Sterile compounding is a critical process that involves the preparation of medications under strict conditions to maintain sterility and prevent contamination. One of the most important components of sterile compounding is maintaining a clean and controlled environment, which is achieved through the use of cleanrooms.
In a post on Cleanroom Technology from January 2023, it was mentioned that while the critical area is the primary location for compounding, the surrounding areas also play an essential role. These supporting areas are where non-sterile components, in-process materials, equipment, containers, and formulated products are managed.
To put it simply, designing and operating a cleanroom for sterile compounding requires compliance with complex regulations and standards. In this article, we will explore some of the specific guidelines and regulations governing cleanroom compliance in sterile compounding.
Regulatory Bodies and Standards
The regulatory bodies and standards that govern cleanroom compliance in sterile compounding vary depending on the region and industry. However, the following are some of the most common regulatory bodies and standards:
United States Pharmacopeia (USP):
As a non-profit organization, the USP is responsible for establishing standards to ensure that medicines have the necessary identity, strength, quality, and purity. In addition to these standards, the USP also provides guidelines for sterile compounding.
One such guideline is the USP General Chapter <797>, which specifies the standards and requirements for designing, constructing, and operating USP 797 cleanrooms. These cleanrooms are essential for compounding sterile preparations that meet USP standards for safety, sterility, and quality.
Adhering to the USP General Chapter guidelines is critical for maintaining compliance and ensuring patient safety, according to information shared by American Cleanroom Systems. By following these guidelines, healthcare professionals can be confident in the safety and efficacy of the medications prepared within USP 797 cleanrooms.
Food and Drug Administration (FDA):
The FDA regulates the manufacturing, labeling, and marketing of drugs in the United States. The FDA’s Current Good Manufacturing Practice (CGMP) regulations provide guidance for the design, construction, and operation of cleanrooms.
Cleanroom Technology has reported in another article that the FDA is also responsible for investigating various adverse events caused by contaminated compounded drugs. These events include deaths and are linked to drugs that are produced in cleanrooms operating under unsanitary conditions.
International Organization for Standardization (ISO):
ISO is an independent organization that sets standards for quality management systems, including those related to cleanroom design and operation. The ISO 14644 series provides specific standards for cleanrooms, including air quality, particle counts, and other parameters.
The design of a cleanroom for sterile compounding must adhere to specific guidelines and standards to ensure a controlled environment that minimizes the risk of contamination. Some of the key design considerations for cleanrooms include:
Cleanrooms must maintain a controlled environment that minimizes the amount of airborne particles and microorganisms present. This requires specialized air filtration systems, such as high-efficiency particulate air (HEPA) filters, to maintain appropriate levels of cleanliness.
Room layout and flow:
The physical layout of the cleanroom must be designed to minimize the risk of contamination and promote efficient workflow. This includes things like designated areas for gowning and de-gowning and separate areas for different stages of the compounding process.
Materials and surfaces:
All materials and surfaces used in the cleanroom must be carefully selected to ensure they are compatible with the sterile environment. This includes things like flooring, wall coverings, and furniture.
In addition to proper design, cleanrooms for sterile compounding must be operated in a way that maintains a sterile environment. Some of the key operational considerations for cleanrooms include:
Proper training for all personnel who work in the cleanroom is essential to maintain compliance with regulatory standards. This includes training on aseptic techniques, gowning procedures, and environmental monitoring.
Regular monitoring of the cleanroom environment, including air quality and surface contamination, is essential to identify potential sources of contamination and maintain appropriate levels of cleanliness.
Cleaning and disinfection:
Cleanrooms must be regularly cleaned and disinfected using appropriate cleaning agents and procedures to ensure that surfaces and equipment are free from contamination.
According to the American Pharmaceutical Review, proper disinfection of cleanrooms is of utmost importance. This involves a thorough cleaning and disinfection process carried out in accordance with a written schedule. To ensure the effectiveness of the disinfection process, it is essential to first remove any surface contamination through prior cleaning.
The process of sterile compounding in pharmaceuticals requires a high level of precision and adherence to strict regulations and standards to ensure patient safety. The design and operation of cleanrooms play a crucial role in minimizing the risk of contamination during compounding.
Proper air filtration systems, room layout, materials, and surface selection are key design considerations, while personnel training, environmental monitoring, and cleaning and disinfection processes are crucial operational factors.
Ultimately, compliance with regulatory bodies and standards, along with a commitment to maintaining a sterile environment, is essential in the pharmaceutical industry to ensure the safe and effective preparation of medications.