Positive controls for container closure integrity testing (CCIT)

In the field of container closure integrity testing (CCIT), positive controls, otherwise known as artificial leaks, or simulated leaks, are critical in helping qualify leak test equipment, confirm MALL (Maximum Allowable Leakage Level) and LOD (Limit of Detection) factors, and validate die ingress and microbial ingress programmes. Positive controls aim to simulate natural defects found in real situations and environments.

OpTek is a full service, one-stop-shop for all types of positive controls, including:

  • Laser drilling
    • Able to drill all materials down to a few microns
    • Glass: Tubular glass (ampoules, vials, pre-filled syringes, cartridges), moulded glass
    • Polymers: IV bags, PP/PE bottles, BFS plastic ampoules, COC/COP vials, etc
    • Others: Aluminium blister packs, API metal containers, food packaging, packets, cans, etc
  • Orifice plates
    • Provision of orifice plates with holes down to a few microns
    • Plate material (glass, metals, polymers, ceramic) and thickness (0.02-2mm) can be customized to better mimic real containers
  • Micropipettes
    • Individually tested, with tip diameters ranging from 0.1 micron to more than 20 microns
    • Customizable tip diameter, taper length, and taper geometry
  • Capillaries
    • Variety of sizes, can be supplied pre-cut and pre-measured, or in bulk
    • Proprietary laser cutting option available for increased precision, eliminating glass debris and chippings that may block hole
  • Wires
    • Provision of wires with diameters 10 microns and above
    • Variety of wire materials available

Key value added

  • Provision of CoC (Certificate of Conformance) to validate defect size
  • Strong knowledge of leak detection and experiment techniques (dye ingress, microbial ingress, vacuum decay, high voltage, helium etc). Able to work closely with customers to recommend the most suitable positive control type, simulation location, and sample quantity based on experiment and product type
  • Services: Capillaries and micropipettes can be inserted into the container (neck, body, bottom, etc), sealed, and tested on behalf of customers
  • Local manufacturing in Europe, North America, Asia, enabling fast turnaround

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