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USP Compounding Cleanrooms: A Comprehensive Guide to Design and Compliance

June 5, 2023
USP Compounding Cleanrooms: A Comprehensive Guide to Design and Compliance

Introduction to USP Compounding Cleanrooms

United States Pharmacopeia (USP) is a nonprofit organization that provides regulatory standards for quality and purity of medicines. Stringent requirements like those set forth in USP General Chapters 797 and 800 ensure the safety and efficacy of compounded sterile and hazardous drug preparations  and need to be considered when designing a cleanroom. At Instant Cleanroom Solutions, we specialize in designing and building state-f-the-art USP compounding cleanrooms for the pharmaceutical industry.

Importance of USP Compounding Cleanrooms

Ensuring Patient Safety: Compounding cleanrooms are essential for maintaining the safety and integrity of compounded medications. By controlling air quality, temperature, humidity, and contamination, our cleanrooms help prevent harmful bacteria, fungi, and other contaminants from compromising the quality of the drugs being prepared.

Meeting Regulatory Compliance: Our USP compounding cleanrooms adhere to rigorous standards and guidelines set by regulatory agencies, including the USP and the Food and Drug Administration (FDA). Compliance with these requirements is crucial for ensuring the safety of patients and staff, and for maintaining the integrity of your pharmacy's reputation.

Features of Our USP Compounding Cleanrooms

Optimal Airflow and Filtration: Our cleanrooms are equipped with advanced High Efficiency Particulate Air (HEPA) filters that remove 99.99% of particles as small as 0.3 microns. The rooms maintain positive or negative pressure, depending on the type of compounding, to ensure optimal air circulation and prevent cross-contamination.

Seamless, Easy-to-Clean Surfaces: We utilize non-porous, antimicrobial materials for walls, floors, and ceilings, making our cleanrooms easy to clean and maintain. This helps minimize the risk of microbial growth and contamination.

Modular and Customizable Design: Our Modular Cleanroom designs allow for easy scalability and adaptation to your specific needs. From small, single-room facilities to large-scale, multi-room operations, our cleanrooms can be tailored to suit your pharmacy's requirements.

Proper Cleanroom Classification and Design

ISO Classification: Our USP compounding cleanrooms are designed in compliance with ISO 14644-1 cleanliness standards, ensuring that they meet the specific requirements for air cleanliness and particle count limits.

USP 797 Compliance: For sterile compounding, our cleanrooms adhere to USP 797 guidelines. This includes maintaining ISO Class 5 conditions in primary engineering controls (PECs), ISO Class 7 conditions in buffer areas, and ISO Class 8 conditions in ante areas.

USP 800 Compliance: For hazardous drug compounding, our cleanrooms follow USP 800 guidelines. We provide negative pressure rooms and dedicated spaces for the handling, storage, and compounding of hazardous drugs to minimize exposure risks for staff and patients.

Staff Training and Cleanroom Procedures

Proper Garbing and Gowning: Comprehensive training for staff on proper garbing and gowning procedures is critical to ensure aseptic conditions within the cleanroom. This includes the correct use of gloves, masks, hair covers, disposable gowns, and other necessary personal protective equipment (PPE).

Cleaning and Disinfection: Our cleanrooms are designed for easy cleaning and disinfection, and we provide detailed protocols for maintaining the required level of cleanliness. This includes daily cleaning, as well as periodic deep cleaning and sterilization.

Cleanroom Layout

Quality Assurance and Continuous Improvement

We understand the importance of maintaining the highest standards in our USP compounding cleanrooms. To ensure ongoing compliance and optimal performance, we offer quality assurance services, including:

Regular Inspections and Maintenance: We recommend performing regular inspections and maintenance of your cleanroom facilities to ensure that all components are functioning properly and that the cleanroom maintains its designated classification. If third party inspection is required, we are happy to connect you with a certified company.

Certification and Recertification: We ensure that your cleanroom is certified according to ISO 14644 standards, and we provide recertification services to maintain compliance over time. Certification processes include thorough testing of air quality, pressure, temperature, and humidity, as well as particle count measurements.

Continuous Improvement Initiatives: We are dedicated to staying up-to-date with the latest advancements in cleanroom technology and best practices. Our team of experts is constantly researching and implementing new techniques and improvements to enhance the performance and efficiency of our USP compounding cleanrooms.

Expert Support and Consultation

Our team of cleanroom specialists is available to provide ongoing support and consultation throughout the design, construction, and operation of your USP compounding cleanroom. We can assist with:

  • Cleanroom design and layout planning
  • Regulatory compliance consultation
  • Staff training and education
  • Cleanroom certification and recertification
  • Quality assurance and continuous improvement initiatives

By partnering with us for your USP compounding cleanroom needs, you can be confident that you are working with a team of experts who are committed to delivering the highest quality products and services to support your pharmacy's success.

Get Started Today

To learn more about our USP compounding cleanroom solutions, or to schedule a consultation with one of our cleanroom specialists, please contact us today. We look forward to helping you design, build, and maintain a state-of-the-art cleanroom facility that meets the needs of your pharmacy and the patients you serve.


Our USP compounding cleanrooms offer a comprehensive solution for pharmacies seeking to meet regulatory requirements and ensure the safety of their compounded medications. With our state-of-the-art design, customizable options, and adherence to USP <797> and <800> guidelines, we are committed to providing the highest level of quality and service. By choosing our cleanrooms, you can be confident in your pharmacy's ability to deliver safe, effective, and compliant compounded medications to your patients.