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If the new rule goes into effect, manufacturers of antibacterial soaps will be required to prove that their antibacterial soap(s) work better than washing with plain ordinary soap and water. They will also be required to prove that there are no long-term harmful effects of using these antibacterial soaps. There has been recent concern that prolonged use of antibacterial soaps may cause pathogenic bacteria to become resistant to the antibiotics commonly used to fight disease. There is also concern that the antibacterial soaps may cause a hormonal imbalance in the human body.

The primary active ingredient is triclosan in liquid soaps and triclocarban in hard bar soaps. Hormones produced by the thyroid decrease in rats exposed to these chemicals. This is highly suggestive the same could happen in humans too. The FDA first proposed to not allow triclosan in cleaning products back in 1978. However, no official action was taken then. Subsequently, the usage of this harmful chemical proliferated to include about 2,000 different products labeled "antibacterial." In fact, it is difficult to avoid antibacterial soaps as they are used in almost every public bathroom in the United States.

  Microbiology quality assurance businesses will surely be involved in testing the effectiveness of antibacterial soaps for the government, soap manufacturers, and others concerned about this issue. Microbiology quality assurance businesses are also often consulted by other businesses and individuals who are concerned about the effectiveness of cleaning products. For example, the food industry must maintain sterile surfaces where food is processed and employees' hands must also be sterilized while they are handling the food. In this instance, a microbiology quality assurance business may be consulted to test surfaces that come in contact with food and employee hands when using different cleaning agents and different cleaning techniques. Bottled water plants, beer breweries, meat packing facilities, seafood processing plants, health spas, and nursing homes are more examples of businesses that may need these types of services.

  Contact Biolumix to learn more about microbiology quality assurance testing.

One issue that has arisen with GMOs is that there are no natural boundaries. After planting, they can contaminate conventional crops growing in nearby fields. Organic farmers with land nearby often have to incur significant costs remedying the damages that happen when genetic trespass occurs. When wind and water runoff carry spores and seeds, the GMOs enter other fields. There, they generate genetically altered plants, but the farmer who owns that land does not realize that genetic pollution has taken place.

  Mixing crops together during harvest is another source of GMO pollution. If farmers lease combines at harvest time, and the combines have not been sufficiently cleaned, GM grains remaining from previous jobs can pollute the new crop. Even one particle can contaminate an entire field. One suggested response has been to develop GMOs with sterile offspring, although that suggestion has not yet borne significant effort.

There have not been any long-term research studies about the safety of GMO crops for people to consume. GMO corn has special engineering to generate pesticides inside its very own tissues and receives Environmental Protection Agency governance as an insecticide. However, at the grocery store, it sells without any labeling in the United States, even though 61 countries representing almost half the population of the world currently require labeling, including China and the European Union. This is one of the primary reasons that, even though no studies have yielded results showing long-term harm from GMOs, that groups are pressing for legislation in the United States requiring labeling. One example that turned out to be a poor choice was the combination of Brazil nuts and soybeans, which manufacturers had to abandon because of an excessive number of allergic reactions. As a result, a number of natural retailers attempt to keep products with GMOs off the shelf, a process that admittedly would be easier with labeling requirements.

Situations of food quality are just one instance that makes microbiology quality assurance so vital. Because of the existing lack of governance of GMOs in the United States, consumers have some risk when it comes to consuming foods that may or may not cause harm over time. There is significant room for microbiology firms to step in and alleviate much of the unease surrounding this element of the food market. Until some resolution comes to the labeling issue, this sort of operation can be a major bulwark between producers and the consumer.

  Contact Biolumix to learn more about microbiology quality assurance testing.

  A fact that may surprise many people is that all of us have Candida. Candida is present in the intestine of every healthy human being. Candidiasis is a condition that often occurs after antibiotics have been used to get rid of a bacterial infection. It may also occur if the person’s immune system has been compromised, prime examples being infection from diseases such as AIDS and cancer. It may also occur if the person has any form of critical illness.

  Candida has been blamed for gas and bloating, this is impossible because yeast makes carbon dioxide and carbon dioxide is quickly diffused into the bloodstream and promptly exhaled by the lungs. It doesn’t matter how much candida is in your colon it cannot possibly make you bloated or cause gas. Carbon dioxide does not stay in your colon long enough to make you flatulent. If you have a lot of gas it is probably due to an excess of bacteria.

  If you are having chronic yeast infections cutting products made with yeast from your diet will not stop the infection, this is because the Fungi Kingdom has over 1,500 different species. Yeast is used in so many products that one specific type used in yogurt, bread, beer or anything else you eat could not and will not be single handedly responsible for continued infection.

  There are websites that claim that a person can get Candida overgrowth; these claims are completely false. They may also claim that Candida can come through the walls of the gut and enter the bloodstream causing headaches, depression and also affect the systems of the body. It is impossible for Candida to penetrate the walls of the gut unless it has been damaged or punctured, unless significant trauma occurs fungi cannot travel through the blood.

  So if your health care practitioner diagnoses Candida overgrowth and does tests that confirm this, it may be that you were environmentally exposed and your immune system developed antibodies. If stool tests find candida in your colon, this is not unusual. Since no normal amount has been established for the presence of candida in the gut then there can be no official abnormal amount.

  Microbiological testing is the public's guarantee that the products they are consuming or using have been evaluated for safety while they are in the process of being made and after they have finished the manufacturing process. Yeast and mold can be dangerous to people and animals and must be detected before products are placed on the market. Microbiology quality assurance tests using high-tech microbiological instruments are necessary for yeast and mold detection because these organisms are capable of deteriorating the product being produced and must be detected and eliminated for quality control. These tests need not take days to complete as there are now rapid detection systems that can detect yeast and mold quickly. This makes quality assurance testing easy and accurate.

  Contact Biolumix to learn more about microbiology quality assurance for yeast, mold, and other organisms.

When a person is infected with the salmonella bacteria, they can experience symptoms such as fever, chills, diarrhea, abdominal cramps, nausea and vomiting. People infected with salmonella are usually sick for up to seven days and, in most cases, they are able to recover without the need for treatment intervention.

But in this recent national outbreak, the strains of salmonella turned out to be particularly virulent, giving rise to a number of serious cases that were certainly a cause for concern. According to the Center of Disease Control and Prevention, of the individuals who became ill after getting infected from the salmonella infected Foster Farms chicken, about 42% had to be hospitalized. This is twice the normal hospitalization rate for salmonella infection. A few of the strains in this incident were also found to be resistant to antiobiotics, posing a problem for effective treatment of the infection.

This case has raised awareness of the importance of consumers taking precautions when handling chicken to protect themselves and their families against illness caused by food contamination. One key precaution that is being advised by researchers is that people should refrain from washing chicken in their sinks. This is because splashed water from washing the chicken can land onto surrounding kitchen surfaces, such as countertops, dish racks and towel, which spreads the bacteria. There is also a high risk of the bacteria ending up on your hands or coming into contact with other foods.

According to the U.S. Department of Agriculture, contrary to what many people think, not all types of bacteria can be removed by washing the chicken. This is because some bacteria cling firmly to the chicken so washing it once or several times won't make a difference. However, washing can help take out other types of bacteria from the chicken. Another thing is very important is to clean kitchen surfaces where the water from washing has splashed, as these areas will harbor bacteria that can contaminate other foods prepared in the kitchen. It is also recommended by the CDC that people use different cutting boards for meat and produce in order to reduce the risk of cross-contamination taking place.

As this incident has highlighted, microbiology quality assurance is of utmost importance when it comes to product manufacturing. Microbiological analysis of products is necessary to determine that their quality is in line with certain industry standards and is safe for use by consumers. Several microbiology instruments are available to test the quality of products and detect any traces of microbiological organisms. A salmonella vial which can be used to see whether a product sample is contaminated with salmonella to ensure the product is safe for consumption. Microbiology quality assurance provides an effective way of assessing products and ultimately making sure they are safe for consumption.

  Contact Biolumix to learn more about salmonella vial and other forms of microbiology quality assurance.

  1. Total Aerobic Count (TAC)

Total Aerobic Count vial’s sensor is based on the principle that all microorganisms produce carbon dioxide as a metabolite. The vial contains a solid but transparent sensor at the bottom. The metabolism of bacteria causes a release of CO2 into the sensor, where it reacts with reagents in the sensor to indicate their presence. The sensor is only permeable to gases, but not microorganisms, particulate matter, or liquids. 

  2. Coliforms

This is a membrane vial, in that it uses a membrane filter to separate the reading or detections zone from the incubation zone, where the sample being checked for microorganisms is contained. The presence of coliform bacteria causes lactose to ferment in highly selective media, resulting in a pH shift that causes the color to change for easy detection. 

   3. Enterobacteriaceae

The vial is in the form of a membrane filter that separates the incubation zone from the detection zone. The presence of Enterobacteriaceae organisms cause glucose to ferment in highly selective media, casing a change in pH that can be easily monitored. 

  4. Yeast & Mold Count

The yeast and mold count vial’s sensor contains a solid but transparent sensor at the bottom, and a selective medium from the top. Whenever CO2 diffuses into the sensor, it interacts with the indicator reagent, causing it to change its optical properties. 

  5. Gram Negative Bacteria

The gram negative bacteria membrane vial examines the utilization of a distinct fluorescent dye, which is placed in a selective media that prevents gram-positive bacteria from growing. 

  6. Lactic Acid Bacteria

The membrane filter is sandwiched between the sample containing area and the detection or reading area, where it monitors a change in color caused by a change in pH as Lactic acid bacteria (LAB) causes Dextrose to ferment in a selective medium with fortified MRS. 

  7. Probiotics

The disposable probiotic vial contains a solid but transparent sensor at the bottom of a liquid medium with a modified MRS containing the sample and presumed microorganisms. In the event of probiotic bacteria metabolism in the medium, the CO2 generated diffuses into the sensor below, and interacts with an indicator reagent causing it to change its optical properties for easy detection. 

  8. E. Coli

For the E. coli vials, the incubation zone, which contains the sample, media and microorganism, is separated from the measuring zone in the bottom using a membrane filter. It takes about 20 hours for the detector in the measuring zone to identify any 4-methylumbelliferyl-B-D-glucuronide (MUG) microbial cleavage, using the fluorescence sensor. 

  9. Salmonella

The Salmonella vial’s sensor is located at the bottom of the incubation zone (containing a liquid medium and sample with presumed microorganism). The metabolism of Salmonella in this zone causes CO2 to be generated. The CO2 diffuses into the sensor where it mixes with the indicator reagent, causing it to produce optical properties signifying the presence of microorganisms. 

  10. Staphylococcus

The vial is contained below the membrane filter, which separates it from the selective and differential growth medium that has mannitol and Phenol Red, a pH indicator. Growth of staphylococcus produces a color shift from red to yellow.  

  With the exception of Yeast and Mold vials, which produced results in about 48 hours, the other vials used in rapid automated microbiology produce test results within a day. Contact Biolumix for more information about rapid microbiology testing.

  Ideally, it is the assumption that any analytical test method will perform in a certain manner each time it is used. Suitability testing ensures that the entire system is working properly at the time of the analysis, and provides the assurance that the test methods will deliver accurate and precise data for the intended purpose. As such, system suitability tests are performed prior to each reading session, in order to ensure that the equipment, the environment, and the reagents are functioning as intended. In other words, the test ensures that the method used does not prevent the growth and recovery of microorganism that may be present in a sample, thereby making the test valid for the detection of microorganisms within the product. 

  The system suitability test selected for microbiology quality assurance should be dependent on the intended use of the procedure, the type of analysis, and the stage of development. While the USP employs conventional microbiology quality assurance methods, it permits the use of alternative microbiology methods like automated procedures, as long as you can provide evidence of their similarity to Pharmacopeia methods. Rapid Methods for suitability testing have been validated to provide similar results to those of USP methodologies. In fact, regulators encourage the use of rapid methods due to better process control and earlier product release. 

  The test described in USP <61> requires the use of several methods including pout plating, spread plate and membrane filtration to perform the Total combined Yeast and Mold and total Aerobic Microbial Count tests. This ensures the validity of a testing procedure by indicating the recovery of microorganisms while in the presence of the sample product. For instance, a suitability test that seeks to show the use of a suitable neutralizer would inactivate the preservative in the sample product to illustrate that microorganisms like molds or bacteria yeast would, in fact, grow and be detected, if they were present. 

  For suitability testing using USP <62>, selective media are used to detect multiple organisms like Pseudomonas aeruginosa, Staphylococcus aureus, Escherichia coli, Clostridia, bile-tolerant gram-negative bacteria, Candida albicans and Salmonella. It is extremely important that microbiologists take the necessary precautions when conducting suitability tests in order to avoid contamination, so that the microorganisms being tested are not affected. Basically, you are required to inoculate the neutralized sample with low cfu, usually less than 100, and using the prescribed method to detect the organisms. 

  There are many benefits of the rapid suitability testing methods, including time and labor efficiency. Traditional procedures that take 5 days or 48 hours to deliver results, can be substituted with rapid methods that take less than 48 hours or 18 hours to provide results, respectively. The assay setup can also be made much faster using rapid methods, allowing laboratories to save on hands-on labor owing to its simplicity of use and automation. Contact Biolumix for more information.

  The markets for generics, biologics and over-the-counter (OTC) drugs have continued to grow and become increasingly competitive. The research sector, alone, has recorded an average annual growth of 28% since 2,000. The success of pharmaceutical products is largely dependent on competition in price, product quality, and safety and efficacy. The continued favorable support from the U.S. government in biomedical research, ultimate scientific and research base, and the innovative biotechnology sector make it the ideal home for the development of the pharmaceutical industry.  

  However, the massive expenditure directed toward research may compel some manufacturers to rush the release of their products, leading to grave repercussions. For instance, the number of drug recalls in the pharmaceutical industry increased drastically between 2008 and 2009, from 426 to 1,742, mostly due to microbial contamination. A manufacturer suffers immeasurable damage when their drug product is recalled, including the loss of product sales, reduced consumer confidence, tarnished brand and company name, and legal proceedings, in most cases. Fortunately, there is increased access to rapid microbiology testing systems that streamline production and promote efficient laboratory practices for increased throughput and product safety.  

  Quality control is a critical function in the pharmaceutical industry. It is essential for drug manufacturers to scrutinize their test materials, equipment, processes, environments, personnel and techniques to ensure that the safety, consistency, effectiveness and predictability of their final products. However, multiple factors have necessitated the delivery of speedy test results, including regulatory agencies, corporate quality initiatives, and the need to save on resources (money, space and personnel).  

  Rapid microbiology testing systems are applicable in a wide range of quality control operations including in-process monitoring, purified and process water testing, environmental monitoring, manufacturing process design, raw materials and excipients testing, and investigations and final products release testing. The latter is the most critical test due to the immediate impact that any undetected contamination could have in the consumer population. Rapid microbiology systems provide timely results that are either similar or better than those obtained in traditional methods. The use of an incubation phase also ensures that less time is spent to obtain results, compared to 14 days using conventional methods, in addition to making them easier to interpret and compare.  

  Other benefits of the rapid method include: reduced plant downtime, decreased warehouse space and raw material costs; fast final-product release; shorter product release cycle times; labor and time savings in the lab during manufacturing; risk reduction in manufacturing; reduced cycle times in terms of reduced backorder and product losses; risk reduction in manufacturing; increased business and production flexibility; increased capabilities in manufacturing and product development; robust understanding of manufacturing processes; proactive control as seen in the shift from quality control to quality assurance procedures; immediate detection and correction of contamination; instant cleaning validation; and better protection of consumers and company image.  

  Generally, rapid microbiology testing systems enable the pharmaceutical industry to perform many tests using less time, money and effort, in order to ensure the delivery of safe products. 

  Contact Biolumix for more information about rapid microbiology testing for the pharmaceutical industry.