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Allied Cleanrooms
Phone: (800) 962-3058
E-Mail: [email protected]

California - CSLB #730592B
GSA Contract # 47QSWA19D0062

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Speak with a Cleanroom Specialist 1 (800) 962-3058

USP 797/800 CLEANROOMS

 

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).

 

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

At Allied Cleanrooms, our goal is to help our customers solve problems and deliver an experience that exceeds our customers’ expectations.

 

To get started on your 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.