Every compounding pharmacy understands the critical importance of maintaining a sterile, controlled environment. USP 797 and USP 800 Compliance​ aren’t just acronyms—they set the bar for ensuring patient safety when handling sterile and hazardous drugs. Failing to meet these standards can lead to costly remediation, regulatory fines, and, more importantly, serious health risks for patients. At PureLinc Cleanrooms, we recognize that the heart of any compliant compounding operation is a purpose-built cleanroom engineered to the exacting requirements of USP 797 for sterile preparations and USP 800 for hazardous drugs.

USP 797 and USP 800 Compliance for Hazardous and Non-Hazardous Sterile Compounding

USP 797 and USP 800 Compliance for Hazardous and Non-Hazardous Sterile Compounding

USP 797 outlines stringent controls around air quality, environmental monitoring, and personnel practices to prevent contamination in sterile compounding. USP 800 extends those principles to hazardous drug handling, demanding additional measures—specialized ventilation, containment strategies, and rigorous decontamination protocols. Achieving compliance with USP 797 and USP 800 Compliance​ means striking a delicate balance: you need a robust, sealed environment that still allows for efficient workflow, quick maintenance, and adaptability as standards evolve.

That’s where PureLinc Cleanrooms’ expertise comes in. We don’t offer off-the-shelf solutions; we partner with you from initial design through installation, validation, and ongoing support. Our team of certified hygienic PVC installers and cleanroom specialists brings deep knowledge of pharmacy regulations, industry best practices, and material science. Whether you’re setting up a new sterile compounding suite or upgrading an aging facility to handle hazardous drugs, PureLinc Cleanrooms ensures your cleanroom not only meets—but exceeds—USP 797 and USP 800 Compliance​ requirements. You’ll get a turnkey solution that protects your team, your patients, and your reputation, without compromising on functionality or aesthetic appeal.

Key Features of Our USP 797 & USP 800 Compliant Cleanrooms

  • Certified Hygienic PVC Wall Cladding

    Seamless, heat-welded PVC panels provide a monolithic surface that’s easy to clean, chemically resistant, and built to withstand frequent wipe-downs and harsh disinfectants.

  • Modular Cleanroom Systems for USP 797 and USP 800 Compliance

    Removable, reusable panels allow for quick reconfiguration or expansion as your compounding needs grow, minimizing downtime and renovation costs.

  • Epoxy and Safety Flooring for Hazardous and Non-Hazardous Sterile Compounding Areas

    Slip-resistant, chemical-resistant flooring enhances safety and simplifies decontamination—crucial for both sterile and hazardous compounding areas.

  • Specialized Ventilation & Airflow Controls for USP 797 and USP 800 Compliance

    Designed to maintain ISO-classified air cleanliness levels, our HVAC integrations ensure proper differential pressures and unidirectional airflow for both USP 797 and USP 800 zones.

  • Integrated Cleanroom Doors & Pass-Throughs

    Airtight, stainless-steel–trimmed doors prevent cross-contamination and support safe material transfer between clean and buffer zones.

  • Regulatory Validation Support for USP 797 and USP 800 Compliance

    We provide guidance and documentation to streamline your validation process, including performance qualification (PQ) and environmental monitoring protocols.

Benefits of USP 797 and USP 800 Compliance with PureLinc Cleanrooms

Benefits of USP 797 and USP 800 Compliance with PureLinc Cleanrooms

Guaranteed Compliance with USP 797 and USP 800 Compliance

PureLinc Cleanrooms ensures your cleanroom is built to meet all necessary standards, including NAPRA, Ontario College of Pharmacists, USP 797, and USP 800. With our expertise, you can reduce the risk of failing inspections and costly non-compliance penalties. We build with regulatory adherence in mind, so you can rest assured that your cleanroom will pass the toughest inspections, safeguarding your business and patients.

Enhanced Operational Efficiency for Sterile Preparation Guidelines

Our modular cleanroom systems are designed for quick installation with minimal disruption to your daily operations. Our in-house team works efficiently to ensure that your project is completed on time, allowing you to focus on patient care and compounding. With faster project timelines and less downtime, you can get your operations up and running without unnecessary delays.

Long-Term Durability for Hazardous Sterile Compounding Areas

Long-Term Durability for Hazardous Sterile Compounding Areas

We use only high-quality materials like BioClad, True North, and Altro Whiterock to ensure the longevity of your cleanroom. These durable materials can withstand daily wear and frequent cleaning, minimizing maintenance needs and reducing the cost of replacements. By choosing PureLinc Cleanrooms, you're investing in a facility that will last, saving you money on upkeep for years to come.

Customized Solutions for Your Unique Sterile Preparation Guidelines

Every pharmacy has different workflows, and we understand the importance of creating a cleanroom that works for you. PureLinc Cleanrooms offers customized solutions, tailoring layouts, finishes, and airflow systems to meet the specific needs of your facility. Whether you need additional workspace or specialized airflow designs, we ensure that your cleanroom is fully optimized for your operations.

Expert Support and Training for C-PEC and Compounding Aseptic Containment Isolator (CACI)​ Systems

At PureLinc Cleanrooms, we go beyond installation. We provide ongoing expert support and training, ensuring that your team is fully prepared to maintain the cleanroom’s compliance and functionality. From gowning procedures to preventive maintenance plans, we guide you through every step to ensure your cleanroom continues to operate at peak performance.

Why Choose PureLinc Cleanrooms for Hazardous and Non-Hazardous Sterile Compounding

Why Choose PureLinc Cleanrooms for Hazardous and Non-Hazardous Sterile Compounding

Decades of Specialized Experience in C-PEC Systems

Our team has delivered hundreds of pharmacy cleanrooms across Ontario and beyond, mastering the nuances of sterile and hazardous compounding environments.

Certified & Accredited Installers of Biological Safety Cabinet (BSC)

As elite Hygienic PVC installers, we uphold rigorous quality controls—turning installations into an art form that meets the highest regulatory benchmarks.

Turnkey Project Management for Negative Pressure Cleanrooms

From initial concept drawings to final validation, PureLinc Cleanrooms handles every detail: structural framing, PVC cladding, flooring, doors, HVAC coordination, and more.

Seamless Collaboration with Containment Primary Engineering Controls (C-PEC)

We partner with your architects, engineers, and pharmacists to ensure absolute alignment on timelines, budgets, and technical specifications.

Proven Track Record in Compounding Aseptic Containment Isolator (CACI)​ and Biological Safety Cabinet (BSC)​ Installations

With glowing client testimonials and case studies showcasing successful USP 797 and USP 800 compliance projects, PureLinc Cleanrooms is the trusted name in cleanroom solutions.

FAQs

FAQs About USP 797 and USP 800 Compliance

What’s the difference between USP 797 and USP 800 compliance?

USP 797 focuses on preventing microbial contamination during sterile compounding, while USP 800 adds requirements for handling hazardous drugs, including specialized ventilation, containment, and decontamination.

How long does it take to install a USP-compliant cleanroom?

Project timelines vary with size and complexity, but a typical modular cleanroom installation can be completed in 4–8 weeks, including framing, cladding, flooring, HVAC tie-ins, and final validation.

Will PureLinc help with regulatory validation and documentation?

Absolutely. We provide comprehensive validation support—performance qualification protocols, environmental monitoring templates, and on-site training—to streamline regulatory approvals and inspections.

Ready to Elevate Your Pharmacy’s Sterile & Hazardous Drug Practices?

Contact PureLinc Cleanrooms today at (705) 503-9119 or email admin@purelinc.ca to schedule a free consultation. Let us design and build a cleanroom that not only meets USP 797 and USP 800 requirements but also enhances your operational efficiency and peace of mind.

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