Package Inspection Products & Services

  1. Annex 1 Pharmaceutical Container Closure Integrity Testing Requirements 4/14/2023

    As the governing regulatory document of the European Medicines Agency (EMA), EU GMP Annex 1 discusses a full host of concepts related to manufacture of sterile medicinal products. In contrast to guidance documents issued by the FDA, EU GMP Annex 1 is interpreted as law, requiring strict adherence to the regulatory expectations contained, numerous of which allude to container closure integrity testing. In fact, current proposed and ongoing revisions increase the expectations of scrutiny on package integrity.

  2. 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.

  3. Used Optel Label Vision Inspection System: OP300 12/19/2024

    Used Optel label vision inspection system, model OP300, with label printer and handheld scanner, mounted on stainless steel table, 120 volts, system serial# OP6354-09.

  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. Global VersaWeigh and Global Versa GP 7/12/2016

    Improve efficiency and profitability with a checkweigher designed for better accuracy and faster speeds. The Thermo Scientific™ Global Versa GP Checkweigher is a versatile, general purpose checkweigher that scans at line speeds up to 350 packages per minute without ever sacrificing accuracy, and now it features more than 10 engineering and functionality improvements to reduce maintenance and cost of ownership. The Versa GP Checkweigher comes with a compact cantilever construction for height adjustment and is ideal for packages up to 3 kilograms (6.6 pounds).

  6. 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.

  7. High Voltage Leak Tester for Ampoules and Bottles 5/28/2015

    Integrity testing of pharmaceutical packages, e.g. plastic containers, has always been an important phase of the manufacturing process.

  8. Pharmaceutical Automated Sample Handling System For Headspace Testing 7/16/2024

    This collaborative automated sample handler eliminates manual sample handling enabling testing of large sample sets and collection of statistically significant data, while freeing analyst’s time. The FMS Automation Module has a sample capacity of hundreds of vials and can complete headspace testing with a throughput as high as 300 samples per hour.

  9. Low Profile Scale: PUA579 4/28/2022

    Low Profile – When the Height Matters
    The low overall height of 35 resp. 45mm makes the PUA579 low-profile scales ideal for floor installations with approach ramps - no costly pit installation!

  10. Combination X-Ray Inspection - Weight Control System: CX Combination 11/26/2024

    Combined high-precision weighing with advanced x-ray technology for a precise system that meets industry standards and your individual requirements. Easily mix and match the solution to fit your budget.