Guide to Cleanrooms and Their Classification System

A cleanroom refers to a highly-controlled environment containing a low level of pollutants. High-tech filters process the air that enters the cleanroom and removes particles from the air such as dust, chemical vapors, aerosols, and other airborne microbes. Cleanrooms are used across a variety of industries in processes where small particles can adversely affect outcomes. You are highly likely to encounter cleanrooms in semiconductor manufacturing, biotech, and pharmaceutical companies.
Using a Biosafety Cabinet the Right Way

What You Should Know about ASHRAE 100 Fume Hood Testing

Face Velocity
Face velocity measures the speed at which air enters fume hood openings. Different fume hoods have different specifications for face velocity. Testers compare face velocity with manufacturer’s specifications to ensure a fume hood is meeting safety guidelines. Different safety organizations also provide safety standards for face velocity. For example, the Occupational Safety and Health Administration recommends that air flow into and within the hood should not be turbulent.Flow Visualization

Tracer Gas
The ASHRAE 110 fume tests for leaks inside the hood. A mannequin is placed in different spots around the fume hood for five minutes at a time, as the sash is opened and closed. The test uses a probe attached to the mannequin to measure how many parts per million of tracer gas escape. Fume hoods are a critical component of lab safety. When the fume hood leaks, dangerous fumes and chemicals can escape creating a potential hazard. Fume hood inspections are the law, and ASHRAE 110 fume hood test standardizes the way these critical safety components can be inspected. In addition to regular testing, OSHA also encourages laboratory staff to create and implement measures for the proper usage of fume hoods.What the Updates to USP 797 Mean to Your Pharmacy

Procedures
The pharmacy needs to follow certain procedures in order to follow the USP 797 guidelines. The procedure begins with determining the risk level of the substances that are being compounded. Once this is determined, it's important to complete a gap analysis. Then the pharmacy should develop an action plan with simple procedures for handling CSPs (Compounded Sterile Preparations) based on their risk level. During this process, it's also important to monitor the air quality of the pharmacy.CSP Risk Levels
USP 797 states that there are 3 risk levels for CSPs. The levels are low, medium, and high. In general, anything that is classified as ISO Class 5 is high risk, 7 are medium risk, and ISO Class 8 is low risk. The risk level refers to the chances of not achieving the sterility level that is required for that classification. Of course, these levels are only guidelines. The actual risk depends on the viable data gathered through sampling the location. Proposed changes to USP 797 collapse the three CSP risk levels into two categories. Category 1 CSPs have a shorter maximum beyond use date (BUD), while Category 2 CSPs have a longer maximum BUD. These are based upon several factors such as sterility considerations.Viable Sampling
