Hazardous Compounding Pharmacy (USP-800)
(Sterile)
We hear more and more about USP-800, the new chapter of compounding standards for safe handling of hazardous drugs. Although initially set to go into effect July 1, 2018, USP has announced it is postponing the official date for the application of USP-800 to December 1, 2019. This extra time is crucial as building a facility for hazardous drug (HD) compounding is much more complex than for non-HD sterile compounding (USP-797), and will give pharmacies more time to comply with the new regulations.
Hazardous Drug Compounding CLEANROOM DESIGN
Modular Pre-Fabricated Clean Room Solution
Mecart cleanrooms are pre-fabricated in our manufacturing plant, shipped to and installed in your pharmacy making installation worry-free. Mecart cleanrooms are typically designed to be fully independent systems. Modules have their own structure for mechanical equipment. All services are built into the panels, reducing on-site risks, delays, and projects overall costs.
USP 797/800 Compliant Cleanroom
Mecart guarantees its cleanroom facilities’ compliance with local and national requirements, such as USP 797 and USP 800. Our experienced in-house engineers will help you meet the quality standards for compounded sterile preparation (CSP) and assist you in selecting the right components and features to fit your needs. Our cleanroom walls can be equipped with windows to monitor your employees’ compounding activities from the outside, hence helping to preserve the sterile environment.
360° Virtual Tour of an HD Compounding Cleanroom
HD Compounding Pharmacy’s work zones
ISO 7/8 Anteroom (positive pressure)
The anteroom, also called ante-room, is an area in close proximity to the cleanroom where technicians perform support tasks. The anteroom is usually equipped with a sink, cabinets, bench, etc. The anteroom is engineered as an ISO 7 environment under positive pressure.
ISO 7 Buffer Zone or Clean Room (negative pressure)
The actual cleanroom or buffer zone is equipped with workstations. It must be negative pressurized for hazardous drug preparation. It is critical to maintain an appropriate cascade of pressure to preserve a clean and safe environment in your cleanroom. Mecart cleanrooms are double sealed and balanced.
Mecart’s package for HD Compounding Pharmacies
100% modular shell
- Integrated windows
- Integrated low wall air return
- Mecart-made doors
- Integrated electrical outlets and services (no need for electricians on site)
- Other services
Mecart Air Handling Unit and HVAC System
- Cooling and heating
- Humidifying
- High performance ventilation & filtration
Control & Monitoring Systems
- Pressure
- Temperature
- Humidity
- Particle Counts
Commissioning
- Ready for certification
Guaranteed Compliance
Mecart guarantees its cleanroom facilities’ compliance with local and national requirements, such as USP 797 and USP 800.
Choose Mecart for your USP 800 cleanroom
Turnkey Solution, in-house specialists dedicated to your project
- custom design
- manufacturing
- shipping
- installation
- commissioning
Learn more about our Turnkey Services
Satisfaction Guarantee
- Guaranteed Performance
- Guaranteed Delivery
- Guaranteed Quality
- Guaranteed Price
Learn more about our Waranties
Modular clean room, a real asset
Mecart cleanrooms can be modified, expanded, moved to other facilities and even sold as assets.
Learn more about our Modular System.
Let us advise you
We’ll present a solution matching your needs and budget!