USP 800 Facility Design

Mobile Pharmacy Clean Room by Odulair
Mobile Pharmacy Clean Room by Odulair

The USP 800 Mobile Pharmacy Clean Room is a facility design by Odulair that means guaranteed USP 800 & USP 797 compliance. Our designs and technical drawings have been stamped and approved by the proper authorities for compliance with USP 800 design guidelines. Are you looking for a permanent or temporary solution to handling Hazardous Drugs? Odulair designs and builds USP 800 Mobile Pharmacies that are perfect to temporarily replace your existing facility while under renovation. Odulair Mobile Compounding Pharmacy Trailers are focused on patient and staff safety and include transportation, training on how to operate and manage a modern USP 800 compliance Compounding Pharmacy, and 24/7 service and customer support. Odulair USP 800 Solutions feature pre-approved USP 800 design layouts that meet all safety requirements for the legal compounding of hazardous drugs. USP standards are federal and state guidelines that exist to protect patients and healthcare workers from potential harm, and include USP General Chapters <800> for Hazardous Drugs, Handling in Healthcare Settings <797> for Pharmaceutical Compounding, and Sterile Preparations, developed to provide a complete set of standards for all healthcare workers to help ensure the safe handling of hazardous drugs.

Mobile Pharmacy Trailers, Mobile Compounding Pharmacy Trailers, USP 800 Mobile Pharmacy Trailers, and Mobile Cleanroom Trailers by Odulair are available for sale and rental in the USA.

USP800 New Regulations: Why Upgrade Hospital Pharmacies?

USP 800 Trailer by Odulair
USP 800 Trailer by Odulair

The USP 800 is a new regulation to promote patient health, worker safety, and address environmental concerns. USP 800 applies to all pharmacies, hospitals, patient treatment centers, patient treatment clinics, physician practice facilities, surgical centers, veterinarians, home health centers, and skilled nursing facilities that handle or compound hazardous drugs. Hazardous drugs pose a threat to the safety of patients and employees due to the ability to cause cancer, affect fertility, damage DNA or cause organ damage. All facilities compounding hazardous drugs will be required to utilize these specific kinds of pharmaceutical powder containment hoods starting December 1, 20191. Odulair provides mobile compounding pharmacy trailers that are fully compliant with USP 800 regulations.

Mobile Pharmacy Trailers, Mobile Compounding Pharmacy Trailers, USP 800 Certified Mobile Pharmacy Trailers, and Mobile Cleanroom Trailers by Odulair are available for sale and rental in the USA.

What is a Negative Pressure Room?

USP 800 Modular Clean Room
USP 800 Modular Clean Room

Prior to USP 800 , third party testing of wipe/swab samples revealed contamination problems both inside the lab and, more troubling, in general areas like break rooms and retail space. Similar results found in compounding pharmacies throughout the USA. To prevent that, USP 800 has as requirement negative pressure rooms in order to eliminate the problems associated with air exchanges between compounding pharmacy labs and adjoining areas. Most compounding labs are positive pressure environments, meaning, pressure differentials can cause air exchanges which carry airborne particles of hazardous drugs outside of the lab, to areas such as break rooms and retail spaces. In the extreme case of an accidental chemical spill, millions of particles are airborne and have a more real potential for exchange and exposure in common areas. Additionally, HVAC systems circulate air through pharmacy labs and common spaces, but the lack of filtration system fails to produce clean room air exchanges. HVAC systems were not designed for the purpose of hazardous drug handling.Odulair provides a negative pressure ISO 7 room with tight tolerance for hazardous drug compounding and storage.

USP 800

Mobile Clean Room Trailer Rental by Odulair
Mobile Clean Room Trailer Rental by Odulair

The United States Pharmacopeia (USP™) is the only independent, non-profit, and non-governmental organization responsible for establishing an inventory of drug and supplement standards. Their main function is to maintain a global catalog of over 4,500 monographs for prescription and over-the-counter (OTC) drugs, dietary supplements, and medical devices. 

The USP 800 guidelines developed by the United States Pharmacopeia were created to protect the working environment of pharmacists and technicians when dealing with compounding Hazardous Drugs. This was first published in 9/29/2019, becoming official on 7/1/2018. USP 800 guidelines and standards can vary by State. USP 800 is specific for compounding Hazardous Drugs, while the USP 797 is specialized for Non-Hazardous Drugs. 

USP 800 also enables the ability to work in a negative pressure environment. All medical equipment comes standard to meet USP 800 cleanroom requirements compliance, excluding floor color. Often times, these units are referred to as a compounding pharmacy or “Clean Room.” This is a room designed to be free from dust and other harmful contaminants using a combination of High Efficiency Particulate Air (HEPA) filtration air supply in the room. They require a certain amount of pressurization (comparable to an airplane) and specific number of Air Exchanges per Hour (ACH) to turn air at a constant rate. The cleanrooms are classified into ISO1-ISO9 with the larger the ISO# having more particles in the air. They have been designed as a place for the pharmacist to mix together the exact dosage of ingredients when creating personalized medications.