USP 797 Clean Rooms for Compounding Pharmacies

Building a compounding pharmacy can be challenging. Mecart modular cleanrooms are the perfect solution for your compounding pharmaceutical cleanroom needs. At Mecart, we oversee the entire project and let you do what you do best, serve your patients. Mecart’s in-house team of engineers will take care of every aspect of the project from the design of your custom compounding pharmaceutical facility to the on-site installation and commissioning.

Mecart builts state-of-the-art cleanrooms and guarantees compliance with cGMP, FDA, USP-797, USP-800 and NAPRA. Our cleanrooms are ideal for 503B outsourcing facilities! Our modular cleanrooms offer scalability and flexibility. Mecart cleanrooms can be modified, expanded, moved to other facilities, and even sold as assets. Mecart will help design your cleanroom to optimize the size and shape of the compounding facility.

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Sterile 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.

sterile compounding pharmacy cleanroom manufacturing facilities

Compounding Pharmacy’s work zones

ISO 7/8 Anteroom

The anteroom, also called ante-room or antechamber, 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 can be engineered as an ISO 7 or ISO 8 environment depending on the risk level of the sterile products being prepared in the critical area.

ISO 7 Buffer Zone or Clean Room

The actual cleanroom or buffer zone (sometime called white room) is equipped with workstations. It must be  negative pressurized for hazardous drug preparation or  positive pressurized for sterile non-hazardous compounding preparations. 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 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 (AHU)

  • Cooling and heating
  • Humidifying
  • High performance ventilation & filtration

Control & Monitoring Systems

  • Pressure
  • Temperature
  • Humidity
  • Particle Counts

Commissioning

  • Ready for certification

Mecart guarantees its cleanroom facilities’ compliance with local and national requirements, such as USP 797 and USP 800.

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Choose Mecart for your USP 797 cleanroom

Turnkey Solution, in-house specialists dedicated to your project

  • custom design
  • manufacturing
  • shipping
  • installation
  • commissioning

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Satisfaction Guarantee

  • Guaranteed Performance
  • Guaranteed Delivery
  • Guaranteed Quality
  • Guaranteed Price

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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!

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