Showing posts with label Pharmaceutical processing. Show all posts
Showing posts with label Pharmaceutical processing. Show all posts

Sunday, 18 May 2025

AI-Driven Calibration Tools Are Transforming Sterility Assurance

Sensor. Image by Filya1 - Own work, CC BY-SA 3.0, https://commons.wikimedia.org/w/index.php?curid=6304562

New sensor technologies offer greater accuracy than ever when verifying sterility in pharmaceutical environments. However, issues like calibration drift stand in the way of that reliability. Even the most sophisticated monitoring tools can slowly become less precise over time. Calibration is the obvious solution, but it is not a foolproof process, so errors are still possible. Artificial intelligence (AI) may provide a better way forward.


By Emily Newton


The Problem With Conventional Calibration


Just as sterility monitoring is only as reliable as its sensors are accurate, calibration is only helpful when it is both comprehensive and precise. That leaves considerable room for human error.

Calibration mistakes and other human errors are a common cause of equipment downtime in health care and pharmaceuticals. It is easy not to calibrate a sensor along its entire range or to adjust a machine incorrectly according to test results. Maintaining utmost care takes a lot of time and focus — two things which are typically not humans’ strong suit.

Manual testing and adjustment can also be slow, which creates two issues. First, it means extended machine downtime, leading to lost productivity. Second, it means the employees performing this work may get tired, overloaded and distracted, raising the risk of human error all the more.

In light of these shortcomings, it should be no surprise that calibration drift may be more common than companies realize. Thankfully, there is another way.


Where AI Comes In


Like many pharmaceutical processes, calibration drift tests can benefit heavily from automation. AI-enabled calibration automation is becoming increasingly commonplace, and it is unlocking new standards of sterility assurance in several areas.


Automated Calibration Drift Tests


At its most simplistic, AI can automate the same kinds of sensor tests a human would normally perform. This has two main advantages — accuracy and efficiency.

Humans are infamously prone to mistakes when taking on repetitive, data-heavy work. Pharma entities lose millions of dollars annually because of these errors, but the workflows people struggle with are typically where AI is most reliable. Consequently, a sensor array that detects and corrects its own calibration drift will make more accurate adjustments than a manual process.

Automated testing and tweaking also mean lab staff do not need to take time out of their busy days to perform such work. The equipment will correct sensor accuracy issues as soon as they are measurable, so labs avoid scheduling complications, too.


Adaptive Calibration


AI-driven sensor calibration can also adapt over time. As machine learning models get new information, they can adjust their approaches to account for larger trends. That way, auto-calibrating systems can manage things like wear, temperature fluctuations and more, which may cause conventional strategies’ dependability to vary over time.

These ongoing improvements are especially valuable when dealing with equipment with broad factory calibration settings. Expert calibration can make tools more accurate, turning cheaper machinery into top-of-the-line assets. In addition to preventing sterility reading errors, this can save money on lab equipment.


Predicting Calibration Drift


Some AI models can even predict calibration drift before it happens. Predictive analytics models will learn how frequently sensors need calibration and what events lead to it as they monitor the system. They can then recognize when adjustments will be necessary in the future for more proactive steps.

It is the same underlying concept as predictive maintenance, which can reduce downtime by 15% and has become popular among manufacturers. Instead of predicting breakdowns, though, the model detects the risk of calibration drift before it occurs so it can recalibrate sensors early and prevent errors entirely.

Eliminating calibration errors means sterility monitoring tools remain as accurate as possible throughout their useful service lives. That presents massive savings potential and makes regulatory compliance much easier.


Remaining Obstacles With AI Calibration


AI-driven calibration is too promising to ignore. At the same time, it is easy to get stuck in the same trap with AI as the one leading to undetected calibration drift in the first place. No technology is perfect, so over-relying on it is a sure path toward significant issues.

Most notably, AI needs a lot of high-quality data to be reliable. This data demand can result in lengthy, expensive model training processes, which may weaken some of the calibration’s cost-saving impacts. Even the most reliable machine learning models can still hallucinate, too, so experts must verify the work periodically to ensure everything stays on track.

Some sterility sensor arrays are also not the most computationally complex systems. While that is good news for affordability and ease of use, it also means not all equipment has the hardware to support an advanced AI model. Consequently, implementing self-calibrating models can entail some costly upgrades. The resulting savings should compensate for the investment over time, but the initial expense remains a barrier for some labs.


AI Calibration Can Unlock New Standards of Sterility Assurance


While it may not be perfect, AI calibration shows a lot of promise. Labs that invest in it now and account for its shortcomings could make their sterility assurance processes more efficient, accurate and reliable than ever. AI is not a panacea, but it is a big step in the right direction.

Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

Friday, 27 December 2024

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/)

Tuesday, 30 July 2024

Cervical Cancer Vaccine in India - Which, When and How


 

In India, cervical cancer is a major health problem that results in a sizable number of deaths annually. It is the only cancer for which there is a vaccination, offering a vital line of defense against the illness. Leading Cosmetic Gynecologist and PCOS Specialist Dr. Shraddha Goel stresses how crucial it is to comprehend and use this vaccine in order to properly fight cervical cancer.

Prevalence of Cervical Cancer in India

Cervical cancer ranks second in terms of incidence and fatality rates among women in India. Approximately 67,000 women die from the disease each year, and over 1,22,000 new cases are identified annually, according to the latest statistics. These statistics show how urgently preventive steps, including vaccination, must be taken in order to lower the incidence of cervical cancer in the nation.

Understanding Cervical Cancer and the HPV Vaccine

Human Papillomavirus (HPV) infections that are high-risk, especially those types 16 and 18, are the main cause of cervical cancer. Globally, these two kinds account for over 70% of instances of cervical cancer. By focusing on these high-risk strains, the HPV vaccine stops infection and the subsequent growth of cervical cancer.

Who Should Get the HPV Vaccine?

It is recommended that women and girls between the ages of 9 and 45 get the HPV vaccine. Pre-adolescent girls (9–14 years old) are the main target group for vaccinations because the shot works best when given before HPV exposure. But older girls and women up to 45 years old who have never had a vaccination benefit from it as well.

Why Boys Should Also Be Vaccinated

While women are most affected by cervical cancer, HPV infection has also been connected to other diseases, such as male penile cancer. By focusing on the same high-risk HPV strains, vaccinations for young males can help prevent these malignancies. This broader vaccination strategy promotes herd immunity and lowers the overall incidence of cancers linked to HPV.

Types of HPV Vaccines Available in India

Gardasil

The quadrivalent vaccine Gardasil guards against HPV strains 6, 11, 16, and 18. About 90% of genital warts are caused by kinds 6 and 11, but types 16 and 18 are linked to cervical and other cancers.

Dosage Schedule for Gardasil

  • For girls aged 9-14 years: Gardasil is given in two doses spaced 6-12 months apart.
  • For individuals aged 15-45 years: It takes three doses; the first dose should be taken 1-2 months later, and the second dose should be taken six months later.

Cervarix

The goal of the bivalent vaccine Cervarix is to prevent cervical cancer by precisely targeting HPV strains 16 and 18.

Dosage Schedule for Cervarix

  • For girls aged 9-14 years: Cervarix is given in two doses separated by 6 months.
  • For individuals aged 15-45 years: It is necessary to take three dosages, the second of which should be taken 1 month after the first and the third 6 months after the first.

Gardasil 9

Nine HPV types are protected against by the nonavalent vaccine Gardasil 9: 6, 11, 16, 18, 31, 33, 45, 52, and 58. A greater proportion of HPV-related cancers are prevented because of this wider protection.

Dosage Schedule for Gardasil 9

  • For girls aged 9-14 years: 6-12 months separate the administration of the two dosages.
  • For individuals aged 15-45 years: It takes three doses; the first dose should be taken 1-2 months later, and the second dose should be taken 6 months later.

When to Get the HPV Vaccine

Pre-adolescent females are advised to get the HPV vaccine since the best time to do so is before they are exposed to the virus. But older women and girls who have never received a vaccination can still benefit from the shot. The vaccine window is wide, spanning from 9 to 45 years, therefore a sizable population can be shielded from cancers related to HPV.

How the HPV Vaccine Works

The HPV vaccine functions by inducing the production of antibodies against the virus by the immune system. The targeted HPV kinds can no longer infect a person because of these antibodies. By preventing new infections rather than treating current ones, the vaccination lowers the chance of developing cancers related to HPV.

Safety and Efficacy of the HPV Vaccine

Numerous clinical studies have shown the HPV vaccine's effectiveness and safety. It has been demonstrated to offer enduring defense against HPV infections and related cancers. Frequent moderate side effects include headache, fever, and injection site soreness. Rarely do side effects get serious.

The Importance of Public Awareness and Vaccination Programs

In India, vaccination rates and knowledge of HPV remain low despite the vaccine's effectiveness and availability. Campaigns for public health and educational programs are essential to raising vaccine awareness and promoting vaccination uptake. In order to increase vaccination rates and guarantee that more women and girls are shielded from cervical cancer, schools, healthcare facilities, and community organizations are essential partners.

Conclusion

The HPV vaccine is a potent weapon in lowering the incidence and mortality of cervical cancer, a condition that can be prevented. Cosmetic gynecologist and PCOS specialist Dr. Shraddha Goel promotes mass immunization to safeguard women's health and lessen the incidence of cervical cancer in India. Through being aware of the vaccines that are available, when to get them, and how they operate, people may make educated decisions and help ensure a healthier future. Vaccination is an essential public health measure since it not only prevents cervical cancer but also has wider benefits in avoiding other cancers linked to HPV.

About the Author

 

Dr.Shraddha Goel, MS DNB FICOG is the Head and Director of PCOSmetic Gyne Clinic, Jaipur. She has more than 16 years of vast experience in the field of Obstetrics and Gynecology. She is among very few gynecologists in Jaipur who is very well versed with antenatal and intranatal care of high risk pregnancy cases and care of Recurrent pregnancy loss.

 

Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

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