USP 800 Clean Rooms

USP 800 (Hazardous Drugs) Clean Room Design and Construction By DESCCO

USP 797 Cleanroom

The United States Pharmacopeial Convention (USP) Chapter 800 provides standards for handling hazardous drugs to promote patient safety, worker safety, and environmental protection.

USP 800 pertains to anyone involved with hazardous drugs and includes but is not limited to compounding, storage, receipt, dispensing, administration, disposal and transportation. Chapter 800 can be viewed on the USP Website.

The National Institute of Occupational Safety and Health (NIOSH) maintains a list of hazardous drugs used in the healthcare industry. The NIOSH list contains criteria that must be used to identify hazardous drugs.

USP Chapter 800 will be published in February 2016. The final implementation date will be July 1, 2018, allowing sufficient time for all entities to implement the chapter.

What Is USP?

USP General Chapter 800 provides standards in the safe handling of for hazardous drugs to reduce or remove the risk of exposure to patients and to the personal work environment.

USP.org defines USP 800 as:

General Chapter <800> describes requirements including responsibilities of personnel handling hazardous drugs; facility and engineering controls; procedures for deactivating, decontaminating and cleaning; spill control; and documentation.

These standards apply to all healthcare personnel who receive, prepare, administer, transport or otherwise come in contact with hazardous drugs and all the environments in which they are handled.

 

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USP 800 Facility Requirements

Facilities that handle hazardous drugs must take steps to promote patient and worker safety, environmental protection, and infection prevention. Restricted access areas must be created to prevent unauthorized personnel from hazardous drug exposure or handling.

There must be designated areas for Receipt and Unpacking, Storage of Hazardous Drugs, Sterile and Nonsterile Compounding of Hazardous Drugs.

In addition to the designated areas, proper signage, labels, and warnings must be in place to prevent exposure to or mishandling of the hazardous drugs.

Improved communication programs and safety compliance must also be achieved with:

  • Hazard Communication Program and awareness training
  • Additional Personal Protective Equipment including gloves, disposable gowns, head, hair, shoe, sleeve covers, face protection, and respiratory protection.
  • Spill Control training and cleanup kits
  • Proper disposal practices
  • Complete documentation and standard operating procedures

USP 800 Cleanroom Requirements for Hazardous Drugs:

  • ISO Class 7 Anteroom with a positive pressure of 0.02 inches of water column relative to all adjacent unclassified areas. 30 Air Changes per Hour (ACPH) of HEPA filtered air.
  • ISO Class 7 Cleanroom or Buffer Room Negatively Pressurized between 0.01 and 0.03 inches of water column.
  • A minimum of 12 ACPH of HEPA filtered supply air and externally vented.
  • Containment Primary Engineering Control (C-PEC) placed inside of the negative buffer room. The P-SEC shall be externally vented and could be a Compounding Aseptic Containment (CACI) or a Class II Biological Safety Cabinet (BSC)
  • Handwashing sink in the ante room
  • A clear line of demarcation within the negative pressure hazardous drug cleanroom
  • Pass-through cabinets are required to transport hazardous drugs, CSPs, and waste into and out of the negative pressure cleanroom
  • Non-hazardous drug compounding must be done in an ISO Class 6 cleanroom

We Are Your Expert Cleanroom Design & Construction Provider

DESCCO Design & Construction has the expertise required to design, engineer, and construct your USP 800 cleanroom. Our services also include on-site consultations, budgeting, and cleanroom validation.

Our knowledgeable team can assist you and your facility with USP 800 requirements.

 

 

DESCCO Design and Construction

Experienced USP 800 Clean Rooms Design and Construction Contractor in Reading, Berks County, PA

 

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