Compliance Testing USP 797

USP 797 Compliance

Compliance Testing USP 797

Compliance Testing USP 797 – Sterile compounding procedures require clean facilities and compliance testing according to USP 797 standards, specific training for operators, air quality evaluations, and a firm knowledge of sterilization and stability principles. The risk of contaminating a compounded sterile product depends on proper hand hygiene and garbing practices, compounding personnel aseptic technique, and the presence of surface contamination. Compliance Testing USP 797 provides guidelines, procedures and compliance requirements for compounding sterile preparations (CSP). The USP 797 sampling program and visual audit that Healthy Building Science provides is designed to evaluate the competency of work practices in accordance with the USP 797 regulations.

Compliance Testing USP 797 – Requirements

USP 797 refers to the United States Pharmacopeia (USP) chapter 797 “Pharmaceutical Compounding – Sterile Preparations,” It is the first set of enforceable sterile compounding standards issued by (USP). Healthy Building Science inspectors will determine USP 797 conformance in 3 areas:

  • Air Testing
  • Surface Testing
  • Personnel Testing.

If conformance standards are not met, Healthy Building Science will work with you to determine the source of the problem, eliminate the problem, and guide you toward compliance with the standard.

Compliance Testing Data InterpretationCompliance Testing USP 797

Emlab P& K provided the following example of data interpretation “Data interpretation begins by comparing the results of nonviable and viable air particle testing and viable surface particle testing to the recommended action levels in USP 797. These recommended action levels have been reproduced in Table 1 (9). If the number of particles detected by nonviable air particle testing, viable air particle testing or viable surface particle testing, exceeds the levels given in table 1, then it is necessary to begin a full root cause investigation of the contamination source, followed by the steps necessary to bring particulate levels within acceptable limits.


Table 1: Recommended Action Levels. (9)
ISO Class ≥ 0.5 µm Nonviable
Viable Airborne
Viable Surface
(cfu/contact plate)
5 3,520 > 1 > 3
7 352,000 > 10 > 5
8 3,520,000 > 100 > 100


For example, if a viable airborne particle sample from an ISO 7 clean room yielded a total of 11 cfu/m3, it would be higher than the recommended action level of greater than 10 cfu/m3and a full investigation into the source of contamination would be necessary. Alternatively, if the same sample had only 9 cfu/m3, the recommended action level would not have been exceeded and a full investigation would not need to be initiated. It is also necessary to implement an investigation and remediation in the event that there are particulates identified above historically detected levels for a given facility.

There is also a special requirement for viable air particle samples. If any cfu’s are detected on a viable airborne particle test plate from an ISO 5, 7 or 8 area, then USP 797 requires that the colonies growing on that plate be identified to at least the genus level, even if the number of colonies is below the recommended action level. The reasoning behind this requirement for genus identification is that there are some organisms that cannot be tolerated in a clinical environment at any concentration.

USP 797 Sample Projects

The rigorous sampling and performance requirements of the USP 797 test can be applied to any building and business type, but the most common businesses looking for a USP 797 consultant include:

  • Pharmacies
  • Medical offices
  • Medical packaging facilities
  • Medical implant manufacturing facilities
  • Cleanrooms
  • High tech data centers

797 Guidelines for Risk

The greatest risk (and nightmare) is a purchaser of your product gets sick and regulatory agencies find your company is not in compliance with USP 797 guidelines. Companies not following regulatory guidelines may find their insurance company will not back them if a law suit is filed claiming an individual was harmed by contaminated drugs or medical implants.

Compounding risk levels are based on the likelihood of contaminating a compounded sterile preparation (CSP) with microorganisms, spores, endotoxins or other miscellaneous material. Here is an abbreviated USP summary of the different risk levels and how they are defined. These are important because they impact temperature and storage requirements within these spaces.

  • Low-risk conditions: Compounding using only sterile products and devices in Class 5 ISO or higher. Low-risk compounding includes using sterile needles and syringes to transfer sterile liquids from manufacturer-sealed ampules or vials to sterile devices or other sterile packages. Manually mixing and measuring up to three (3) manufactured products to create a CSP or nutritional solution is also included in this low risk category.
  • Medium-risk conditions: Compounding or mixing multiple doses of sterile products for multiple patients bumps the classification up to medium-risk. Medium risk compounding examples may include compounded total parenteral nutrition fluids that require multiple injections, detachments and attachments of nutritional products, and filling injection or infusion devices with multiple sterile drug products.
  • High-risk conditions: Use of non-sterile ingredients or non-sterile devices creates a high degree of risk. Exposing sterile ingredients and devices to air quality below ISO Class 5 will create a high-risk compounding situation. Extended storage of opened or partially-used products that lack antimicrobial preservatives in an environment in less than ISO Class 5 conditions is also considered high risk. Chemical purity and strength of bulk ingredients must be tested and verified to meet their specifications in high risk environments.

USP 797 Summary Recommendations

Training staff on USP 797 regulations is one of the most effective risk reduction strategies to ensure that CSPs are prepared according to USP 797 guidelines. Common components of a USP 797 training program include:

  • Regular USP 797 inspections and gap analysis
  • Cleaning techniques and how to properly personal protective equipment (PPE)
  • Proper hand washing techniques are critical to success
  • Documentation protocols are part of compliance
  • Robust internal training and evaluation process

USP 797 Compliance San Francisco Bay Area

Healthy Building Science is an environmental consulting firm providing USP 797 compliance testing services to pharmacies, food and medical packaging facilities, hospitals and medical facilities in the greater San Francisco Bay Area and all of Northern California. Cities we service include San Francisco, San Jose, Oakland, Sacramento, Santa Rosa, Hayward, Sunnyvale, Fremont, Concord, Salinas, Santa Clara, Berkeley, Vallejo, Fairfield, Antioch, Richmond, Daly City, San Rafael, San Mateo, Vacaville, San Leandro, Livermore and Alameda County, Contra Costa County, Marin County, Napa County, San Mateo County, Santa Clara County, Solano County and Sonoma County.

We would be pleased to become your go-to USP 797 consultant and help you with any of regulatory testing needs.

Please call 415-785-7986 or complete this online form today!