The pharmaceutical industry has very stringent quality requirements on parenteral containers. Many biotechnological medications, highly viscous or low-dosage drug formulations, and oncologic and ophthalmologic medications make high demands of primary packaging components. Packaging injectable solutions on the market should be free of particulate contamination.
Meeting pharmaceutical regulations
As regulatory expectations increase, drug product manufacturers or contract packagers face increased pressure to prevent defects and minimize rejects of finished drug products. Particulate matter in finished pharmaceuticals can come from a number of sources, including the container closure system.
Primary packaging components, the parts in direct contact with the drug, are the following;
- Glass products as vials, bottles, syringes, ampoules & cartridges
- Rubber components like stoppers, plungers, tips caps, seals and needles shields
Contamination and imperfections of these components are a source of risk and can cause end-of-line reject.
Improving quality with visions inspected components
Top-of-the-range pharmaceutical component suppliers supply 100% automatically vision verified products, free of visible defects and contamination. This reduces end-of-line rejects and enhances product quality and patient safety.
The machine vision systems provide imaging-based automatic inspection and analysis for such applications as automatic inspection and process control. Cameras are used to capture the image data from the examined closure. This can be provided on a HMI and stored in a database according for further process analyses. Digital interfaces are to prefer for connecting to existing production management tools.
100% vision inspection can detect “visible” defects even when less than 50 um in size. The high-end systems available can even detect invisible defects, like metal particles that are embedded in the elastomeric rubber material of the closure. Also X-ray techniques are used to inspect e.g. needles already placed inside a shield.
Choose systems that are designed, engineered and built in house according to GMP standards. As an alternative integrate machine vision expertise in existing product lines. This in case when space is limited or specific integration is required.
Provider of bespoke systems should have experience in life sciences areas and typically capable of dealing with ISO-5 or ISO-7 cleanrooms.