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Phone: 1 (800) 962-3058
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California - CSLB #730592B
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USP 797/800 CLEANROOMS

 

A USP 797 cleanroom is a controlled sterile environment required for the compounding of non-hazardous sterile drugs. These cleanrooms comply with the United States Pharmacopeia (USP) Chapter 797, which outlines standards for air quality, cleaning, temperature, humidity, and pressure to ensure patient safety.

 

USP 797 is a regulation document that outlines procedures and environmental criteria for compounded sterile preparations. It went into force on January 1, 2004. It outlines procedures and environmental requirements for compounded sterile preparations (CSPs). As a top-rated cleanroom manufacturer, we can provide USP 797/800 complaint cleanrooms.

 

UPS 797/800 compliant cleanrooms require non-unidirectional airflow, a properly arranged workstation layout, guidelines for operator procedures, proper sanitation, and air cleanliness.

 

Facilities must pressurize non-hazardous compounding and storage spaces according to USP Chapter 797/800 cleanroom design. Primary engineering controls, buffer rooms, and ante-rooms are all supported in ISO 5, 7, and 8 environments.

 

  • Primary Engineering Control (ISO Class 5)
  • Positive Pressure Buffer Area (ISO Class 7)
  • Positive Pressure Ante Room (ISO Class 8)

 

Positive pressure ensures that even if a barrier is breached, the region remains sterile. TPN (Total Parenteral Nutrition), antibiotic injections, eye drops, infusions, syringes, salves, oils, and more can all be compounded in positive pressure rooms. At least 30 ACH is required in a direct compounding area with an ISO Class 5 laminar flow equipment (air changes per hour).

GET MY USP 797 CLEANROOM QUOTE

As a top-rated cleanroom manufacturer, our goal is to help our customers solve problems and deliver an experience that exceeds our customers’ expectations.

 

To get started on your USP 797 / USP 800 cleanroom quote

we will need to gather a little information to ensure a successful project kickoff. Please take a moment to complete the form on this page. Once completed, you can expect a brief call and email from one of our Client Engagement Specialists.

 

The Client Engagement Specialist will start your quote file and answer any questions you may have regarding your project. During this conversation, please provide Allied Cleanrooms with any drawings or requirements.

 

Once we have completed a successful kickoff call, our Client Engagement Specialist will connect you with one of our Sales Engineers. Our Sales Engineer will be your direct contact throughout the remainder of your cleanroom needs.

 

We look forward to working with you to deliver another outstanding Allied Cleanrooms project. Our goal is to be the best cleanroom supplier, one project at a time: starting with yours.

Frequently Asked Questions About USP 797 Cleanrooms

What is a USP 797 cleanroom?
A USP 797 cleanroom is a sterile compounding environment that meets the standards of USP Chapter 797 to ensure the safe preparation of non-hazardous sterile medications.

Who needs a USP 797 cleanroom?
Pharmacies, hospitals, compounding centers, and healthcare facilities that prepare sterile medications are required to comply with USP 797 standards.

What are the main requirements of USP 797?
USP 797 requires ISO-classified cleanroom spaces (typically ISO 7 buffer areas and ISO 8 ante rooms), air filtration, temperature and humidity control, and proper personnel practices to reduce contamination risk.

How does a modular USP 797 cleanroom compare to traditional construction?
Modular cleanrooms are faster to install, fully compliant, and easily modified or relocated—making them ideal for healthcare settings that require speed and flexibility.

Can Allied Cleanrooms customize my USP 797 facility?
Yes. Allied Cleanrooms can design and build modular USP 797 cleanrooms tailored to your facility’s layout, workflow, and ISO class requirements.

Applications for USP 797 Compliant Cleanrooms

  • Sterile compounding in hospital pharmacies

  • Outpatient care facility medication preparation

  • Centralized compounding pharmacies

  • Research labs handling non-hazardous sterile drugs

  • Teaching hospitals and university compounding facilities

 

USP 797 Cleanroom Features

Feature Benefit
ISO 7/ISO 8 Cleanroom Spaces Meets required classifications for buffer and ante rooms
HEPA Filtration Ensures air cleanliness and particle control
Modular Construction Fast installation with minimal disruption
Temperature & Humidity Control Meets USP 797 environmental standards
Custom Layouts Designed to match your workflow and facility constraints
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