Inspection goes truly on-line

From innovative, web-based system architecture to the latest in barcode scanners – Andrew Smith looks at what's new in the on-line inspection sector

Increasingly rigorous standards set by the licensing authorities combined with an ever more litigious society have driven the steady improvements made in pharmaceutical QC in the past three decades. During this period, product security has moved on from simple barcode scanners to sophisticated, multi-tasking systems incorporating a variety of sensor types which check an array of parameters.

This has meant the integration of the various security systems into production lines; to put the latest developments into perspective, it is necessary to review the manner in which this has happened

Early systems, for whichever inspection duty, typically consisted of a scanning device interfaced with a control and evaluation unit, which was used for all set-up and diagnostic functions, as well as for processing the signals from the scanner. Systems were generally application-specific, so that a standalone system would be necessary for each inspection duty required on the line.

This picture changed somewhat in recent years with the advent of 'intelligent' scanners, so called because all logic required for the decoding and evaluation of signals is contained within the scanner itself. Thus, the functions required of the evaluation unit became fewer, with the focus being on configuration visualisation, programming and diagnostic functions.

creating potential

The Original Equipment Manufacturer (OEM) frequently carries out installations of security systems on new packaging lines before shipping. The availability of intelligent scanners created the potential for security installations which dispensed with the security systems' control units, since it was now possible to interface scanners directly with the machine's PLC control unit to produce a less complex and cheaper security system.

Functions such as shift registers, counters, eject verification and the machine PLC can easily control packaging component reconciliation. Increasingly, therefore, OEMs have been requesting a simple adaptor box with which to connect intelligent scanners directly to their PLCs.

However, not all in the industry believe this is an ideal solution. Paul Osborne, head of vision development at Romaco group company Laetus, says this approach has two significant drawbacks.

'If the control unit is dispensed with, then all diagnostic functions are also lost, creating the potential for unacceptable levels of downtime in the event of technical problems on the line. Also, whenever the security system manufacturer makes operational enhancements, or introduces a new type of scanner, the OEM must reflect this with parallel modifications to his operating system. In the case of equipment already installed, this requires visits by engineers from the OEM and inevitably, raises questions over re-validation.'

To counter these problems Laetus is now launching the iBox, which it describes as an 'intelligent universal system' that enables any developments to be automatically recognised by the OEM side of the operation. The company says the launch of the iBox allows security systems to be installed on packaging lines as a miniature ethernet, forming a local 'web' of intelligent devices.

Each iBox connects a single intelligent security device, such as a code reader, to the web. A complete web server is built into the iBox, which has a unique IP address and contains all the screens, or masks, required for the configuration, operation and most importantly, says Laetus, the diagnostics of the security device.

web technology devices

To complement this design, the company has developed its own browser, the Laetus Navigator, specifically for operation with its own web technology devices. Once installed on the OEM's control unit, this browser can be activated to configure any number of security devices. On demand the relevant user-masks are requested from the iBox and displayed on the OEM monitor. Feedback to the iBox is via on-screen buttons and controls such as sliders.

Hayden Waller, print & security team leader at Romaco UK, says this approach offers significant advantages for OEMs and end users alike. 'On-line security inspection is now generally far more complex than a few years ago, with many users requiring barcode verification, blister inspection and overprint verification on a single line. Previously Laetus would have recommended the installation of separate systems for each core task. However, the launch of Navigator and the iBox allows us to supply an integrated system to handle the entire inspection requirement at a lower cost.

'While other manufacturers can offer PC-integrated security systems, none has an equivalent of the iBox, which means that they are 100% reliant on the security and functionality of the PC,' he says. 'Apart from the potential for computer failure, this approach raises questions in respect of software validation and change control. Laetus, on the other hand, has developed the iBox with full documentation to the relevant regulatory issues, such as GAMP 3, throughout. Additionally, the Navigator itself requires no change control if the security systems functionality is extended.'

Where appropriate, the company intends to integrate the iBox into individual units. The first example of this is the launch of the Bcam — an intelligent camera system design for pharmaceutical print inspection with integral iBox functionality. The successor to the company's Polyphem 1040 colour blister inspection system, the 2040, will go a step further again by including both a server and a browser within the unit, allowing a separate point of access to the entire security system should this be required.

Another technologically impressive innovation comes from the US-based spectrophotometer and analyser manufacturer, Analytical Spectral Devices (ASD), which has co-operated with packaging machinery concern, Kloeckner Medipak, to devise a blister pack inspection system that ensures the correct product is put into the correct pack.

According to sales and marketing director at ASD, John Enterline, 'Existing pharmaceutical blister packaging equipment utilises vision systems that identify tablets by their shape, size and colour to verify that they are packaged correctly. Up to now, however, there were very few systems that could distinguish if an errant tablet of the same size, shape and colour were put into the package.'

verifying composition

Making its debut at this year's Interphex USA, the QualitySpec TI uses near infrared technology to verify the chemical composition of solid dosage products in each individual blister pocket and is said to provide 100% non-destructive in-line screening. At the heart of the unit is a spectrometer which measures reflectance, transmittance and transflectance which has a spectral range of 350nm–2500nm with a wavelength accuracy of ±0.8nm and wavelength repeatability of ±0.02nm.

Suitable for high volume environments, the QualitySpec TI has a scan time of 0.1 sec and an evaluation speed of 90 cycles/min/head that can 'easily accommodate up to 200 tablets/cycle', giving it the capacity to scan 18,000 tablets/min. ASD says it is also easily integrated into any pharmaceutical packaging system.

Also based on near infrared technology is the Lynx-Focon, an on-line pore detection unit for aluminium or aluminium laminate foils, which is said to be able to detect pores and cracks down to 25µm. Launched at Achema last year, it is made by Scanware of Germany and is available in the UK through F J Pistol.

The unit is configurable to either one or two zones of detection, depending on the machine layout. According to Scanware, this unique feature splits the detection area along the centreline of the foil material, allowing for discrimination of faulty blister packages. A reduction of some 50% in material wastage is claimed.

The company says the unit can be installed on any thermoforming machine and integrated into any existing blister line without machine reprogramming, thus avoiding software revalidation which saves on downtime. All programming and parameter setting is done through a simple operator interface consisting of an LCD and a few function keys. There is a multi-language facility and access to the system can be barred to prevent any inadvertent or undesired changes in the settings once the system has been validated.

Scanware also supplies inspection machines to check the presence of solid dose forms in blister packs and ampoule inspection units for checking the colour of ampoule ring codes.

total inspection

Also available through F J Pistol is the Visitab 2 made by Proditec of France. This is said to offer 100% inspection of tablets for size, aspect defects and surface defects at speeds up to 180,000 tablets/hr. Suitable for all shapes and sizes of tablets, the Visitab is based on artificial vision technology which has acquisition speeds of more than 2,000 line images/sec.

Barcodes have come a long way since their origins as a simple method of identification and so has the technology that reads them. The latest offering from Bar Code Systems is the SV series of high-speed, on-line barcode verifiers which are said to ensure barcodes are 100% compliant as they are being produced. The company says it will work with almost all label materials, from matt, high gloss and coloured labels, to metallised polyester and direct thermal barcodes. The units can also cope with multiple barcodes on each label.

The five model range can analyse between 100 and 200 codes/sec and 'report virtually every barcode identification parameter known'. CEN/ANSI and traditional print quality parameters are transmitted along with decoded data and the reported symbol quality parameters ensure that print quality is optimised. 'Importantly,' says the company, 'the system will also isolate the source of any problem so that it can be immediately corrected before any sub-standard barcodes are printed.'

For those looking for a low-cost, off-the-shelf solution for barcode reading, DataCell has now introduced the Eye-Sys 200, a machine vision system consisting of a small, intelligent, DVT Legend 530 SmartImage sensor with Windows-based application software. Real-time data capture enables measurement, counting, feature finding, comparison of likeness, reading of linear and 2D barcodes as well as trainable OCR reading. Remote access for on-line diagnostics and inspection management is also possible via the internet.

The Legend 530 features an embedded processor which can be programmed in-situ from a PC using the DVT FrameWork software provided. Cost of ownership is said to be reduced by the ability to re-program the sensor for new applications.

Metal detectors are not yet ubiquitous in the pharmaceutical production environment, but increasingly demanding market and consumer conditions are likely to see them becoming more commonplace, especially when product is destined for markets such as Japan.

Lock Inspection Systems has upgraded its MET 30+ Pharmaceutical metal detection unit with increased sensitivity and a newly designed stainless steel reject mechanism. The unit, suitable for tablets, granules and powders, is said to be able to detect and reject microscopic contaminants such as tiny lengths of sieve mesh and press tooling fragments at speeds up to 30,000 tablets/min.

removed, cleaned and replaced

The company says the new reject mechanism offers a robust, resilient alternative to the plastic reject mechanism which also facilitates the cleaning process as all components can be 'removed, cleaned and replaced within minutes'.

Meanwhile, Safeline claims to have the 'most sensitive metal detector on the market' in the shape of its Tablex unit which can detect metal particles down to 1mm in size. Now available in three sizes to enable the inspection of 'virtually any sized tablet, all units incorporate full stainless steel construction with FDA approved contact parts'.

Cognex puts BesPak in the right dimension

BesPak, an Apex, NC, US-based manufacturer of HFC and CFC pharmaceutical metering valve products, needed to measure various critical dimensions on injection-moulded plastic inserts as they were assembled to inhaler shells. The company had attempted to use a machine vision system in place of an older random-sample checking process, but the system had trouble adhering to BesPak's reliability and repeatability testing requirements. "Our internal requirement was no more than 20% variability in performance, though our ultimate goal was to achieve less than 10%, but with that particular system we were struggling to get below 30-40% variability, which was unacceptable and was leading to an excessive amount of falsely-rejected products," says Jim Gallion, BesPak manufacturing engineering manager. After evaluating several products, the company eventually chose a Cognex Checkpoint 900 vision system to inspect both the diameter and "ovality" of the inserts. "The purpose of the vision system is to reject inserts that do not meet the 0.63-0.77mm diameter tolerance, and verify that the insert's orifice is not more than 20% oval when comparing the longest axis against the shortest axis. "The Checkpoint system proved capable of measuring the inserts within these strict tolerances, and passed the original validation tests as well as many additional validation tests with flying colours," says Gallion.