Good Manufacturing Practices (or GMPs) are essential for performance in any number of industries, including the biotechnology, pharmaceutical, and microelectronics industries. Although things like cleanroom design are important for productivity and to maintain proper standards, that alone isn't enough. At Atlantic Technical Systems, we strive to ensure that we deliver the best products, support, and services to leading-edge companies, so that they can continue to maintain top-notch performance and innovation while leading the charge in dynamic technologies, tools, systems, and services. Good Manufacturing Practices are a big part of that process, and these practices rely on much more than just having the latest equipment.
The first clean rooms were created in wartime, say historians. During World War II, American and British industrial manufacturers realized that in order to improve the reliability of the instrumentation used for weapons and tanks, a clean production environment was needed. Some wartime experts say it was during the Manhattan Project, when the first atomic bomb was created, that engineers designed and implemented a basic form of the modern-day, cleanroom HEPA filters, which were used to filter out dust and other pollutants from the production areas.
The cleanliness of cleanrooms (like those that exist in the medical or semiconductor industry) is a constant concern for those who are responsible for maintaining the sanitary conditions that are mandatory for performing work in these rooms. Strong bacterial-fighting cleaning supplies can keep walls, floors, equipment, surfaces and other areas clean. Personnel can follow rigid hygiene regimens and wear frequently-laundered protective clothing along with head and mouth coverings, but the real hero of achieving contamination control is the air filtration system. The air filtration system relies heavily on filters that trap harmful contaminants. Experts who sell cleanroom filters & supplies, like Atlantic Technical Systems, know the importance of air filtration filters and would like to tell you about some of the different types of filters which may work best for your particular filtration system.
In a properly controlled cleanroom, there are specified limits for the concentration of airborne particles which must be continually removed from the air. Those particles might be created by the workers, the equipment, the process, or the facility itself. Air filtration and flow is critical to avoid cleanroom contamination. In order to visualize the room’s air flow and to comply with ISO Class 5 specifications, airflow visualization studies, also known as smoke studies, are performed to ensure that the airflow is exiting through the cleanroom HEPA filters in a single direction. In case of contamination, the smoke studies offer visual verification of where the contaminant would move within the room.
Cleanrooms utilize specialized technology and employee cleanliness protocols to maintain an environment free of all pollutants, including dust and other airborne particles. When enough protocols are put in place, the company can achieve cleanroom certification, which puts their business at the top of the industry in maintaining a carefully maintained environment. There are a number of unique industries that benefit from cleanroom certification.
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 VelocityFace 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 VisualizationFlow 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 GasThe 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.
ProceduresThe 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 LevelsUSP 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 SamplingThere 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 ChangesOther 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.
Building a cleanroom is not a typical construction project. With the federal and international standards required for cleanroom classification, staying within a required budget is a challenge. And for many East Coast businesses, there is an additional hurdle--finding the space for a cleanroom. While it may be a challenging task, it isn't impossible. Cleanrooms don't require an entire building to meet classification standards, and can be built in a much smaller space. In fact, there are options available to transform an empty office into a cleanroom that will meet all the specifications required, in much less time than it would take for the construction or full renovation of a new space.
There are several classifications of cleanrooms, determined by the maximum level of particles allowed in measurements of the air within the room. Whether a class 1 room—with the most stringent restrictions on air quality and a difficult and rare condition to achieve—or a less restrictive class, when it comes to allowable contaminates all require expert protocol and cleanroom solutions. Since all classes share a common goal to eliminate and avoid contamination of the area, understanding the potential sources of contamination is important. Once the sources are identified, proper actions can be taken to address each and improve the conditions of the room.
Biosafety cabinet classification can be a delicate thing. This is not something that can be done quickly or without great care. When biological safety cabinet testing is needed, it means that some complex work will be happening that is entirely dependent on the right conditions being present in the atmosphere of the new cabinet. In order to commission such a space, the following requirements must be in place.