The pharmaceutical and biotech industries have unique concerns when manufacturing their products. Clean rooms are used both to make these products and also to sterilize material and equipment. However, the standards for purity depend on more than just the clean room. If the equipment is not chosen properly, even sterile materials can become contaminated. Additionally, products must be both sterile and clean. Manufacturers need be proactive to ensure their final product is safe for the public.
Pharmaceutical Processing published an article titled, “How to Specify Equipment for High-purity Processes” that examines the many considerations in the design of fluid motion and control systems. Contamination via equipment, according to the article, is a possibility when there are “dead cavities, corners, seams or obstructions that exist in processing equipment.” These concerns can arise anywhere from the valve to the surface finish.
One of… Read more
The evolution of mankind creates a constant need for the pharmaceutical industry (PI) to keep up. As technology and medicine develop, so do strains of viruses and bacteria. The PI has to develop effective solutions to evolving problems, and a crucial component of this development is the clean room.
All cleanrooms are not equal. Electronics manufacturing has different requirements than pharmaceutical. There are different methods and limits to consider for the protein-based products created and monitored in pharmaceutical manufacturing. Just as the public’s needs for pharmaceuticals changes, so do the industry’s needs in clean room design. While quality control is essential to a clean room in any industry, compromising quality in this field can have devastating effects on the public’s health. So what considerations go into today’s pharmaceutical clean rooms?
The PI is not immune to economic crisis. Capital… Read more
A clean room is a space where environmental pollutants are controlled to a specific level. These rooms are commonly utilized in manufacturing, scientific research, and medical applications when even the tiniest of contaminates will compromise a project. Contaminants include things like dust, airborne microbes, aerosol particles and chemical vapors. They can come from facilities, people, tools, fluids, and products. Even cosmetics, including cologne, hairspray, and fingernail polish, are banned from a clean room. While it is impossible to completely eliminate all contaminants, the levels of acceptable contaminates vary by clean room.
Definition of Classes
The controlled level of contamination is designated by the number of allowed particles per cubic meter at a specified particle size. A discrete-particle-counting, light-scattering instrument measures the particles in the air. There are different standards used to denote the accepted level of contaminates. The Federal Standard 209… Read more