Developing a USP 800 <800>Compliance Gap Analysis
This article was written by David Aguero, manager of pharmacy operations and technology at St. Jude Children’s Research Hospital, and Kristin Marge, PharmD, BCPS, PGY1 residency program director at Inova Health System Mount Vernon Hospital.
This article recounts the systematic process that Inova Health System went through to document its current system relative to USP 800 compliance.
To read the full article: https://www.pppmag.com/article/1989
Additional Resources:
Follow USP.org:
USP.org on Twitter: https://twitter.com/uspharmacopeia
USP.org Blog: http://qualitymatters.usp.org/
USP.org on LinkedIn: https://www.linkedin.com/company/uspharmacopeia
USP.org on Facebook: https://www.facebook.com/USPharmacopeia
Follow USP800.guru:
USP800.guru on Twitter: https://www.twitter.com/usp800
USP800.org on Blogger: http://usp800.blogspot.com/
USP800.org on LinkedIn: https://www.linkedin.com/company/usp800-guru
USP800.org on Facebook: https://www.facebook.com/USP800
Follow USP797.org:
USP797.org on Twitter: https://www.twitter.com/usp797
USP797.org on Blogger: http://usp797org.blogspot.com/
USP797.org on LinkedIn: https://www.linkedin.com/company/usp797-org-inc-
USP797.org on Facebook: https://www.facebook.com/usp797
Follow PharmacyDesign.org:
PharmacyDesign.org on Twitter: https://twitter.com/pharmacydesign
PharmacyDesign.org on Blogger: http://pharmacydesigns.blogspot.com/
PharmacyDesign.org on LinkedIn: https://www.linkedin.com/company/pharmacy-design
PharmacyDesign.org on Facebook: https://www.facebook.com/pharmacydesigns/
To reach USP797.org:
USP797.org
1483 York Avenue - #20602
New York, NY 10021
T: 800-974-3109
E: info@usp797.org
W: www.usp797.org
Showing posts with label USP 800 Publications. Show all posts
Showing posts with label USP 800 Publications. Show all posts
Friday, February 24, 2017
USP 797 Pharmacy Design Project in Connecticut
USP 797 Pharmacy Design Project in Connecticut
Pharmacy design architect Bernstein & Associates, Architects (http://bernarch.com/healthcare-design-pharmacy/) is pleased to announce that architectural and engineering construction documents for a new pharmacy project in Connecticut have been completed.
Bernstein & Associates, Architects provided pharmacy design services for this project including: pharmacy programming, pharmacy planning, pharmacy design, and pharmacy equipment planning.
The pharmacy design project is for a new, compounding suite for an inpatient, hospital pharmacy. It includes a state-of-the-art, ISO 7 compounding suite, with both hazardous compounding and non-hazardous compounding, designed to comply with USP 797 and USP 800 regulations.
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, and has designed over (35) hospital pharmacies in the last 10 years, which have included 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.
USP 800 compliant design is also a specialty of Bernstein & Associates, Architects. The firm currently has (11) projects in the design and construction phase which have been designed to comply with USP 800.
A new article on the architectural design of USP 800 compliant pharmacies was published in Health Facilities Management. The article can be found here:
http://www.hfmmagazine.com/articles/2526-handling-hazardous-drugs-in-health-care
Pharmacy design projects by Bernstein & Associates, Architects are featured on:
- www.bernarch.com/healthcare-design-pharmacy/ (Pharmacy Design by Bernstein & Assoc., Architects)
- www.twitter.com/pharmacydesign (Pharmacy Design on Twitter)
- www.pharmacydesign.org (the Pharmacy Design website)
- https://www.linkedin.com/company/pharmacy-design (Pharmacy Design on LinkedIn)
- https://www.facebook.com/pharmacydesigns/ (Pharmacy Design on Facebook)
- www.usp797.org (USP 797 news, USP 797 education, and USP 797 vendors)
- www.usp800.guru (USP 800 news, USP 800 education, and USP 800 vendors)
For more information about healthcare and hospital design and construction, including pharmacy design and pharmacy construction, contact Bernstein & Associates, Architects at:
New York (Headquarters)
Bernstein & Associates, Architects
122 E 42nd Street - 17th Floor
New York, NY 10168
T: 212-463-8200
F: 888-214-0670
Email: info@bernarch.com
Also in Hartford, Princeton, Charlottesville, and Los Angeles
Additional ways to follow Bernstein & Associates, Architects, include:
Bernstein & Associates, Architects on Twitter: https://twitter.com/bernsteinarch
Bernstein & Associates, Architects on Blogger: http://bernarch.blogspot.com/
Bernstein & Associates, Architects on LinkedIn: https://www.linkedin.com/company/bernstein-&-associates-architects
Bernstein & Associates, Architects on Facebook: https://www.facebook.com/bernsteinarchitects/
Pharmacy design architect Bernstein & Associates, Architects (http://bernarch.com/healthcare-design-pharmacy/) is pleased to announce that architectural and engineering construction documents for a new pharmacy project in Connecticut have been completed.
Bernstein & Associates, Architects provided pharmacy design services for this project including: pharmacy programming, pharmacy planning, pharmacy design, and pharmacy equipment planning.
The pharmacy design project is for a new, compounding suite for an inpatient, hospital pharmacy. It includes a state-of-the-art, ISO 7 compounding suite, with both hazardous compounding and non-hazardous compounding, designed to comply with USP 797 and USP 800 regulations.
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, and has designed over (35) hospital pharmacies in the last 10 years, which have included 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.
USP 800 compliant design is also a specialty of Bernstein & Associates, Architects. The firm currently has (11) projects in the design and construction phase which have been designed to comply with USP 800.
A new article on the architectural design of USP 800 compliant pharmacies was published in Health Facilities Management. The article can be found here:
http://www.hfmmagazine.com/articles/2526-handling-hazardous-drugs-in-health-care
Pharmacy design projects by Bernstein & Associates, Architects are featured on:
- www.bernarch.com/healthcare-design-pharmacy/ (Pharmacy Design by Bernstein & Assoc., Architects)
- www.twitter.com/pharmacydesign (Pharmacy Design on Twitter)
- www.pharmacydesign.org (the Pharmacy Design website)
- https://www.linkedin.com/company/pharmacy-design (Pharmacy Design on LinkedIn)
- https://www.facebook.com/pharmacydesigns/ (Pharmacy Design on Facebook)
- www.usp797.org (USP 797 news, USP 797 education, and USP 797 vendors)
- www.usp800.guru (USP 800 news, USP 800 education, and USP 800 vendors)
For more information about healthcare and hospital design and construction, including pharmacy design and pharmacy construction, contact Bernstein & Associates, Architects at:
New York (Headquarters)
Bernstein & Associates, Architects
122 E 42nd Street - 17th Floor
New York, NY 10168
T: 212-463-8200
F: 888-214-0670
Email: info@bernarch.com
Also in Hartford, Princeton, Charlottesville, and Los Angeles
Additional ways to follow Bernstein & Associates, Architects, include:
Bernstein & Associates, Architects on Twitter: https://twitter.com/bernsteinarch
Bernstein & Associates, Architects on Blogger: http://bernarch.blogspot.com/
Bernstein & Associates, Architects on LinkedIn: https://www.linkedin.com/company/bernstein-&-associates-architects
Bernstein & Associates, Architects on Facebook: https://www.facebook.com/bernsteinarchitects/
Friday, November 4, 2016
USP 800 and USP 797: What is New and What is the Same
A new article on creating a USP 800 compliant pharmacy, by William N. Bernstein, AIA, has just been published in Health Facilities Management.
Entitled “USP 800 Brings New Regulations to Hospital Pharmacies”, the article is a comprehensive guide to designing clean room environments for sterile compounding and non-sterile compounding in accordance with the new USP 800 guidelines.
The USP 800 pharmacy design article can be found at:
http://www.hfmmagazine.com/articles/2526-handling-hazardous-drugs-in-health-care
Below are some of the topics covered in this USP 800 article:
• History of USP 800
• Deadline for compliance with USP 800
• Relationship of USP 797 and USP 800
• Changes in guidelines on sterile compounding of hazardous drugs relative to previous guidelines in USP 797
• What does USP 800 mean when it refers to “hazardous drugs”
• Latest list of USP 800 hazardous drugs
• Frequency of review of list of USP 800 hazardous drugs
• Introducing new hazardous drugs in a USP 800 compliant facility
• Exceptions to list of USP 800 hazardous drugs
• Discussion of investigational drugs in USP 800 guideline
• Under what circumstances do hazardous drugs fall outside of USP 800 guidelines
• Discussion of “assessment of risk” in USP 800 guidelines
• Areas governed by USP 800
• How does USP 800 address storage of hazardous drugs
• How does USP 800 address compounding of hazardous drugs
• When is a negative pressure room required under USP 800
• How many air changes does USP 800 require
• What additional space does USP 800 require
• How does USP 800 address refrigeration of hazardous drugs
• Locations of refrigerated storage of hazardous drugs in USP 800
• Location of exhaust relative to refrigerator in USP 800
• Discussion of details of storage room shelving in USP 800
• Seismic considerations discussed in USP 800
• Discussion of which drugs go into the USP 800 storage room
• Storage of sterile and non-sterile hazardous drugs in USP 800
• Under what circumstances can sterile and non-sterile drugs be stored in the same room in USP 800
• Discussion of compounding vs. fixed formulations in USP 800
• Types of controls related to the compounding process in USP 800
• C-PEC in USP 800
• C-SEC in USP 800
• Closed-system, drug transfer device in USP 800
• When is an ISO-5 environment required in USP 800
• When is an ISO-7 environment required in USP 800
• When is a negative-pressure room required in USP 800
• USP 800 discussion of loss of power
• USP 800 discussion of emergency power
• Discussion of worker safety in USP 800
• Types of Biosafety Cabinets discussed in USP 800
• USP 800 eliminates available options that existed in USP 797
• USP 800 discussion of signage
• Location of spaces discussed in USP 800
• Receipt and unpacking of hazardous drugs as discussed in USP 800
• Water column measurements in USP 800
• What has to be externally vented in a USP 800 compliant pharmacy
• Air exchange rate requirements in USP 800
• USP 800 discussion of maintaining power to ventilation systems in a power outage
• Different USP 800 requirements for sterile compounding vs. non-sterile compounding
• Definition of non-sterile compounding in USP 800
• Definition of sterile compounding in USP 800
• Under what circumstances does USP 800 permit both sterile and nonsterile compounding in the same room
• Under what circumstances does USP 800 permit sterile compounding in a non-ISO space
• USP 800 discussion of segregated compounding area (C-SCA).
• USP 800 requirements for non-sterile compounding
• Carry-over of certain requirements from USP 797 in terms of cleanroom design in USP 800
• Discussion of USP 795, Pharmaceutical Compounding — Nonsterile Preparations, in USP 800
• Under what circumstances does USP 800 permit sterile and nonsterile compounding in the same room
• Relationship of storage and compounding spaces in USP 800
Author of this USP 800 article is William N. Bernstein, LEED AP, AIA, the principal of Bernstein & Associates Architects. His firm has been at the forefront of designing USP 797 and USP 800 compliant pharmacies across the US. He can be reached at info@bernarch.com.
Follow Bernstein & Associates, Architects:
Pharmacy Architecture and Design: http://bernarch.com/healthcare-design-pharmacy/
USP 797 Architecture and Design: http://bernarch.com/healthcare-design-usp-797-compliant-pharmacy-design-and-consulting/
USP 800 Architecture and Design: http://bernarch.com/healthcare-design-usp-800-compliant-pharmacy-design-and-consulting/
Bernstein & Associates, Architects on Twitter: https://twitter.com/bernsteinarch
Bernstein & Associates, Architects on Blogger: http://bernarch.blogspot.com/
Bernstein & Associates, Architects on LinkedIn: https://www.linkedin.com/company/bernstein-&-associates-architects
Bernstein & Associates, Architects on Facebook: https://www.facebook.com/bernsteinarchitects/
Follow Empire Projects, Inc.:
Healthcare project management services, see: http://empireprojects.com/healthcare-project-management/
Hospital project management services, see: http://empireprojects.com/healthcare-project-management-hospitals/
Empire Projects, Inc. on Twitter: https://twitter.com/empireprojects
Empire Projects, Inc.on Blogger: http://empireprojects.blogspot.com/
Empire Projects, Inc. on LinkedIn: https://www.linkedin.com/company/empire-projects-inc.
Empire Projects, Inc. on Facebook: https://www.facebook.com/empireprojectsusa/
Follow USP.org:
USP.org on Twitter: https://twitter.com/uspharmacopeia
USP.org Blog: http://qualitymatters.usp.org/
USP.org on LinkedIn: https://www.linkedin.com/company/uspharmacopeia
USP.org on Facebook: https://www.facebook.com/USPharmacopeia
Follow USP797.org:
USP797.org on Twitter: https://www.twitter.com/usp797
USP797.org on Blogger: http://usp797org.blogspot.com/
USP797.org on LinkedIn: https://www.linkedin.com/company/usp797-org-inc-
USP797.org on Facebook: https://www.facebook.com/usp797
Follow USP800.guru:
USP800.guru on Twitter: https://www.twitter.com/usp800
USP800.org on Blogger: http://usp800.blogspot.com/
USP800.org on LinkedIn: https://www.linkedin.com/company/usp800-guru
USP800.org on Facebook: https://www.facebook.com/USP800
Follow PharmacyDesign.org:
PharmacyDesign.org on Twitter: https://twitter.com/pharmacydesign
PharmacyDesign.org on Blogger: http://pharmacydesigns.blogspot.com/
PharmacyDesign.org on LinkedIn: https://www.linkedin.com/company/pharmacy-design
PharmacyDesign.org on Facebook: https://www.facebook.com/pharmacydesigns/
To reach USP797.org:
USP797.org
1483 York Avenue - #20602
New York, NY 10021
T: 800-974-3109
E: info@usp797.org
W: www.usp797.org
Entitled “USP 800 Brings New Regulations to Hospital Pharmacies”, the article is a comprehensive guide to designing clean room environments for sterile compounding and non-sterile compounding in accordance with the new USP 800 guidelines.
The USP 800 pharmacy design article can be found at:
http://www.hfmmagazine.com/articles/2526-handling-hazardous-drugs-in-health-care
Below are some of the topics covered in this USP 800 article:
• History of USP 800
• Deadline for compliance with USP 800
• Relationship of USP 797 and USP 800
• Changes in guidelines on sterile compounding of hazardous drugs relative to previous guidelines in USP 797
• What does USP 800 mean when it refers to “hazardous drugs”
• Latest list of USP 800 hazardous drugs
• Frequency of review of list of USP 800 hazardous drugs
• Introducing new hazardous drugs in a USP 800 compliant facility
• Exceptions to list of USP 800 hazardous drugs
• Discussion of investigational drugs in USP 800 guideline
• Under what circumstances do hazardous drugs fall outside of USP 800 guidelines
• Discussion of “assessment of risk” in USP 800 guidelines
• Areas governed by USP 800
• How does USP 800 address storage of hazardous drugs
• How does USP 800 address compounding of hazardous drugs
• When is a negative pressure room required under USP 800
• How many air changes does USP 800 require
• What additional space does USP 800 require
• How does USP 800 address refrigeration of hazardous drugs
• Locations of refrigerated storage of hazardous drugs in USP 800
• Location of exhaust relative to refrigerator in USP 800
• Discussion of details of storage room shelving in USP 800
• Seismic considerations discussed in USP 800
• Discussion of which drugs go into the USP 800 storage room
• Storage of sterile and non-sterile hazardous drugs in USP 800
• Under what circumstances can sterile and non-sterile drugs be stored in the same room in USP 800
• Discussion of compounding vs. fixed formulations in USP 800
• Types of controls related to the compounding process in USP 800
• C-PEC in USP 800
• C-SEC in USP 800
• Closed-system, drug transfer device in USP 800
• When is an ISO-5 environment required in USP 800
• When is an ISO-7 environment required in USP 800
• When is a negative-pressure room required in USP 800
• USP 800 discussion of loss of power
• USP 800 discussion of emergency power
• Discussion of worker safety in USP 800
• Types of Biosafety Cabinets discussed in USP 800
• USP 800 eliminates available options that existed in USP 797
• USP 800 discussion of signage
• Location of spaces discussed in USP 800
• Receipt and unpacking of hazardous drugs as discussed in USP 800
• Water column measurements in USP 800
• What has to be externally vented in a USP 800 compliant pharmacy
• Air exchange rate requirements in USP 800
• USP 800 discussion of maintaining power to ventilation systems in a power outage
• Different USP 800 requirements for sterile compounding vs. non-sterile compounding
• Definition of non-sterile compounding in USP 800
• Definition of sterile compounding in USP 800
• Under what circumstances does USP 800 permit both sterile and nonsterile compounding in the same room
• Under what circumstances does USP 800 permit sterile compounding in a non-ISO space
• USP 800 discussion of segregated compounding area (C-SCA).
• USP 800 requirements for non-sterile compounding
• Carry-over of certain requirements from USP 797 in terms of cleanroom design in USP 800
• Discussion of USP 795, Pharmaceutical Compounding — Nonsterile Preparations, in USP 800
• Under what circumstances does USP 800 permit sterile and nonsterile compounding in the same room
• Relationship of storage and compounding spaces in USP 800
Author of this USP 800 article is William N. Bernstein, LEED AP, AIA, the principal of Bernstein & Associates Architects. His firm has been at the forefront of designing USP 797 and USP 800 compliant pharmacies across the US. He can be reached at info@bernarch.com.
Follow Bernstein & Associates, Architects:
Pharmacy Architecture and Design: http://bernarch.com/healthcare-design-pharmacy/
USP 797 Architecture and Design: http://bernarch.com/healthcare-design-usp-797-compliant-pharmacy-design-and-consulting/
USP 800 Architecture and Design: http://bernarch.com/healthcare-design-usp-800-compliant-pharmacy-design-and-consulting/
Bernstein & Associates, Architects on Twitter: https://twitter.com/bernsteinarch
Bernstein & Associates, Architects on Blogger: http://bernarch.blogspot.com/
Bernstein & Associates, Architects on LinkedIn: https://www.linkedin.com/company/bernstein-&-associates-architects
Bernstein & Associates, Architects on Facebook: https://www.facebook.com/bernsteinarchitects/
Follow Empire Projects, Inc.:
Healthcare project management services, see: http://empireprojects.com/healthcare-project-management/
Hospital project management services, see: http://empireprojects.com/healthcare-project-management-hospitals/
Empire Projects, Inc. on Twitter: https://twitter.com/empireprojects
Empire Projects, Inc.on Blogger: http://empireprojects.blogspot.com/
Empire Projects, Inc. on LinkedIn: https://www.linkedin.com/company/empire-projects-inc.
Empire Projects, Inc. on Facebook: https://www.facebook.com/empireprojectsusa/
USP.org on Twitter: https://twitter.com/uspharmacopeia
USP.org Blog: http://qualitymatters.usp.org/
USP.org on LinkedIn: https://www.linkedin.com/company/uspharmacopeia
USP.org on Facebook: https://www.facebook.com/USPharmacopeia
Follow USP797.org:
USP797.org on Twitter: https://www.twitter.com/usp797
USP797.org on Blogger: http://usp797org.blogspot.com/
USP797.org on LinkedIn: https://www.linkedin.com/company/usp797-org-inc-
USP797.org on Facebook: https://www.facebook.com/usp797
Follow USP800.guru:
USP800.guru on Twitter: https://www.twitter.com/usp800
USP800.org on Blogger: http://usp800.blogspot.com/
USP800.org on LinkedIn: https://www.linkedin.com/company/usp800-guru
USP800.org on Facebook: https://www.facebook.com/USP800
Follow PharmacyDesign.org:
PharmacyDesign.org on Twitter: https://twitter.com/pharmacydesign
PharmacyDesign.org on Blogger: http://pharmacydesigns.blogspot.com/
PharmacyDesign.org on LinkedIn: https://www.linkedin.com/company/pharmacy-design
PharmacyDesign.org on Facebook: https://www.facebook.com/pharmacydesigns/
To reach USP797.org:
USP797.org
1483 York Avenue - #20602
New York, NY 10021
T: 800-974-3109
E: info@usp797.org
W: www.usp797.org
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