Freestanding Cleanroom for 503B Compounding Pharmacy - MECART Cleanroms - 1920 x 800 (3)

Freestanding Cleanroom for 503B Compounding Pharmacy

Challenge: STAQ Pharma constructed a new operational facility, but a study of the roof structure found that it could not withstand additional weight loads. It became necessary to find a modular cleanroom solution that didn’t require attachment to the roof, which is quite uncommon. 

Solution: MECART’s modular system is engineered to provide a completely autonomous structure. MECART built and delivered a 2,774 sqft freestanding cleanroom that requires no attachment to the main building structure.


Columbus, Ohio




503B - Sterile Injectables Manufacturing


2,775 sqft

Cleanroom Class

ISO 7 (Class 10,000) & ISO 8 (Class 100,000) - USP 797/800

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.


Freestanding Cleanroom for 503B Compounding Pharmacy - MECART Cleanroms - 352 x 250 (7)Freestanding Cleanroom for 503B Compounding Pharmacy - MECART Cleanroms - 352 x 250 (7)Freestanding Cleanroom for 503B Compounding Pharmacy - MECART Cleanroms - 352 x 250 (7)

2. A Walkable Cleanroom Ceiling for Easy Maintenance Access & Cost Reduction

A walkable ceiling in a cleanroom environment provides several benefits, including lower contamination risks, convenient maintenance access, the ability to install new equipment, optimal use of the space, and the integration of services, among other advantages.


Easy Access for Maintenance & Reducing Contamination Risks

The 503B pharmaceutical compounding company was in search of a hardwall cleanroom solution that would facilitate easy and swift maintenance access without requiring entry into the cleanroom.

Once the MECART freestanding cleanroom is assembled, its robust structure features a walkable ceiling, enabling facilities and engineering teams to access HVAC and fan filter units for preventive maintenance.

This access is facilitated and enables your teams to work faster without the need to enter the cleanroom space, minimizing contamination risks.


Reducing Construction Costs with Truly Walkable Ceiling

Cleanroom manufacturers, claiming to provide walkable ceilings, typically achieve this by integrating mezzanines or walkways, a necessity due to the limited load-bearing capacity of their cleanroom ceilings.

This, however, introduces an additional challenge for customers: a surge in the overall cost of the cleanroom. The inclusion of mezzanines or catwalks substantially raises the project price.

MECART’s modular cleanroom system goes beyond mere claims, providing a genuinely walkable ceiling, unlike anything on the market.

The MECART walkable ceiling effortlessly supports the weight of the HVAC system, air handling units (AHUs), workers, or technicians without the need for additional catwalks or structural reinforcements to the customer’s building, resulting in a cost-saving solution for the customer.

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.’’



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.

Jon Hicks

Director of Pharmacy at STAQ

STAQ Pharma

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.’’


Did you know that according to the FDA, one of the main reasons why 503B outsourcing facilities exited the market is the difficulties related to maintaining compliance with cGMP regulations

Choosing the appropriate cleanroom and working with a manufacturer experienced in cGMP projects is crucial for maintaining compliance. It is important to find a cleanroom manufacturer that understands the specific requirements and can assist with facility design and engineering. Look for a cleanroom designed for easy cleaning and maintenance, ensuring long-term compliance. 


Contact us to learn more about our cGMP-compliant modular cleanroom system


*source: State of Outsourcing Facility Sector and Possibilities for the Future  

Freestanding Cleanroom for 503B Compounding Pharmacy - MECART Cleanroms - 1080 x 1080

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