Project sixteen
Modular Cleanroom Solution for NAPRA Compliant Pharmacy

This case study explores how ACH - A Cleanroom Hub successfully installed a custom pharmaceutical cleanroom that complies with NAPRA regulations for a client. This project sought to assist the user in producing compounding formulations of the highest caliber and making significant contributions to the healthcare sector. To meet the unique requirements of the client, ACH engineered a six hundred square foot cleanroom facility in an industrial warehouse, that was divided into multiple separate rooms using creative and useful solutions. The facility includes sterile hazardous, non-sterile hazardous (Level-C), sterile non-hazardous and an ante room.

The Compounding Pharmacy Cleanroom: 
The primary objective was to design and install multiple cleanrooms with an ante room within six hundred square feet while adhering to stringent NAPRA and ASHRAE guidelines as well as meeting OBC (Ontario Building Code). Converting a warehouse space into a dynamic facility presented both opportunities and challenges. We recognized the immense potential of the existing structure while acknowledging the need for extensive modifications to fulfill the client's vision. By leveraging the inherent characteristics of the warehouse, such as high ceilings and expansive floor space, we crafted a design that seamlessly integrated modern functionality with industrial charm.

Space Identification and Property Management Co-ordination:
The foremost challenge was identifying an appropriate space, meeting the client's requirements. This involved finding a site that was suitable for installation, accessible, and met regulatory standards. To tackle this, ACH undertook a comprehensive approach. This involved conducting a thorough client needs assessment to understand requirements, followed by extensive market research to identify potential spaces. Rigorous evaluation of regulatory compliance ensured alignment with standards. Subsequent site visits provided firsthand assessments of suitability, while collaborative discussions with property owners facilitated negotiations.
Through these efforts, ACH successfully identified a compliant and efficient space, laying the groundwork for the successful implementation of the NAPRA compounding pharmacy cleanroom project.

Working with City:
Navigating regulatory hurdles and obtaining necessary permits is often a daunting task in construction projects, especially when repurposing existing structures. In this case, we proactively engaged with municipal authorities on behalf of our client, streamlining the approval process and ensuring compliance with local building codes. Our collaborative approach with the city not only expedited the project timeline but also demonstrated our commitment to delivering results while adhering to regulatory standards.

No wastage of space and Regulatory Compliance:
Once the space was selected and occupied, ACH pivoted to address the challenge of optimizing space utilization while maintaining regulatory compliance and workflow efficiency. ACH's design team embarked on a meticulous process of layout design, employing innovative techniques to maximize functionality within the available space. This involved strategic placement of equipment, workstations, and storage areas to minimize wasted space and streamline workflow processes. Modular solutions were implemented to allow for flexibility and adaptability as operational needs evolved. Throughout the design phase, stringent adherence to regulatory standards remained a top priority, with every aspect of the layout carefully evaluated to ensure compliance. By balancing functionality, compliance, and efficiency, ACH successfully designed a layout that fully utilized the available space while meeting the client's operational requirements and regulatory obligations.

Other key highlights of the NAPRA Compliant Compounding Pharmacy:

Customized panels with inbuilt conduits to ensure cleanliness and safety.

Self-supporting modular cleanroom structure for flexibility.

Stand-alone monitoring system in each room ensures continuous control of critical parameters like temperature, pressure, and humidity, ensuring compliance with regulatory standards.

Walk-on ceiling for future maintenance easements.

Through meticulous planning and collaborative problem-solving, we addressed structural limitations, logistical constraints, and regulatory hurdles with agility and expertise. Our unwavering commitment to excellence fueled our ability to deliver results that surpassed expectations.

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DID YOU KNOW?
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