Clean Rooms: 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 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. All common 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.

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.

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What is USP 800?

Rental Compounding Trailers by Odulair
Rental Compounding Trailers by Odulair

The United States Pharmacopeia organization, also known as USP, is the only independent, not-for-profit, non-governmental pharmacopeia in the world. It is a volunteer organization that was founded in 1820. USP is global and has offices in China, India, Brazil, Ethiopia, Ghana, and Switzerland. It provides a global compendium of over 4,500 monographs for prescription and OTC drugs, dietary supplements, and medical devices. The USP also establishes standards for the production of drugs and supplements. One of those newly established standards is USP <800>. The USP <800> was published to help ensure a quality environment and protect pharmacists and technicians compounding Hazardous Drugs. There exists growing evidence highlights acute and chronic health effects can occur due to occupational exposure to over 200 Hazardous Drugs. The standard was published 9/29/17 to become official on 7/1/18. Deadline has been extended multiple times, with the current deadline for hospitals to be compliant is 12/1/19.

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.

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USP 800 – What is it and Why

Modular Clean Room for Sale by Odulair
Modular Clean Room for Sale by Odulair

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 a specific number of Air Exchanges per Hour (ACH) to turn air at a constant rate. The clean rooms 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.

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.

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What is USP 800 & USP 797

USP 800 Trailer by Odulair
USP 800 Trailer 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.

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.

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Rental Mobile Pharmacy Trailers USP 800

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

If you are in the process of renovation, or you are approaching the USP 800 compliance deadline – December 1, 2019, you are probably looking into buying, renting or leasing an Odulair Mobile Pharmacy Clean Room – USP 800 Mobile Compounding Pharmacy – USP 800 Mobile Compounding Pharmacy Trailer by Odulair. The Odulair Mobile USP 800 Compounding Pharmacy and Mobile USP 800 Cleanrooms can be quickly shipped, established on-site, and prepared to run in a timely manner. Odulair Mobile Pharmacy Clean Room – USP 800 Mobile Compounding Pharmacy – USP 800 Mobile Compounding Pharmacy Trailer by Odulair are the right choice for disaster relief and emergency response situations.

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.

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USP 800 Compounding Pharmacy: Mobile Compounding Pharmacy by Odulair

USP 800 Trailer by Odulair
USP 800 Trailer by Odulair

A USP 800 is specifically designed to accommodate the specifications of the standard. There are three main components – rooms in the build. The Odulair USP 800 Mobile Compounding Pharmacy Trailer and USP 800 Clean Room Trailer implements a positive pressure Ante Room, negative pressure Hazardous Drug (HD) Buffer Room and a mechanical room housing the Heating Ventilation Air Conditioning (HVAC) system and back-up generator with automatic transfer switch. Mobile medical trailers by Odulair are perfect for USP 800 compouding pharmacy renovations. The Odulair USP 800 Mobile Compounding Pharmacy Trailer is a mobile medical facility built on 53 ft long trailer chassis.

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.

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How to rent USP 800 Pharmacy Trailer

Rental Compounding Trailers by Odulair
Rental Compounding Trailers by Odulair

The units in Odulair’s fleet – namely Odulair Mobile USP 800 Compounding Pharmacy and Mobile USP 800 Cleanrooms can be swiftly distributed, stationed on-site, and ready to be used at a moment’s notice. Odulair Mobile Pharmacy Clean Room – USP 800 Mobile Compounding Pharmacy – USP 800 Mobile Compounding Pharmacy Trailer by Odulair is perfect for the time you are revamping your facility or you are setting up a new establishment. They prove invaluable in times of emergency or crisis.

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

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USP 800 Compounding Pharmacy: Modular Compounding Pharmacy by Odulair

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

Building or renovating to USP 800 compounding pharmacy can be a daunting task with so many regulations and specifications. Modular Cleanrooms USP 800 Ready by Odulair are the best solution for your USP 800 compounding pharmacy cleanroom demands. Odulair takes care of the project, installation, and training. Odulair also provides 24/7 assitance and technical support. The Odulair USP 800 Modular Compounding Pharmacy includes an Ante Room, Hazardous Drug (HD) Buffer Room and a mechanical room housing the Heating Ventilation Air Conditioning (HVAC) system. The Modular Compounding Pharmacy can include Non-Hazardous Buffer Rooms if needed and be sized according to your needs. This usp compliant pharmacy unit connects to a back-up power system. The Modular Compounding Pharmacy is installed on-site by an Odulair crew. The Modular Compounding Pharmacy can be built as a temporary or permanent Compounding Pharmacy facility.

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

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What is the purpose of USP 800? Learn why USP 800 Replaces USP 797

USP 800 Trailer by Odulair
USP 800 Trailer by Odulair

Odulair transforms your existing pharmacy environment into a fully compliant USP 800 Pharmacy facility. USP 800 sterile compounding pharmacies by Odulair can be installed virtually anywhere and can be relocated and expanded. It’s important to note that USP 800 replaces USP 797 for compouding pharmacies. If your compouding pharmacy facility is built to 797 code, then check the dates that apply to your state, as compounding pharmacies will have to be in compliance with USP 800 design guidelines. All Mobile Compounding Pharmacies and Modular Compounding Pharmacies by Odulair are compliant with the new requirements in USP 800 guidelines. These new USP 800 guidelines go well beyond the previous hazardous drug guidelines established by USP 797. Among those changes, the new USP 800 design guidelines are different in respect to negative pressure environments, requires a dedicated space for any hazardous drug compounding, warning signs and demarcation lines for hazardous areas, labeling requirements, and pass thru requirements between areas.

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.

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503(a) and 503(b) Identification Regarding Compounding Pharmacies

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

There are some notable differences between 503(a) and 503(b) identifications. Compounding pharmacies are identified as a 503(a) traditional compounding pharmacy or a 503(b) outsourcing facility. USP standards and State Board of Pharmacy regulations, including USP 795 are applicable to all non-sterile compounding, USP 797 applies to all sterile compounding, and USP 800 applies to all compounding that uses hazardous drugs. A USP 800 is specifically designed to accommodate the specifications of the standard. There are three main components – rooms in the build. The Odulair USP 800 Mobile Compounding Pharmacy Trailer and USP 800 Clean Room Trailer implements a positive pressure Ante Room, negative pressure Hazardous Drug (HD) Buffer Room and a mechanical room housing the Heating Ventilation Air Conditioning (HVAC) system and back-up generator with automatic transfer switch. Odulair Mobile Pharmacy Trailers are fully compliant with USP 800 guidelines and standards, and are equipped with HVAC units specially designed by Odulair to meet all USP 800 HVAC requirements.

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

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