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Deep in the Heart of Innovation: USP 800-Compliant Sterile Compounding Cleanroom
ISO 7 Compounding Cleanroom Design for USP 800 Applications
MECART engineers, manufacturing experts, and installation professionals successfully completed a cutting-edge ISO 7 cleanroom project for Ivy Specialty Compounding, a company in Lubbock, Texas, that specializes in sterile and non-sterile preparation of personalized medications.
Partner:
Ivy Specialty Compounding
Location:
Lubbock, Texas
Industry:
Compounding
Application:
Sterile Compounding Pharmacy for Hazardous USP 800 Materials
Size:
Under 500 sqft
Cleanroom Class:
Class 10,000 / ISO 7
Ivy Specialty Compounding
Ivy Specialty Compounding, founded by a physician and two pharmacists, is driven by a shared passion for improving healthcare delivery and accessibility, with a focus on patient experience, customer service, and provider convenience. The Ivy team specializes in both non-sterile and sterile compounding. Their mission is to provide reliable access to high-quality compounded prescription medications to their community. Their vision is to continuously strive for excellence in pharmaceutical care and customer service while seeking innovative ways to improve the delivery of healthcare. Official Website: https://www.ivy-rx.com
This advanced USP 800 compliant cleanroom project meets the most stringent USP 800 requirements for hazardous material handling while showcasing MECART’s expertise in healthcare facility solutions. This project, fully compliant with FDA regulations, has enabled Ivy to offer and sell new products, expand market reach, and drive business growth.
Overcoming Facility Design Challenges
With A Custom Cleanroom Solution
The USP 800 cleanroom project presented a significant engineering challenge: there were only 18-20 inches of overhead clearance for the complete ISO 7 cleanroom infrastructure. Undaunted, the MECART engineering team developed an innovative design for accommodating all critical systems—HVAC, HEPA filtration, and environmental monitoring—without compromising compounding requirements.
By designing custom air handling solutions and a modular wall system with integrated utility chases, the MECART engineering team maximized the limited space while maintaining stringent cleanroom classification standards. This efficient cleanroom design ensures proper air change rates and particle control while providing necessary access for maintenance.
Advanced USP 800 Cleanroom Design
MECART’s compounding cleanroom, designed to exceed ISO 7 standards, optimizes every square foot of space. The cleanroom modular design ensures seamless future expansion while maintaining continuous compliance with USP 800 requirements for hazardous drug handling.
The cleanroom system features advanced environmental controls for maintaining a sterile and secure environment. Those controls include the latest in contamination-prevention technology and systems specifically designed to protect patients and staff.
Pharmaceutical-Grade Environmental Controls
The cleanroom’s environmental control system represents the latest in contamination prevention technology.
MECART’s HVAC system delivers precise temperature and humidity control, while the advanced multi-stage HEPA filtration maintains ISO 7 air quality standards through:
- Consistent air changes exceeding USP 800 requirements
- Optimized unidirectional airflow patterns
- Real-time environmental monitoring
- Pressure cascade systems protecting critical sterile compounding areas
The individual components work in harmony to create the ideal environment for sterile pharmaceutical compounding.
Additionally, MECART incorporated multiple layers of safety features throughout the facility. Those layers include specialized containment strategies for hazardous materials, chemical-resistant surfaces, and emergency response systems.
“We were extremely satisfied with MECART. Our cleanroom was delivered punctually, it showcases exceptional design, and the support from installation and customer service teams has been superb. Our cleanroom’s functionality has significantly elevated our operations, enabling us to offer a unique range of products that set us apart in our local market.”
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Cleanroom Installation Timeline
The 11-month project was divided into carefully orchestrated phases.
- The manufacturing phase showcased MECART’s expertise in cleanroom manufacturing capabilities, with every modular component crafted to precise specifications.
- All modular components were delivered in a single shipment.
- The final installation and validation phase brought together all elements, resulting in a fully operational, certified cleanroom facility.
Maximizing Workflow Efficiency and Eliminating Contamination Risk
Since completion of the cleanroom, Ivy has transformed the operational capabilities of its pharmacy. The facility has enabled full compliance with regulatory requirements and enhanced particle removal efficiency.
The cleanroom design has significantly improved workflow efficiency and eliminated contamination risks, enabling the pharmacy to expand its sterile compounding services while maintaining the highest standards of patient safety.
Check out Ivy’s MECART-designed cleanroom: https://fb.watch/vmjmSOuxs3/
MECART’s Cleanroom Manufacturing Expertise
With more than 3,400 completed projects and 45 years of experience in manufacturing and design, MECART continues to set industry standards for healthcare facility solutions. Our expertise includes a comprehensive understanding of pharmaceutical operations, regulatory requirements, and technological innovation.
This successful collaboration between MECART and Ivy Specialty Compounding Pharmacy demonstrates the potential of modern cleanroom design in compounding applications. Our modular cleanroom systems enable customers to meet the myriad performance needs of today’s pharmaceutical operations. Our modular systems also provide the flexibility to evolve seamlessly with future advances in healthcare technology.
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