Quality Control Advances - Pharmaceutical Technology

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Quality Control Advances
Highly automated and sensitive quality-control equipment quickly identifies product faults.


Pharmaceutical Technology
Volume 36, Issue 8, pp. 32-34

Leak detection/seal integrity

A high-speed, vacuum-based system provides 100% inspection of prefilled syringes for leaks at up to 600 syringes per min. The patented system positions the syringe so its entire surface can be checked without altering the position of the stopper or affecting the product. (Wilcomat R 36 MC/LFC high-speed leak tester, Wilco AG).


Figure 1. A seal inspector is based on infrared technology (infrared seal inspector, Qipack).
An inspection system based on infrared technology confirms seal integrity in flexible packaging and between thermoformed trays and lidstock (see Figure 1). A high-definition infrared camera captures an image of each seal immediately after sealing. Software analyzes the image, detects any abnormality in the seal, and rejects leakers. The equipment also monitors sealer function and can provide an alert if maintenance is needed (infrared seal inspector, Qipack BVBA).

High-voltage leak detection (HVLD) finds flaws in prefilled syringes, liquid-filled vials, blow–fill–seal containers, ampuls, and liquid-filled pouches. The off-line laboratory instrument nondestructively tests container/closure integrity and locates pinholes, microcracks, and other defects as small as 1 micron. Seamless migration to production-scale systems simplifies validation of 100% inline testing (Nikka Densok E-Scan 625 HVLD micro leak detection system, PTI Inspection Systems).

Checkweighing

Checkweighing improves product quality, meets regulatory requirements, and reduces production costs, according to a downloadable guide that helps drug packagers establish a checkweighing program and covers checkweigher design features, equipment accuracy and statistical process control (2). The document also defines operating goals, total cost of ownership, and metrological regulations and guidelines while supporting installation, verification, and limit setting to maximize efficiency and minimize costs (Principles of Checkweighing Guide, Mettler-Toledo Hi-Speed).

A family of mid-range, servo-driven checkweighers measures up to 7500 g at 250 per min and features a touch-screen operator interface, a 100-recipe memory, four password-protected user levels, validation support, and an extended event log. Product transport belt changes require no tools, and a variety of reject devices are offered. High ground clearance simplifies cleaning (HC-M-WD washdown IP69K checkweigher, HC-M-VA stainless steel design IP65 checkweigher, and HC-M-MDi checkweigher/metal detector combination, OCS Checkweighers).


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