Ensuring Sterility in Pharmaceutical Milling Processes

 

Particle size is critical to a pharmaceutical product’s effectiveness. Consequently, milling is a crucial process for drug manufacturers, but any amount of physical contact introduces cross-contamination concerns in this industry. As drugmakers consider how these workflows meet particle size and efficiency needs, they must also ensure sterility.

 

By Ellie Gabel  

Historically, meeting high standards of cleanliness and sanitation has led to complications and high costs in pharmaceutical manufacturing. Today, new technologies let pharma companies ensure sterility while minimizing production time and expenses. These innovations can apply to milling before, during and after the actual grinding phase.

Preventing Cross-Contamination Before Milling

Pharmaceutical sterility begins with preventing contaminants from entering the workspace in the first place. Contact between equipment and materials cannot produce cross-contamination if no microbes, dirt or other pollutants ever reach the machinery.

Creating a reliable clean room environment is crucial. Airflow is one of the most critical considerations here. Laminar flow will keep contaminants out by pushing inside air in one direction to move it away from sensitive equipment and toward filters. All clean room HVAC systems should include HEPA filters, which can remove 99.97% of airborne pollutants of 0.3 microns or larger.

Internet of Things (IoT) sensors can help by monitoring pollutants in real time. As a result, it becomes easier to ensure protective measures are working correctly or enforce sanitary workflow policies. IoT solutions can also track equipment maintenance to help HEPA filters and other sanitation machinery remain in acceptable condition for longer.

Using Contamination-Resistant Milling Methods

The pharmaceutical milling process itself can adapt to become more contamination-resistant, too. While manufacturers often choose methods based on particle size and efficiency needs, some systems provide sterility benefits over their alternatives.

Conical grinding may be the most common option, but micronization minimizes contamination risks by producing no heat and can achieve smaller particle sizes. In instances where drug classes are incompatible with this method, manufacturers could use cryogenic grinding, which has similar temperature-related benefits. These more advanced solutions may incur higher upfront costs, but they often produce better results and higher efficiency, which can make up for the investment over time.

The optimal method depends on the drug and manufacturing process in question. Generally speaking, though, wet techniques are preferable to dry alternatives, as they require a contained system. This containment, in turn, minimizes cross-contamination and material loss.

Post-Milling Sterilization

Even with thorough preparatory steps, contamination is still possible. Consequently, pharma manufacturers must also apply post-milling sterilization measures to counteract any sanitation issues that may have arisen in the previous steps.

Physical filtration is a reliable way to remove contaminants from drug solutions after milling. Studies show that 200-nanometer particles easily pass through most readily available sterile filtration solutions, while most bacteria are larger than that. As a result, manufacturers can mill their pharmaceutical ingredients as small as possible so they can pass through such pores while the filters catch pollutants.

Chemical and thermal sterilization may provide additional benefits, but manufacturers should approach them carefully. Many pharmaceuticals are sensitive to heat, and chemicals introduce the risk of unwanted reactions. The optimal solution will depend on the kinds of materials a process is dealing with, and organizations will likely need to use various methods to serve different products’ needs.

Pharma Manufacturers Must Address Sterility at Every Point

Contaminants can enter the pharmaceutical production process at many points. Consequently, manufacturers in this industry must ensure high standards of sterility at each step throughout the workflow. Failure to account for any area could result in far-reaching consequences if the pollution is significant enough.

Technologies like the IoT, novel milling equipment and advanced filtration make sterility easier to achieve than ever before. Businesses must recognize the potential such solutions hold and take advantage of them to stay compliant with rising demands and regulations. Getting ahead of tech trends will also keep organizations competitive in a fast-changing environment.

 

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

Tattoo inks and microbial contamination

This week's article looks at microbial contamination risks associated with tattoo inks and the tattoo process and assesses recently published US FDA guidance: 

https://www.linkedin.com/pulse/tattoos-microbial-infection-risks-tim-sandle-ph-d-cbiol-fisct-eqiue/

Save 50.0% on select products from Colourbing with promo code 50LQ68OG, through 1/5 while supplies last. 

Many tattoo inks are contaminated, although different rounds of laboratory analysis show a degree of variation according to locale and ink source. However, there has been a commonality over the past decade for ~50% of inks found to contain microorganisms (10–80% of unopened commercial tattoo inks are contaminated with microorganisms according to my review of the literature. The populations recovered are up to 3·6 × 10^8 CFU per gram. It should be noted that studies tend to pinpoint higher rates of contamination in North America compared with Europe.

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

The Role of Robotics Programming In Science

The world is changing faster than ever, and robots are leading the charge! They're building our cars, performing surgeries, and even exploring the depths of space. But how do these incredible machines know what to do? The answer lies in the fascinating world of robotics programming, which is the secret code that brings robots to life."

What is Robotics Programming?

Picture that you have a robot friend, but it does not know how to walk or talk. You need to teach it! Robotics programming is like giving your robot friend instructions. These instructions are written in special languages that robots can understand.

To get started with robotics programming, you'll need to learn a programming language. C/C++ are powerful languages that give programmers a lot of control over the robot's hardware. They're often used for tasks that need speed and efficiency, such as controlling robot movements. Python is great for tasks that involve artificial intelligence (AI), like helping a robot recognize objects or make decisions, and Java is good at handling lots of data and complex tasks. It's often used for programming robots that interact with the real world. Some examples include self-driving cars or robots that work in warehouses. Even cooler, new 'no-code' platforms are popping up, making it easier than ever for anyone to try their hand at robotics programming, even without knowing complex languages! To illustrate, Pepper is a humanoid robot often used in customer service roles. PandaSuite allows users to create interactive behaviors for Pepper, such as greeting customers, answering questions, and providing directions, all without coding.

The Role of Robotics Programming in Science

Robotics programming is super important in science because it helps us do incredible things. Scientists use robots to explore dangerous places, such as the deep sea or outer space, where humans cannot easily go. These automatons can also help us with difficult tasks, such as manufacturing products or assisting in surgeries. In car factories, robotic arms weld parts together with pinpoint accuracy to make sure every car is built tough, and when it comes to your phone or computer, tiny robots place the super-small parts onto circuit boards way faster and better than any human could. Even in giant warehouses, robots zoom around, lifting and stacking those huge boxes of stuff like it's nothing. Robots are also being used in STEM education.

What You Should Know About Programming in Robotics

If you think robotics programming sounds exciting, here are some things to keep in mind. First, it involves problem-solving. You need to figure out the best way to tell a robot to complete a task. This can be tricky, but it is also extremely rewarding when you find a solution. Additionally, robotics programming requires creativity. You can program these machines to do all sorts of things, from playing music to drawing pictures. The possibilities are endless! Finally, do not be afraid to make mistakes. Everyone makes mistakes when they are learning something new.

Robotics Programming is Fun!

Robotics programming may sound complicated, but it can be a lot of fun. There are many resources available to help you learn, such as books, websites, and online courses. On top of that, you can even join a robotics club or team to learn from others and work on projects together.

So, there you have it! Robotics programming is a fascinating field that combines technology, science, and creativity. If you are curious and love to solve problems, robotics programming might be the perfect thing for you.

Written by Taylor McKnight, Author for Automation Integration Solutions, LLC
 

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

Diet matters less than evolutionary relationships in shaping gut microbiome

 

Gut microbes provide many services for their hosts, including digesting their food. Researchers have long known that mammals with specialized diets, such as carnivores and anteaters, have special types of gut microbes that allow them to eat that diet.

Is the same true in primates? In the largest published comparative dataset of non-human primate gut microbiomes to date, a new Northwestern University study set out to find whether leaf-eating primates have similar gut microbes that help them break down their leafy diet, which is full of fiber and toxins.

A common theme in the microbiome field is that host diet has large effects on the gut microbiome — both across lifespans (week-to-week changes in host diet change the gut microbiome) and across evolution (mammals with similar diets have similar gut microbes regardless of their evolutionary histories), said Katherine Amato, lead author of the study and assistant professor of anthropology in the Weinberg College of Arts and Sciences at Northwestern.

Therefore, they expected to see many similarities between leaf-eating primates, regardless of how closely related they were to each other. Rather, the researchers discovered that diet mattered much less than host evolutionary relationships in shaping the gut microbiome.

“Our data suggest that, across evolution, the effect of primate diet on the primate gut microbiome is not large,” Amato said. “Evolutionary relationships between primates are much more important for predicting microbiome composition and function.” 

The study is the first cross-species comparison of the gut microbiota that exclusively uses samples from wild animals.

“We conclude that although gut microbes play a critical role in supporting host dietary specializations, their impact is regulated through host physiology,” Amato said.

“Leaf-eating primates shared very few gut microbial characteristics. Instead, New World monkeys shared the most gut microbial characteristics with each other, regardless of diet. The same was true for Old World monkeys, lemurs and apes. These patterns appear to be the result of host physiological traits such as how the gastrointestinal tract is built.”

Cross-mammal examinations of the gut microbiome have been performed, Amato said, but they all had weaknesses in that species with similar diets also had similar evolutionary histories or physiology. Many studies also mixed captive and wild animals, and captivity is known to change the gut microbiome.

“This study was able to eliminate these issues due to the fact that leaf-eating evolved independently multiple times in the order Primates and is associated with a different physiology in each part of the primate tree,” Amato said. “We also only used wild primates, which compared to captive primates, are more likely to have gut microbiomes like those they evolved with.”

Further research could involve looking at more primate species with more varied diets and understanding how the human gut microbiome fits into this bigger evolutionary picture and what it can tell us about our physiology and health, Amato said.

“Evolutionary trends in host physiology outweigh dietary niche in structuring primate gut microbiomes” published online earlier this month in the ISME Journal: Multidisciplinary Journal of Microbial Ecology.

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

Unmasked: The Science Powering Human, Humanized, Chimeric, and Single-Domain Antibodies

 Antibodies, the immune system’s frontline fighters, are nature’s way of keeping pathogens in check. Thanks to biotech innovation, these proteins have been reimagined to tackle everything from cancer to autoimmune diseases. Let’s unpack the fascinating world of engineered antibodies—human, humanized, chimeric, and single-domain—and see how they’re changing the medical game.  

By Bella Smith, Creative Biolabs

Human Antibodies: The Real Deal  

Human antibodies are as close as it gets to the natural defenders produced by your immune system. Fully derived from human genes, they boast unmatched compatibility, significantly reducing the risk of adverse immune responses. Advances like transgenic mice and phage display tech have made producing these antibodies a breeze, making them MVPs in treating chronic conditions and infections.  

Humanized Antibodies: The Perfect Blend  

When it comes to balancing efficacy and safety, humanized antibodies steal the show. Initially generated in animals, these antibodies are modified to replace non-human components with human ones, keeping only the antigen-binding regions intact. This reduces the risk of rejection while maintaining functionality.  

They’ve become a go-to for autoimmune and cancer therapies, ensuring cutting-edge solutions that won’t make your immune system go haywire.  

Chimeric Antibodies: A Best-of-Both-Worlds Hybrid  

Chimeric antibodies are the ultimate mash-up, blending human and non-human regions to maximize both safety and efficacy. By combining a human constant region with a variable region from another species (often mouse-derived), researchers create highly effective antibodies for tough targets.  

This hybrid approach has seen massive success, with drugs like rituximab paving the way for cancer immunotherapies. Chimeric antibody products illustrate the versatility of this design in the clinic.  

Single-Domain Antibodies: Tiny Titans  

Single-domain antibodies, are a stripped-down, no-frills version of the traditional antibody. Sourced from camelids like llamas and alpacas, these mini marvels are small but incredibly mighty. Their compact size lets them access hard-to-reach spots and bind with precision.  

Applications in imaging, diagnostics, and targeted therapies are expanding fast, with products like single-domain antibodies pushing the boundaries of what these tiny proteins can do.  

Antibody Engineering: What’s Next?  

From lab bench to bedside, engineered antibodies are shaking up the medical world. These biotechnological breakthroughs are unlocking new possibilities for personalized medicine, improving outcomes, and delivering hope to patients battling complex diseases.  

With experts like Creative Biolabs offering solutions that span the antibody spectrum, researchers have the tools to push innovation further than ever before. Whether it’s human, humanized, chimeric, or single-domain antibodies, these scientific marvels are rewriting the rules of modern medicine.  
 

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

Innovations in rapid microbiological methods

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

Introduction to sterility assurance (video)

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)