Pharmaceutical rubber stoppers are used as the secure flexible closure for vials. When a vial is filled with medication and then closed with a rubber stopper, an aluminum cap is placed over it to securely fix the both together. The aluminum cap has an opening to let the needle pass through the stopper into the vial.
The above construction clearly demonstrates that a stopper is in contact with the medication and with the needle tip. Both moments of contact must be guaranteed without any influence from the rubber stopper itself. This makes a stopper a vital element in the medication method.
This article reviews the quality control device for a cap, if you are interested in learning more about vial quality control see the Vial Quality Control article from a source.
The world fastest inpection system
Already 20 years ago, Simac Masic bv designed and built its first rubber stopper inspection machine. Now, these 5th generation machines belong to the world fastest inspection systems for Pharmaceutical rubber stoppers inspections. It is a complete quality control system within clean-room conditions ISO class-5.
Modular designed system
The designed system is flexible and can be easily adapted to specific customer needs.
A. The HMI:
Human Machine Interface, presents all the machine functions on screen. The machine control is really intuitive and all the changes and adjustments are displayed ‘real-time’ on the screen.
The vision terminal shows all the vision inspection results. Here the operator can follow statistics, processing results, individual images and ‘operational-check’ the current product run.
C: Bowl feeder
The bowl feeder is automatically fed from the supply bunker. In the bowl feeder the stoppers are correctly positioned and lined-up. Form the line-up the stoppers then go one by one into a separation wheel.
D: Quality control inside the cap
With the stopper in the separation wheel an inspection camera on position D inspects the inside of stopper.
E: Cap transmission routes
After the inside inspection of the stopper, oked stoppers continue on to a non-metal transport ring for further inspection.
F: Apparent quality control of the cap
In the housing F there are 5 to 6 camera’s to inspect the total outside surface of the stopper.
G: metal detector
After the stopper has passed the inspection in F it goes through a metal detector. Minimal metal detection (Ø mm): 0,4 ferro; 0,5 nonferro; 0,6 stainless steel.
H: The ejection system
The ejection system separates good from bad, counts the numbers per bag, separates sample for testing and is the last check in the product-flow-control system.
- Stopper sizes (Ø mm) : 12 to 35
- Max speed ( stoppers per sec.): 13
- Different stopper colors possible
- Minimum defect detection of 50 µm square
- The rejected stoppers are categorized in separate containers and statistically traced.