Freestanding Cleanroom for 503B Compounding Pharmacy

A Freestanding Cleanroom to Overcome Building Structural Challenges

STAQ Pharma, a 503B pharmaceutical compounding company, needs a modular cleanroom manufacturer to provide them with USP 797 & USP 800 cleanrooms for the cGMP sterile injectables manufacturing in response to the US drug shortage crisis.

For their operations at their 503B outsourcing facility, they need two compounding rooms and two NPR laboratories in a single cleanroom. The space needs to meet the ISO 7 and ISO 8 cleanroom classifications as per the ISO 14644-1 standards.

Upon reaching out to multiple modular cleanroom manufacturers, STAQ Pharma discovered that an overwhelming majority of cleanroom solutions involve directly affixing the HVAC system, ceiling grids, and ceiling panels to the main building’s roof structure.

Consequently, STAQ Pharma initiated a structural analysis to assess the building’s load-bearing capacity. The findings revealed that the existing roof structure could not support any additional weight, eliminating the majority of cleanroom manufacturers from consideration. 

With a freestanding cleanroom system, MECART emerged as the ideal solution for overcoming the structural challenge of the building.

A Unique Modular Cleanroom System for cGMP Pharmaceutical Compounding

STAQ Pharma requires more than just a self-supporting modular cleanroom system; it wants a solution that offers 3 specific key features, all while going live as soon as possible to help stock up on much-needed medications.

• A Freestanding Cleanroom System with Heavy Load-Bearing Capacity
• A Walkable Cleanroom Ceiling for Easy Maintenance Access & Cost Reduction
• A cGMP-Compliant Modular Cleanroom System

The engineering powering the MECART cleanroom system satisfies all STAQ criteria and checks every box.

1. A Freestanding Cleanroom System with Heavy Load-Bearing Capacity 

The STAQ Pharma’s roof structure couldn’t bear any weight – not just the cleanroom shell, but also the considerable load of the HVAC system and utilities vital for cleanroom operations. The MECART modular cleanroom system is purposefully designed to tackle both challenges, ensuring a self-supportive structure while managing the demands of supporting heavy loads.

This capability is made possible by the engineering behind the manufacturing of MECART’s modular cleanroom wall system, where each panel is designed to withstand 3,000 pounds of compression force.

Once the panels are assembled and the cleanroom is erected, it transforms into a self-contained structural entity—a solid, robust box-in-a-box solution, effortlessly bearing heavy loads without requiring additional reinforcement of your building structure, which overcomes all STAQ Pharma structural challenges.

3. A cGMP-Compliant Modular Cleanroom System 

STAQ Pharma must maintain compliance with FDA-enforced current Good Manufacturing Practices (cGMP) while manufacturing sterile injectables. 

STAQ was in search of a cleanroom manufacturer that not only met their requirements for being cGMP-compliant but also had a proven track record of completing multiple cGMP cleanroom projects in the past.Once more, the MECART modular cleanroom system fulfills all the requirements. Jon Hicks, Director of Pharmacy at STAQ, expressed why he decided to partner with MECART as their cleanroom manufacturer, stating, ‘’we really felt like MECART had just the quality of materials and sort of the fit and finish that we were looking for in a cGMP clean room.’’

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A Great Experience with MECART: Picking the Right Cleanroom Manufacturer

In summary, STAQ Pharma chose MECART hardwall modular cleanrooms because of the:

• Freestanding cleanroom system: This eliminates the need for attachments to the main building.
• Walkable ceiling: Along with its capacity to support heavy loads (HVAC) and provide easy maintenance access.
• cGMP cleanroom: The cleanroom is constructed using top-notch materials, ensuring its durability and ability to withstand harsh chemicals. It also features flush finishes, making it easier to clean and preventing particles from accumulating in hard-to-reach areas. 

After working with MECART, STAQ Pharma expressed their ongoing dedication to the partnership, citing a great overall experience. They highlighted the collaborative process, the expertise of MECART’s in-house specialists, and the professionalism displayed throughout the project. 

‘’We had a great experience working with MECART and it was a great collaborative process from beginning to end. Everyone worked together really well to come up with a design that we felt really optimized the people and materials flow for the clean room.’’

‘’We just felt like MECART was really committed to collaborating with us, to working as a team on the project, and that showed throughout the entire process. We had a great experience with the project team, with the installers. It was really top quality and very professional.’’