Quality Control Solutions at INTERPHEX: Optical Inspection

Demand remains high for quality-control technology, driven by high-profile recalls, revised guidelines like the United States Pharmacopeia (USP) General Chapter <1207> Sterile Product-Integrity Evaluation, the expanding population of biologic products, serialization requirements, and the evolution of a worldwide supply chain. One way to experience many quality-control systems in a short period of time is at the annual INTERPHEX trade show. As always, exhibitors at this year’s show (held Apr. 21–23, 2015, at the Javits Center in New York) displayed a full array of quality-control technologies, including optical inspectors.

Packaging quality is crucial to drug-product quality. Optical inspection is an important piece of quality control, but building quality in begins with primary container production. For parenteral products, reducing or eliminating particulate contamination is imperative. To meet this need, West Pharmaceutical Services has developed ways to minimize particulate generation from the packaging components it supplies, such as ready-to-sterilize containers.

Optical inspection
Product quality may be supported by standalone or in-line optical inspection systems. In-line systems can integrate multiple inspection functions or be built into a packaging machine. The Cremer CFS-622*4 tablet counter from NJM Packaging, for example, features an integrated CountSafe inspection and automatic ejection system from Optel Vision. The camera/strobe system is compatible with any electronic counter. When it identifies tablets with a wrong shape, color, or size; broken product; or rogue product, a vacuum device sends rejects to a closed bin.

Another integrated system, the HSAjet PV650 carton printer/inspection system from HSA USA, confirms print quality and correctness. A camera and optical character recognition and optical character verification software check alphanumeric information. The system also verifies Datamatrix and linear bar codes.

Optical inspection is commonly used to check vials and other parenteral packaging formats for surface flaws and particulate contamination. The latest model from Brevetti CEA, the BL-S300 inspection system, is a highly configurable, camera-based machine designed to perform a three-part inspection (particle, fill level, and cosmetic) of vials and large volume parenterals ranging in size from 100 to 1000 mL.

Two tabletop systems for visual inspection, the Maschinpex Visomat IV-T model from Driam USA and the DI-100 LT machine from Dabrico, handle vials, ampules, cartridges, and syringes in a wide range of sizes and liquid or lyophilized product. Designed for small batch sizes and laboratory applications, the semiautomatic units feature easy changeover. Speed depends on operator experience, product, and scope of inspection. Dabrico’s servo-driven DI-100 LT machine controls all functions from the operator interface.

A linescan camera is the basis of an optical inspection system from Innoscan that converts a three-dimensional (3D) surface to a single, high-resolution two-dimensional image. Originally developed for insulin syringes, the rotary system with integrated high-voltage leak detection detects particles, cosmetic defects, and package integrity problems at up to 660 containers/min. Redundant particulate and cosmetic defect inspection stations minimize false rejects. If both paired stations don’t pass or fail a container, the system recirculates for another cycle. After the second pass, if the stations still don’t agree, the container is rejected.

The GF Bag Control machine from ACIC inspects intravenous bags against a black or white background and prevents printing on the bags from causing false rejects. Color cameras and different wavelengths of light ensure identification of black, white, and translucent particles. An integrated load cell checks seal integrity by detecting changes in pressure during compression.

To overcome problems traditional vision systems experience with opaque and non-round containers, Rommelag has developed a two-station, eight-camera unit that puts containers in a horizontal position. Cameras capture images from above and below as containers are vibrated. Although currently limited to inspecting blow-fill-seal containers, the technology is suitable for detecting flaws in other difficult-to-inspect containers.  

For solid-dosage forms, the camera-based Teonys vision sorter from Proditec checks for cosmetic defects, rogue tablets or capsules, and off-specification dimensions. Modular design enables top or top-and-bottom surface inspection. An optional laser head measures thickness to detect doses that contain too much or not enough active ingredient.  

Upgraded software helps Scanware Lynx-Spectra systems from Pharmaworks inspect printed tablets and capsules. This task can be challenging because the print message often is not the same on the top and bottom of the dose. In addition, the print may be the same color as the background or look like a contaminant.

A tablet and capsule inspection service from Visionspect provides on-site operators and equipment from Daiichi Jitsugyo Viswill. The 3D inspection systems feature LED lighting, color cameras, more sophisticated inspection algorithms, easy cleanability, fewer changeparts, and a simpler operator interface.

Visionspect provides tablet and capsule inspection equipment from Daiichi Jitsugyo Viswill. Image courtesy of Hallie Forcinio. 

Optical inspection systems also document optimum performance and assist in troubleshooting packaging machines. The Hindsight 20/20CAM portable, washdown-compatible, high-speed video system from Monitoring Technology captures and stores images of machine operation in the cloud for easy sharing of video, which can be examined frame-by-frame if necessary. The system fits in a suitcase and accompanying backpack and consists of a monochrome or color camera head, image processor, laptop, remote control or manual lens, lighting, power cords and adjustable mounting gear. Options include an aseptic camera head and lens cover, wireless operation for recording inside clean rooms and a caster-equipped stainless-steel cart for multiple camera applications. 

Look for more news on quality control equipment in July’s Equipment & Processing Report; an article will describe checkweighers, metal detectors, x-ray inspection systems, leak detectors, and headspace analyzers on display at INTERPHEX 2015.