Quality control always is a prime concern, and pharmaceutical manufacturers continue to express high levels of interest in
flaw-detection equipment. Particularly notable is the growing number of multifunctional systems, many capable of providing
100% inspection at line speeds.
A low-power diode-laser system with as many as four heads checks vials of freeze-dried, liquid, or powder products for raised
stoppers and headspace moisture and oxygen. Because the laser can be tuned to match the wavelength of the gas, it also can
be set to detect nitrogen levels. Stand-alone or on-line configurations handle single vials or trays. Container sizes range
from 1 to 200 mL. The system can check as many as 600 containers/min (high-speed headspace-inspection machine, Lighthouse
Instruments, Charlottesville, VA).
Raised stoppers also can be detected by camera-based systems. Capable of measuring variations of ±1 mm, an intermittent-motion
unit holds vials steady to ensure that good images are captured. The system bolts to existing capping equipment and also analyzes
headspace or checks for the presence of moisture with the addition of a laser or near-infrared module, respectively. Other
options include application and verification of lot numbers (vial-inspection platform, Genesis Packaging Technologies, Exton,
Improved operation and connectivity characterize a new leak detector for syringes and vials. Electronic vacuum control increases
precision and shortens cycle time, enabling the detection of leaks as small as 0.005 cm3 per minute. To check for leaks, packages are placed in a test fixture inside a test chamber and a vacuum is pulled. If leaks
or other defects are present, the equipment will register changes in absolute and differential vacuums. The nondestructive
test is more sensitive than the traditional dye-ingress test (VeriPac 455 leak detector, Packaging Technologies and Inspection,
Another multifunctional system checks headspace oxygen with a laser, confirms container–closure integrity with a vacuum, and
measures lyophilized-cake quality and moisture content with near-infrared technology. An integrated camera performs surface
inspections and verifies two-dimensional data matrix codes. A timing screw–starwheel arrangement provides positive container
handling and rejection (Wilcomat R 36 MC–LFC–V–HAS–NIR leak tester, Wilco, Wohlen, Switzerland).
Microflow technology detects leaks as small as 0.2 μm in blister packs, pouches, vials, syringes, cartridges, and other flexible
and rigid packages. Available in two designs for sterile and nonsterile products, the patented system checks for gross and
fine leaks by measuring the mass of molecules in motion. Flow rate is proportional to defect size. Inline models run at speeds
as high as 200 packs/min (Model ME2 packaging leak tester, ATC, Indianapolis, IN).
ATC's ME2 microflow leak tester identifies container–closure integrity problems in packages of injectable products. (PHOTO
IS COURTESY OF ATC)