Hospitals are one of the most tightly-controlled spaces in terms of monitoring the indoor environment.ASHRAE Standard 170is used by both The Joint Commission (TJC) and Centers for Medicare and Medicaid Services (CMS) as the fundamental reference for adequate levels of temperature, humidity,differential pressure, and air change rate in many spaces within a hospital. The ability for healthcare facilities to monitor, verify, and control these conditions is crucial not only for passing these rigorous inspections but also for protecting the health and safety of their patients and staff.
In other industries, such as pharmaceutical compounding and certain manufacturing applications, airborne particle counting is required to be continuously monitored.Particle counters and indoor air quality monitorscan detect and measure contaminants such as dust, mold spores, debris, volatile organic compounds (VOCs) and even airborn bacteria in a given environment and report those findings through a building management system (BMS).
As of 2018, TJC and CMS do not have particle counting requirements for any part of the hospital, including operating rooms and patient isolation rooms. With that being said, certain healthcare spaces like hospital pharmacies are starting to adopt particle counting guidelines from those other industries. While not required now, many healthcare engineers and facility managers are anticipating a particle counting requirement in the near future and some are beginning to take proactive measures in order to stay ahead of the curve.
Cleanroom standards
Because of the nature of the work being done in cleanrooms for pharmaceutical compounding and the consequences for improper environmental monitoring, the U.S. Food and Drug Administration (FDA) has stringent guidelines for temperature, humidity, air changes, and for airborne particle counting.
FDA使用的ISO 14644-1标准规定了洁净室中每平方米颗粒的最大浓度。ISO 14644-1对0.1μm(小于细菌)到5 μm(花粉碎片和霉菌孢子)的颗粒有不同程度的严格分类，并被世界各地的监管机构用作通用参考标准。
Hospital pharmacies
For many years, theU.S. Pharmacopeia Standard 797 (USP 797)has been the guiding principle for cleanliness in hospital pharmacies, especially those that create compounding sterile preparations (CSPs) for cancer treatments. However, USP 797 is under review and USP 800 is expected to become the standard bearer in this space in environments that handle hazardous materials, like chemotherapy medication.
USP 800 at a glance:
- Facilities must build out a pressurized storage closet
- Recommends that non-sterile prep areas are pressurized
- Must monitor both differential pressure and air changes per hour (ACH)
- Must have redundant HEPA filters
- Must comply over the next 18 months
- Restricted access barrier systems (RABS), also known as glove boxes, must be ISO 7 class environments rather than ISO 5 class environments in order to be in compliance.
RELATED BLOG:Are hospital pharmacies moving towards cleanroom standards?
Future standards
虽然TJC和CMS目前没有粒子计数标准，但医院环境监测的相关规定只会继续增加。医院药房已经被要求持续监测颗粒，手术室和病人隔离室也将被要求监测只是时间问题。不仅是技术的可用性和可行性，而且设施管理者也会重视知道他们最敏感的环境是干净和安全的安心。
Many facility managers are already being proactive.With increasing pressure to maintain cleanliness in these critical environments, facility managers and healthcare engineers are choosing to employhandheld particle countersto show that air flow is working, also allowing them to reduce air flow and conserve energy when particle counts are low. In addition, particle counters can be used around construction sites within a hospital to ensure construction debris is being contained and not being spread throughout the rest of the facility.
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