Hung Joseph C, Anderson Michelle M
Division of Nuclear Medicine, Department of Radiology, Mayo Clinic, Rochester, Minnesota 55905-0001, USA.
J Nucl Med. 2009 Jan;50(1):156-64. doi: 10.2967/jnumed.108.054742. Epub 2008 Dec 17.
According to the United States Pharmacopeia (USP) General Chapter <797> (USP <797>), "Pharmaceutical Compounding-Sterile Preparations," the compounding facility must be physically designed and environmentally controlled to minimize airborne contamination from contacting critical sites. The goal of the project was to evaluate the appropriateness and effectiveness of our approaches in meeting <797> requirements.
USP <797> standards, radiation safety concerns, and work-flow patterns were the focal points in our assessment of 4 laboratories: 2 nuclear pharmacy laboratories that engage in preparing sterile (low-, medium-, and high-risk levels), nonsterile, or possible hazardous radioactive drugs and 2 other laboratories in which only low-risk-level preparations are involved.
Each laboratory was constructed with a physically separated International Organization for Standardization Class 7 anteroom and clean room to allow us to maintain an appropriate air quality, a consistent operation, and a desirable flexibility. An isolated area within the laboratory was designated for preparing nonsterile products. Higher air change per hour was used in the areas with higher traffic or smaller space. Lead-lined biological safety cabinets (BSCs) were segregated and used depending on the risk category of the preparations. In 1 laboratory, the exhaust flow for the BSC was too great, and a lead-lined compounding aseptic containment isolator (CACI) was installed. Air in the BSC and CACI was 100% exhausted to the atmosphere. 99Mo/99mTc generators were placed in the negative-pressure clean room to ensure a more efficient operation and cleaner air environment. Clean-room equipment (i.e., keyboards, printers, and telephones) was installed, and refrigerators or freezers and the central-processing unit of each computer were placed outside clean room.
Our wide-range preparations of sterile, nonsterile, or potential hazardous radiopharmaceuticals, coupled with the limited space of each laboratory and existing antiquated mechanical systems, presented a challenge. Nevertheless, we successfully remodeled each nuclear pharmacy laboratory to meet USP <797> requirements for facility design and environmental controls.
根据美国药典（USP）通则<797>（《USP <797>：药物配制 - 无菌制剂》），配制设施的物理设计和环境控制必须能尽量减少空气传播污染接触关键部位。该项目的目标是评估我们的方法在满足<797>要求方面的适当性和有效性。
USP <797>标准、辐射安全问题和工作流程模式是我们对4个实验室评估的重点：2个核药房实验室，从事无菌（低、中、高风险级别）、非无菌或可能的危险放射性药物的配制；另外2个实验室仅涉及低风险级别的制剂配制。
每个实验室都建造了物理分隔的国际标准化组织7级前室和洁净室，使我们能够保持适当的空气质量、一致的操作和理想的灵活性。实验室内部设有一个隔离区域用于配制非无菌产品。人员流动较多或空间较小的区域采用了更高的每小时换气次数。根据制剂的风险类别分隔并使用了铅衬里生物安全柜（BSC）。在1个实验室中，BSC的排气流量过大，因此安装了铅衬里配制无菌隔离器（CACI）。BSC和CACI内空气100%排放到大气中。将99Mo/99mTc发生器放置在负压洁净室内，以确保操作更高效、空气环境更清洁。安装了洁净室设备（如键盘、打印机和电话），冰箱或冰柜以及每台计算机的中央处理器放置在洁净室外。
我们广泛配制无菌、非无菌或潜在危险的放射性药物，再加上每个实验室空间有限以及现有的陈旧机械系统，构成了一项挑战。尽管如此，我们成功改造了每个核药房实验室，以满足USP <797>对设施设计和环境控制的要求。
