. is an FDA registered, DEA licensed, and cGMP compliant laboratory for compounding pharmacies and parenteral drug manufacturers impacted by USP 797. In business since 1981, EMSL is the fourth largest independent testing lab in the US. We offer all the microbiological, chemical, and physical testing necessary for active pharmaceutical ingredients, environmental monitoring samples, and product release testing required under the USP guidelines. We offer USP 71 sterility testing, media fill testing, stability testing, and USP 788 particulate identification (including nanoparticle analysis) in addition to the routine analysis of fingertip, air and surface samples. EMSL’s Products Division also supplies swabs, agar, and contact plates for USP 797 environmental sampling. We are an AIHA accredited lab for environmental samples. For more information please contact Diane Miskowski, Business Development Manager at:

EMSL Analytical, Inc.
200 Route 130 North
Cinnaminson, NJ 08077
Ph : 800-220-3675 x2528 / Fx: 856-303-2528 / dmiskowski@emsl.com
www.pharmaceuticaltestinglaboratory.com

Cleanroom Products / Contamination Control

Acute Care Pharmaceuticals

For over 15 years, Acute Care Pharmaceuticals has been servicing the healthcare industry by delivering exceptional products and services to healthcare providers nationwide. As your partner in the compliance of USP <797> regulations, they can supply your facility with the correct disposable products and the knowledge necessary to support the operation of your barrier isolator and all your cleanroom procedures. Their disposables are manufactured under the highest standards resulting in reliable and 100% compliant products that you can trust. Acute Care Pharmaceuticals has made it easy for Pharmacies to purchase at their wholesaler or direct. To view a product catalog or Wholesaler Item Numbers go to http://www.pharma-choice.com/download-catalog.

Acute Care Pharmaceuticals
12225 World Trade Drive- Suite A, San Diego, California 92128
Phone: 888-909-7700
Fax: 858-675-9380
www.Pharma-Choice.com

Berkshire Corporation

Great Barrington, Mass.-based Berkshire Corporation has been an innovator of contamination control products for over 40 years. Berkshire’s collection of cost-effective, non-shedding USP 797-compliant cleaning solutions are used to properly clean and sanitize a broad range of compounding areas, including surfaces, floors, equipment, and fixtures. To find out exactly which of Berkshire’s non-shedding products will be most beneficial for compliance in your particular environment, call Berkshire at (800) 242-7000.

Berkshire Corporation
21 River Street. Great Barrington, MA 01230
Phone: 800-242-7000
Fax: 336-446-0156
www.berkshire.com

Clean Air Essentials

Clean Air Essentials is focused on consumables and standard operating procedures (SOPs) for sterile and safe chemo compounding, to ensure USP 797 compliance. To order or for a RFQ, please visit our website www.CleanAirEssentials.com or call us at 1.855.ISO.4797. Clean Air Essentials is a sister company of IsoTech Design, a leading designer and manufacturer of USP 797 clean air solutions such as isolators and modular clean rooms.

IsoTech Design, Inc. (Head Office)
1320 Graham Blvd #120, Montreal QC. HP3 3C8 Canada
Ph : 514-956-1602 / Fax: 514-956-1032 Email: info@isotechdesign.com
www.isotechdesign.com

IsoTech Design USA (US Distribution Center)
29 Distribution Way, #45, Plattsburg, New York 12901
Ph : 1-800-476-2010 Email: info@isotechdesign.com
www.isotechdesign.com

Cleanroom Connection, Inc.

Cleanroom Connection is the nation’s leading compounding pharmacy cleanroom supplier. Cleanroom Connection specializes in helping compounding pharmacies and pharmaceutical manufacturers achieve USP 797, USP 800 and cGMP compliance. Cleanroom Connection works alongside PCAB, IACP, ACA, USP and the FDA to keep up-to date with all of the latest updates and requirements to ensure their pharmacy cleanroom supplies are complaint. Cleanroom Connection has been supplying compounding pharmacy cleanrooms for the past ten years and has a team of USP compliance consultants, veteran pharmacists, sales consultants as well as cleanroom designers to answer even the most technical of compounding questions, free of charge. On-site training, consulting and implementation of USP 797, USP 800 as well as cGMP is available through Cleanroom Connection. Cleanroom Connection stocks a hand-picked selection of pharmacy cleanroom supplies that have been evaluated and well-reviewed by the nation’s leading sterile compounding pharmacies. Free samples are available on all products sold by Cleanroom Connection. Free guidance to help each pharmacy choose the proper cleanroom supplies is available to all clients. Take advantage of their “Best Price” guarantee.

Cleanroom Connection stocks the following cleanroom supplies:
• Lint Free Wipes & Sterile Pharmacy Cleanroom Wipes
• Compounding Pharmacy Cleanroom Mops & Sterile Mop Covers
• Sterile Pharmacy Cleanroom Apparel – Coveralls, Lab Coats, Frocks
• Sterile Gloves & Chemo Rated Gloves
• Sticky Floor Mats
• Pharmacy Tacky Roller Mops
• Sterile Disinfectants, Sporicides, Bleaches, Sterile 70% Isopropyl Alcohol
• USP 800 Compliant Chemotherapy Handling Products
• Compounding, Infusion and Pharmacy Cleanroom Products
• Contact Plates, Media Fill Tests and Sterility Testing Products

Cleanroom Connection Inc.
Long Island – New York
P 800-616-5319
F 516-596-8619
E Sales@CleanroomConnection.com
www.CleanroomConnection.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 26 years of experience providing simple solutions for complex problems of contamination and infection control in critical environments, including pharmacy 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 single-use specialty wipes, sterile alcohol, mopping systems, isolator cleaning tools, disinfectants, swabs, cleanroom gloves and garments, available in a wide variety of formats that meet the requirements of USP <797> and draft USP <800> guidance. 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. Cleaning made simple, compliance made easy with Contec.

Contec, Inc.
525 Locust Grove, Spartanburg SC 29303
Ph: 864-503-8333, 1-800-289-5762
www.contechealthcare.com

Criti Clean Cleanroom Products

Criti-Clean is a manufacturer of high quality USP 797 cleaning supplies including include lint free wipes, lint free cleanroom mops, lint free swabs, face masks and cleanroom paper products. We specialize in helping our customers achieve USP 797 compliance with our clean room cleaning supplies as well as expert guidance by our on-staff compounding pharmacist consultants. We offer both sterile and clean versions of our products.

Criti Clean Cleanroom Products
POB 417 – Cutchogue NY 11935
Ph: 800-616-5319 / Fax: 516-960-7769 / Email: Sales@Criti-Clean.com
www.Criti-Clean.com

Decon Labs Inc.

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

Hutchins & Hutchins, Inc.

Hutchins and Hutchins, Inc. is a cleanroom equipment and supply facility, distributing products to critical environments to facilitate in the restoration and saving of lives. Whether you’re outfitting a new cleanroom or restocking an existing one, we make every effort to offer a full spectrum of the most current innovations in equipment and supplies. For over three decades, our customers have relied on us as a master distributor of quality products. Our capable staff works with you to fulfill all of your critical environment needs with supplies from industry leaders such as Kimberly Clark, Texwipe, Veltek and Micronova to smaller firms that specialize in the semiconductor, pharmaceutical, biotechnology, medical device and tissue bank industries. USP Chapter has been revised and dictates compounding be performed under ISO 5 (Class 100) conditions. Compliance with USP Chapter is a challenging requirement that will be strictly enforced.

Hutchins & Hutchins, Inc. | Your Cleanroom Supplier
39 Hutchwood Ln, Waynesboro VA, 22980
(P) 1-540-949-6663 | (TF) 1-800-554-4736 | (F) 1-540-943-9803
yourcleanroomsupplier.com
sales@yourcleanroomsupplier.com

IsoTech Design

IsoTech Design is a leader in designing and manufacturing of turnkey barrier isolators, RABS, microenvironments and clean air environments solutions. We also offer several Total Support Plans (TSPs) that will simplify and assure your compliance to USP 797. They include certification, technical support, SOP, a year supply of some consumables, and many more options; all to ensure the proper operation and compliance of the unit. Call customer service for more information. Our sister company Clean Air Essentials offers all the essentials necessary for sterile, chemo and hormone compounding that is required for USP 797 compliance.

IsoTech Design, Inc. (Head Office)
1320 Graham Blvd #120, Montreal QC. HP3 3C8 Canada
Ph : 514-956-1602 / Fax: 514-956-1032 Email: info@isotechdesign.com
www.isotechdesign.com

IsoTech Design USA (US Distribution Center)
29 Distribution Way, #45, Plattsburg, New York 12901
Ph : 1-800-476-2010 Email: info@isotechdesign.com
www.isotechdesign.com

Cleanroom Design/Build Companies

AM Cleanroom Build and Performance

AM Cleanroom Build and Performance offers complete turnkey of ISO Cleanroom construction projects in the Semiconductor, Biopharm, Life Science, Data Centers, Research and Higher Education markets. Our project teams carefully listen to customer requirements and create a solution that prioritizes the customer’s best long and short-term interests.

We have over 30 years of cleanroom construction experience building various types of cleanrooms regardless of the ISO class (3-8), type of flooring (raised, epoxy, ESD, welded seam), size (<1000 to >265,000), room specifications (FDA, cGMP, USP 797, USP 800, 503B), airflow design (plenum, direct duct, fan filter units) or component manufacturer (Plascore, Portafab, Dagard). We have extensive knowledge of cleanroom remediation that identifies issues and develops a project plan to bring your facility up to specification in the most efficient manner possible. We have relocated cleanrooms and reconfigured to ensure compliance with the latest standards. We have teams all over the US.

AM Cleanroom Build and Performance
2213 RR 620 N. Suite 105, Austin, Texas 78734
Phone: 214-287-0432
www.amcleanroombuild.com

Connecticut Clean Room Corporation    

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

Hutchins & Hutchins, Inc.

Hutchins and Hutchins, Inc. is a cleanroom equipment and supply facility, distributing products to critical environments to facilitate in the restoration and saving of lives. Whether you’re outfitting a new cleanroom or restocking an existing one, we make every effort to offer a full spectrum of the most current innovations in equipment and supplies. For over three decades, our customers have relied on us as a master distributor of quality products. Our capable staff works with you to fulfill all of your critical environment needs with supplies from industry leaders such as Kimberly Clark, Texwipe, Veltek and Micronova to smaller firms that specialize in the semiconductor, pharmaceutical, biotechnology, medical device and tissue bank industries. USP Chapter has been revised and dictates compounding be performed under ISO 5 (Class 100) conditions. Compliance with USP Chapter is a challenging requirement that will be strictly enforced.

Hutchins & Hutchins, Inc. | Your Cleanroom Supplier
39 Hutchwood Ln, Waynesboro VA, 22980
(P) 1-540-949-6663 | (TF) 1-800-554-4736 | (F) 1-540-943-9803
yourcleanroomsupplier.com
sales@yourcleanroomsupplier.com

IsoTech Design

IsoTech Design is a leader in designing and manufacturing of turnkey barrier isolators, RABS, microenvironments and clean air environments solutions. We also offer several Total Support Plans (TSPs) that will simplify and assure your compliance to USP 797. They include certification, technical support, SOP, a year supply of some consumables, and many more options; all to ensure the proper operation and compliance of the unit. Call customer service for more information. Our sister company Clean Air Essentials offers all the essentials necessary for sterile, chemo and hormone compounding that is required for USP 797 compliance.

IsoTech Design, Inc. (Head Office)
1320 Graham Blvd #120, Montreal QC. HP3 3C8 Canada
Ph : 514-956-1602 / Fax: 514-956-1032 Email: info@isotechdesign.com
www.isotechdesign.com

IsoTech Design USA (US Distribution Center)
29 Distribution Way, #45, Plattsburg, New York 12901
Ph : 1-800-476-2010 Email: info@isotechdesign.com
www.isotechdesign.com

Micro Filtrations, Inc.

Micro Filtrations, Inc. – Micro Filtrations, Inc. offers a full range of USP <797> services. From consultation and design to testing and certification, our team of professionals is equipped with the knowledge and experience that can guide you through the process of achieving USP <797> compliance. Our expert staff holds NSF, NEBB and CETA certifications.

Micro Filtrations, Inc.
491 N. State Rd. 434, Suite 125
Phone: 800-962-7973 Fax: 407-682-0843 / email: pyaros@mficertify.com
www.mficertify.com

Travis Cleanair, Inc.

TCA builds Custom Cleanrooms and guarantees them in writing to meet current USP 797/800 guidelines. Should your compounding needs change in the future…breathe easy. Our Cleanrooms utilize a modular system and may be altered or moved, ensuring you never lose your initial investment. We are the only cleanroom manufacturer that is owned and operated by a registered pharmacist with infusion, hospice, home health and compounding experience. As a result, you’ll find that we pay close attention to every detail, in order to help your team work more efficiently while providing safer medications.

TCA has installed over 1,200 cleanrooms in 48 states, Puerto Rico and Canada. Having built a range of projects from small 80 sq ft. cleanrooms to large cleanrooms suites for 503b facilities; we’ve been there, and know what you need. Our experienced design team will customize a cleanroom suite to your specific needs. Your cleanroom suite is built off-site at our plant, then delivered personally by our installation crew. They will have your room up and running within 2-4 days, limiting the inconvenience to your daily business operations.  Our crews receive high marks all across the country for their efficiency and professionalism.  From start to finish, we are here for you every step of the way.

Travis Cleanair, Inc.
3985 S. Lincoln Ave Ste 204
Loveland, CO 80537
www.traviscleanair.com
970.203.0516

Environmental Monitoring

Atlantic Technical Systems

ATS is known for providing cleanroom solutions in mission-critical environments where there is simply no room for error. We combine engineering excellence with contamination control expertise to create cleanroom solutions for pharmaceutical, biotech, semiconductor, micro-electronic organizations and more. The driving force behind our approach is ATS president and founder Brian Flynn. A mechanical engineer by training, Brian spent nearly 15 years overhauling and refueling nuclear submarines, using engineering-based problem solving skills to resolve issues including preventing radiation contamination. It was in these highly sensitive environments that Brian honed his expertise in the identification and elimination of dangerous contaminants of all kinds. And it was there that he learned how important credentials, professionalism and commitment are to the process. He founded ATS with these priorities in mind. Today, all ATS technicians have engineering training and strong analytical skills. Most importantly, ATS technicians understand both the big-picture implications of cleanroom management and detailed interactions within controlled environments. As a result, they excel at troubleshooting and problem solving.

ATS offers services that support everything from cleanroom design to construction and final qualification. For example, ATS can:
– Analyze facilities, advise clients on contaminant control, and certify their facilities
– Capture airborne contaminants and analyze them
– Collect and grow contact samples to determine bacterial and fungal levels
– Investigate air flows, airborne contamination, HEPA filter integrity, room pressurization, temperature, and humidity to optimize operating parameters
– Issue certification reports that assess the health of a facility
– Create sterile environments

Atlantic Technical Systems (ATS)
P.O. Box 249 Annapolis, MD 21404
Phone: 410.507.2779
sales@atscert.com 443.223.5110

ENV Services, Inc.

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 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

IsoTech Design

IsoTech Design is a leader in designing and manufacturing of turnkey barrier isolators, RABS, microenvironments and clean air environments solutions. We also offer several Total Support Plans (TSPs) that will simplify and assure your compliance to USP 797. They include certification, technical support, SOP, a year supply of some consumables, and many more options; all to ensure the proper operation and compliance of the unit. Call customer service for more information. Our sister company Clean Air Essentials offers all the essentials necessary for sterile, chemo and hormone compounding that is required for USP 797 compliance.

IsoTech Design, Inc. (Head Office)
1320 Graham Blvd #120, Montreal QC. HP3 3C8 Canada
Ph : 514-956-1602 / Fax: 514-956-1032

IsoTech Design USA (US Distribution Center)
29 Distribution Way, #45, Plattsburg, New York 12901
Ph : 1-800-476-2010

Email: info@isotechdesign.com
www.isotechdesign.com

Lab797

Lab 797 works in conjunction with individual compounding facilities as well as certification companies across the country to perform environmental testing in cleanrooms and other designated areas. Specializing in microbial identification, Lab 797 offers reliable, cost-effective testing with quick turn-around times. We offer a variety of biological media for the recovery of viable organisms. All media distributed by LAB 797 is internally validated and subjected to growth promotion, ensuring you receive the highest quality products.

Services Include:

  • Analysis of air, surface and personnel sampling plates
  • Microbial identification to the genus/species level for both bacterial and fungal growths
  • Media-fill testing
  • Growth promotion
  • Trending CFU counts over time

Species-level identification (bacterial and fungal) is currently available for all viable organisms recovered. Detect and identify any highly pathogenic organism that may be present in your pharmacy. Preliminary reports are available within 48-72 hours.  Species-level identification delivered within 10 days.

At LAB 797 we strive to provide your pharmacy with the highest quality biological media and most rapid, accurate organism identification.

LAB 797
3985 S. Lincoln Ave.
Suite 204
Loveland, CO 80537
(970) 612-1970
Info@LAB797.com
www.lab797.com

Micro Filtrations, Inc.

Micro Filtrations, Inc. – Micro Filtrations, Inc. offers a full range of USP services. From consultation and design to testing and certification, our team of professionals is equipped with the knowledge and experience that can guide you through the process of achieving USP compliance. Our expert staff holds NSF, NEBB and CETA certifications.

Micro Filtrations, Inc.
491 N. State Rd. 434, Suite 125
Phone: 800-962-7973 Fax: 407-682-0843 / email: pyaros@mficertify.com
www.mficertify.com

Technical Safety Services, Inc. [TSS]

TSS is your best resource for USP compliance. From gap analysis to environmental monitoring, test, and certification services – the experts at TSS can help you navigate USP regulations to ensure your facility’s compliance. Contact TSS for more information, to schedule services, or to sign up for our FREE Guide to USP Compliance Webinar. Technical Safety Services, Inc. is ISO 9001 Certified, ISO 17025 Accredited, and staffs CETA credentialed RCCP-SC specialists as well as more NSF Accredited field technicians than any other service provider.

Technical Safety Services, Inc. [TSS]
Nationwide locations – online at www.techsafety.com
800.877.7742
info@techsafety.com

Equipment Planning

Equipment Planning, Inc.

Equipment Planning, Inc. is national company, headquartered in NYC 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.
1201 Broadway – 803, New York, NY 10001
800-974-3109
www.equipmentplanning.org
New York-Cincinnati-Charlotte

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
1201 Broadway – 803, New York, NY 10001,
Telephone : 800-974-3109
www.cardiologybusiness.org

ENV Services, Inc.

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 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

HospitalSafety.com

HospitalSafety.com is a privately-owned resource developed to help increase safety in the design, construction and operation of hospitals. A greater focus on hospital safety will lead to safer hospitals, which is in the interest of patients, staff and visitors. Greater emphasis on hospital safety leads to healthier and happier patients, staff and visitors. By focusing on hospital safety, hospital planners and administrators can transform the hospital environment into an important component of the healing process.

HospitalSafety.com
1201 Broadway – 803, New York, NY 10001
ph : 212–463-0800
www.hospitalsafety.com

Micro Filtrations, Inc.

Micro Filtrations, Inc. – Micro Filtrations, Inc. offers a full range of USP <797> services. From consultation and design to testing and certification, our team of professionals is equipped with the knowledge and experience that can guide you through the process of achieving USP <797> compliance. Our expert staff holds NSF, NEBB and CETA certifications.

Micro Filtrations, Inc.
491 N. State Rd. 434, Suite 125
Phone: 800-962-7973 Fax: 407-682-0843 / email: pyaros@mficertify.com
www.mficertify.com

Technical Safety Services, Inc. [TSS]

TSS is your best resource for USP compliance. From gap analysis to environmental monitoring, test, and certification services – the experts at TSS can help you navigate USP regulations to ensure your facility’s compliance. Contact TSS for more information, to schedule services, or to sign up for our FREE Guide to USP Compliance Webinar. Technical Safety Services, Inc. is ISO 9001 Certified, ISO 17025 Accredited, and staffs CETA credentialed RCCP-SC specialists as well as more NSF Accredited field technicians than any other service provider.

Technical Safety Services, Inc. [TSS]
Nationwide locations – online at www.techsafety.com
800.877.7742
info@techsafety.com

Pharmacy Design

Pharmacy Design

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
1201 Broadway – 803, New York, NY 10001,
Ph : 800-974-3109
www.pharmacydesign.org

Project Management

Empire Projects, Inc.

Empire Projects, Inc. is a project management company serving the healthcare industry, with a subspecialty in pharmacy project management. Pharmacy consulting team includes architects, engineers, construction managers and pharmacy operations consultants.

Empire Projects, Inc.
1201 Broadway – 803, New York, NY 10001,
800-974-3109
www.EmpireProjects.com
New York-Charlottesville-Los Angeles

Testing & Certification

AM Cleanroom Build and Performance

AM Cleanroom Build and Performance has helped develop the industry’s standard protocols for cleanroom testing and certification. With over 30 years of experience, and the NEBB Certification, the AM Technical Solutions Engineers and Technicians can identify and analyze cleanroom performance problems; and suggest the most effective solutions or self-perform the corrections. More than any other company in the industry, we understand cleanrooms from the inside out. Our Engineers and Technicians are experienced in the most sensitive environments such as ISO 14644, Class 1 through Class 100,000 (ISO3-ISO8) as well as cGMP facilities.

We are knowledgeable of the USP 797 and USP 800 requirements and have experience in working in these environments. This includes establishing routine cleanroom testing requirements that are performed semiannual and annually. We have 24 standardized tests that can be performed depending on the cleanroom class and process environment.
We conduct Viable Airborne Testing with customized test procedures and location based on each cleanrooms layout, use, and risk level. Sample extraction and testing via in house customer or laboratory testing. We have teams all over the US.

AM Cleanroom Build and Performance
2213 RR 620 N. Suite 105, Austin, Texas 78734
Phone: 214-287-0432
www.amcleanroombuild.com

Atlantic Technical Systems

ATS is known for providing cleanroom solutions in mission-critical environments where there is simply no room for error. We combine engineering excellence with contamination control expertise to create cleanroom solutions for pharmaceutical, biotech, semiconductor, micro-electronic organizations and more. The driving force behind our approach is ATS president and founder Brian Flynn. A mechanical engineer by training, Brian spent nearly 15 years overhauling and refueling nuclear submarines, using engineering-based problem solving skills to resolve issues including preventing radiation contamination. It was in these highly sensitive environments that Brian honed his expertise in the identification and elimination of dangerous contaminants of all kinds. And it was there that he learned how important credentials, professionalism and commitment are to the process. He founded ATS with these priorities in mind. Today, all ATS technicians have engineering training and strong analytical skills. Most importantly, ATS technicians understand both the big-picture implications of cleanroom management and detailed interactions within controlled environments. As a result, they excel at troubleshooting and problem solving.

ATS offers services that support everything from cleanroom design to construction and final qualification. For example, ATS can:
– Analyze facilities, advise clients on contaminant control, and certify their facilities
– Capture airborne contaminants and analyze them
– Collect and grow contact samples to determine bacterial and fungal levels
– Investigate air flows, airborne contamination, HEPA filter integrity, room pressurization, temperature, and humidity to optimize operating parameters
– Issue certification reports that assess the health of a facility
– Create sterile environments

Atlantic Technical Systems (ATS)
P.O. Box 249 Annapolis, MD 21404
Phone: 410.507.2779
sales@atscert.com 443.223.5110

ENV Services, Inc.

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

Medrep Technologies, Inc.

Medrep Technologies, Inc. was established in 1984, and since that time we have built a reputation for accuracy in testing, knowledge of procedures, and honesty in dealing with our customers. Medrep does not sell any equipment; our only concern is always the proper operation of your existing equipment. Yet, we maintain a working relationship with all the manufacturers, and are considered authorized by all the leading manufacturers of this equipment. Medrep Technologies, Inc. carries a full inventory of parts, including HEPA filters, motors, germicidal lamps, speed controls, fluorescent lamps, et cetera. All are available at a fair cost. Medrep Technologies, Inc. specializes in the inspection and certification of:
• Biological Safety Cabinets
• Laminar Flow Clean Benches
• Fume Hoods (ASHRAE 110 Testing)
• Clean Rooms
• Biological Containment Facilities
• Viable Sampling
• Biological Decontamination

Medrep Technologies, Inc.
PO Box 494273
Port Charlotte, FL 33949-2473
Office: (941) 627-8858
Fax: (941) 629-9698
For Service: service@medrep.us

Micro Filtrations, Inc.

Micro Filtrations, Inc. – Micro Filtrations, Inc. offers a full range of USP <797> services. From consultation and design to testing and certification, our team of professionals is equipped with the knowledge and experience that can guide you through the process of achieving USP <797> compliance. Our expert staff holds NSF, NEBB and CETA certifications.

Micro Filtrations, Inc.
491 N. State Rd. 434, Suite 125
Phone: 800-962-7973 Fax: 407-682-0843 / email: pyaros@mficertify.com
www.mficertify.com

Technical Safety Services, Inc. [TSS]

TSS is your best resource for USP compliance. From gap analysis to environmental monitoring, test, and certification services – the experts at TSS can help you navigate USP regulations to ensure your facility’s compliance. Contact TSS for more information, to schedule services, or to sign up for our FREE Guide to USP Compliance Webinar. Technical Safety Services, Inc. is ISO 9001 Certified, ISO 17025 Accredited, and staffs CETA credentialed RCCP-SC specialists as well as more NSF Accredited field technicians than any other service provider.

Technical Safety Services, Inc. [TSS]
Nationwide locations – online at www.techsafety.com
800.877.7742
info@techsafety.com

USP 800

USP800 Guru

USP800.guru is a privately-owned resource developed to aid public understanding of the USP 800 regulation developed by U.S. Pharmacopoeia, and its JCAHO-mandated schedule for implementation. What you will find on USP800.guru : USP 800 regulations – USP 800 vendors – USP 800 products – USP 800 articles – USP 800 cleanrooms – USP 800 barrier isolators – USP 800 software.

USP 800 Guru
1483 York Avenue – #20602, New York, NY 10021
800-974-3109
www.usp800.guru

Vendors