CCIT

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Lenox Laser is committed to ensuring the integrity of container closure systems in pharmaceutical and critical packaging. As part of this commitment, we adhere to the latest Container and Closure System Integrity Testing (CCIT) guidelines.
These guidelines, established by the FDA, recommend methods other than sterility testing to confirm container and closure system integrity. They apply to sterile biological products, human and animal drugs, and medical devices. Here are the key points:

Purpose and Scope:

  • The guidance provides recommendations for manufacturers.
  • It emphasizes using alternative methods to sterility testing for confirming container and closure system integrity.
  • These methods are essential components of stability protocols for sterile products.

Why CCIT Matters?

  • Federal Standards: Compliance with federal standards is crucial to prevent widespread damage to products and ensure public safety.
  • Reliable Testing: Companies need reliable methods to identify defects that compromise product integrity.
  • Calibration Assurance: Ensuring that machines detecting imperfections are correctly calibrated is vital.

What’s Lenox Laser’s Role?

  • Leak Detection Reliability: We contribute to the reliability of leak detection processes.
  • Calibrated Leaks: By intentionally introducing calibrated leaks using our products, pharmaceutical companies can monitor and verify that their systems meet quality standards.
  • Precision and Accuracy: Our proprietary laser drilling and flow calibration processes allow us to create orifices on a micron and sub-micron scale in various packaging materials.
  • Custom Solutions: We tailor our processes to accommodate specific requirements.

For inquiries about our capabilities or to request a custom CCIT job quote, feel free to reach out. Unsure about the orifice size you need? Check out our custom orifice calculator on our website.

Advancements in Microscope Calibration could Provide a Better Look at Viruses

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Microscopes reveal many things in the world of science, such as organisms and cells, giving us an up close and personal look at tiny lifeforms. Using new techniques, the accuracy of microscopes could be enhanced to view the cell makeup of a sneeze by studying the volume of micro droplets. This is done by methodically tinkering with the calibration of optical microscopes. Most importantly this new venture could give insight into how airborne viruses evolve and spread so rapidly. The National Institute of Standards and Technology (NIST) is spearheading the research, with measurements of volume being tested on samples that are 1e-11mL, around the volume of a red blood cell. With these optical microscopes, scientists can see the various dimensions and positions of droplets, within a potential tolerance of less than 1%. The method utilized to accomplish this is known as gravimetry which relates to the measurement of weight, giving them the ability to weigh droplets and see how much could fit into specially designed containers. Some of the test tools used were calibrated plastic spears to simulate the boundaries of an image once captured.

It was found that whenever the droplets landed on the surface the liquid evaporation trail could be used for study. It is not yet known how these images will be captured and what resolutions they will be. Focus and distortion were a couple of variables that were calibrated in the microscopes to improve the captured results. While this breakthrough is still in the initial stages, it is hoped that once perfected, we can have a more complete picture of diverse types of viruses, how they function, and how we can stop them in their tracks. This is an especially huge breakthrough that could end up being a great defense against coronaviruses. We wish everyone involved the best of luck on this ongoing research.

Click here, to read previous blog entries covering recent innovations.

Medical Innovation with Synthetic Hydrogel

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A group of scientists, engineers, and physicists at McGill University hope to improve the
recovery period from various surgeries with the use of a synthetic hydrogel biomaterial. The hydrogel
can theoretically repair muscles including heart tissue and vocal cords. The challenge was to make
biomaterial strong enough to be protective, while being able to withstand the body’s everyday
movements. The gel would work by creating a protective barrier around the surgical area, allowing
healthy cells to replicate within the organ as they typically would. If this biomaterial becomes fully
approved, it will be the first of its kind to exist.

Testing of this new synthetic is extensive and thorough. One of the key challenges was making
certain that the hydrogel would not lose its structure without inhibiting tissue growth. Liquids can be
very dense preventing cells from passing through. The team added a porous polymer that would allow
living cells to move freely around the healing area. Getting approval to use this gel would be a
monumental innovation for medicine. The hope is that it can be utilized in fighting a wide variety of
health concerns.


To read more from McGill, click here.
Click here, to read past blog posts about innovations.

New Pressure-Sensitive Wearable Medical Devices

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                Thanks to the evolution of technology, personally monitoring one’s health has never been easier. Products such as Apple watches to Fitbits have made it much more accessible. The variety of these devices can have endless possibilities from devices that measure vitals, weight loss, and the number of steps taken in a day. This has become another major part of the multibillion-dollar mobile technology industry.

Medical device technology continues to grow and change in making unique and effective ways to function. One of those iterations is wearable pressure sensor technology. With the slightest amount of pressure, doctors will now be able to read and see more of a person’s vitals than before. Materials like stronger elastics help make sure that the sensors not only function more efficiently but also last longer. Elastics can house mechanical elements such as wires and body sensors too. Some of the materials used have included adhesive pads for placing on the skin—these materials in the devices (cobalt chrome alloy, titanium, and stainless steel). Along with the sensors and monitors, gels are used known as hydrogels that can be applied to the skin and help measure body heat and the patient’s overall temperature and its own active biosensor. They can monitor blood pressure, pulse, and even vocal cord vibrations.

Creating these new fabrications also helps address medical teams’ many issues, such as moisture from the body, disrupting the sensors to water evaporation, and structural damage. These innovations can give physicians the ability to measure every critical aspect of the patient’s body, both internal and external, giving doctors the freedom to remotely help their patients.

               Behind this innovation is the Terasaki Institute of Biomedical Innovation. They believe giving patients a more convenient and affordable option, such as these sensors and devices, could drastically impact medical care in the future.

If you would like to read more, you may click here or here for more information.