USP 795/797/800
Search
Filters
Close

Frequently Asked Questions

Disposable Apparel & Cleaning Products

Ordering & Pricing

How can I place an order?

Orders can be placed via our website or email order@chdisposables.com. To place an order on our website, customer must register and create an account. 

Can I get a price list or catalog?

Yes, request our latest catalog by contacting us at order@chdisposables.com or register an account to view products and pricing.

Shipping & Delivery

What shipping options do you offer?

We offer standard, expedited, and freight shipping depending on order size and location.

How long does deliver take?

Delivery times vary but typically range from 3–10 business days within the U.S.

Inventory & Availability

How can I check product availability?

Contact us by phone (407-296-6689) or via email at order@chdisposables.com for product availability.

Do you back-order out-of-stock items?

Yes, we offer back-ordering with estimated restock dates for selected products.

Cleanroom

Compliance

What is the difference between USP 795, 797, and 800—and how do these standards impact the design of my cleanroom?

USP 795, 797, and 800 each define specific requirements for compounding environments, and understanding the distinctions is essential for a compliant build.

 

  • USP 795 governs non‑sterile compounding and focuses on workflow, containment, and cleanability.
  • USP 797 outlines the standards for sterile non-hazardous compounding, including air quality classifications, pressure relationships, and engineering controls.
  • USP 800 adds requirements for handling hazardous drugs, including negative‑pressure containment and specialized exhaust systems.

 

At Carter Health, we incorporate these standards in our cleanroom designs based on production requirements. Our team evaluates your compounding activities, workflow, and facility constraints to ensure your space meets the appropriate chapter requirements while supporting long‑term operational efficiency.

How do you ensure our cleanroom design remains compliant as USP standards evolve?

Regulatory expectations change, and your cleanroom should be built to adapt. Carter Health continuously monitors updates from USP, state boards of pharmacy, and accrediting bodies. We incorporate flexible design strategies—such as scalable mechanical systems, adaptable pressure cascades, and modular components—so your facility can evolve without major reconstruction. Our team also provides ongoing consultation to help you stay ahead of regulatory shifts.

What level of documentation and support do you provide after the build is complete?

Carter Health delivers comprehensive documentation to support certification and inspection. This includes:

 

  • As‑built drawings
  • Close-out Documentation: Material and equipment specifications
  • 1-Year Warranty

 

Carter Health offers an ongoing maintenance program to support your continued compliance. This includes:

 

  • Annual cleanroom review
  • Airflow testing
  • Visual HEPA filter checks
  • Environmental performance review
  • Visual inspection of physical plant

 

Carter Health developed and offers a documentation software program called, CHAART.The program is web-based and supports the pharmacy’s efforts to easily record and quickly demonstrate ongoing compliance with the click of a few buttons.

Design

What makes your cleanroom designs different from modular “one size fits all” solutions?

Many cleanroom providers rely on prefabricated kits that force your pharmacy to adapt to their room design. Carter Health takes the opposite approach. We engineer every cleanroom around your workflow, your space, and your compliance needs. From custom room design to tailored pressure relationships and material selection, we build environments that support safe, efficient compounding—not generic boxes that limit your operations.

What materials do you use for walls, ceilings, and flooring—and why are they chosen for USP compliance?

We select materials based on durability, cleanability, and long‑term compliance. Carter Health uses seamless, non‑porous surfaces that withstand aggressive disinfectants, resist chemical damage, and minimize microbial harborage. Every component—from wall panels to flooring transitions—is chosen to support a controlled environment that remains compliant and easy to maintain.

Can you retrofit or upgrade an existing cleanroom to meet USP 795/797/800 requirements?

Absolutely. Many facilities don’t require a full rebuild. Carter Health evaluates your current infrastructure to determine what can be preserved and what must be upgraded. We offer cost‑effective retrofit strategies that improve compliance while minimizing downtime and disruption to your operations.

Environmentals

How do you validate airflow, pressure differentials, and containment strategies for USP 800 hazardous compounding rooms?

Hazardous drug handling requires precise engineering. Carter Health works closely with engineering teams to validate airflow patterns, pressure relationships, and exhaust routing. We optimize hood placement, negative‑pressure containment, and HEPA filtration to ensure hazardous drugs remain controlled at every stage of the compounding process. Pressures are monitored via pressure sensors with digital displays and audible/visual alarms.

How do you design airflow and pressure requirements to meet USP 797/800?

The mechanical system is the backbone of a compliant cleanroom. After consulting with our clients to understand their compounding activities, the team designs pressure cascades, calculates air changes per hour, and filtration needs. We design systems that deliver consistent performance, energy efficiency, and reliable environmental control—ensuring your cleanroom maintains compliance day after day.

Consultation

What makes your consultation process different from other cleanroom builders?

We don’t just build rooms—we build long‑term partnerships. Carter Health’s consultation process is collaborative, transparent, and grounded in regulatory expertise. We take the time to understand your goals, challenges, and operational needs so we can design a solution that supports your success today and in the future. As a turn-key solutions partner, Carter Health offers disposable PPE, as well as USP documentation software, CHAART.

How do you help pharmacies prepare for certification and inspection?

Certification can feel overwhelming, but we make it manageable. Thru our cleanroom maintenance program, Carter Health conducts pre‑certification walkthroughs, reviews documentation, verifies pressure relationships, and ensures your engineering controls are functioning as designed. With Carter Health’s 20+ years of experience in building over 500 cleanrooms nationally, we guarantee a passing initial certification and inspection when our services are used from initial design to final build.

How do you help pharmacies budget for USP compliant cleanroom construction or upgrades?

We provide clear, detailed cost breakdowns and help you evaluate options such as phased implementation, retrofits, or full rebuilds. Our team also discusses long‑term cost‑of‑ownership, current operational needs, and future growth considerations so you can make informed decisions that balance compliance, performance, and budget. Our mantra is to plan appropriately up front to avoid unnecessary costs in the end.

CHAART USP Compliance Software

What is CHAART?

CHAART is a USP 795/797/800 compliance documentation software that is designed to assist independent compounding pharmacies and hospital pharmacies with maintaining compliance through task documentation and personnel certification management. This solution allows pharmacies to monitor their operational efficiency, ongoing compliance, and maintain audit readiness.

How difficult is it to transition from paper/manual documentation to CHAART?

Transitioning is straightforward. CHAART is designed for ease of adoption, with guided onboarding and minimal disruption to your workflow. Many of our current active facilities describe CHAART as user-friendly with a welcoming interface.

How can software help pharmacies prepare for pharmacy inspections?

CHAART transforms inspection preparation from reactive to proactive. With automated tracking, reminders, and real-time compliance visibility, your team is always inspection-ready.

Can multiple technicians document tasks simultaneously?

Absolutely. CHAART is built for real-world pharmacy workflows, allowing multiple users to document in real time without overlap or data loss. Additionally, when one task has been completed, it is removed from the task list to prevent duplicate entries. Tasks may also be assigned to one personnel or a group of personnel.

Does CHAART alert personnel when documentation tasks are missed?

Yes—CHAART sends automated reminders and alerts so nothing slips through the cracks, reducing compliance risk. These reminders and alerts are prompted whenever tasks are overdue, incomplete, or out-of-range.

Does CHAART track personnel media fill and gloved fingertip testing?

Yes—CHAART tracks all personnel competency requirements, including scheduling, completion, and historical performance.

Can pharmacies customize documentation logs to match their workflow?

Yes. CHAART is fully customizable, allowing you to align logs, workflows, and processes with your exact operational needs—not force you into a rigid system.

What happens if documentation is missed or incomplete?

CHAART flags missing or incomplete entries in real time, giving your team the opportunity to correct issues immediately before they become inspection findings. Through our reporting, administrators can run internal reports on overdue task rates, out-of-range rates, amongst others.

How long does CHAART retain documentation records?

CHAART securely retains documentation for as long as your organization is subscribed to CHAART, supporting USP retention standards and internal policies. Records are never lost, overwritten, or misplaced—ensuring complete historical traceability. Should the CHAART subscription become inactive, all documentation reporting will remain available for 2 years thereafter.

Can CHAART store certification reports for cleanrooms and hoods?

Absolutely. CHAART provides a secure repository for all certification reports, ensuring they’re always accessible and audit-ready. Additionally, each report allows the administrator to monitor the reviewer of each certification report to maintain and ensure internal accountability.

How is pharmacy documentation stored securely?

CHAART is a secure, cloud-based platform, eliminating the need for local servers or manual backups. CHAART uses enterprise-level security protocols, encryption, and controlled access permissions to keep all data protected.