Pharmaceutical compounding requires a sterile, controlled environment to ensure product safety and efficacy. For facilities in regions like Central and South America, meeting global standards while navigating local regulations presents a unique challenge. Custom compounding clean rooms provide the necessary solution, offering controlled spaces that prevent contamination and ensure compliance.
Modern modular construction has transformed the process of building these specialized areas. Instead of long, disruptive traditional builds, modular systems offer a faster, more flexible alternative. A recent project in Panama demonstrates this efficiency. Labs USA designed and delivered two turnkey USP 800-compliant compounding clean rooms in just six to eight weeks, showcasing a rapid and adaptable approach to complex pharmaceutical needs.
TL;DR: Key Takeaways on Custom Compounding Clean Rooms
- Compliance is Critical: Custom clean rooms must meet standards like USP 800 and ISO 5, along with local health authority rules, such as those in Panama.
- Pressure Matters: Positive pressure rooms protect non-hazardous drugs from outside contaminants, while negative pressure rooms contain hazardous drugs to protect personnel.
- Modular is Faster: Modular construction, in partnership with fabricators like Panel Built, allows for project completion in 6–8 weeks, minimizing operational downtime.
- Customization Solves Problems: Designs can be adapted to site constraints, such as low ceilings, using solutions like low-profile HEPA filters and side-mounted airflow systems.
- Turnkey Solutions Streamline Projects: A single point of contact for design, installation, and certification simplifies communication and ensures a smooth process from start to finish.
Project Scope: Two USP 800 Compounding Rooms in Panama
A pharmaceutical facility in Panama required two distinct compounding environments to meet both international and local health standards. The project called for a precise and compliant solution that could be delivered quickly to avoid interrupting facility operations.
The final layout included two 10 m² clean rooms, each with an attached 3.5 m² anteroom for gowning and material staging. This design satisfies common clean room workflow requirements.
- One room maintains positive pressure for compounding non-hazardous sterile drugs. This pressure differential pushes air out of the room, preventing airborne contaminants from entering and protecting the product.
- The second room uses negative pressure for handling hazardous drugs. This setup pulls air into the room, containing any potentially harmful particles and protecting laboratory personnel.
To comply with local Panamanian health regulations, each room was also equipped with two pass-through chambers, one for inputs and another for outputs. This system allows materials to move in and out of the sterile environment without compromising air quality or requiring personnel to enter and exit. These types of projects are streamlined with Labs USA’s Modular Cleanroom Solutions.
Design Constraints and Engineering Solutions
Every construction project has unique challenges, and this Panama installation was no exception. The primary constraint was an existing 3-meter (approximately 9.8 feet) ceiling height. This limitation made standard top-mounted HEPA filtration units impractical, as they would have significantly reduced the usable workspace.
To overcome this, Labs USA engineered a custom solution.
- Low-profile HEPA filters were used to maximize vertical space while still delivering the required air purity.
- Side-mounted airflow systems were integrated to ensure proper air circulation and particle removal throughout the entire space.
This customized approach allowed both rooms to achieve ISO 5 classification, the standard required for sterile compounding. The design also included 6-foot laminar flow cabinets for product protection and integrated systems for ducted Laboratory Fume Hoods. The facility specifically required Bench-Top Fume Hoods to manage hazardous vapors safely within the negative pressure room.
Safety, Exhaust, and Compliance
Handling hazardous substances requires strict engineering controls to ensure personnel safety. For the negative pressure compounding room, a dedicated exhaust system was critical. The room was designed to connect directly to a basement exhaust duct, which safely removes filtered air from the facility without risk of recirculation.
This design aligns with the stringent safety protocols outlined in USP 800 standards. Adherence to these guidelines is not just a best practice; it is a requirement for facilities handling cytotoxic and other hazardous drugs.
Successfully executing multi-region projects like this requires experience and coordination. As one of the leading Cleanroom Construction Companies, Labs USA manages all aspects of the project, from design to final validation, ensuring all local and international standards are met.
Certification and Validation
Designing and building a clean room is only half the process. The final step is validation, where an independent third party certifies that the room performs to its specified standard. Both clean rooms in the Panama project were designed to meet ISO 5 particulate levels, which is one of the highest levels of air cleanliness.
Third-party certifiers conducted a series of tests to validate performance.
- Particle Counts: Measured the number of airborne particles to confirm ISO 5 classification.
- Airflow Balancing: Verified that the positive and negative pressure differentials were stable and effective.
- Filter Integrity: Tested HEPA filters to ensure they were free of leaks.
This rigorous testing provides the documentation needed to prove compliance. For more details on this process, you can review common Cleanroom Certification Requirements to understand the full scope of validation.
Rapid Project Delivery
One of the most significant advantages of modular construction is speed. Using stocked, pre-fabricated components and a streamlined approval process, the entire Panama project was completed in just 6 to 8 weeks. This rapid timeline is nearly impossible with traditional construction methods, which often take many months.
The project’s efficiency was driven by close collaboration. Ben Adams of Labs USA and Megan Wood of Panel Built, the modular fabrication partner, led the process. Their coordinated efforts ensured that manufacturing and site preparation occurred simultaneously, keeping the project on its fast-track schedule. For pharmaceutical clients, this pre-fabricated approach significantly reduces downtime and allows operations to begin much sooner.
Collaborative Planning and Communication
Clear and constant communication was essential to the project’s success. Carlos Rojer-Abadia, the client representative, maintained direct contact with the Labs USA team throughout the project. This continuous dialogue allowed for rapid design modifications and approvals.
When questions arose or adjustments were needed, the responsive communication loop among all teams prevented delays. This collaborative model is a core part of the Labs USA process, ensuring that the final product precisely matches the client’s operational needs and regulatory obligations.
Room Comparison Table
This table summarizes the key differences between the two custom compounding clean rooms installed in Panama.
| Room Type | Pressure | Purpose | Key Features |
|---|---|---|---|
| Non-Hazardous Compounding | Positive | Pharmaceutical prep of standard compounds | 6-foot laminar flow cabinet, dual pass-throughs, gowning anteroom |
| Hazardous Compounding | Negative | Cytotoxic and hazardous drug handling | Dedicated exhaust duct, sealed pass-throughs, side-mounted HEPA filtration |
Why Speed and Compliance Matter
In the pharmaceutical industry, time is a critical resource. Fast installation minimizes operational downtime, allowing research, development, or production to start sooner. This speed provides a significant competitive advantage. However, it cannot come at the expense of safety or quality.
Labs USA’s modular clean rooms are designed to meet or exceed internationally recognized standards, including the ISO 14644-1 Cleanroom Classification system. The quick-ship capability, combined with a deep understanding of compliance, ensures that clients receive a high-quality, validated environment without compromising safety protocols.
5-Step Checklist for Choosing a Clean Room Solution
Selecting the right clean room involves careful planning. Use this checklist to guide your decision-making process.
- Define Your Application: Determine if you will be handling hazardous, non-hazardous, or both types of compounds. This will dictate your need for positive or negative pressure rooms.
- Identify Regulatory Requirements: List all applicable standards, such as USP 797/800, ISO classifications, and any specific rules from local health authorities.
- Assess Your Facility: Measure your available space, noting constraints like ceiling height, column locations, and access to existing HVAC and exhaust systems.
- Evaluate Timeline and Budget: Compare the long-term value and rapid deployment of a modular system against the timeline and potential disruptions of traditional construction.
- Choose an Experienced Partner: Select a company with a proven track record of designing and installing compliant pharmaceutical clean rooms, especially one that offers turnkey project management.
Frequently Asked Questions About Custom Clean Rooms
1. What is the main difference between a positive and a negative pressure clean room?
A positive pressure clean room is designed to protect the product inside from contamination by pushing clean, filtered air outward. A negative pressure room is designed to protect personnel outside the room by pulling air inward, containing any hazardous particles.
2. How long does a typical modular clean room installation take?
While project complexity can vary, a typical modular clean room can be installed and certified in 6 to 8 weeks, compared to many months for traditional construction.
3. What ISO class is required for sterile compounding?
The primary engineering control (like a laminar flow hood) must be ISO 5. The buffer room where compounding occurs is typically ISO 7, and the adjacent anteroom is ISO 8.
4. Can you install a clean room in a facility with a low ceiling?
Yes. Custom engineering solutions, such as low-profile fan filter units and side-mounted air returns, can be used to achieve full compliance even in spaces with height restrictions.
5. What is included in a turnkey clean room solution?
A turnkey solution includes everything from initial design and engineering to component fabrication, shipping, on-site installation, and final third-party certification.
6. Does Labs USA handle projects outside of the United States?
Yes, Labs USA manages clean room projects globally, including in Central and South America, ensuring compliance with both international standards and local regulations.
Conclusion
Labs USA provides custom compounding clean room solutions that combine regulatory compliance, quality engineering, and rapid installation. By using a modular approach and maintaining close partnerships with fabricators like Panel Built, we deliver validated environments that meet the stringent demands of the pharmaceutical industry. The successful project in Panama highlights our ability to adapt to unique site challenges and deliver turnkey systems on an accelerated timeline.
Whether you are upgrading an existing facility or building a new one, our team is ready to help you design a space that is safe, efficient, and fully compliant.
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