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/)

How Calibration and Regular Maintenance Ensure Accurate Pharmaceutical Testing

 Cleanroom calibration (designed by Tim Sandle)

Pharmaceutical testing is a critical quality control step that ensures the produced products can withstand specific activities and will perform as patients expect. Friability testing examines tablets’ strength, verifying that they will not break or crumble during transport or handling. Drug assays reveal whether the strength of active ingredients in a tested sample matches its label. Performing these tests and others on the required schedules allows pharmaceutical manufacturers to operate within regulatory requirements.

 

By Emily Newton

 

However, the testing equipment must be properly calibrated and maintained for reliable results. Maintenance and calibration-related shortcomings can have far-reaching effects that disrupt operations and cause the affected companies to receive unwanted scrutiny.

Calibration and Maintenance Flagged by Inspectors

Pharmaceutical companies are in a tightly regulated industry, which means periodic checks occur to confirm that the entities follow all required procedures. When inspectors visited the New Jersey site of an American multinational pharmaceutical company, they found eight problems, including some related to the calibration and maintenance of equipment.

 

More specifically, the inspection report showed some of the plant staff who tested its products did not have adequate training. Since knowing how to perform a test means understanding when and how to calibrate the associated equipment, the lack of role-related education could have serious consequences. Additionally, inspectors discovered stability samples were missing for some drugs, suggesting workers did not perform them on the appropriate schedule.

 

Another testing-related issue was that problems associated with the company’s electronic data-tracking system left test information open to tampering. In any case, when maintenance and calibration do not happen as required, people cannot trust that the results are accurate.

 

Inspectors want to see that the parties handling the calibration, testing and recording of the outcomes have the proper training and that all steps have occurred consistently and at the right times. Otherwise, all the results could become untrustworthy, making it impossible to ensure the safety of those taking the affected drugs.

Sensors Installed to Maintain Consistency

Pharmaceutical companies often rely on sensors to maintain consistent conditions in demanding environments. The sensor data can also alert workers to an abnormality that could render test results inaccurate. For example, nitrogen is a carrier gas used with some chromatography testing equipment. The pharmaceutical industry typically uses a type with a 99.99% gas concentration, marketed as ultra-high-purity nitrogen. If the gas is less pure for any reason, an alert is necessary.

 

Pharmaceutical tests need specific environments and correctly calibrated, well-maintained equipment to achieve accurate results. Fortunately, connected sensors can generate notifications when they encounter unusual conditions or reminders for maintenance. Some sensor equipment also connects to recordkeeping platforms, registering when individuals perform particular steps.

 

Even highly observant pharmaceutical factory workers cannot manually check all environmental parameters. However, sensors can work in the background and alert staff when readings fall outside of preset parameters.

 

Similarly, sensors can verify when machines are correctly calibrated, eliminating or reducing many of the manual checks. Even the most observant workers sometimes get tired or become distracted. Strategically deployed sensors increase awareness, so poor calibration or inadequate maintenance cannot disrupt the production environment. Some pharmaceutical executives already use sensors for supply chain monitoring. This decision can halve associated costs, making it worth pursuing.

Automation Used to Reduce Manual Work

Many pharmaceutical decision-makers have realized automated technologies are essential for helping calibration and testing go more smoothly and efficiently. One reason automation is so beneficial is because it boosts productivity by handling many of the steps workers formerly did manually. Additionally, automated sensors with predictive algorithms measure machine operations in real time, detecting abnormal vibrations, temperatures out of an acceptable range or other unusual details.

 

Some businesses also use robots to test injectable drugs, such as verifying the volume of the delivered medicine or the force a patient must apply to remove the injector’s safety cap. Since robots excel at repetitive tasks, they are ideal for these quality control verifications. Also, people who formerly oversaw manual tests can reskill to set up and supervise the automated testing equipment. Then, there is a reduced likelihood of testing mistakes that degrade accuracy.

 

Moreover, sensors that automate calibration give people more confidence in their results. One example measures pH and automatically performs a standard calibration before transferring all the associated data to the process control system. That approach creates a reliable audit trail and shows that the pharmaceutical company has prioritized recordkeeping. Additionally, when calibration requires adjusting the machine, the necessary steps always occur in the same sequence.

 

Leaders in other industries — such as oil and gas — have used robots to check equipment and take readings for validation. Applying that option to pharmaceutical facilities could save time while ensuring accuracy because there is a lower chance of humans accidentally contaminating the environment when they take measurements by hand.

Accuracy Solidifies Trust

The pharmaceutical industry is highly competitive and tightly regulated. Patients, those who prescribe medications and other stakeholders must trust that the products made within this sector are safe and effective. Well-maintained, carefully calibrated testing equipment fits leaders’ quality control goals while bolstering brand reputation and loyalty.

 

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

New edition of ISO/IEC 17025

News in from the International Standards Organization: ISO/IEC 17025: 2017 has is available.

ISO/IEC 17025:2017, General requirements for the competence of testing and calibration laboratories, is the international reference for laboratories carrying out calibration and testing activities around the world.

Producing valid results that are widely trusted is at the heart of laboratory activities. ISO/IEC 17025:2017 allows laboratories to implement a sound quality system and demonstrate that they are technically competent and able to produce valid and reliable results.

ISO/IEC 17025 also helps facilitate cooperation between laboratories and other bodies by generating wider acceptance of results between countries. Test reports and certificates can be accepted from one country to another without the need for further testing, which, in turn, improves international trade.

In order to reflect the latest changes in market conditions and technology, the new edition of the standard encompasses the activities and new ways of working of laboratories today. It covers technical changes, vocabulary and developments in IT techniques and takes into consideration the latest version of ISO 9001 on quality management.

What are the main changes in the 2017 version?

• The scope has been revised to cover testing, calibration and sampling associated with subsequent calibration and testing.
• The process approach now matches that of newer standards such as ISO 9001 (quality management), ISO 15189 (quality of medical laboratories) and ISO/IEC 17021-1 (requirements for audit and certification bodies).
• The standard has now a stronger focus on information technologies and incorporates the use of computer systems, electronic records and the production of electronic results and reports.
• A new chapter introduces the concept of risk-based thinking.

See: ISO

   Posted by Dr. Tim Sandle

Should You Try New Approaches to Instrument Calibration?

Validation and instrument calibration are a necessity in every manufacturing and production unit. Calibration procedures have witnessed some changes and new techniques have been introduced. New approaches such as instrument diagnostics and calibration analysis have significantly improved efficiency. Read on to know more.

What is INSTRUMENT DIAGNOSTICS?

It is essential that instruments and devices used in your company are routinely calibrated to ensure that you get accurate measurements. However, it should be noted that not all instruments need to be calibrated at the same time or with the same frequency. Instrument diagnostics is the practice of analyzing the level of calibration different instruments require and which instruments can be shifted from periodic schedule to on-demand calibration.

While some devices have to be calibrated periodically without fail, the less critical instruments can be monitored carefully to observe if they indicate any change that needs immediate attention, which then should be calibrated as per requirement. On-demand calibration will eliminate hundreds of unnecessary calibrations per year. Instrument diagnostics ensure that efficiency is increased by folds, without compromising on the quality.

How Does PAPERLESS CALIBRATION Benefit You?

Calibration was a manual process and so was documenting. With automation, it became possible to achieve paperless calibration where the data pertaining to calibration can be recorded, stored and documented electronically. Paper is completely eliminated which helps in saving money.

The calibration process can be significantly streamlined by optimizing periodic calibration schedules, synchronizing instrument data in the calibration management system and using documenting calibrators. Paperless documentation allows technicians to access the required information and upload calibration results from any location, at any time. Further, it eliminates the necessity for administrative technicians and staff to manually fill out the data which usually takes a lot of hours. Needless to say, paperless calibration is faster, efficient and streamlined.

What is CALIBRATION ANALYSIS?

If possible, the interval between calibrations can be extended to reduce the overall number of procedures that are performed annually. These extensions are done in a manner that they remain in compliance with company regulations and policies. Calibration analysis identifies those instruments that don’t need to be calibrated as often as the others. This is achieved through an on-going, computer-driven analysis of the available historical data.

Calibration analysis includes safety and quality related instruments which need to be calibrated on a schedule but it has to ensure that the calibrations are done on the right schedule. It doesn’t matter if you calibrate some instruments on a yearly basis instead of calibrating every six months, but you have carefully monitor and check if they are performing as designed without compromising or affecting the quality between calibrations.

Results of Practicing New Approaches of Calibration

A number of critical instruments were observed to study if they showed any tendency to under-performed when the calibrations intervals were extended. All the product-related instruments were studied and depending on the result, they were moved into the ‘on-demand’ schedule. It was ensured that none of the instruments were over-calibrated or under-calibrated. Instrument calibration and diagnostics showed promising results and an increased efficiency by facilitating the following:

Reduced the time spent per calibration by at least 15 minutes, which equated to hundreds of hours saved per thousands of calibrations

Thousands of sheets of paper were saved per year
Over 200 hundred calibrations eliminated every year by extending calibrating intervals

A minimum of 500 hours saved per week due to elimination of manual data entry

Reduction in human errors

At least 30% of instruments (not related to safety and quality) shifted from scheduled calibration to an on-demand schedule, annually saving up to approximately 300 hours.

Author Bio:

Edward Simpson is a seasoned Calibration and Technical Engineer working for RS Calibration Inc. Edward has a knack for finding faults in machines and does not rest until they are rectified to perfection. He lives in Pleasanton, CA and can be contacted anytime for matters related to machines on his email edward@rscalibration.com. He also invites people to visit his company www.rscal.com to learn more about the type of calibration work he does.

On-line calibration reference book

The company Vaisala are offering a free on-line ebook in relation to the calibration of equipment.

The introduction to the book explains its purpose:

“This book was written to help the readers with the measurements they perform. The intent is to help the readers and their organizations determine the most appropriate activities that ensure the quality of their measurements. We hope this book provides the readers with a framework in which to place their own activities.

This book serves as a generic introduction to calibration. We discuss the rationale behind calibration, and the factors that affect the need to calibrate. The book also provides some specific information on calibration of relative humidity, dewpoint temperature, temperature, and barometric pressure.”

To access the book, go to Vaisala

Posted by Tim Sandle