Showing posts with label sterility assurance. Show all posts
Showing posts with label sterility assurance. 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/)

Sunday, 1 December 2024

Introduction to sterility assurance (video)


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

Monday, 14 November 2022

Comparison of radiation methods for the sterilisation of cleanroom items


 

Many items entering cleanrooms, especially aseptic processing facilities, are required to be sterile. Sterilisation by an ionising radiation source is the most common way of achieving sterility and is used for cleanroom garments as well as for plastic items intended for single use, such as sampling containers, aseptic connectors, biocontainer bags, and mixers. For several decades, Gamma radiation was the standard method for the irradiation of cleanroom consumables. In more recent years, both electron beam and X-rays have been added as ionising radiation methods for the processing of cleanroom items.

 

 

The increase in use of these latter technologies is evidenced by change control notifications from cleanroom product companies indicating a move away from Gamma radiation to these alternative radiation sterilisation methods (primarily electron beam but sometimes X-rays). The shift away from Gamma is because the process of radioactive decay utilises costly isotopes which require periodic replacement (typically five years) and because international transport for radioactive materials has become far more difficult.

 

This article looks at the similarities and differences between the three types of irradiation sterilisation technologies commonly used to irradiate items going into the cleanroom: Gamma, E-beam, and X-ray.

 

Sandle, T. (2022) Comparison of radiation methods for the sterilisation of cleanroom items, Clean Air and Containment Review, Issue 47, pp20-23

 

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

Saturday, 27 August 2022

Revised Annex 1 is out - and here is the link

Here is the link to hge revised Annex 1 (The Rules Governing Medicinal Products in the European Union Volume 4 EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use): https://health.ec.europa.eu/system/files/2022-08/20220825_gmp-an1_en_0.pdf

The implementation date for most parts is August 2023.

 

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

Monday, 16 May 2022

Alternative method for sterilisation: X-rays



Compared with gamma, X-rays used for sterilisation have the highest potential penetration depth in a product. This advantage is off-set by the few number of X-ray generators available and less product validation or compatibility data being available. While the decontamination of products and materials with high-energy X-rays was developed during the 1970s, the first application of the technology for sterilisation (medical devices) did not begin until the early-2000s. 

 

 

The lower take-up may be about to change since interest in X-rays for sterilisation has increased in the 2020s following advances with higher beam power ratings of industrial electron accelerators. Along with e-beam and gamma radiation, three related-yet-different technologies are available.

 

Reference:

 

Sandle, T. (2021) Alternative method for sterilisation: X-rays, Staxs article, https://hubs.li/H0_LGcf0

 

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

Monday, 11 October 2021

Prefilled Syringes: Best Practices For Using X-Ray Analysis To Assess Container Closure Integrity



 

The presentation of pharmaceutical preparations in the form of prefilled syringes continues to grow. The addition of drugs in prefilled insertable and disposable cartridges is driven by manufacturing economics (including the avoidance of overfill, common with dispensing into vials, which saves on product yield); clinical preference, including better accuracy of dose delivery and avoiding the cross-contamination that can occur with a separate syringe and vial; and an expansion of medications that can be self-administered by the patient in the home. The syringe plays a dual role in the prefilled syringe product — as a container closure system and as a delivery device.

 

 

Prefilled syringes vary in terms of their method of manufacture, method of filling syringes with a drug product, and the types of syringes available. Several variations are required due to product incompatibility in particular drug combinations and material types. Products in prefilled syringes must be chemically, physically, and biologically stable and, based on the route of administration, the combination product must be sterile and apyrogenic. Product manufacturing requirements are set out in the ISO 11040 standard, such as Part 8, which presents the “Requirements and test methods for finished prefilled syringes.” One important aspect of assessing prefilled syringes relates to the integrity of the filled syringe. The process of assessing integrity is generally more complex than the process of assessing glass vials due to the presence of more sealing areas. This article looks at the broad requirement, together with a recent innovation for integrity testing based on X-rays.

 

Reference:

 

Sandle, T. (2021) Prefilled Syringes: Best Practices For Using X-Ray Analysis To Assess Container Closure Integrity, Pharmaceutical Online, 18 August 2021; https://www.pharmaceuticalonline.com/doc/prefilled-syringes-best-practices-for-using-x-ray-analysis-to-assess-container-closure-integrity-0001

 

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

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