USP Standards for Cleanrooms and Storage Monitoring
The Role of United States Pharmacopeia (USP)
The United States Pharmacopeia (USP) is working to help protect patient safety. They build standards to supply safe and quality medicine. USP 800 provides some specific criteria for the secure handling of such medications. These standards aim to lessen exposure to hazardous drugs. The USP General Chapter <800> outlines the requirements in handling dangerous drugs.
Storage is the backbone of a cleanroom environment. It is more of a significant element in a hazardous drug cleanroom facility. The likes of hazardous antineoplastic drugs need specific storage requirements. Antineoplastic drugs are medications for cancer treatment. They contain a high level of toxicity which can be harmful during handling. To decrease potential risks, following some standard storage monitoring is critical:
- separate storage of hazardous antineoplastic drugs from non-hazardous drugs
- need for entity policy permission for specific hazardous drugs
- dedicated refrigerator units for antineoplastic drugs; negative air pressure; maintenance of 12 ACPH
- exhaust feature is necessary for refrigerators located in a negative pressure room
The USP 800 guideline also suggests the use of a pressure gauge. The gauge can maintain proper pressure on storage cabinets while limiting extra risk.
Cleanrooms are the primary facility used in bioprocess or pharmaceuticals. To medicate different diseases, the manufacturing of disease-specific drugs is necessary. The bioprocess demands a regulated room such as the cleanroom. It is a space to control particulate contamination and other environmental parameters. Some environmental parameters for monitoring in a cleanroom are:
Cleanrooms control the adverse effect of particles in the manufacturing process. As such, there is a classification level for cleanrooms. The basis of classification is on how clean the air is. In the US Federal Standard, the category accounts for the number of particles inside. There are some features for a safe and secure cleanroom basing on USP 800 standards.
1. Negative pressure cleanroom
Because cleanrooms regulate many environmental factors, adequate air pressure is a must. Negative air pressure is beneficial to a cleanroom. A room with lower pressure ensures harmful gases and toxic compounds cannot spread. But, the adjacent spaces should have higher pressures. This ensures that hazardous elements cannot escape from the cleanroom during door opening.
2. Air Filtration
An efficient air filtration system also limits contamination in a cleanroom. The use of a high-efficiency particulate air HEPA filter can help in the filtration. An airtight door plus a calibrated HVAC system eases the exhaustion of aerosols. A good HVAC system also circulates fresh airflow.
3. Cleanroom Design
A high rate of contamination is a bad indicator in a cleanroom. Sterile hazardous drug compounding design can prevent high contamination levels. This design follows the standards like:
- under negative pressure (0.01 – 0.03 inches of water column) relative to adjacent spaces
- at least 12 air changes per hour (ACPH) maintenance
- direct airflow vents outside
- daily monitoring and alarm
In a pharmacy setting, it is often the manufacturer who assesses storage equipment. But specific USP requirements outline primary engineering controls to review and understand. These requirements outline the desired parameters for storage spaces and.
Containment ventilated enclosure makes use of HEPA filtration to ventilate storage devices. Through this filtration system, the removal of air pollutants is easy. The removal capacity assures that contaminants do not pollute the workstation.
Cleanroom Environmental Monitoring
USP 800 provides guidelines in ensuring proper environmental monitoring. Some of the guidelines touch on the specific administration of drugs. There are also instructions in placing HVAC systems. The USP 800 guidelines focus on features of standard monitoring protocols. These guidelines assure that the compound area environment runs within proper safety standards.
Environmental monitoring documentation is an evidence-based recording of all activities. Accurate and precise recording of parameters helps personnel achieve an efficient cleanroom. Pharmaceutical cleanrooms need documentation of all activity. In a regulated setting, recording all incidence is essential. This is because data is a crucial element in running a pharmacy. It not only denotes good inventory management practices. Data recording also accounts for the back-end processes. This includes the transit of drugs up to the storing activity. When verifiable data is available, it hastens compliance as well. Data may contain parameters, date, time, and personnel access.
2. Data Analysis
A pharmaceutical runs a continuous operation. With the constant activity, regular recording is a necessity. Also, standard regulation needs data from the start to the endpoint. So deriving better trend analysis requires a comprehensive data recording. Through data recoding, the analysis can then establish parameter thresholds and acceptable ranges.
Loggers can ease the process of recording. Manual recording activity cannot detect some data indicators. For example, there are specific sensors made for air particle detection, for example. These sensors can define particle accumulation metrics in the air. Manual recording can’t detect air pressure as well. Using these sensors can augment the limitation of a manual recording. This is where monitoring devices become handy. The gathered data on indicators can better detect fluctuations in the environmental parameters. It can also surmise the normal distribution of microbial loads. It can determine the trend distribution of air particles. The outlining of patterns and trends ease better data analysis.
This is because effective data analysis can forecast and predict action steps. Deriving best practices from these data trends serve to be practical. It can result in an outline of corrective actions. Moreover, data analysis can streamline standard operating procedures.
Environmental monitoring is an iterative process. Different situations occur daily in a pharma operation. Catching these situations is crucial. Regular storage monitoring can track these situations. With records and documentation, reporting is more straightforward. Access to electronic records is simple in looking for data trails whenever needed. Regulatory agencies also need reports, so maintenance of these documents is vital.
AKCP Storage Monitoring
AKCP’s network-enabled sensors are tailor-fit to any monitoring needs. Cleanroom monitoring can use sensor solutions capable of environmental monitoring. A few of the wireless sensors in the AKCP monitoring solutions are:
- airflow sensor
- temperature and humidity sensor
- wireless air quality sensor
- wireless air differential sensor
Wireless Tunnel Technology
The NIST temperature sensor has a built-in calibration check to ensure record integrity. Airflow sensors can track the status of flowing air. It is best to get alerts in case of air condition failure to ensure continuous airflow. Storage monitoring equipment such as cabinets is crucial in a cleanroom as well. Cabinet analysis sensors are capable of checking differential pressure. It provides efficient cooling of storage cabinets. Wireless air quality sensors combine different monitoring capacities. They are capable of detecting air particles, metal oxide gases, temperature, and humidity. Tracking all parameters using a single sensor is cost-effective.
These sensors serve as data loggers doing most of the real-time monitoring. Data logging is continuous. There are also alerts when parameters go beyond the threshold. A user can download data. Graphing it for report analysis is more accessible.
AKCP Pharma-mon Server
Pharmaceutical and laboratory monitoring follows many regulatory requirements. These requirements are due diligence to ensure safety compliance. Good practices such as that of USP 800 are critical in drug storage monitoring. AKCP provides a solution in pharmaceutical facilities such that of a cleanroom.
The Pharma-mon server acts as central management software. It is efficient in monitoring Pharma-mon sensors in a single interface – AKCPro server. It features data graphing capacities to check parameters and location. It can visualize drug storage down to pallets, cartons, and vials. The server can generate a PDF report in full compliance with regulations. Through all capacities, Pharma-mon is ideal for documentation, data analysis, and storage monitoring. All these capacities can streamline any cleanroom monitoring rule.
The principal risks of hazardous drugs to healthcare personnel are significant. In a pharmaceutical setting, ensuring a quality cleanroom is a topmost priority. The standards such as USP 800 highlights the importance of protecting healthcare personnel. Reducing the risks by maintaining USP 800 standards is imperative. In the end, once we ensure the safety of our healthcare personnel, we also guarantee the lives of patients.