Iso 8573-7 Pdf Free Download

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Analyzingmicro burden data at point of use outlets throughout compressed air pipeline systems at a given time, acts as a window of observation into the control of the facility. Maintaining control means proper preventative maintenance, microbial monitoring scheduling and risk assessment must be appropriate for the industry being monitored. Many accreditation bodies can aid in the understanding of microbial limits and specifications, critical to specific industry needs. Once the compressed air microbial monitoring plan is approved, a sampling procedure that provides the company with the results suitable to its limits and specifications needs to be established. This requires the use of a procedure that accurately measures and samples a specific volume of air for microbial burden analysis inside the tested compressed air system.

Some microbial air impact samplers, like the SAS Pinocchio Super II, are designed to diffuse the air flow from a regulated point of use outlet, and then measure the flow rate to achieve the recommended rate by the OEM. This allows the end user to only monitor the time required to meet the desired total sample air volume; in most cases, 1000 liters. When using impact samplers, various sampling heads exist to disperse the air onto the recipient agar plate. Slit samplers and sieve samplers are the most prevalent.

With a focus on Demand-Side Optimization, compressed air dryers, filters, condensate management, tanks, piping and pneumatic technologies are profiled. How to ensure system reliability, while reducing pressure drop and demand, is explored through System Assessment case studies.

Most impact air samplers are made to use a sterile tube to sample the outlet air into the inlet port of the unit for analysis. For simplicity reasons this article will focus on the use of a Pinocchio Super II sampler. The compressed air is then passed through a manifold that measures the air through the calibrated flowmeter, and pressure gauge. Per the OEM the compressed air must measure to an appropriate rate (in this case 100LPM) with pressure under 3 Bar. Once the flow rate has been established, the air valve to the pressure gauge and flowmeter is closed. Since no adjustments were made at the inlet valve, the valve to the sampling funnel head can now be completely opened for measurement.

See Table 2 for calculations of measurement times relative to air flow rate. When the appropriate time has lapsed to sample 1000 liters, the inlet valve is closed, the plate is removed aseptically, labeled, and shipped to the testing lab for analysis. When sampling media is placed on the clips for testing, all efforts should be made to avoid secondary contamination. It only takes one breath, sneeze, loose gloved finger to make an entire point of use sample worthless. Paying attention to aseptic technique is imperative to taking a true compressed air microbial sample.

Aseptic technique is a term that refers to movements, actions, attire and attitude when working in a scientific or environmental sampling capacity. Testing compressed air may not seem like the proverbial environmental sample, but it is. Taking a small sample of the microbial profile of a point of use environment and growing it up in a laboratory takes skill and awareness. Aseptic technique functions to prevent contamination of media and reagents by microorganisms. The first action is to always wear the minimum appropriate personal protective equipment, PPE (Table 3): fitted gloves, eye protection, clean lab coat, and hair net. Before handling any media, gloves should be rubbed down or sprayed with greater than or equal to 70% Isopropanol Alcohol or Ethanol. Not doing this important step will almost certainly result in contaminated blinds and samples. When in doubt, change your gloves or wipe them down with alcohol. The simplest and most economical way to reduce contamination is to work on a cleaned, disinfected work area.

Food industries who sample on sorting floors are subjected to a lot of dust. Cleaning and disinfecting the area that the microbial air sampler sits upon should be routine and thorough. Afterwards, open the contact plate or petri dish for sampling, the lid should always be placed down, as to not catch any floating microbial vectors like dust inside the lid. These are all points of contamination that are easily avoidable. Most plates are sent with sterile bags to send back to the testing lab. Feel free to place the lid face down inside the sterile bag provided, making sure gloves are clean.

Sampling technicians should make sure to never open multiple petri dishes at a time. Sealing the petri dishes is the next best mode of avoiding contamination. If a locking mechanism exists on the plate, make certain to lock it once the sample is taken. Always parafilm or tape the plate, this protects the lid from falling off during transit, and keeps moisture in the plate. Good personal hygiene acts to not only protect the sampling technician from environmental contaminants, but also protects the samples from contamination like shed skin, dirt and dust from street clothes.

Laboratory measurements always involve uncertainty, which must be considered when analytical results are used as a part of a basis for making decisions like pass/fail. Some monitoring plans require that the actual sample number fall within the limitations of the measurement of uncertainty. Usually it is the responsibility of the facility, not the lab to determine a pass/fail status.

The only analysis required by ISO 8573-7 is colony forming unit enumeration. However, if a facility requires microbial identification, Gram staining is done for bacterial colonies. Gram staining classifies most bacterial colonies into two groups; Gram positive or Gram negative. Additional information is noted on shape and morphology upon Gram staining. Most pathogenic organisms can begin to be identified from this simple strain. For instance, if the air sample was contaminated with Gram positive cocci bacteria, there is no need to test for Listeria since Listeria is a Gram positive, non-spore forming rod. It should be noted however, that these samples, while informative, are a snap shot of the level of control in the facilities compressed air system. Continual monitoring and quarterly or at minimum biannual testing is recommended.

ISO 8573-7:2003 specifies a test method for distinguishing viable, colony-forming, microbiological organisms (e.g. yeast, bacteria, endotoxins) from other solid particles which may be present in compressed air. One of a series of standards aimed at harmonizing air contamination measurements, it provides a means of sampling, incubating and determining the number of microbiological particles. The test method is suitable for determining purity classes in accordance with ISO 8573-1, and is intended to be used in conjunction with ISO 8573-4 when there is need to identify solid particles that are also viable, colony-forming units.

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Micro Testing of Compressed Air or Bioburden Testing per ISO 8573-7 is generally conducted by the pharmaceutical, medical device and food industries. Microbial contaminants found in the compressor or compressed air lines can be devastating to a final product in these industries. A regular Micro Testing program can provide insight to a potential problem long before it brings production to a halt.

Most pharmaceutical, medical device, and food manufacturing environments have environmental air sampling programs in place. However, compressed air or process air is frequently overlooked. Compressed air and process gases can be sampled using specialized samplers that use contact plates to capture any microorganisms present. Micro testing is imperative to avoid microbial contaminants inside controlled environments including production areas and clean rooms.

Microorganisms include bacteria, yeasts, molds and viruses. Millions of microorganisms enter the air system through the compressor intake. Intake filters do not remove these viable particles. Modern compressor systems, which are properly maintained, should have properly sized filtration and point-of-use filters to remove these contaminants. A monitoring program is essential to verify that filtration and routine maintenance is providing the protection required to keep your products safe. For more information about contaminants, visit our web page about Compressor Contamination Sources.

Compressed air systems can harbor the nutrients required for microbes to grow; namely water, oil, and warm temperatures. Maintaining a dry water level of -40F can inhibit the growth of microbes but will not eliminate them. Bacterial spores can be resistant to U.V., desiccation or heat and can remain dormant for long periods, thus creating the potential for a reccurring problem. Further, there is another nasty contaminant known as biofilm. Biofilm can have negative effects on the compressed air quality as well. Biofilm creates a safe haven for bacteria and can provide nutrients to bacteria under conditions that might normally be considered too harsh. To learn more about biofilm, read this Microbiology Online article by Fabio Pacheco.

International standards and internal facility health and safety regulations exist to improve and protect the health and welfare of consumers and facility employees respectively. Some regulations directly impact the product being manufactured, while others have roles in the daily function of the overall facility. In either case, when compressed or environmental air meets food, regulations must be in place to deem that food or beverage safe for consumption.

In 2014, Parker Hannifin Corporation released a case study about a bakery in Illinois that recognized its need to test the compressed air in direct and indirect contact with their food products. During testing, the bakery mixed ambient air with their compressed air resulting in false positive microbial contamination. After several months of retesting, they evaluated their sampling procedure and discovered it to be the issue.1 In this instance, understanding the standard for testing compressed air for microbial contamination (ISO 8573-7) would have aided in the resolution of the issue in a more timely manner.

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