If you’re creating a disinfectant program for your cleanroom, be sure to check these six points before making a decision. Disinfectant programs are vital to pharmaceutical and medical device manufacturers. Cleanrooms must not only be cleaned, but also disinfected to remain compliant. A program entails a disinfectant rotation as well as the disinfectants themselves. Here […]

When it comes to air sampling for the cleanroom, there are many options. Consider each before choosing the right one for your class of cleanroom Proactive companies know the importance of an active air-sampling program in a cleanroom. As with anything, each method has different benefits and problems specific to compliance needs.  When it comes […]

Guidelines for an online water bioburden analyzer may soon lead to a more reliable and sophisticated method of water quality assessment. Risk reduction and process control in the pharmaceutical industry are in desperate need of modern technologies. This couldn’t be truer when it comes to water quality assessment. The traditional method leaves a lot to […]

Improper seals in cleanrooms can devastate the integrity of its environment and production therein. Here is one solution to this problem. Cable management is essential to the integrity of a cleanroom, though it is often overlooked in the design process. Without proper seals, air leaks can contaminate the environment. Any sealing solution must be: Designed, […]

OSHA industry standards apply to most, if not all, cleanroom operations in the Code of Federal Regulations (CFR) 29 CFR. This standard is more commonly known as the General Industry Standard, 29 CFR 1910. (Not every cleanroom falls under standard 1910.) These standards are complex, so we have summarized the primary components to make them […]

While liquids that are tested in pharmaceutical manufacturing are expected to be free from contamination, particles can enter as a result of handling and managing the water supply. Therefore, it is vital to measure particle contamination in these processes. Particle counters are primarily used to test finished products, but a second and equally-important application is […]

Traditional methods of detecting and correcting the presence of viable particles in a cleanroom can be lengthy. If present, viable particles can result in weeks of lost manufacturing time. However, non-traditional microbe detection significantly hastens the process of detecting and correcting the presence of viable particles. As with anything, there are downsides to these options, […]

There are two primary methods to produce water-for-injection (WFI) for cleanroom applications: multiple-effect distillation and vapor compression. Each method offers different advantages. Here are some key features to consider when determining the right WFI for you: The breaking point for ROI is 600 gallons/hour. The capital cost of vapor compression is higher than multiple-effect. However, […]

Relative humidity is a fickle issue in your cleanroom. Both outdoor and indoor factors affect it. Too much humidity will increase particulates and provide a breeding ground for biological contaminants. Too little humidity creates electrostatic discharge. Both instances can cause serious damage to your product and environment. The ideal humidity is right around 50 percent. […]

When it comes to your cleanroom, safety is multifaceted. Safety programs use OSHA standards, internal company requirements, and national consensus standards to ensure that work is performed ergonomically, efficiently, and safely. These programs are designed to protect employees and the integrity of the cleanroom. Your cleanroom safety plan should address appropriate employee behavior, functionality of […]