The two most important critical process quality attributes in a glass container handling process are maintaining the sterility of the containers and the indemnification of foreign particle absence within a closed container.
In order to meet these demands, WILCO of Switzerland has, besides its offering of various leak detection technologies, also developed a foreign particle detection system based on X-ray. “This allows for the first time ever detecting non-visible particles in lyo cakes and in suspensions at speeds of up to 400cpm,” states Dr Heino Prinz, head of WILCO’s research and development department.
Usable for vials, ampoules and syringes, the key elements of this development are:
- Particles can now be detected in lyo cakes after the lyo process
- Non-visible particles inside the lyo cake and inside a suspension can now be detected like visible particles outside
- Possible for metal, glass and many other particles
- Bubbles do not cause false rejects, since these are practically invisible
- Modular design, allowing integration of the technology into the FINAL QUALITY machine platform or use as stand-alone technology
- Using a low-energy radiation source ensures the product integrity
- Combinable with CCI and cosmetic inspection
“By now WILCO already is working with several major US and European-based pharmaceutical companies to explore this exciting new development to its full potential, so it can be used to help make pharmaceutical manufacturing even safer,” states Gerhard Schramm, WILCO’s sales director.
This X-ray-based foreign particle detection technology can be integrated into WILCO’s FINAL QUALITY machine concept, combining it with a laser-based headspace analysis and a NIR-based moisture detection to completely inspect for example lyophilized products. “This FINAL QUALITY machine concept reduces overall equipment purchase costs, saves on footprint dimensions and greatly reduces the risk of glass damage due to transport, since products do not have to be transported anymore from one machine to the other,” announces Gerhard Schramm further.
Operation
While passing through the low-energy X-ray field, any particles, visible and non-visible, are being magnified onto a fast CMOS detector array. The resulting size of the particle picture can be calculated due to the distance relations between X-ray source/sample and sample/detector.
The detector converts the incoming X-rays into light and transfers the picture onto the CMOS diode array. The results are immediately available and are evaluated instantaneously, allowing the processing of high production speeds.
The energy, to which the products are actually subjected to, is in the µW range, guaranteeing this process to be absolutely safe.
Non-accepted containers are tracked and separated when they reach a reject station, with the physical removal confirmed in a fail-safe manner.
WILCO will be at booth A31 in hall 13 at the Interpack exhibition.