Applications in Microbiological Testing

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Microbiological Testing: 2017 Trends

The latest Microbiology Testing Market report is out and showing the microbiological testing market is expected to grow at 5.69% CAGR over the next four years. The main factors leading to this growth include large disease burden of infectious diseases, increase in laboratory automation and increases to both access to medical insurance and healthcare expenditure.  While this growth is expected, the industry will still need to be aware of the restraints to the market. These include: medical device regulation policies, advancements in molecular diagnostic technologies, and reimbursement issues.

Microbiological testing is used in various markets, including pharmaceuticals/medical, food/beverage, energy and cosmetics with the use of specialized products to test water contamination, pharmaceuticals and food samples. Types of testing can include, but is not limited to culture testing and food pathogen tests.

Overall, the testing market is in place to make sure the products used and food eaten in everyday life is safe to the individual. Based off of standards created by the FDA, labs continuously work to ensure these standards are met. Besides ensuring the safety of the products used or food eaten, microbiology testing is used in the following capacities:

·         Check products and equipment in labs

·         Verifying growth mediums are clean in order to use them to culture desired microorganisms

North American trends

Microbiology marketing trends in North America are continuing upward thanks in part to the increase in prevalence of pathogenic diseases, growth in discovery of mutating and adapting bacterium, and growing need for speedy testing methods.

Asian trends

The Asian market, consisting of Asia Pacific and Latin America, is expected to increase as well. This is a result of an increase in the number of new labs and the automation of existing ones. Additionally, hospitals are opening new centers throughout the regions and there is an increase in government expenditure.

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Tips for Preventing Microbial Contamination in a Lab Setting

There are literally millions of potential contaminants that could hurt the integrity of a drug. Microbial contamination is serious, and it could potentially lead to product recall or even a public health issue. This is why quality control is so heavily regulated by the FDA and why pharmaceutical companies must pay close attention to microbial and environmental monitoring – whether they manufacture and test the product in-house or they outsource to a contract manufacturing organization. In general, there are three areas of contamination prevention that can greatly impact whether or not a product goes to market without a quality issue or future adverse event:

 Facility Design: If a pharmaceutical organization outsources to a contract manufacturing organization, it must ensure that it is outsourcing to an organization that has facilities that are FDA-registered and fully compliant with GMP and GLP testing services and standards.  Facility design is essential to quality control as factors like HVAC capacity for temperature and humidity control or the use of moisture-resistant materials in the construction of the facility could greatly affect how well workers are able to maintain sterility and monitor the environment. Poor construction materials or design may ultimately require a facility renovation or redesign to prevent long-term events and recalls.

 Staff Training: In addition to facility design, staff members must be trained to adhere to a facility's cleaning processes to prevent adulteration.  They must know which chemicals are safe to use and when and understand the ramifications of deviating from accepted standards. There are an infinite number of ways that an environment can be compromised through inadequate training, so this must be addressed in initial and ongoing training programs. If a pharmaceutical company outsources, it should make sure that the contract manufacturing organization has a robust training program in place to prevent human contamination.

 Environment Cleaning: Finally, an organization must adhere to best practices defined by standards and regulatory guidance documents. Although each facility will have slightly different cleaning requirements, these defined standard cleaning procedures can provide the background necessary to maintain environmental control. Considerations for proper environmental cleaning to satisfy all cGMP requirements include the types of disinfectants and sporicides that should be used, when and how often they should be used and rotated, and the specified applications for those cleaning agents.

 Pharmaceutical organizations face high expectations: they are looking to keep costs down and also achieve a fast turnaround time to bring the product to market. However, these cost-saving goals are mitigated if quality isn't of the utmost concern. When considering a contract manufacturing organization as a manufacturing partner, make sure that quality is its number one priority as well.

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Minimizing Cleanroom Contamination: Understanding the Risk People Pose

Cleanrooms play a vital role in maintaining contamination-free environments for pharmaceutical products.

With the use of environmental monitoring methods, cleanrooms are thoroughly assessed to analyze the quality of the environment.  While it’s important to maintain a cleanroom free of contamination, cleanroom contamination can arise. Although there are a number of causes for this, most contamination can be traced to humans working inside the cleanroom. It’s vital that pharmaceutical facility members understand how personal hygiene and habits can impact the cleanliness of a cleanroom. The following are tips to help maintain an area free of contamination.

 Cleanroom Clothing and Body Products

In addition to good personal hygiene, it is extremely important to be mindful of the clothing you wear and the body products you use if you work in a cleanroom since you don’t want contamination to make its way inside.

In regards to clothing, you should get into the habit of wearing non-linting clothes made of cotton or polyester. Avoid nylon or other synthetic fabrics that have a tendency to create static. Daily bathing and shampooing are important as it helps control flaky skin and dandruff. Ensure deodorant is dry, unscented and not a powder. Your hair should be combed frequently before entering since combing removes dandruff and loose hair. Always wear a bouffant cap and never remove it in case hair falls. Fingernails should be trimmed fairly short and it’s best to advoid wearing nail polish. Cosmetics such as lipsticks, eye shadows, mascara, and foundation, as well as perfumes and colognes are not recommended.

Always wash your hands prior to entering the cleanroom to remove dead cells and prevent your skin from flaking. Avoid scratching or rubbing your skin once inside the cleanroom since this can cause exfoliation and product contamination.

Avoid Wearing Dangling and Hanging Jewelry Wedding and engagement rings are usually acceptable, but any jewelry with sharp edges or prongs should be avoided since they can puncture gloves or garments. Dangling earrings, necklaces, and other hanging jewelry is not recommended since they can interfere with cleanroom activities. Personal items such as purses and wallets should not be kept in the cleanroom.

Wear Cleanroom Garments and Accessories Accordingly Cleanroom garments must not touch the floor since this contaminates the garment. Garment pockets should always be empty.  Eyeglasses or goggles are strongly recommended since our eyes spew out mucus each time we blink. Dry skin and saliva can cause product contamination, so wearing a face mask may be necessary.

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Environmental Monitoring in the News

While environmental monitoring is a critical component of much lab-based work, like product testing or monitoring existing resources, the effects of environmental monitoring research spread far beyond the lab.

 The results of environmental monitoring research appear frequently in the news as these increasingly advanced scientific findings impact a wide variety of important issues.

 In fact, in the past few weeks alone, environmental monitoring research has played a key role in each of these news stories:

 Chinese environmental protection officials detained for tampering with data, Chinese government vows changes

At the end of October, five officials in the Chinese city of Xian were detained for falsifying data and tampering with air-quality monitoring equipment. Reports state staff took measures like stuffing sensors with cotton to lower emission readings and removing surveillance tapes.

 The Straits Times reported China’s Ministry of Environmental Protection said fraudulent administrative interference in monitoring processes like these are on the rise. Problems like this are perhaps why China’s government plans to create a comprehensive environmental monitoring system by 2030.

 According to Reuters, “Pollution has been identified as one of the biggest threats to public health in China... Air pollution killed more than 1 million people in China in 2012 alone, the World Health Organisation said in a study published in September.”

 Pollution-detecting plants: The future of environmental monitoring?

In a Live Science article by Edd Gent also published at the end of October, Gent cites researchers who claim that, “Bionic plants that can detect explosives in real time could be the future of environmental monitoring and urban farming.”

 Researchers developed spinach plants that give off infrared light which are sensitive to different chemical compounds. The team said plants make excellent chemical sensors due to their extensive root networks and ability to utilize minimal solar energy to draw up groundwater.

 NASA/NOAA orbiting partnership contributes major environmental monitoring advances

At the beginning of November, SpaceDaily reported that, “After five years in space, the NASA/NOAA Suomi National Polar-orbiting Partnership (Suomi NPP) mission continues to contribute significant advances in severe weather prediction and environmental monitoring.”

Suomi NPP bridges NASA with the National Oceanic and Atmospheric Administration's (NOAA) next generation of weather satellites. We can thank this partnership for better forecasts and situational awareness for the people in the United States and around the world.

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Contaminants that Could Affect Your Cleanroom

When it comes to microbiological testing, one cannot underscore the importance of having a cleanroom that is completely free of all contaminants. In order to standardize testing and ensure there aren’t any variables added to the testing, pharmaceutical and life sciences companies will go to great lengths to maintain the integrity of the cleanroom. 

This could include everything from installing air filters to training technicians on the basics of maintaining a cleanroom. The goal is to minimize the chances for contamination. This is why food isn’t allowed in the cleanroom; nor is someone allowed to wear deodorant or cologne and go into the cleanroom. 

Contaminants that Could Enter Cleanroom

However, this is not to say that micro-particles of various origins couldn’t potentially still affect the integrity of the cleanroom. In general, there are two different types of contaminants that could be present in a cleanroom. The first are non-viable particles. These are particles that come from a person's clothing or even his or her dead skin. In addition to that, metal specks or flakes from any tools or equipment in the cleanroom could potentially contaminate the cleanroom too.

This is juxtaposed by viable particles, which are bacteria, virus, fungal spores, molds, and yeast. Typically, these airborne particles enter the cleanroom through ventilation or air conditioning. Personnel may bring in these particles as well. In fact, according to statistics, personnel represent as much as 80% of the particles generated in the cleanroom.

It's for this reason why training is so important so personnel do not unintentionally bring in contaminants into the cleanroom. For example, personnel should not walk into the cleanroom with their street clothes. They should only wear approved cleanroom clothing. In addition to that, labs might want to invest in cleanroom testing services to ensure there isn't a hidden source of contamination that is affecting testing. 

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What Is a Cleanroom for Lab Testing?

All around us there are microscopic airborne particles. In normal cases, this isn’t a big deal, but when it concerns product production and lab testing, these microscopic airborne particles could cause contamination. It’s for this reason why cleanrooms are established. Cleanrooms. are designed to keep those particles out as much as possible. Given the fact that there are anywhere from 500,000 to 1,000,000 airborne particles at any given time in an office, a cleanroom must be well-designed and special attention must be paid at all times to ensure its integrity.

There are many ways to ensure that contamination doesn’t take place. Here are several that should be a part of any cleanroom:

Implementing High Efficiency Particulate Air Filters

Enlisting Environmental Monitoring Services

Utilizing Additional Filters to Remove Particles from Gas and Liquids

Cleaning for Contamination Prevention

Training Employees on Cleanroom Best Practices

The cleanroom is an essential part of many different applications, so it’s important to maintain its integrity to prevent contamination from occurring. In many cases, it might be of best interest to the organization to enlist third party services to certify the purity of the cleanroom. 

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Four Hot Careers in Pharmaceuticals

It’s a tough economy, and people are doing whatever they can to survive it. Some people are lucky enough to have careers in industries that never seem to hit financial snags, but others aren’t as lucky. Some people feel like they’re stuck in the current career they’re in, and they can’t see any other way to get out of it. They’d be willing to go back to school, but they’re worried about picking another dead end industry.

If you want to work in an industry that’s always growing and can utilize people with a variety of skills, you need to look into pharmaceuticals.  Pharma is always growing as a field, and you don’t necessarily have to be a highly trained biologist to find work in it. If you want to break into big pharma, you should consider doing any of the follow jobs.

Biostatician

You’ve never been great at science, but you’ve found that you have a gift for mathematics and numbers. If you’d like to get into the analytical side of pharma, there are tons of companies that are looking for a reliable biostatician to help sort data. Statistics are important part of medical research, and the numbers you analyze could help shine a light on the next big breakthrough in medical science.

Research/Development Manager

You wouldn’t call yourself a devotee to hard science, but you do know a thing or two about managing new projects and ideas. Pharmaceuticals wouldn’t exist if it wasn’t for the constant strides being made in research and development. You’d handle the management of projects to make sure that they’re on track to be finished on time.  You could help find the right talent to bring in to help on your next big project.

Quality manager

Do you hate seeing inferior products being released on the market?  When it comes to pharmaceuticals, quality is everything. A faulty medication or medical tool can harm people, that’s why every pharma company needs a good quality manager on their team. If you have a keen eye for detail and know how to follow process to a T, this could be perfect job for you.

Sales 

You may not be great at math or science, but you have a gift for talking to people and being persuasive. If you have sales experience, or have ever thought about going into sales, any company would be happy to have you on board promoting their pharma solutions to doctors and investors. The sales side of pharma has been growing steadily over the past few years, and as advanced in medical science continue to come out you won’t have to worry about finding work.

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What Goes into Heartworm Prevention?

Heartworm is an incredibly serious disease that is often fatal in dogs. Luckily, it is also very treatable, especially if it is caught early. It occurs when foot-long heartworms become present in the lungs, heart, and associated blood vessels of a dog. Although heartworm can affect cats, it is typically not as serious as adult heartworms don’t typically survive in cats. 

Dogs are different though, and some dogs could have hundreds of worms in their bodies at a given time if the disease is left untreated. These worms could do serious damage to the pet, inhibiting arterial function, lung capacity, and diminishing quality of life. 

The summer is typically bad for heartworm for dogs as it can be spread by mosquitoes, which tend to run rampant in the warmer months. When a mosquito bites an affected pet, it can then spread the disease to another pet when it goes to feed again. This is why it is especially important to safeguard against heartworm in the summer months. 

Prevention is the Best Medicine

Heartworm medication does not kill adult heartworms, but it can prevent younger heartworms from developing into adults. Therefore, it's important to keep your dog medicated with heartworm medicine year-round. Heartworm medication undergoes thorough microbiological testing from a CMO that can ensure the drug's safety and efficacy.

However, it's important to remember that you must have your pet tested yearly by your veterinarian to ensure that an infection isn't present, which could potentially cause adverse effects if the medication is administered. Your veterinarian will assess your dog's history and tests to determine the best type of heartworm medication that will keep him or her protected.

And always be mindful of heartworm symptoms. The most common symptoms include a mild cough, reluctance to exercise, decreased appetite, and general malaise. Symptoms are usually more pronounced when the disease has progressed, so early stages may produce few or no symptoms. However, if you do notices changes in your dog's behavior or diet, please consult your veterinarian immediately.