Our USP-797 Compliant Cleanrooms

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The Cleanroom Design LLC Advantage

  • CRD is a full service cleanroom company and your one-stop-shop for cleanroom audits, design, design improvement, engineering, consulting, construction, installation, commissioning, training, preventative maintenance, and certification. Whether you are looking for a traditional modular cleanroom that utilizes primary engineering controls (PECs) or an open architecture design, CRD is here to help.
  • CRD’s high volume clients such as large scale hospitals realize a 75% average savings per year on hazardous and non-hazardous sterile pharmaceuticals that they compound internally, in CRD’s open architecture cleanroom design, versus purchasing those same drugs from a third party supplier.  The 75% average annual savings takes into account everything needed to compound the pharmaceuticals internally. This includes labor cost, energy cost to operate the room, cost of supplies, and the reduction of inventory reaching it’s beyond use date (BUD).
  • The average return on investment for CRD’s open architecture modular cleanroom design is less than one year but depends on each customer’s production volume. We can tell you exactly what that timeline is after performing a detailed audit of your facility.
  • Alleviate the common issue of exhausting inventory of a particular pharmaceutical, especially in large hospital settings, and with special regards to Oncology drugs.
  • Guaranteed certification and compliance of cleanroom standards for USP 797 or cGMP. CRD’s ISO 5 (Class 100) certified, sterile compounding cleanrooms, and our ISO 4 (Class 10) sterile compounding zone within the room, are equipped with motorized ULPA filters that consistently filter out over 99.9995% of all particles at a size of 0.12 Microns or larger. This makes CRD’s design one of the most technologically advanced as well as one of the cleanest compounding environments in the industry.
  • A Primary Engineering Control (PEC) such as an aseptic isolator and a biological safety cabinet are still a must for hazardous sterile compounding and must be within an ISO 7 (Class 10,000) cleanroom environment, at minimum. However, CRD offers an open architecture design for non-hazardous sterile compounding that no longer requires a PEC. CRD’s design turns the entire room into a “hood,” therefore increasing efficiencies and decreasing contamination and cost.
  • CRD offers a full scope of hands-on-training programs. Training sessions include personnel gowning, internal cleanroom operations, cleanroom cleaning procedures, preventative maintenance, cleanroom environmental monitoring, and material handling.
  • CRD has an integrated control and monitoring system to provide continuous control and USP 797 required data-logging of space temperature, relative humidity, differential pressures, refrigerator and freezer storage temperature, and particulate counts through random sampling. This further ensures the sterility, safety and efficacy of the preparations by removing human error from the data-logging process as well as providing real time updates to lead personnel.
USP-797 & USP-800 Compliant Hazardous Sterile Compounding Room (ISO Class 7)
USP-797 Compliant Non-Hazardous Sterile Compounding Room (ISO Class 5)
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