Containment and particle processing are key aspects of providing a safe and healthy environment in cleanrooms for the safe process involved in the manufacturing and packaging of pharmaceutical powders during sampling, weighing, and packing. Cleanrooms are contained rooms with highly efficient fan filter units that vacuum the air particles in the room through a set of HEPA filters. This highly precise ventilation system controls the temperature, air pressure and continuously cleans and filters the air to eliminate the risk of contaminated products and to protect staff from exposure to highly potent pharmaceutical ingredients.
Clean rooms are specified by how clean the air is needed in the room, the source and size of the contaminated particles that need to be removed and how much air needs to be recirculated to remove the contaminants. Although it is impossible to remove all the particles from a room, there are strict classification guidelines for companies to follow. Pharmaceutical cleanrooms classifications generally range between ISO 5 and ISO 8 or slightly higher depending on the level of medication. Cleanrooms provide better containment of active ingredients ensuring medicinal products are packaged in pristine condition. As the development of new strengths of medication grows so does the need to safeguard staff working in these environments. Some pharmaceutical powders can be highly potent and therefore cleanroom designers in this sector have strict guidelines to follow to eliminate exposure. The number of personnel allowed to occupy the room at one time is also limited to reduce the risk of contaminating the products. Protective clothing must be worn at all times and training is to be completed on procedures for use of the room, environmental safety, contamination issues and accidents. It is important that all personal using these rooms know how to clean the room, change air filters and monitor the air flow of the room.
Pharmaceutical cleanrooms require three or four stages of HEPA filters and therefore need higher pressure fans than usual HVAC systems. The purpose of containment and particle processing in a clean room is to regulate the supply of cleaned fresh air and to reduce the particle content of the air in the room as low as possible which reduces the risk of any contamination. High performance ventilation systems ensure consistent clean air with a high air exchange rate and the correct measure of pressure, temperature and humidity. Even the smallest contaminated particle can affect products so it is vital for patient safety that companies are complaint with good manufacturing practices and adhere to the classification guidelines. The classification is made by determining the number of contaminants that are likely to be produced, the size of the particles that need to be filtered and the flow of air that is needed to remove and purify the air. The size of the room will depend on the equipment needed and the number of processes required. A fan filter unit serves to generate a uniform, particle free air flow in the clean room.
Fan filter units have been a popular choice in this industry since they were first introduced in 1984. The technology behind it is simply a HEPA filter attached to an EC Plug Fan and it can offer highly efficient filtration to cleanrooms. Our EC modular plug fans are energy efficient and enable more compact air handling. G wheel backward curved fans will generate the airflow required and will work against the increasing resistances of any filters to deliver a constant volume of air. With reductions in operating noise, low running costs and high efficiency filtration that is easy to maintain the EC plug fan is the perfect solution for maintaining a clean, safe and cost effective clean room. Cleanrooms operate continuously and therefore tend to have high running costs so the initial capital outlay for incorporating energy efficient plug type fans is soon returned with the significant energy savings. The option of speed control allows for slowing down the fan filter unit when not in use to reduce power consumption and improve the life of the motor and filters. Learn more about Rosenberg fans suitable for clean rooms by downloading the pdf.
Sheet Steel Metal Impeller coated in Quartz Grey (RAL7039)
6 backward curved, profiled blades and efficiency optimised diffuser wheel. Sound optimised. Mounting either horizontally or vertically.
Optimised for Pressure & Constant Volume
Fluid optimised inlet cone made of galvanised sheet steel. Airflow measuring equipment by circular pressure connections.
EC Generation 3 External Rotor Motor
Exceeds in accordance with IEC 60034-30-2 minimum requirements for IE5 (Ultra Premium Efficiency)
Rosenberg G Wheel EC-Plug fans combined with electronically commutated motors (EC-motors), form a very compact, efficient and optimized fan unit. They impress with low installation depth and a simple installation. Fast start-up is ensured because of well-integrated components. Available in a wide range of sizes and specifications. Above drawing for illustration only.
Low Noise Impeller Design
Low Installation Depth
Fast Start Up
Available Sizes: 355 – 630 Diameter