Compounding Pharmacy: 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. Typical 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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Hospitals and Facilities Upgrade

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

Odulair is here to transform your existing pharmacy facility 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. USP 800 Pharmacy Trailers by Odulair are available for lease, rental, or purchase. For hospitals renovating their current facilities looking to meet the new USP 800 standards, Mobile Compounding Pharmacies by Odulair include ready-to-go Compounding Pharmacies and Cleanrooms that can be built on trailers and modular buildings and can perform as temporary or permanent USP 800 compliant pharmacies and clean rooms. USP 800 compliant Mobile Compounding Pharmacies and Cleanrooms by Odulair are available in the US for sale, rental, or lease.

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 a Negative Pressure Room?

USP 800 Trailer by Odulair
USP 800 Trailer by Odulair

Multiple tests proved the need for standard shielding healthcare employees. Before the introduction of USP <800>, performed tests of wipe/swab samples revealed contamination problems in the lab compartment and also in break rooms and retail space. The USP has determined comparable results found in most compounding pharmacies throughout the United States. In order to avoid and prevent that, USP <800> introduces negative pressure rooms to eliminate the problems linked to air exchanges between compounding pharmacy labs and other areas. Most compounding labs are positive pressure environments – pressure differentials are likely to cause air exchanges which disperse airborne particles of hazardous drugs outside of the lab, to locations such as retail spaces and break rooms. In the uttermost incident of an incidental chemical spillage, millions of particles are airborne and have a more realistic potential for exchange and exposure in common areas. In addition, 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.

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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Who Enforces USP800? Why Upgrade Hospital Pharmacies?

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

When it comes to enforcement, agencies could be different in each state. It could be:
• Federal Government for federally owned facilities;
• State Board of Pharmacy;
• State Board of Medicine;
• State Public Health Department;
• OSHA (Occupational Safety and Health Administration) (because it relates to employee health);
Creating the very tight tolerance for negative pressure & dedicated exhausting 100% of the HD Buffer Room air outdoors is typically very difficult because many Compounding Pharmacies are built in the basement or lower floors of multi-story hospitals with no way to direct vent the air outside. Odulair could not find even one “off-the-shelf” HVAC system that would meet the required specifications. The company had to design their own HVAC system and find a company to build it for them.

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 the meaning of USP 800?

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

USP 800 “Hazardous Drugs – Handling in Healthcare Settings” outlines regulations for compounding pharmacies, which are set to take effect on July 1, 2018. USP 800 guidelines are designed to integrate procedures and engineering controls which minimize worker and environmental exposure to hazardous drugs. Regulations are clearly designed to implement safe handling of hazardous drugs. Where USP 795 fails to thoroughly address worker safety and allows for vague terminology pertaining to handling of hazardous drugs, USP 800 places a greater emphasis on worker safety and sets specific requirements for “negative pressure” environments in compounding pharmacies.

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 Clean Room Rental

Rental Compounding Trailers by Odulair
Rental Compounding Trailers by Odulair

Let’s face it – healthcare is a turbulent industry and technology advancements help to shape new regulations on a weekly basis. In case you are in the process of construction or refurbishing your facility, or you are approaching the USP <800> compliance deadline – December 1, 2019, chances are you are looking into buying, renting or leasing a compounding facility. Fear not, because there are easy solutions for your need: USP 800 Modular Clean Room, Mobile Clean Room Trailer Rental, Rental Compounding Trailers or Mobile Compounding Pharmacy. The Odulair Mobile USP 800 Compounding Pharmacy and Mobile USP 800 Cleanrooms can be quickly transported, based on-site, and settled 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 choice for disaster relief and emergency response situations.

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

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Rent a USP 800 Pharmacy Trailer

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

Fact: Healthcare is a turbulent industry and technology advancements help to shape new regulations on a daily basis. If you are in the process of refurbishing or you are in the process of construction of your facility, or you are approaching the USP <800> compliance deadline – December 1, 2019, chances are you are looking into buying, renting or leasing a compounding facility. Fear not, because there are easy solutions for your need: 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 are 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, and Mobile Cleanroom Trailers by Odulair are available for sale and rental in the USA.

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Mobile Compounding Pharmacy USP <800> Trailer by Odulair

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

Chances are you’ve noted the freshly introduced regulations regarding healthcare employee safety: USP <800>. Currently, the deadline to comply is December 1, 2019. Your compounding facility will have to seize operation past that date if it does not meet the safety standard. 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 an automatic transfer switch. Mobile medical trailers by Odulair are perfect for USP <800> compounding 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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Compounding Pharmacy USP 800 : Odulair Modular Compounding Pharmacy

USP 800 Trailer by Odulair
USP 800 Trailer by Odulair

Constructing or refurbishing to USP 800 compounding pharmacy can be a challenging project with so many classifications and details. Modular Cleanrooms USP 800 Ready by Odulair are the finest solution for your USP 800 compounding pharmacy cleanroom requirements. Odulair takes care of the planning, fitting, and coaching. Odulair also provides around the clock assitance and technical backing. The Odulair USP 800 Modular Compounding Pharmacy includes a Hazardous Drug (HD) Buffer Room, an Ante Room and a mechanical room housing the Heating Ventilation Air Conditioning (HVAC) system. The Modular Compounding Pharmacy can accommodate Non-Hazardous Buffer Rooms if required and be assessed according to your demands. This USP compliant pharmacy unit it attached to a back-up power system. The Modular Compounding Pharmacy is commissioned at your location by certified experts. The Modular Compounding Pharmacy can be assembled as a provisional or set 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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Hazardous Drugs Compounding Pharmacy: USP 800 Replaces USP 797

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

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, Mobile Cleanroom Trailers and other permanent of temporary facilities by Odulair for the compounding of hazardous drugs, are available for sale and rental in the USA.

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