Package Inspection Products & Services

  1. Inspection Technologies 8/30/2021

    With an extended portfolio and a wide expertise in advanced inspection technologies, we can deliver flexible inspection solutions at any stage of the product journey; from lab development to high volume production.

  2. Pharmaceutical Mass Extraction Vacuum Leak Testing Equipment For Vials And IV Bags 8/3/2021

    Our USP <1207> and ASTM (F-3287-17) recognized Mass Extraction Technology works on the principle of rarefied gas flow. Testing takes place in vacuum conditions to attain higher sensitivity. This patented technology type of testing is particularly suitable for pharmaceutical packaging such as IV bags, pouches, or glass vials. Larger defect and defects as small as 1 μm can be detected with this method. The technology is thereby suitable for laboratory applications as well as for the use in production environment allowing stability control as well as automated 100 % testing (also in inline machines).

  3. Optical Emission Spectroscopy Equipment For CCIT 8/3/2021

    Our patented O.E.S. (Optical Emission Spectroscopy) method does not require any specific tracer gas. Instead, the gas mixture present in the container headspace of the primary packaging is used to perform high sensitivity tests with high throughput. A multi-gas sensor is used to independently track the different gases (i.e. argon, nitrogen, CO2, humidity,…) escaping from a leaky container exposed to vacuum. Our method is non-destructive, deterministic, easy to use and to set up, faster and has higher sensitivity than other conventional methods. O.E.S. is able to detect down to 0.2µm defect size on glass containers which corresponds to the sterility barrier defined as the MALL (Maximum Allowable Leak Limit) in the USP<1207> guidelines.

  4. Container Closure Integrity Systems For Pharmaceutical Drug Packaging 8/3/2021

    While in the early development stage of packaging, the supplier is obliged to ensure that the packaging is by design capable of ensuring sterility. Therefore, the packaging must to be tested for defects in the range of 0.2 µm, respectively 6 * 10-6 mbar*l/s („maximum allowable leak level“; MALL). Based on a study from Kirsh, this is the defect size where the microbial ingress failure rate is 0 %. Integrity tests are mainly performed in the range of 2 to 20 µm defect size. The main reason for this is the feasibility of the available methods to detect smaller defects in a reasonable test time. When dealing with 100 % inspection of the production line that operates at speeds for 120 to 600 parts per minute, the allowed defect size is sometimes even increased to a significantly higher level. To compensate on the risk-based approach, additional off-line sample testing is performed to a tighter specification in the range of 1 to 10 µm. This also applies to stability testing which is performed in laboratory tests. Here again the sensitivity is more important than the test time.

  5. Vision Inspection System For IV Bags 4/28/2021

    The new automatic high-speed bag inspection machines are specially designed to treat soft IV bags. These machines are the ideal solutions to ensure parenteral products are essentially free of foreign particles that can affect their sterility.

  6. Pharmaceutical Vision Inspection System For Parenterals 4/27/2021

    The LYNX automatic inspection machines are specially designed for particles and cosmetic inspections of LVPs (Large Volume Parenterals) in both glass and plastic containers.

  7. Pharmaceutical Vision Inspection System For Syringes: A&V GS 4/27/2021

    The A&V GS automatic inspection machines are designed for particles and cosmetic inspection of pre-filled syringes. The versatility of these machines allows to inspect water-like and viscous products.

  8. Pharmaceutical Vision Inspection System For Ampoules, Vials, and Cartridges: A&V 4/26/2021

    The A&V automatic inspection machines are designed for particles and cosmetic inspection of ampoules, vials, and cartridges.

  9. Pilot Scale/Laboratory High Voltage Leak Detection System For IV Bags 4/14/2021

    Inspect critical areas with our leak detection system.

  10. High Voltage Leak Testing Feasibility Testing 4/14/2021

    Nikka Densok USA offers complimentary feasibility testing for your CCIT project. Whether the need is for stability testing or initial inspection capability, Nikka’s HVLD systems are here to support your CCIT needs.