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.

Visit us at PACK Expo 2021 in Las Vegas

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The annual PACK expo is making a triumphant return to Las Vegas live and in person September 27th to the 29th at the Las Vegas Convention Center and Lenox Laser could not be more excited to attend this event. There are so many amazing highlights this year including a dedicated packaging robot which is the first of its kind by Schubert Group, industry first early 1900s liquid filling machines, and the innovative gluing machine that was sold to Abbott Labs in 1937. A variety of manufacturers will be on hand from all areas of the packaging industry. From Coca-Cola, to pharmaceutical, to candy companies, they will all be there showing those in attendance the latest and greatest innovations in packaging and product innovation. Learn about maximizing profits to get the best out of the product and audience that they sell to. In person workshops and live demonstrations will be happening to give a first-hand account of what goes on behind the scenes to give consumers the products they hold tried-and-true in their everyday lives. While there, you can learn about cost-effective digital printing solutions for any packaging business.  

For our part of the expo, Lenox Laser will be excited to show guests our Container Closure Integrity Testing (CCIT) methods in a live talk and demonstration session taking you through the various stages of packaging testing that we do on a weekly basis. Our CCIT methods allow us to laser drill calibrated microleaks to test the durability of critical packaging and containers. We drill a wide variety of metals, alloys, plastics, glass, and composites. We test under many different conditions, whether open or closed, sealed or not. The utmost care and safety standards are delivered to our customers every time. 

Look for us at booth number 6817 as we proudly show you just one of our company’s many services held in high esteem for over 40 years now. We are excited to be a part of this massively popular show within the packaging industry and we sincerely thank all involved at PACK for having us as a guest speaker, we will be thrilled to see you there. 

Click here to visit the PACK Expo site for more information.

To join Lenox Laser at the event, register to attend, here.

Join Lenox Laser at 2021 PACK EXPO

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The 2021 PACK EXPO will be one of the first major in-person healthcare product events since the COVID-19 lockdown last year. The expo will encompass many different companies and experts in the healthcare field discussing various packaging and processing methods. It is estimated that over 20,000 experts will be in attendance when the event takes place this September 27-29 at the Las Vegas Convention Center. PACK is expected to have an estimated 1,500 exhibitors showing off their products. Topics covered will include cost-effective digital printing solutions in pharmaceuticals, recyclable, and bio-based packaging. The expo will also have an exhibit that will take visitors through the evolution of processing and packaging in the pharmaceutical industry and more. The expo sponsors and hosts include the Reusable Packaging Association, the National Confectioners Association, and many more.

Lenox Laser will be in attendance at booth #6817, showcasing our Container Closure Integrity Testing (CCIT) methods and services, which we have continued to evolve in our excellent 40 years in business. We are privileged and very honored to be a part of the expo and cannot wait for you all to see what we have in store. Given the immense challenge 2020 presented, an event like this will prove significant. To all those attending and showcasing, we hope you enjoy the expo and send our best wishes. See you in September. 

For more information and registration on PACK EXPO, please click here. You can join Lenox Laser at PACK EXPO using our comp code here.

A Look into Our CCIT Capabilities

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Picture of Pharmaceutical Vials
Courtesy of National Cancer Institute

As the pioneer in laser drilling, Lenox Laser takes pride in the various services that we provide to our customers. In light of the COVID-19 pandemic, the importance of Container Closure Integrity Testing (CCIT) has become abundantly clear. Confidence in pharmaceutical packaging is vital to prevent widespread damage caused by the failure of critical seals. Lenox Laser assists in this process by producing standards that calibrate leak-detection systems in order to assure the quality and safety of the packaging.

By utilizing lasers, Lenox drills precise, microscopic imperfections in a wide variety of packaging. Our systems are capable of drilling metals and alloys, glass, plastics, and more. We can accommodate custom materials and requirements upon request. All orifices drilled for CCIT are calibrated to NIST secondary standards using our proprietary flow calibration processes, ensuring precise measurements. Recalibration services are also available to ensure the accuracy of previously drilled parts. Our standard products are optically measured, but when a greater level of accuracy is required, Lenox Laser can drill orifices to produce a specific flow rate for custom applications. Calculate a custom orifice diameter based on your specifications with our orifice calculator.

On top of CCIT, Lenox Laser provides other services such as laser machining, laser engraving, and more. Lenox Laser also offers standard products for optical and flow applications. For any questions you have about our capabilities, please contact us.

We thank our customers for their continued support over the past 40 years. It is with your help that Lenox Laser continues pioneering in the small-hole industry.

Innovations in Pharmaceutical Manufacturing

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              With the vaccine for Covid-19 arriving late last year, people are now starting to see a glimmer of hope for the future. The challenge now is keeping up with demand in several markets because there are currently shortages. According to a report recently released by the Washington Post, as of the time writing this, approximately 20.3 million people have received doses of the vaccine. However, all over the world, vaccine distribution is moving at a desperately slow pace. This is what started the idea of using multi-product facilities to speed up the production and distribution of the vaccine as quickly and safely as possible. The first step to this needing to be conquered is updating outdated facilities and equipment. Grand River Aseptic Manufacturing (GRAM), a contract-based manufacturer of sterile injectable drugs based out of Grand Rapids, Michigan, is stepping up to aid in this goal.

              One of the significant parts of this initiative is to create massive facilities that are top-of-the-line with the most advanced equipment possible, bringing these facilities into a new era of prosperity. When the virus started, it has been a massive time crunch ever since to get to where we are today. Billions of dollars have been spent on creating and distributing this vaccine. Having updated facilities and converting as many areas as possible to allow it, GRAM believes, could reduce costs and spare precious time. The company is investing in other businesses to bring this innovation to them.

              GRAM will invest in equipment to prevent cross-contamination and improve safety and health protocols and flexibility for all parties involved. As the world’s current state has been in, it is a true marvel to see just how far the medical community has come with innovations, technology, and sustainability.

If you would like to read more about the future of the pharmaceutical industry, please click here.

Laser Technology and Its Applications in Today’s Market

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Some of the most innovative companies in the DelMarVa area came together at Lenox Laser for a recent conference discussing the theme “Micro-to-Nano” technologies. The conference included talks on a range of topics, including Nanotechnology, Pharmaceutical research, Rapid Prototyping, and Laser Drilling.

John Bishop of Norsam Technologies addressed conference attendees on the topic of Ion Beam drilling. Visitors from Northrop Grumman and other local corporations reviewed digital presentations on Nanostructures, MEMS manufacturing, Advances in Laser Drilling, and Microlensing.

The wide overview of current techniques and new ideas provided an excellent forum for group discussions as innovators met manufacturers in this unique scientific environment. Lenox Laser plans to host future collaborative conferences focusing on subjects such as Rapid Prototyping and Micro-fluidics.

Do You Need Microleaks in Food or Drug Packaging?

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The Lenox Laser Corporation of Glen Arm, Maryland, has mastered several processes unique to the food, drug and pharmaceutical industries. Lenox Laser has created traceable flow rate validation techniques in a wide range of materials and products including bags, cans, bottles, vials, ampoules, etc. We feature both short and long run leak testing processes. For more information, call Bob Gidner, senior flow engineer, at 410-592-3106 or email engineering@lenoxlaser.com