usp 797 consulting services

www.usp797.org, inc. is a privately owned company, committed to public education and consulting on the usp 797 regulation.

We have been at the forefront of the usp797 regulation since 2005. Our website --- www.usp797.org – was launched in 2005, and is updated regularly.

usp797.org, inc. provides consulting to pharmacy clients, looking to upgrade or maintain their conformance to all of the latest usp 797 guidelines. Our consulting team has been built utilizing only the most knowledgeable and experienced professionals in the pharmaceutical industry, all of whom have a significant sub-specialty in the area of usp 797 theory and implementation.

Amongst the usp 797 consulting services offered by www.usp797.org, inc. are: architecture, engineering, construction, project management, analytical testing, recommendation of cleanroom products and contamination control, design/build, compliance action plans, environmental monitoring, software, and testing & certification.

Please note: usp797.org, inc. supports the important work of the USP, but has no affiliation with USP.

For further information about usp 797 consulting, please contact:

usp797.org, inc.
59 West 19th St. - 6A, NY, NY 10011
Telephone : 212-463-0800
Fax : 212-463-9898
Email : info@usp797.org

New Pharmacy Design Website Now Online

For Immediate Release (06/12/09)

Pharmacy Design (www.pharmacydesign.org) is a comprehensive new pharmacy website that is now online. The site will be useful to pharmacists, pharmacy vendors, pharmacy administrators, pharmacy managers, and pharmacy students.

Pharmacy Design is a comprehensive source for pharmacy owners, or managers, looking to upgrade their facility to a state-of-the-art pharmacy environment.

Why Pharmacy Design?

Are you interested in upgrading your pharmacy (either a hospital pharmacy or community health center pharmacy or retail pharmacy) to create a more functional, efficient, and appealing pharmacy environment? A facility that is also focused on patient and staff safety?

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.

For more information about pharmacy design and construction, including usp 797 compliant pharmacy design, visit Pharmacy Design (www.pharmacydesign.org).

New Article Published on Pharmacy Design

For Immediate Release (06/10/09)

New Article Published on Trends in Pharmacy Design and Operations

Bernstein & Associates, Architects is pleased to announce the publication of an article on recent trends in pharmacy design and pharmacy planning.

The article was published in the June 2009 edition of Pharmacy Design, the pharmacy design and pharmacy planning website, located at www.pharmacydesign.org.

The article discusses the latest trends in pharmacy design in the following areas:
- Pharmacy design has been undergoing dramatic changes in recent years
- A main trend has been the need to modernize and automate the production, packaging, distribution, and provision of drugs, particularly of prescription drugs, which have to be monitored and secured at all times.
- Clients looking to design a pharmacy will want to be cognizant of these trends.
- The movement towards pharmacy automation has been spurred by a number of factors
- The new electronic systems mean fewer medication errors and tighter security, not to mention more reliably safe drugs.
- Successful pharmacy plans from now on
- Clean rooms in pharmacies
- USP 797 for pharmacies
- automated drug management
- Pharmacy automation equipment within the pharmacy
- Swisslog PillPick
- McKesson ROBOT-Rx
- Pharmacy automation equipment connecting the pharmacy to other hospital departments
- Pyxis Medstation
- Bedside pharmacy dispensers
- Pneumatic tube systems in the pharmacy
- Future of the retail pharmacy
- Latest trends in retail pharmacy interior design

About Bernstein & Associates, Architects:

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 architecture, including a sub-specialty in usp 797 compliant pharmacy design and construction. The firm has designed over twenty new pharmacies, pharmacy renovations, and pharmacy relocations in the past five years. The firm is featured on the pharmacy design website, www.pharmacydesign.org, and the usp 797 website, www.usp797.org. The firm's principal --- William N. Bernstein, LEED®AP, AIA --- is a well known pharmacy architect. He has written extensively on pharmacy design and pharmacy construction including usp 797 compliant pharmacies. Mr. Bernstein's pharmacy design articles can be found on www.pharmacydesign.org, and his usp 797 articles can be found on the usp 797 website www.usp797.org.

For more information about healthcare and hospital design and construction, including pharmacy design and construction, contact Bernstein & Associates, Architects at:

Bernstein & Associates, Architects - PLLC
59 West 19th Street - 6A, NY, NY 10011
T: 212.463.8200
F: 212.463.9898
E: info@bernarch.com
www.bernarch.com
NEW YORK - HARFTFORD - PRINCETON

New Article Published on Greening the Hospitals Environment

For Immediate Release (04/24/09)

Bernstein & Associates, Architects is pleased to announce the publication of a new article on greening the Hospital environment.

The article has been published in the May 2009 edition of Hospital Newspaper.

The article discusses opportunities to introduce green or sustainable design principles into a Hospital environment. The article references the LEED for Hospitals Green Building Rating System, as well as the Green Guide for Healthcare (GGHC). The principles discussed can be used to create sustainable Hospital design. The article includes discussion of the following areas: Sustainable Sites for Hospitals, Water Efficiency for Hospitals, Energy & Atmosphere for Hospitals, Materials & Resources for Hospitals, Environmental Quality for Hospitals, and Innovation & Design Process for Hospitals.

The article was written by the firm’s principle, a well-known expert in green hospital design, William N. Bernstein, LEED®AP, AIA.

About Bernstein & Associates, Architects: Founded in 1990, this company is an award-winning architectural firm specializing in sustainable hospital design and construction. The firm takes pride in providing the highest level of sustainable hospital design work, with additional expertise, energy saving measures for hospitals, cost reduction strategies for hospitals, hospital safety and patient safety.

For more information about green design for hospitals, please contact:
William N. Bernstein, LEED®AP, AIA
Principal - Bernstein & Associates, Architects - PLLC
59 West 19th Street - 6A New York, NY 10011
Office: 212.463.8200 - Fax: 212.463.9898
Email: info@bernarch.com
www.bernarch.com

Architect Selected to Provide Pharmacy Design Consulting on New USP 797 Compliant Pharmacy in Santa Barbara

For Immediate Release (04/07/09)

Bernstein & Associates, Architects, is pleased that it has been selected to provide pharmacy design consulting for a new hospital in Santa Barbara. Services will include pharmacy programming, pharmacy adjacency diagrams, pharmacy flow diagrams, pharmacy equipment planning, and usp 797 pharmacy design.

The pharmacy project is a complete new pharmacy. The project includes all new iso 7 anteroom, iso 7 hazardous compounding room, and iso 7 non-hazardous compounding room. The facility is a state-of-the-art pharmacy that includes the latest pharmacy automation equipment.

About Bernstein & Associates, Architects:

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 http://www.usp797.org/.

For more information about healthcare and hospital design and construction, including pharmacy design and construction, contact Bernstein & Associates, Architects at:

Bernstein & Associates, Architects - PLLC
New York:
59 West 19th Street - 6A, New York, NY 10011
T: 212.463.8200
F: 212.463.9898
Hartford:
100 Pearl St. - 14th Floor, Hartford, CT 06103
T: 860-616-2200
F: 860-616-0018
E: info@bernarch.com
W: www.bernarch.com

USP 797 Newsletter (February 2009 edition)

This is a summary of the February 2009 edition of the USP 797 Newsletter:
(produced by the privately-owned website www.usp797.org)
usp797.org - Vendor News
"EMSL analytical offers analysis for USP 797 samples", 01/14/09
"EMSL Analytical, a leading provider of laboratory services, recently announced they have begun to analyze samples for USP 797. Issued by the US Pharmacopoeia (USP), USP 797 regulations provide a standard for all pharmacies that prepare ‘compounded sterile preparations’ (CSPs). Most pharmacies must comply with this regulation and many hospitals that operate pharmacies meeting the same criteria are also affected..."
For the full article go to: http://usp797.org/VendorNews-EMSLAnalyticalOffersAnalysisforUSP797Samples.htm
"New Article on Design of Pharmacy to Conform with USP 797 (2008 version)", 01/31/09
"Bernstein & Associates, Architects is pleased to announce the publication of a new article about design of pharmacies to conform to the 2008 version of USP 797. The article has been published in the February 2009 edition of Hospital Newspaper. The article discussed the latest edition of USP 797, and how pharmacists and pharmacy managers should plan, design and construct their pharmacies to conform to USP 797..."
For the full article go to: http://usp797.org/VendorNews-DesignofaUSP797CompliantPharmacy.htm
________________________________________
USP797 Seminars Being Offered
• Aseptic Processing and Compliance Tools for USP <797>
• Practical Application of USP's General Chapter <797>
For more info go to: http://www.usp797.org/Seminars.htm
________________________________________
usp797.org - Questions and Answers (latest Q&A posted on site)
• RJLG Question 12: If chemotherapy medications are stored in the negative pressure cleanroom, how are refrigerated chemotherapy meds supposed to be stored since refrigerators should not be placed in the clean room? Do we have to build a separate negative pressure area for the refrigerator?
• RJLG Answer 12: Although a separate negative pressure room for bulk storage of all hazardous drugs would be ideal, storage in a negative pressure room is recommended by USP797 but not a current requirement.
All hazardous drugs must be stored separately from other inventory. Hazardous drugs should only be stored in the negative pressure buffer room if they are removed from their cartons and decontaminated in the ante area using appropriate procedures and personal protective equipment, and if the stored quantities are required for supporting your compounding operation. Excessive or bulk storage in the buffer room should be avoided.
Regarding your separate refrigerator for refrigerated hazardous drugs, USP797 states, “Placement of devices in ante areas and buffer areas is dictated by their effect on the designated environmental quality of atmospheres and surfaces, which shall be verified by monitoring.”
Answer provided as a courtesy to USP797.org by Matthew Zock of the RJ Lee Group, Inc. (RJLG). Note: Neither RJLG nor USP797.org assumes any liability for the use or interpretation of this information. Please consult your pharmacy consultant prior to taking any actions in your pharmacy.
For more USP 797 Questions and Answers, go to: http://www.usp797.org/Questions_and_Answers.htm
________________________________________
usp797.org Vendors
Architects:
Bernstein & Associates, Architects
Project Management:
Empire Projects, Inc.
Analytical Testing:
EM Lab P&K
EMSL Analytical Inc.
Cleaning Products / Contamination Control:
Acute Care Pharmaceuticals
Attentus Medical Sales, Inc.
Berkshire Corporation
Blue Thunder Technologies, Inc.
Contec, Inc.
Decon Labs Inc.
Dycem's CleanZone
Lymtech Scientific
Medical Specialties Distributors, LLC(MSD)
Techniglove International
Cleanroom Design/Build Companies:
TAC Americas
TCA
Compliance Action Plans:
Clinical IQ, LLC
Global Quality Alliance, LLC
Lasco Services
Quality Solutions, LLC
RJ Lee Group, Inc.
Environmental Monitoring:
AES-Chemunex, Inc.
Biotest
Controlled Environment Testing Association
Lighthouse Worldwide Solutions
RJ Lee Group, Inc.
Technical Safety Services, Inc.
Software:
Simplifi 797
Testing & Certification
Aemtek, Inc.
Certco, Inc.
Technical Safety Services, Inc.
USP 797 Related Products:
The Baker Company
CriticalPoint, LLC
EMSL Analytical Inc.
Esco Technologies
Germfree LaboratoriesIncorporated
Isotech Design
RJ Lee Group, Inc.
Trion, Inc. Air Purification Systems
www.usp797.org is a privately-owned website.
For more information about usp 797, go to the usp 797 website: www.usp797.org. Or go to the USP website itself at www.usp.org.

Storage of Chemotherapy Medications

* RJLG Question 12: If chemotherapy medications are stored in the negative pressure cleanroom, how are refrigerated chemotherapy meds supposed to be stored since refrigerators should not be placed in the clean room? Do we have to build a separate negative pressure area for the refrigerator?

* RJLG Answer 12: Although a separate negative pressure room for bulk storage of all hazardous drugs would be ideal, storage in a negative pressure room is recommended by USP797 but not a current requirement.

All hazardous drugs must be stored separately from other inventory. Hazardous drugs should only be stored in the negative pressure buffer room if they are removed from their cartons and decontaminated in the ante area using appropriate procedures and personal protective equipment, and if the stored quantities are required for supporting your compounding operation. Excessive or bulk storage in the buffer room should be avoided.

Regarding your separate refrigerator for refrigerated hazardous drugs, USP797 states, “Placement of devices in ante areas and buffer areas is dictated by their effect on the designated environmental quality of atmospheres and surfaces, which shall be verified by monitoring.”

Answer provided as a courtesy to USP797.org by RJ Lee Group, Inc. (RJLG) and/or associates of RJLG. We assume no liability for the use or interpretation of this information. Please note that USP797.org is not responsible for this answer.

*

Matthew Zock is an industrial hygienist with the technical consulting services group at RJ Lee Group, Inc. Mr. Zock provides a variety of industrial hygiene, health & safety, and environmental consulting services for heath care, general industry, and litigation support. He manages RJLG's USP 797 services including environmental sampling (microbial), hazardous drug monitoring, and facility design and operation audits. Mr. Zock received his Bachelors in Biology from Clarion University of Pennsylvania, and his Masters in Environmental and Occupational Health Sciences from Hunter College. He can be reached as follows:

Matthew Zock
RJ Lee Group, Inc.
350 Fifth Avenue, Suite 5820
New York, NY 10118
(212)613-2709
mzock@rjlg.com

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
© 2005 USP 797.org / 59 West 19th St. : New York, NY 10011 : (212-463-0800) : info@usp797.org