Monitoring laser power in laser-based fill & finish biopharmaceutical systems

Case study

Application: Laser-based fill & finish systems for biopharmaceutical products

Measurement type: Laser power measurement

Customer goals

COVID pandemic or not, the global demand for vaccines won’t stop anytime soon, and with medical safety norms being constantly challenged to be of the highest standard, filling processes for biopharmaceutical products play a crucial role.

The customer uses innovative laser-based fill and finish systems for the biopharmaceutical industry. More specifically, one of the automated systems they use fills vials with a biopharmaceutical compound, such as a vaccine, and then seals it with a laser beam.

The vials are sealed thanks to a photochemical reaction caused by a low-medium power near-infrared laser. The laser is fired for about just 3 seconds, after which it moves on to the next vial. They know from their past research and experience that the energy delivered in this short burst is enough to cause the photochemical reaction to occur. Therefore, by monitoring the average power of their laser, they can know for sure whether the reaction has been successful.

Because the customer operates in the biopharmaceuticals industry, they are under considerable governmental scrutiny, and so their products and methods must be of the highest standards. Just a simple gap or oversight in their processes can cause substantial damage: most importantly, the human cost, for example, should the vials get contaminated because of an improper seal, but also the financial cost, for example, the lawsuits that may follow.

There’s simply no room for error for them, so their lasers must work as expected at all times. How can they ensure this is the case? Well, this is where Gentec-EO’s laser beam measurement experts come in. Keep reading below.

Challenges

Multiple challenges are coming from this laser application.

First, there’s the fact that the laser shot lasts only about 3 seconds. To have a proper laser power measurement, we need to go for a solution with a rise time that is shorter than that, so that when we reach the 1-second mark, the measurement signal should already be maxed out, preferably.

Second, the solution is to be integrated into their system, therefore it should be as compact as possible, and yet it should be able to handle safely the expected power level (which is a double-digit value), and that, without any kind of forced air or water cooling.

Third, the proposed meter that will be paired with the laser power detector has to be tuned to return the measurement at the 3-second mark precisely: not before, not after. This is because the customer wants measurements taken in the same conditions, so customized firmware with a custom-tuned measurement sequence has to be considered for that.

The fourth challenge is measurement instrument calibration and documentation in a general sense. As is common for customers using lasers in the medical or biopharmaceuticals sector, they are required to have a solution calibrated at a very specific power level, which is not the one that we usually go for, so we will have to adapt our calibration setup accordingly. They also requested a calibration at the specific wavelength that their lasers use.

That’s certainly a challenging situation, but Gentec-EO has dealt with similar challenges many times in the past. Let’s see what solutions our experts came up with.

Gentec-EO’s solutions

One of our greatest strengths at Gentec-EO is our willingness to develop custom products for customers. There are no lasers too exotic or too powerful for us to measure.

We proposed two custom solutions for them, which were based on our UP12E-20H-H5-D0 thermopile-based laser power detector and P-LINK (RS-232) PC interface.

1 - The custom UP12E-20H-H5-D0

The standard UP12E-20H-H5-D0 is a thermal detector for laser power measurement up to 20 W. It offers a fast rise time of only 0.3 seconds and has a high damage threshold of 36 kW/cm².

Overall, this customized UP12E-20H-H5-D0 is similar to the original model, but with some necessary adjustments:

• The default wavelength is set to their desired wavelength (a value between 800 nm and 1000 nm)
• The calibration certificate is also modified to show the calibration at their specific wavelength, for compliance requirements
• The laser power detector is calibrated at its specific power level, which is a value higher than the usual 8 W at which we calibrate for UP12E-20H-H5-D0
• The cable type and length are also customized to meet customer’s requests.

While most vendors only sell standard products and walk away from anything that requires customization, Gentec-EO’s adaptability is what made this project possible for the customer.

2 – The custom P-LINK (RS-232)

The P-LINK (RS-232) is a PC interface for laser power measurement with an RS-232 output. This interface supports serial commands, which means the customer can integrate it seamlessly into their own software, which controls not just the detector, but the overall machine around it.

The customized P-LINK (RS-232) developed for this customer comes with special firmware that sends the measurement (and only 1 measurement) after exactly 2.8 seconds. This is unlike our other power meters, which return the power measurement continuously, multiple times per second.

The combination of these customized UP12E-20H-H5-D0 laser power detectors and P-LINK interface devices was exactly the right solution because it is tailored to the customer’s needs.

Results

The solution provides many advantages to the customer that our competitors may have not been able to comply with:

• Quality control: The proposed solution comes with the best accuracy on the market, which ensures that they can trust the measurements, and will know if something is wrong with the laser in their system as soon as it happens. This manifests as cost and waste reductions for them.
• Calibration: The proposed solution is calibrated exactly at the power level that they have requested, which is the one that they use at all times during their normal operations. It reassures them that they are not compromising at all on the performance and accuracy of their measurements.
• Compliance: They have governmental norms and regulations to comply with, and that requires them to have a solution calibrated at a specific power level, so again, they can rest assured that they won’t get any regulatory problems down the road. We also listened to any other requests that the customer had regarding what should appear on the custom product specifications sheet, which included that we show clearly all compliance standards that the detector fulfills, again so that they don’t run into any legal trouble.
• Cost savings: Every vial that the laser seals with the right amount of power is one less potential vial that would have to be thrown away if they didn’t monitor laser power. They also prevent, at the same time, unforeseen consequences, such as potential lawsuits (for example, if it was ever found that the vials were not sealed properly and that patients were harmed by contaminated biopharmaceuticals).

The customer purchased hundreds of units over the past few years. Gentec-EO continues to work closely with the customer to provide quality support to the customer’s staff when needed and help with other laser beam measurement needs.

Let us help you achieve results

Gentec Electro-Optics specializes in laser beam measurement and analysis. With an outstanding 50-year track record of innovation, developing and providing state-of-the-art technologies to the laser market, Gentec-EO has become The Expert of the laser beam measurement field.

Gentec-EO offers the broadest range of off-the-shelf and custom laser beam measurement solutions. Challenge us with your laser specs and system requirements and we'll come up with the measurement solution that meets your needs.

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