Revised standards for USP General Chapter <797> for compounded sterile preparation (CSP) have been finalized and have an estimated effective date of Nov 1, 2023. These revisions will also affect USP <800> where hazardous drug (HD) compounding is applicable. Both standards include environmental monitoring and management requirements that were not previously enforced and must be met to achieve accreditation through local and national governing bodies come November 2023. Understanding the conditions and monitoring requirements is critical in ensuring compliance.
Below we summarize the environmental monitoring and management requirements for all compounding spaces in both hazardous and non-hazardous environments as defined in USP <797> and USP <800>. Not all conditions require continuous monitoring though it is often considered best practice. The tables below provide indication for the monitoring requirements and minimum condition requirements for each environmental parameter.
Space | Compound Category | ISO Req | Pressurization to Adjacent Space | DP (in WC) | Temp (°C) | RH (%) D | Min ACH Req C |
Compounding Pharmacy (Buffer Room / SEC) | 1 | Unclassified SCA | N/A | N/A | < 20° | Max 60% | Not Specified |
Compounding Pharmacy (Buffer Room / SEC) | 2 | ISO-Class 7 | Positive | 0.02 | < 20° | Max 60% | 30 |
Anteroom | 2 | ISO-Class 8 | Positive | 0.02 | Not Specified | Not Specified | 20 |
Space | Compound Hazard Risk | ISO Req | Pressurization to Adjacent Space | DP (in WC) | Temp (°C) | RH (%) D | Min ACH Req C |
Compounding Pharmacy (Buffer Room / SEC) | High | ISO-Class 7 | Negative | 0.01 - 0.03 | < 20° | Max 60% | 30 |
Compounding Pharmacy (Buffer Room / SEC) | Low/ Medium | Unclassified C-SCA | Negative | 0.01 - 0.03 | < 20° | Max 60% | 12 |
Anteroom | N/A | ISO-Class 7 | Negative | 0.01 - 0.03 | Not Specified | Not Specified | 20 |
Setra provides multiple products that comply with the environmental monitoring requirements of USP <797> and <800>. This includes room pressure monitors, differential pressure transducers and temperature and humidity sensors.
In addition to the environmental conditions and monitoring requirements summarized above, the following must be met to achieve compliance.
ISO Class | Particle Counter Per Cubic Meter > 0.5 um |
3 | 35.2 |
4 | 352 |
5 | 3,520 |
6 | 35,200 |
7 | 352,000 |
8 | 3,520,000 |
*For a full table of ISO classification requirements, see ISO-14644
Meeting standards for compliance is a great start to monitoring and managing environmental conditions in a compounding pharmacy, but the real goal is to create a safe, clean environment that eliminates contaminants and keeps patients and staff safe. In order to provide the best possible environment, there are a few best practices that should be implemented:
Once familiar with the environmental conditions and monitoring requirements for compounding pharmacies it is time to get to work:
Setra is committed to assisting our customers in meeting the new requirements for compounding pharmacies. Our team is ready to provide guidance on our products and solutions to make the transition as seamless as possible.