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. 

If you work in a field where dangerous microorganisms are your closest co-workers, you’re probably familiar with a biosafety cabinet. These state-of-the-art machines create a safe workspace for those who need to work with these pathogens and materials. If you aren’t following these safety guidelines, though, you could find that your biologically safe space contaminated.

Laboratory designers install fume hoods to ensure the safety of researchers, but fume hoods must be annually inspected to maintain researchers and other lab staff aren’t being overly exposed to toxic chemicals and tracer gasses. This testing is not usually used for biological safety hoods, as ASHRAE 110 testing inspects for chemicals and toxins rather than pathogens. The ASHRAE 110 test is generally used to inspect fume hoods in the factory, but these procedures can also be used for testing hoods once installed. Fume hood testing is the law, and most labs use testing standardized by ASHRAE, the Association of the Society of Heating, Refrigerating, and Air-Conditioning Engineers. The ASHRAE 110 protocol is a three-part test which measures face velocity, flow visualization, and trace gas performance. Each of the three categories receives a rating of “good, fair, poor, or fail.” ASHRAE 110 testing doesn’t prescribe a level of performance or safety that a fume hood should meet, but it offers a uniform testing standard that occupational safety organizations can use in the adoption of fume hood safety standards.

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

Flow visualization measures how air flows within the fume hood. Smoke is used to visualize where and if air is escaping from a fume hood. The smoke assists in finding leaks, cracks or other areas in which air may be escaping the fume hood. If smoke escapes from the front of a fume hood, the hood fails the flow visualization test.

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.

If you work at a pharmacy, then it's important to know the proposed updates to USP 797. These updates come from the United States Pharmacopeia (USP). These compliance requirements and standards minimize health risks to patients and staff members in the pharmacy. Here are some of the updates that affect your pharmacy that you should know about.

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

There are 2 types of viable sampling that a pharmacy can complete. The first type of sample that can be used is from the air. These are gathered through impaction on a media plate using a viable sampler machine. The other types of sample that can be used are surface samples. These are required for ISO classified areas. According to USP 797, samples should be periodically taken from the clothing and gloves used in the pharmacy. It's also important to have all employees complete media tests in order to ensure that they're sampling everything correctly. Currently USP 797 requires routine viable sampling be performed.  A proposed change is for viable sampling to be required monthly.

About the Proposed Changes

Other proposed changes include more stringent requirements on gowning, personnel training and facility design.  These changes coupled with changes to CSP risk levels and viable sampling requirements are all designed with safety in mind.  Pharmacies and other ISO classified facilities need to know this information for the best cleanroom management. In order to properly sterilize the area and minimize the risk of infections, diseases, and other issues to patients and staff members of the pharmacy, it's important to know about the proposed updates to USP 797. Following these guidelines will protect your pharmacy and yourself. Make sure to read the updates to USP 797 and understand all of the points to ensure that you're in compliance to all regulations and standards when they are enacted.