Quality Control Solutions at INTERPHEX: Inspection and Detection Systems

Stringent quality-control requirements, the need for more automated inspection, and an ever-stricter regulatory environment keep quality control top of mind for pharmaceutical packagers. As a result, many attendees visited this year’s INTERPHEX (held Apr. 21-23, 2015 at the Javits Center in New York) to see machines in action. In addition to optical inspection systems (see the May 20, 2015 Equipment and Processing Report), exhibitors gave attendees the opportunity to examine checkweighers, metal detectors, x-ray inspectors, leak detectors, and headspace analyzers in standalone or in-line systems.

Checkweighing
The HC-A checkweigher from OCS Checkweighers inspects products at 600 parts/min by measuring current in an electromagnetic coil at a rate of 1000 times/sec. A patented, dual weigh-cell configuration provides active vibration compensation and more accurate weight measurements. One cell captures product and all electronic noise, and the second cell captures only the noise so it can be subtracted, leaving a precise weight.

Forced balance and anti-vibration technology on the Ishida DACS-6 checkweigher from Heat and Control ensure extremely accurate weighing. The sanitary design is washdown-compatible and features tool-less belt removal. Integration with a metal detector results in a dual-purpose system.

Another dual-purpose system, the Ensura model from ACG North America, integrates checkweighing with serialization and vision inspection. The compact machine adjusts for different carton sizes and accommodates virtually any type of printer. Variable speed control enhances flexibility.

Metal detection
Upgraded software adds functionality to the Ceia THS/PH2IN metal detector from Heat and Control. New features include networkability; automatic maintenance alerts; capture, storage, and analysis of performance data; and timed-interval email reports. The all-digital machine eliminates the need for physical calibration. Wi-fi, ethernet, and USB connectivity enables monitoring and adjustment via smartphone.

Insight metal detectors from Loma Systems check tablets and bottles. Generally installed after the tablet press, the smaller Insight Pharma Unit may be specified with a 95 x 38-mm or 95 x 22-mm aperture. Detecting sensitivity ranges from 0.3 mm for ferrous to 0.35 mm for nonferrous and 0.5 mm for stainless-steel contaminants.

The PSG Now metal detector from PPi Technologies Group also checks tablets and is compatible with capsules.

X-ray inspection
X-ray inspection systems sometimes perform the same role as metal detectors, but also can check for other types of contaminants as well as product features. For example, the Xavis x-ray automatic vision inspection system from PPI Technologies Group also locates broken product and incomplete fills, and it confirms seal integrity on pouches and blisters. 

The Ishida IX-GA-S-2462 x-ray inspection system locates foreign, broken, and missing product and also provides weights. An auto-learn feature simplifies setup via use of a known good sample. Sanitary design includes a one-piece, removable, washdown-compatible conveyor.

The G180 x-ray system from Sapphire Technologies USA can be configured to check trays, pouches, cases, bottles, cans, inhalers, pumps, and loose product. High resolution helps the unit locate contaminants; confirm count, mass, and fill level; and detect broken, damaged, or incomplete products.

Leak detection
Lasers in the Vista in-line headspace inspection system from Lighthouse Instruments monitor oxygen, pressure, and moisture levels to confirm container/closure integrity, oxygen levels during filling, and moisture levels in lyophilized product in vials from 1 to 200 mL. Rated at up to 200 vials/min, the system also can detect raised stoppers. In addition, since microbes typically consume oxygen and release carbon dioxide, the unit can identify microbial contamination in media fills by detecting changes in headspace oxygen and carbon dioxide levels. Compared to standard incubation tests, which take 14 days, the laser-based system can deliver results in as little as 24 hours.

The dual-cycle Veripac 455 leak detector from PTI–Packaging Technologies & Inspection looks for large leaks then checks for smaller ones. This sequence is used because if a large leak is present, gas would escape, rendering smaller defects undetectable.

Some leak detectors check container integrity with high voltage (HVLD). Seidenader Maschinenbau has added the standalone HVLD Pro system to its integrated high-voltage leak detector/camera system. Replacing timing-screw transport with servo-motor control reduces variation in the distance between electrode and product and ensures a 360° rotation of each container. An adjustable vial angle maximizes the range of products that can be tested.

The HAS-Lab headspace analyzer from Wilco USA now measures carbon dioxide as well as moisture and oxygen. Carbon dioxide measurements are useful for media-fill analysis and cold-chain process problems. “It’s important to be able to prove elastomeric components won’t be affected by exposure to cold temperatures and leak,” Paul Bilotti of Wilco told Pharmaceutical Technology. The nondestructive, laser-based testing system relies on up to three lasers: one for oxygen (760 nm), one for moisture (1340 nm), and one for carbon dioxide (about 2000 nm), with the most common units pairing oxygen and humidity. 

Mass-extraction technology, which detects leaks as small as 2 microns on a 10-mL vial, is the basis for the ME inspection systems from ATC. Vials enter a vacuum chamber, where a patented flow-measurement sensor detects any outflow of gas from the container of liquid or lyophilized product. The system also can check prefilled syringes and intravenous bags. Models include the standalone ME2 and the fully automated, multi-station ME3.