Decon Labs Inc., market leading manufacturer/supplier of disinfectants and cleaners made specifically for cleanrooms and compounding areas, offers a wide range of sterile alcohol, sterile disinfectants, pre-sat wipes, and cleaners that will help you achieve USP 797 compliance.
See: http://www.usp797.org/decons-70-ipa-and-purified-water-offered-in-both-sterile-and-standard-versions/
CiDehol ST is our sterile, 70% isopropyl alcohol, made with WFI (water-for-injection) water, filtered to 0.2µm and double-bagged in a class 100 cleanroom, irradiated to sterility assurance level of 10-6 and tested for sterility. Each case is shipped with a lot specific document detailing QC, irradiation, endotoxin and sterility. We also offer CiDehol 70 a standard 70% isopropyl alcohol product. Both come packaged in easy-to-use spray bottles and 1G refills.
AquaPur ST is our sterile, purified water for use in dilution of sterile disinfectants, manufacturing, general laboratory and cleanroom applications. AquaPur ST water is filtered to 0.2µm, irradiated to a SAL of 10-6 and tested for sterility and endotoxin. Each case of AquaPur ST ships with a lot specific document detailing QC, irradiation, endotoxin and sterility. Decon also offers a standard version of AquaPur purified water that has been tested to meet UPS/EP specifications for purified water. For laboratory or production applications requiring purified water. Both AquaPur and AquaPur ST are packaging in convenient point-of-use packaging.
All of our testing is completed using current USP test methods.
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
(800) 332-6647
(610) 755-0800
(610) 270-8905 FAX
FAX ORDERS to (610) 270-0808
Showing posts with label USP 797 Press Releases. Show all posts
Showing posts with label USP 797 Press Releases. Show all posts
Friday, November 27, 2015
Hutchins & Hutchins Inc. Celebrates 30 Years of Business
We would like to give a big THANK YOU to our dedicated employees, vendors, business colleagues and customers who have contributed so much to the success of our business. The professionalism, integrity and knowledge of our staff have made this company exceptional. We are grateful not only for our successful years in business, but also for the great relationships with everyone we work with. We look forward in continuing these valued relationships and have high optimism towards building new ones. We stand by our service and are proud to be Your Cleanroom Supplier.
Hutchins & Hutchins Inc.
39 Hutchwood Lane, Waynesboro VA, 22980
(TF) 1-800-554-4736
(P) 1-540-949-6663
(F) 1-540-949-9803
www.yourcleanroomsupplier.com
Hutchins & Hutchins Inc.
39 Hutchwood Lane, Waynesboro VA, 22980
(TF) 1-800-554-4736
(P) 1-540-949-6663
(F) 1-540-949-9803
www.yourcleanroomsupplier.com
Technical Safety Services, Inc. is Offering an Ongoing Educational Series for Pharmacists Involved in Aseptic Compounding
Technical Safety Services, Inc. [TSS] is pleased to offer an ongoing educational series for pharmacists involved in aseptic compounding. Pharmacists throughout North America recently attended the USP 797 Guide to Compliance for Sterile Compounding webinar, presented by TSS’ Andrew King on November 17, 2015.
See: http://www.usp797.org/technical-safety-services-inc/
Andrew King is the USP Compliance and Engineering Specialist for TSS, the largest cleanroom testing and certification company in North America. Andrew is credentialed as a Registered Cleanroom Certification Professional in Sterile Compounding (RCCP-SC) through CETA. He leads TSS’ training program for testing and certification at sterile compounding facilities.
The next USP 797 Guide to Compliance for Sterile Compounding webinar has been scheduled for May 3, 2016. Topics to be covered in this webinar include:
USP 797 & USP 800 regulation enforcement
How to determine what types of testing are needed
Designing and implementing a testing regimen
Investigation and remediation of detected contamination
The webinar is free to attend and open to all pharmacists and regulatory professionals. Learn more at techsafety.com/land/compounding.html or by calling 800.877.7742.
Technical Safety Services, Inc. [TSS]
Corporate Headquarters
620 Hearst Avenue
Berkeley, California 94710
800.877.7742
info@techsafety.com
Nationwide locations – online at www.techsafety.com
See: http://www.usp797.org/technical-safety-services-inc/
Andrew King is the USP Compliance and Engineering Specialist for TSS, the largest cleanroom testing and certification company in North America. Andrew is credentialed as a Registered Cleanroom Certification Professional in Sterile Compounding (RCCP-SC) through CETA. He leads TSS’ training program for testing and certification at sterile compounding facilities.
The next USP 797 Guide to Compliance for Sterile Compounding webinar has been scheduled for May 3, 2016. Topics to be covered in this webinar include:
USP 797 & USP 800 regulation enforcement
How to determine what types of testing are needed
Designing and implementing a testing regimen
Investigation and remediation of detected contamination
The webinar is free to attend and open to all pharmacists and regulatory professionals. Learn more at techsafety.com/land/compounding.html or by calling 800.877.7742.
Technical Safety Services, Inc. [TSS]
Corporate Headquarters
620 Hearst Avenue
Berkeley, California 94710
800.877.7742
info@techsafety.com
Nationwide locations – online at www.techsafety.com
Saturday, February 9, 2013
Techniglove International Presents STN200P Series
Techniglove International
Sterile, Pair Packed, Powder Free, Class 100 Cleanroom Glove, Nitrile 12”, White
Techniglove’s new Latex Free STN200P Series meets requirements for USP 797 and Chemotherapy Drug Applications (see below for a complete list of approved drugs).
The sterile (gamma irradiated) STN200P is L/R pair-packed, 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.
Lot numbers and expiration dates are displayed on all levels of packaging and Certificate of Irradiaiton is provided both with product shipment and online at www.techniglove.com/COI
Techniglove Cleanroom Nitrile Gloves are double-Chlorinated, 100% nitrile, contain no natural rubber or silicone and meet the most stringent requirements for extractables and particles. They contain less than the allowable 20 EU/Device and are suitable for use in Pharmaceutical and Biotech manufacturing. All Techniglove products are manufactured in a Registered ISO9002 Facility.
Available in size XS-XXL (STN200P-STN205P).
1 Pair per Wallet, 20 Wallets per Master Bag, 200 Pairs per Case
******************
Additional USP 797 news can be found on the USP 797 website www.usp797.org - and the USP 797 blog http://www.usp797org.blogspot.com/ - and the USP 797 Twitter account www.twitter.com/usp797
Additional pharmacy design news can be found on the pharmacy design websitewww.pharmacydesign.org – and the pharmacy design Twitter account https://twitter.com/pharmacydesign
Acute Care Pharmaceutical Disposable Medical Products
For over 15 years, Acute Care Pharmaceuticals has been servicing the healthcare industry by delivering exceptional products and services to healthcare providers nationwide. Our disposable medical products are manufactured under the highest standards, resulting in reliable and compliant USP <797> disposable products.
We can supply your facility with the correct disposable products and the knowledge necessary to support the operation of your cleanroom facility and/or barrier isolator set up.
Our Pharma™-Brand products are available through Cardinal, McKesson, Amerisource Bergen, and online at new website, www.Pharma-Choice.com.
Contact: Director of Marketing
12225 World Trade Drive Suite A
San Diego, California 92128
E: Info@acutecareonline.com
P: 1.888.909.7700
***********************
Additional USP 797 news can be found on the USP 797 website www.usp797.org - and the USP 797 blog http://www.usp797org.blogspot.com/ - and the USP 797 Twitter account www.twitter.com/usp797
Additional pharmacy design news can be found on the pharmacy design websitewww.pharmacydesign.org – and the pharmacy design Twitter account https://twitter.com/pharmacydesign
Pharmacy Design Project Out To Bid for New Hospital Pharmacy in New York State
Pharmacy design architect Bernstein & Associates, Architects (http://bernarch.com/Healthcare-Design-Pharmacy/) is pleased to announce that a new hospital pharmacy, designed for a major teaching hospital, is now out to bid.
Pharmacy design services included: pharmacy planning, pharmacy design, pharmacy equipment planning, architectural and engineering services for the new pharmacy, pharmacy construction bidding, and pharmacy construction.
The pharmacy design project is for a complete new hospital pharmacy. The project includes all new: receiving, dispensing and compounding suite. Compounding suite includes: USP 797 compliant anteroom, new USP 797 compliant hazardous compounding room, and new USP 797 compliant non-hazardous compounding room.
About Bernstein & Associates, Architects (www.bernarch.com):
Bernstein & Associates, Architects has specialized in healthcare and lab design and construction since the firm's founding in 1990. This architecture firm is well-known for pharmacy planning, pharmacy design and pharmacy construction, including USP 797 compliant pharmacy design and construction. The firm's principal --- William N. Bernstein, AIA --- is a well-known architect of pharmacies. He has written extensively on pharmacy design and construction including USP 797 compliant pharmacies. Mr. Bernstein's USP 797 articles can be found on the USP 797 website www.usp797.org, and his pharmacy design articles can be found on the pharmacy design website www.pharmacydesign.org.
For more information about pharmacy design and pharmacy construction, contact Bernstein & Associates, Architects at:
New York (Headquarters)
Bernstein & Associates, Architects
1201 Broadway - #803, New York, NY 10001
T: 212-463-8200
F: 888-214-0670
www.bernarch.com
Also in Hartford, Princeton and Los Angeles
EMLab P&K’s Risk Assessment Pathogen Program
Dr. Joseph Manfrida from EMLab P&K’s Risk Assessment Pathogen Program begins collaboration with TestAmerica’s Ask the Expert webinar series
Dr. Joseph Manfrida has begun working with the TestAmerica Ask the Expert webinar series to bring additional opportunities for education to interested professionals. Originally known for his acclaimed presentations in bacteriology, nosocomial mycoses, and USP <797>, Dr. Manfrida is now presenting alongside the scientists of TestAmerica to create opportunities to discuss additional topics.
The Science and Ambiguity of Asbestos, will be presented on October 25th, 2012. The nature of asbestos, the threat it poses to human health, and the technologies available to investigate its presence are frequently misunderstood. Dr. Manfrida will be discussing the science behind asbestos contamination and how it interacts with the medical, legal, and technical aspects of detecting and removing the contaminate. Webinar attendees will leave with a greater understanding of the motivation and reasoning behind current practices regarding asbestos.
Course topics include:
• The controversy surrounding the definition of asbestos as well as give the current operative definition delineated by NIOSH
• Identifying the major types of asbestos
• Major medical conditions resulting from asbestos exposure and current hypotheses regarding how pathologies develop
• Current federal regulations applying to asbestos, including recommended exposure limits
• Technologies for asbestos testing
• Future goals of NIOSH asbestos research and regulation
Register at: http://www.testamericainc.com/services/webinar_series.aspx
Dr. Manfrida will discuss USP <797> on August 2nd, 2012. This USP <797> training course provides information regarding the background and purpose of USP <797> and will discuss designing and executing a USP <797> sampling regimen.
USP <797> course topics include:
• History and background of USP <797>
• Where USP <797> regulation applies
• Determining what types of testing are needed
• Designing a testing regimen
• Interpreting data
• Investigation and remediation of contamination *****************Additional USP 797 news can be found on the USP 797 website www.usp797.org - and the USP 797 blog http://www.usp797org.blogspot.com/ - and the USP 797 Twitter account www.twitter.com/usp797
The Science and Ambiguity of Asbestos, will be presented on October 25th, 2012. The nature of asbestos, the threat it poses to human health, and the technologies available to investigate its presence are frequently misunderstood. Dr. Manfrida will be discussing the science behind asbestos contamination and how it interacts with the medical, legal, and technical aspects of detecting and removing the contaminate. Webinar attendees will leave with a greater understanding of the motivation and reasoning behind current practices regarding asbestos.
Course topics include:
• The controversy surrounding the definition of asbestos as well as give the current operative definition delineated by NIOSH
• Identifying the major types of asbestos
• Major medical conditions resulting from asbestos exposure and current hypotheses regarding how pathologies develop
• Current federal regulations applying to asbestos, including recommended exposure limits
• Technologies for asbestos testing
• Future goals of NIOSH asbestos research and regulation
Register at: http://www.testamericainc.com/services/webinar_series.aspx
Dr. Manfrida will discuss USP <797> on August 2nd, 2012. This USP <797> training course provides information regarding the background and purpose of USP <797> and will discuss designing and executing a USP <797> sampling regimen.
USP <797> course topics include:
• History and background of USP <797>
• Where USP <797> regulation applies
• Determining what types of testing are needed
• Designing a testing regimen
• Interpreting data
• Investigation and remediation of contamination *****************Additional USP 797 news can be found on the USP 797 website www.usp797.org - and the USP 797 blog http://www.usp797org.blogspot.com/ - and the USP 797 Twitter account www.twitter.com/usp797
Additional pharmacy design news can be found on the pharmacy design websitewww.pharmacydesign.org – and the pharmacy design Twitter account https://twitter.com/pharmacydesign
Contec, Inc. Introduces QuicKlean™ Mop System with MicroGenesis™ Wipe
QuicKlean™ System makes ordering more convenient and economical.
Since its inception, the USP<797> market has struggled to find mopping systems to address their unique demands. Pharmacies have had to use products that are inadequate or considered excessive for use in their environments. The challenge that has been brought to our attention is to find ISO Class 7 cleanroom compatible materials that are not cost prohibitive and incorporate easy to use components. Pharmacies also need a system flexible enough to address all the USP<797> needs which include daily floor maintenance coupled with monthly ceiling and wall maintenance.
Contec worked with pharmacy technicians, buyers and directors to develop a system that meets all the USP<797> requirements. The result is the QuicKlean Mopping System. The new QuicKlean Mop System allows customers to use one part number for a smaller order of mop foam heads and covers - two bags of 50 MicroGenesis wipes, six foam mop heads. This is ideal for smaller pharmacies, labs and other critical areas where storage and space can be an issue. QuicKlean offers excellent performance, flexibility, convenience and affordability.
The QuicKlean™ Mop System is used with the latest microfiber wipe from Contec – the MicroGenesis™ wipe. MicroGenesis is a laundered microfiber wipe that is cut to 10” x 18” (25 x 46cm) so it can fit easily with the QuicKlean Mop System. Safe for use with most disinfectants, this system delivers the maximum amount of microfiber to pick-up and retain particles, dust, and other contaminants in cleanrooms and other critical applications.
For more information, please call 864-503-8333 or go to www.contecinc.com.
Contec worked with pharmacy technicians, buyers and directors to develop a system that meets all the USP<797> requirements. The result is the QuicKlean Mopping System. The new QuicKlean Mop System allows customers to use one part number for a smaller order of mop foam heads and covers - two bags of 50 MicroGenesis wipes, six foam mop heads. This is ideal for smaller pharmacies, labs and other critical areas where storage and space can be an issue. QuicKlean offers excellent performance, flexibility, convenience and affordability.
The QuicKlean™ Mop System is used with the latest microfiber wipe from Contec – the MicroGenesis™ wipe. MicroGenesis is a laundered microfiber wipe that is cut to 10” x 18” (25 x 46cm) so it can fit easily with the QuicKlean Mop System. Safe for use with most disinfectants, this system delivers the maximum amount of microfiber to pick-up and retain particles, dust, and other contaminants in cleanrooms and other critical applications.
For more information, please call 864-503-8333 or go to www.contecinc.com.
**************
Additional USP 797 news can be found on the USP 797 website www.usp797.org - and the USP 797 blog http://www.usp797org.blogspot.com/ - and the USP 797 Twitter account www.twitter.com/usp797
Additional pharmacy design news can be found on the pharmacy design website www.pharmacydesign.org – and the pharmacy design Twitter account https://twitter.com/pharmacydesign
Additional pharmacy design news can be found on the pharmacy design website www.pharmacydesign.org – and the pharmacy design Twitter account https://twitter.com/pharmacydesign
Charlotte Safety & CleanroomSupplyConnection.com Expand USP797 Division
Charlotte Safety and CleanroomSupplyConnection.com have expanded their compounding pharmacy and cleanroom product offerings due to recent growth and need of their pharmacy clients. We are now an authorized dealer of SPS Medical sterilization products as well as Criti Clean cleanroom wipes and cleanroom clothing. Charlotte Safety is a master stocking distributor of all cleanroom supplies and products needed for the largest compounding pharmacies – both independent as well as hospital pharmacies. We offer special pricing on cleanroom mops,cleanroom disinfectants, cleanroom clothing, cleanroom presaturated wipes, tacky floor mats,cleanroom swabs and everything else you need to keep your cleanroom in top shape. We work with the country’s most well respected research and pharmaceutical facilities and offer expert advice on supplies, USP 797 protocol and streamlining your cleanroom supply inventory.
We also stock sterile cleanroom supplies including sterile cleanroom coveralls, sterile cleanroom sleeves, sterile face masks and sterile cleanroom paper.
Please visit us online at www.CleanroomSupplyConnection.com or call our toll free phone at 1-800-616-5319.
Contact:
Peter Lojac
Charlotte Safety & CleanroomSupplyConnection.com
P 516.596.8781
F 516.596.8619
E Sales@CleanroomSupplyConnection.com
***************
Additional USP 797 news can be found on the USP 797 website www.usp797.org - and the USP 797 blog http://www.usp797org.blogspot.com/ - and the USP 797 Twitter account www.twitter.com/usp797
Additional pharmacy design news can be found on the pharmacy design website www.pharmacydesign.org – and the pharmacy design Twitter account https://twitter.com/pharmacydesign
Saturday, May 8, 2010
Water System Biofil Testing by Aemtek
[Press Release] 2010.5.8
Aemtek offers in-depth training on water system biofilm
All pharmaceutical, biologics, and medical device facilities are likely to have high purity water systems. In spite of this overt absence of nutrients, microorganisms growing as biofilms can flourish within these systems and lead to undesirable contamination of facility processes and their products. In order to limit the bacteria that may be in the water, one has to understand and control the development of biofilms in the water system. Aemtek offers a two-day course that is designed to provide an in-depth look at how biofilm affects all aspects of water systems, including design, operation, validation, monitoring, sanitization, and excursion investigations. Right and wrong approaches will be discussed along with tips on how to minimize excursions as well as how to perform contamination investigations with example case studies to reinforce this learning.
The course will be taught by renowned industry expert, Dr. TERI C. (“T.C.”) SOLI. Dr. Soli has been consulting for 15 years with training and troubleshooting expertise covering water systems, sterilization, aseptic processing, and validation. He is Vice-Chair of the USP Pharmaceutical Waters Expert Committee and has authored several ISPE and PDA book chapters, papers, and USP Monographs and Chapter revisions, including his complete rewrite of USP’s “water bible”, Chapter <1231>.
This comprehensive course is titled "EVERYTHING YOU NEED TO KNOW ABOUT WATER SYSTEM BIOFILM" and will be held on JUNE 16TH — 17TH, 2010 at AEMTEK TRAINING ROOM, 46309 WARM SPRINGS BLVD., FREMONT, CA 94539. For more information, visit http://www.aemtek.com/training or email training@aemtek.com.
About Aemtek
Aemtek, Inc. is an accredited microbiological testing and research laboratory providing services to multiple industries, including environmental, food, pharmaceutical and compounding pharmacies. We specialize in detection, identification and analysis of fungi and bacteria, using morphological, physiological, biochemical, and molecular methods. Aemtek has repeatedly demonstrated competence and integrity throughout all of our interactions with the regulatory agencies and our customers. Aemtek’s accurate, fast, and reliable laboratory services save you both time and money. Our commitment to scientific excellence, quality service, and advanced technology assures our clients that their projects are done right the first time, every time, on time. Contact information: AEMTEK, INC., 46309 Warm Springs Blvd., Fremont, CA 94539, Phone: 510-979-1979, Fax: 510-668-1980 Email: lab@aemtek.com, web: www.aemtek.com.
Aemtek offers in-depth training on water system biofilm
All pharmaceutical, biologics, and medical device facilities are likely to have high purity water systems. In spite of this overt absence of nutrients, microorganisms growing as biofilms can flourish within these systems and lead to undesirable contamination of facility processes and their products. In order to limit the bacteria that may be in the water, one has to understand and control the development of biofilms in the water system. Aemtek offers a two-day course that is designed to provide an in-depth look at how biofilm affects all aspects of water systems, including design, operation, validation, monitoring, sanitization, and excursion investigations. Right and wrong approaches will be discussed along with tips on how to minimize excursions as well as how to perform contamination investigations with example case studies to reinforce this learning.
The course will be taught by renowned industry expert, Dr. TERI C. (“T.C.”) SOLI. Dr. Soli has been consulting for 15 years with training and troubleshooting expertise covering water systems, sterilization, aseptic processing, and validation. He is Vice-Chair of the USP Pharmaceutical Waters Expert Committee and has authored several ISPE and PDA book chapters, papers, and USP Monographs and Chapter revisions, including his complete rewrite of USP’s “water bible”, Chapter <1231>.
This comprehensive course is titled "EVERYTHING YOU NEED TO KNOW ABOUT WATER SYSTEM BIOFILM" and will be held on JUNE 16TH — 17TH, 2010 at AEMTEK TRAINING ROOM, 46309 WARM SPRINGS BLVD., FREMONT, CA 94539. For more information, visit http://www.aemtek.com/training or email training@aemtek.com.
About Aemtek
Aemtek, Inc. is an accredited microbiological testing and research laboratory providing services to multiple industries, including environmental, food, pharmaceutical and compounding pharmacies. We specialize in detection, identification and analysis of fungi and bacteria, using morphological, physiological, biochemical, and molecular methods. Aemtek has repeatedly demonstrated competence and integrity throughout all of our interactions with the regulatory agencies and our customers. Aemtek’s accurate, fast, and reliable laboratory services save you both time and money. Our commitment to scientific excellence, quality service, and advanced technology assures our clients that their projects are done right the first time, every time, on time. Contact information: AEMTEK, INC., 46309 Warm Springs Blvd., Fremont, CA 94539, Phone: 510-979-1979, Fax: 510-668-1980 Email: lab@aemtek.com, web: www.aemtek.com.
Saturday, March 20, 2010
New USP 797 Postings on Twitter
New USP 797 Twitter Account
USP797.org, Inc. is pleased to announce that a new Twitter account has been estbalished devoted exclusively to USP 797 news. Follow USP 797 on Twitter at www.twitter.com/usp797.
About USP 797:
USP797.org, Inc. is the only pharmacy consulting company in the United States that is focused exclusively on USP 797 guidelines, USP 797 standards, and USP 797 compliance. The firm provides USP 797 consulting, as well as USP 797 information through its well known USP 797 website www.usp797.org.
Amongst the USP 797 topics addressed on www.usp797.org, are the following: usp 797, sterile compounding, compounding sterile, usp 797 guidelines, usp 797 standards, usp chapter 797, compounding sterile preparations, usp797, usp 797 pdf, usps 797, usp 797 summary, biosafety cabinet class, and usp 797 regulations.
For further information about USP 797, please go to the website www.usp797.org, or contact USP797.org, Inc. at:
USP797.org, Inc.
59 West 19th Street – 6a, New York, NY 10011
T: 212.463.0800
F: 212.463.9898
E: info@usp797.org
W: www.usp797.org
USP797.org, Inc. is pleased to announce that a new Twitter account has been estbalished devoted exclusively to USP 797 news. Follow USP 797 on Twitter at www.twitter.com/usp797.
About USP 797:
USP797.org, Inc. is the only pharmacy consulting company in the United States that is focused exclusively on USP 797 guidelines, USP 797 standards, and USP 797 compliance. The firm provides USP 797 consulting, as well as USP 797 information through its well known USP 797 website www.usp797.org.
Amongst the USP 797 topics addressed on www.usp797.org, are the following: usp 797, sterile compounding, compounding sterile, usp 797 guidelines, usp 797 standards, usp chapter 797, compounding sterile preparations, usp797, usp 797 pdf, usps 797, usp 797 summary, biosafety cabinet class, and usp 797 regulations.
For further information about USP 797, please go to the website www.usp797.org, or contact USP797.org, Inc. at:
USP797.org, Inc.
59 West 19th Street – 6a, New York, NY 10011
T: 212.463.0800
F: 212.463.9898
E: info@usp797.org
W: www.usp797.org
Sunday, February 28, 2010
USP 797 Consulting Completes New USP 797 Consulting Assignment
For Immediate Release (02/28/10)
USP 797 Consulting Firm Selected to Provide USP797 Consulting on New Pharmacies in New York
USP797.org, Inc., the only consulting company in the United States focused exclusively on USP 797, is pleased to announce that it recently completed a USP 797 consulting assignment on two new sterile compounding pharmacies in New York.
The two pharmacies, which will be compounding sterile products in separate chemotherapy compounding and non-chemotherapy compounding rooms, required consulting on whether their pharmacy plans and proposed pharmacy equipment, met current USP 797 guidelines. Well known pharmacy design architect William N. Bernstein, AIA led the consulting assignment. The analysis revealed that there were a number of areas where improvements in the project could be made to meet USP 797 guidelines. Amongst the areas identified: selection of USP 797 compliant pharmacy equipment, revisions of HVAC pressurization relationships, and additional USP 797 planning suggestions regarding appropriate pharmacy dimensions, flow and materials.
About USP 797:
USP797.org, Inc. is the only pharmacy consulting company in the United States that is focused exclusively on USP 797 guidelines, USP 797 standards, and USP 797 compliance. The firm provides USP 797 consulting, as well as USP 797 information through its well known USP 797 website www.usp797.org.
Amongst the USP 797 topics addressed on www.usp797.org, are the following: usp 797, sterile compounding, compounding sterile, usp 797 guidelines, usp 797 standards, usp chapter 797, compounding sterile preparations, usp797, usp 797 pdf, usps 797, usp 797 summary, biosafety cabinet class, and usp 797 regulations.
For further information about USP 797, please go to the website www.usp797.org, or contact USP797.org, Inc. at:
USP797.org, Inc.
59 West 19th Street – 6a, New York, NY 10011
T: 212.463.0800
F: 212.463.9898
E: info@usp797.org
W: www.usp797.org
USP 797 Consulting Firm Selected to Provide USP797 Consulting on New Pharmacies in New York
USP797.org, Inc., the only consulting company in the United States focused exclusively on USP 797, is pleased to announce that it recently completed a USP 797 consulting assignment on two new sterile compounding pharmacies in New York.
The two pharmacies, which will be compounding sterile products in separate chemotherapy compounding and non-chemotherapy compounding rooms, required consulting on whether their pharmacy plans and proposed pharmacy equipment, met current USP 797 guidelines. Well known pharmacy design architect William N. Bernstein, AIA led the consulting assignment. The analysis revealed that there were a number of areas where improvements in the project could be made to meet USP 797 guidelines. Amongst the areas identified: selection of USP 797 compliant pharmacy equipment, revisions of HVAC pressurization relationships, and additional USP 797 planning suggestions regarding appropriate pharmacy dimensions, flow and materials.
About USP 797:
USP797.org, Inc. is the only pharmacy consulting company in the United States that is focused exclusively on USP 797 guidelines, USP 797 standards, and USP 797 compliance. The firm provides USP 797 consulting, as well as USP 797 information through its well known USP 797 website www.usp797.org.
Amongst the USP 797 topics addressed on www.usp797.org, are the following: usp 797, sterile compounding, compounding sterile, usp 797 guidelines, usp 797 standards, usp chapter 797, compounding sterile preparations, usp797, usp 797 pdf, usps 797, usp 797 summary, biosafety cabinet class, and usp 797 regulations.
For further information about USP 797, please go to the website www.usp797.org, or contact USP797.org, Inc. at:
USP797.org, Inc.
59 West 19th Street – 6a, New York, NY 10011
T: 212.463.0800
F: 212.463.9898
E: info@usp797.org
W: www.usp797.org
Wednesday, January 14, 2009
New USP 797 Newsletter Introduced into Pharmacy Community
A new usp 797 newsletter has been published by usp797.org. The initial issue was published in January 2009, and included press releases by usp 797 vendors (Bernstein & Associates, Architects, and RJLG), a sample usp 797 question and answer (concerning the use of two different style hoods in the same area), and a list of current usp 797 vendors. To subscribe to the usp 797 newsletter, send a request to info@usp797.org, with contact info and "request usp 797 newsletter" in email subject.
Saturday, November 29, 2008
AIHA Creates New Workgroup to Study USP 797
11/24/08: American Industrial Hygiene Association Creates New Workgroup to Study USP 797. Mission: Mission: Share information on the safe and healthful preparation and/or administration of healthcare involving hazardous or sterile pharmaceuticals; Develop model risk-based programs for the handling of hazardous drugs and/or sterile preparations; Develop models for the incorporation of risk-based programs that mesh patient safety and health, quality assurance, occupational health and safety, and environmental control into a facility continuous improvement program; Develop audit tools for simultaneously assuring patient safety and health, quality assurance, occupational health and safety, and environmental control; Expand the understanding of industrial hygiene issues in healthcare facilities.Project Team Lead:
Lawrence H. Hecker, CIH, PhD
Matthew L. Berkheiser, CSP
Richard D. Bennett, MSPH, CIH
Suzanne S. Blevins
Curtis E. Cannell, CIH
Sumati Dhawan
Brian E Hroch, CIH
J. Daniel James, CIH
Martin L. Jones, PhD, CIH, CSP
John F. Koerner, CIH
Thomas D. Murphy, CIH,CSP,CHMM
Leo T. Old, CIH,PE
John N. Rice
Shirley A. Smith, ASCP
Marissa L. Vieno
Shelley R. Wheeling-Park, MPH, CHMM, CSP, CIH
Matthew M. Winn
Sandra L. Witek-Eames For more information: http://www.aiha.org/Content/InsideAIHA/Volunteer+Groups/USP797.htm
Lawrence H. Hecker, CIH, PhD
Matthew L. Berkheiser, CSP
Richard D. Bennett, MSPH, CIH
Suzanne S. Blevins
Curtis E. Cannell, CIH
Sumati Dhawan
Brian E Hroch, CIH
J. Daniel James, CIH
Martin L. Jones, PhD, CIH, CSP
John F. Koerner, CIH
Thomas D. Murphy, CIH,CSP,CHMM
Leo T. Old, CIH,PE
John N. Rice
Shirley A. Smith, ASCP
Marissa L. Vieno
Shelley R. Wheeling-Park, MPH, CHMM, CSP, CIH
Matthew M. Winn
Sandra L. Witek-Eames For more information: http://www.aiha.org/Content/InsideAIHA/Volunteer+Groups/USP797.htm
USP Releases Chapter 797 Revision
"USP Releases Chapter 797 Revision", (c) Cheryl Thompson, Health-System Pharmacy News, 3/12/07
LAS VEGAS, NV, 03 December 2007 — The new version of United States Pharmacopeia (USP) chapter 797, "Pharmaceutical Compounding—Sterile Preparations," became publicly available today and goes into effect June 1, 2008.
For a limited time, U.S. Pharmacopeia stated, the new version of the chapter on compounded sterile preparations (CSPs) is accessible for no fee at www.usp.org/USPNF/pf/generalChapter797.html. This free offering ends January 1 when USP <797> Guidebook to Pharmaceutical Compounding—Sterile Preparations goes on sale.
The standards-setting organization said the current version of chapter 797, as it appears in The United States Pharmacopeia, 31st Revision, and The National Formulary, 26th Edition, remains the official text until publication of the edition's second supplement, scheduled for June 1, 2008.
The text of the new version is not entirely identical to the proposed revision published in May 2006. For example, the proposed section "Environmental Monitoring" was deleted and the content incorporated elsewhere. The new version has the subsection "Depyrogenation by Dry Heat," whereas the proposed revision did not.
In revising USP chapter 797 from the original text, the organization's Sterile Compounding Expert Committee added the following sections:
Definitions,
Intermediate-Use CSPs,
Single-Dose and Multiple-Dose Containers,
Hazardous Drugs as CSPs,
Radiopharmaceuticals as CSPs,
Allergen Extracts as CSPs,
Personnel Training and Competency Evaluation of Garbing, Aseptic Work Practices, and Cleaning/Disinfection Procedures,
Elements of Quality Control, and
Abbreviations and Acronyms.
The committee also created the section "Maintaining Sterility, Purity and Stability of Dispensed and Distributed CSPs" from the former "Maintaining Product Quality and Control after the CSP Leaves the Pharmacy" and added four appendixes.
"ASHP is pleased," said Cynthia Reilly, ASHP's director of clinical standards and quality, "that USP has released the much-anticipated revisions to chapter 797 to give practitioners time to prepare for when that document becomes official in June.
"The timing also provides ASHP an excellent opportunity to provide valuable information to our members—both here at MCM, at the Midyear Clinical Meeting, via educational sessions taught by experts who were involved in the revision and also on an ongoing basis through our practice standard, Guidelines on Quality Assurance for Pharmacy-Prepared Sterile Products.
"We'll be reviewing the new USP document carefully with an eye towards creating tools and resources that will help our members comply with state board of pharmacy regulations and accreditation standards that might be impacted by the USP changes," Reilly said.
LAS VEGAS, NV, 03 December 2007 — The new version of United States Pharmacopeia (USP) chapter 797, "Pharmaceutical Compounding—Sterile Preparations," became publicly available today and goes into effect June 1, 2008.
For a limited time, U.S. Pharmacopeia stated, the new version of the chapter on compounded sterile preparations (CSPs) is accessible for no fee at www.usp.org/USPNF/pf/generalChapter797.html. This free offering ends January 1 when USP <797> Guidebook to Pharmaceutical Compounding—Sterile Preparations goes on sale.
The standards-setting organization said the current version of chapter 797, as it appears in The United States Pharmacopeia, 31st Revision, and The National Formulary, 26th Edition, remains the official text until publication of the edition's second supplement, scheduled for June 1, 2008.
The text of the new version is not entirely identical to the proposed revision published in May 2006. For example, the proposed section "Environmental Monitoring" was deleted and the content incorporated elsewhere. The new version has the subsection "Depyrogenation by Dry Heat," whereas the proposed revision did not.
In revising USP chapter 797 from the original text, the organization's Sterile Compounding Expert Committee added the following sections:
Definitions,
Intermediate-Use CSPs,
Single-Dose and Multiple-Dose Containers,
Hazardous Drugs as CSPs,
Radiopharmaceuticals as CSPs,
Allergen Extracts as CSPs,
Personnel Training and Competency Evaluation of Garbing, Aseptic Work Practices, and Cleaning/Disinfection Procedures,
Elements of Quality Control, and
Abbreviations and Acronyms.
The committee also created the section "Maintaining Sterility, Purity and Stability of Dispensed and Distributed CSPs" from the former "Maintaining Product Quality and Control after the CSP Leaves the Pharmacy" and added four appendixes.
"ASHP is pleased," said Cynthia Reilly, ASHP's director of clinical standards and quality, "that USP has released the much-anticipated revisions to chapter 797 to give practitioners time to prepare for when that document becomes official in June.
"The timing also provides ASHP an excellent opportunity to provide valuable information to our members—both here at MCM, at the Midyear Clinical Meeting, via educational sessions taught by experts who were involved in the revision and also on an ongoing basis through our practice standard, Guidelines on Quality Assurance for Pharmacy-Prepared Sterile Products.
"We'll be reviewing the new USP document carefully with an eye towards creating tools and resources that will help our members comply with state board of pharmacy regulations and accreditation standards that might be impacted by the USP changes," Reilly said.
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