While the range of ISO levels for pharma clean rooms is wide, it’s important to understand the basics to ensure your facility is safe. Learn about the different types of pharma clean rooms, including ISO 8 to ISO 4 and construction, equipment, and pass boxes. And, of course, get started on your project today!
pharma clean rooms range from an ISO 8 to an ISO 4
There are several types of cleanrooms available for pharmaceutical manufacturing. Typically, a clean room is used by pharmaceutical manufacturers who are subject to validation by the FDA. The cleanroom’s main objective is to maintain the highest level of sterility in manufacturing pharmaceutical products. The room is also used by semiconductor manufacturers for producing ultra-small and super-dense features, such as computer chips. Contamination on a computer chip would prevent the device from functioning properly.
There are several standards for cleanrooms, including those for pharmaceutical and biomedical research facilities, R&D labs, and medical device/packaging facilities. The standards apply to pharmaceutical manufacturing as well as to compounding pharmacies. The standards also define micrometres, which measure the size of particles that must be filtered. In addition to the filtration process, cleanroom air quality is determined by its concentration of particles per volume of air.
The construction of a pharma clean room can be a complex task and can prove daunting. Luckily, there are many resources available to answer questions during the construction process. The State Board of Pharmacy can point out any potential issues, and neighbouring facilities may have recently undergone similar installations. Consulting firms can also provide unique outside perspectives and direct experience with challenges that arise during the construction process.
Increasing demand for vaccines, cell and gene therapies, and biosimilars has resulted in increasing investment in a pharma clean room. In fact, WuXi recently invested $240 million in a new vaccine manufacturing facility in Ireland, which is expected to be commercially-ready by 2021. Cambrex, meanwhile, has expanded its footprint in Europe, completing a 150 sq m research and development laboratory in Italy.
Pharmaceutical facilities use cleanrooms for in-house testing, manufacturing and potential drug development. This environment requires strict sterility, and the proper equipment and supplies are crucial for efficiency. Pharma cleanroom equipment helps pharmaceutical companies meet the standards set by the industry and maintain sterility. Read on to learn about cleanroom equipment and supplies.
The most important element of a clean room is its filtration and air quality. Pharmaceutical cleanrooms must have filtration and air filters, as well as air showers and garment cubicles. Some cleanrooms are even completely sealed, so that only the pharmaceutical products inside can be used. Cleanrooms can be classified according to their purpose, from research and development to manufacturing to testing.
There are different types of pass boxes used in pharmaceutical clean rooms. Pass boxes are also referred to as static or passive pass boxes, and they serve to prevent contamination between different cleanliness areas. Pass boxes are usually mounted between two areas of varying cleanliness levels, and the difference in pressure can prevent contaminants from entering one area or another. In addition, a static pass box usually has ultraviolet light installed to remove contaminants during the transfer of pharmaceutical materials.
The primary sources of contamination in pharmaceutical clean rooms are people, equipment, and room structure. Of these, people are the largest source of contamination. Therefore, pharma facilities must implement safe material transfer mechanisms. Among these, Pass boxes are indispensable. They are fitted between two clean rooms of the same classification. They offer complete sterility due to direct irradiation with UV-C lamps. This type of radiation is highly toxic to bacteria and eliminates the microbial load from the treated products.
A Class 3 cleanroom must meet strict standards for particle size, while a Class 8 cleanroom requires less stringent standards. ISO classification also varies depending on the process used in the manufacturing process. Generally, cleanrooms that are lower in ISO classification will cost more per square foot.
The initial costs for a pharma clean room can be considerable. While a prefabricated, modular, or stick-built facility will be cheaper than a custom-built cleanroom, it will take longer to build and is more expensive than a customized cleanroom. It’s important to note that the cost of a cleanroom structure is generally higher than the cost of the product itself. A monoclonal antibody can cost $20 to $30 million, so even a small delay in setting up the facility can have a major impact on the bottom line.