Friday, October 27, 2006

Tablet Press controls weight and hardness

Tablet press allows independent control of both weight and hardness, reducing 'trial-and-error' operator adjustments for changes in powder characteristics.

A breakthrough innovation from Niro Phama Systems and Courtoy has solved a control dilemma that has faced the pharmaceutical industry ever since automated tablet presses came into use. The problem has been the balancing of weight and hardness of the tablets. Previous technologies required consequential steps by skilled operators in order to keep both weight and hardness to specification.

Niro's engineers have crafted a unique solution that separates the two control systems for simultaneous weight and hardness control on a standard rotary tablet press.

The advantages of the Dual Control System are that is allows independent control of both weight and hardness, reducing 'trial-and-error' operator adjustments for changes in powder characteristics.

In addition, it fine tunes processing to meet all tablet specifications which decreases waste of valuable formulation in non-spec tablets.

The patented Dual Control System physically separates the two control loops to work on separate areas of the press.

Weight is controlled at the pre-compression stage, and hardness is controlled during main compression.

The Dual Control System is now available as an option on all Courtoy Modul tablet presses.

World's most precise pharma benchtop filler

BASCO Technologies has launched its Dispensing Unit Type 533, claimed to be the world's most precise filler, with a drive control rotary piston pump, it achieves fill accuracies of +/- 0.05 per cent.

BASCO Technologies has launched its Dispensing Unit Type 533, claimed to be the world's most precise filler, with a drive control rotary piston pump, the stainless steel Type 533 is said to reliably achieve fill accuracies of +/- 0.05 per cent. The Type 533 can be used as a benchtop filler, or integrated into automatic filling systems for pharmaceutical and biotech applications, said the company. As a benchtop filler, the semi-automatic Type 533 is said to handle up to 30cpm and is suitable for clinical trials and laboratory testing.

Compared to other benchtop fillers, the Type 533 offers reproducible performance that is 10 times more accurate, said BASCO.

It can be integrated into fully automatic production filling systems, either at the time the filler is manufactured by the OEM or later as a retrofit in the field, to produce higher outputs.

That enables companies with products in clinical trials to plan ahead for full production using the same filling technology.

The Dispensing Unit is also said to be able to handle liquid and semi-viscous products, filling volumes from 10 microlitres to 100ml.

Unlike conventional fillers that require the purchase of multiple pumps, the Type 533 can achieve a range of fill volumes with one pump due to the accuracy of the drive system, added the company.

An operator can achieve a fill volume change by downloading pre-programmed product recipes.

Product changes can be made in minutes, without tools, with the use of dedicated pumps.

The Type 533 also features a stainless steel housing that is washdown-safe.

Single-piece, weld-free, stainless steel pumps ensure optimal hygienic performance.

Thursday, October 26, 2006

Adjustable tablet carousel supports analyser

Adjustable tablet carousel accessory for use with a near-infrared analyser product line provides a flexible, cost-effective tool for the analysis of different sized tablets.

Thermo Electron Corporation announces the Adjustable Tablet Carousel accessory for use with the Nicolet Antaris Fourier transform near-infrared (FT-NIR) analyser product line. This patent-pending automated accessory provides a flexible, cost-effective tool for scientists working in pharmaceutical R and D and QC for the analysis of different sized tablets. A single lever adjusts all tablets into position, regardless of tablet size, saving time and eliminating the need to purchase multiple, customised carousels in formulation and method development applications.

Thermo's Adjustable Tablet Carousel accessory offers consistent and reproducible testing results of varying tablet sizes.

Consistent tablet placement, easily achievable with this accessory, plays a critical role in providing data that can be compared without having to make allowances for product positioning.

Designed for the industrial environments of the pharmaceutical industry, Thermo's award-winning Nicolet Antaris is a dedicated FT-NIR analyser developed for at-line and near-line process applications.

The Nicolet Antaris FT-NIR analyser provides a reliable, accurate analytical technique that improves the speed and efficiency of the manufacturing process.

* About molecular spectroscopy - ideal for investigative analysis or quality control applications, spectroscopy systems from Thermo Electron are used to determine the molecular composition of a wide range of complex samples including liquids, solids and gases.

Supported by an expansive range of applications, techniques such as infrared, Raman, UV/Vis and fluorescence provide a molecular fingerprint for both qualitative and quantitative analysis.

For more information.

* About Thermo Electron Corporation - Thermo Electron Corporation is the world leader in analytical instruments.

Our instrument solutions enable our customers to make the world a healthier, cleaner and safer place.

Thermo's Life and Laboratory Sciences segment provides analytical instruments, scientific equipment, services and software solutions for life science, drug discovery, clinical, environmental and industrial laboratories.

Thermo's Measurement and Control segment is dedicated to providing analytical instruments used in a variety of manufacturing processes and in-the-field applications, including those associated with safety and homeland security.

Major upgrade made to paperless recorders

Yokogawa has introduced a number of major enhancements to its DXP family of paperless recorders, which are designed to meet the electronic record and signature requirements of 21CFR Part 11.

Yokogawa has introduced a number of major enhancements to its DXP family of paperless recorders, which are specifically designed to meet the electronic record and signature requirements of FDA Regulation 21CFR Part 11, covering the storage of electronically produced data in the pharmaceutical industry. The new DXP Style 5 recorders are equipped for use with SNTP (Simple Network Time Protocol), so that a recorder can be linked as a client to an SNTP server on a network. Alternatively, one recorder can be used as an SNTP master to a number of other recorders on a network.

In each case, the recorders will be automatically synchronised with the network clock, removing the effects of clock drift between different units.

Any time adjustment by the SNTP client is recorded in the operation log, and the records of access from the SNTP client to SNTP server are recorded in the SNTP log.

The SNTP log can be shown on the DXP itself, and it can be output by communication command.

Thus the all-important audit trail is maintained.

Other new recording and display features include a manual save function, which initiates a memory dump into a ZIP drive; a first-in/first-out facility for recording on external media; automatic configuration for daylight-saving time; and the ability to configure the time, number of users and calibration during memory start.

It is also possible to carry out calibration correction and user name changes while the unit is actually running, eliminating the need to halt the recording process in the event of an incorrect password being entered, for example.

Authority for the calibration correction configuration can be given to users, and sequential multiple channels can be set at the same time.

Up to 90 users can access the system simultaneously.

Other new features include the ability to change the monitor display format - from digital to trend, for example, without a user being logged in, plus a wide range of communications functions.

The Yokogawa DAQSTATION DXP family of pharmaceutical recorders save data in secure, binary-encrypted files, which include batch information, configuration settings, and the audit trail of the access to the recorder system, including the serial number of the device the data was recorded on.

Log-in functions require user name, user ID and password security, and provide controlled access to all recorder functions including the application of electronic signatures.

Full access to the recording system is provided by the administrator log in, of which there are three.

User access is set up by the administrator, who also determines the rights of each user.

No user or administrator can see anybody else's password, and a password ageing function allows passwords to be periodically changed at the request of the system.

These recorders have been designed to meet the requirements the United States Food and Drug Administration's regulation 21 CFR Part 11, which identifies the requirements necessary for the storage of electronically produced data within the pharmaceutical industry.

Using electronic records provides a solution to the problems encountered by paper based recorders, for example data being lost due to consumables such as pens and paper running out during recording, the difficulty of storing paper after data recording, and data management.

In addition, it simplifies the retrieval of historical records by the ability to search by batch name.

About Yokogawa Electric Corporation Yokogawa's global network of 18 manufacturing facilities, 82 affiliate companies, and over 650 sales and engineering offices spans 28 countries.

Since its founding in 1915, the US$4 billion company has been engaged in cutting-edge research and innovation, securing more than 7,000 patents and registrations, including the world's first digital sensors for flow and pressure measurement.

Industrial automation and control, test and measurement, information systems and industry support are the core businesses of Yokogawa.

* About Yokogawa Europe - the European headquarters were founded in Amersfoort, the Netherlands in 1982.

Throughout Europe Yokogawa has its own sales, service and engineering operations.

This dedicated network has been extended to Central and East Europe and Southern Africa to further enhance the coverage and support associated with serving the process control and automation market place.

We develop and produce flowmeters at Rota Yokogawa in Germany, liquid analysers and industrial safety systems in the Netherlands.

In addition to this dedicated network of Yokogawa subsidiaries a select organisation of Test and Measurement (T and M) subsidiaries and distributors is established in certain areas to support the specific customer needs of this continuously developing and specific market of T and M instrumentation.

* About Yokogawa UK - Yokogawa UK, part of the global Yokogawa Corporation, is a supplier of enterprise technology solutions to the process, manufacturing and utility sectors.

The company is a technology and market leader in instrumentation and control, and holds many key patents and national and international approvals.

Wednesday, October 25, 2006

Tablet press measures, records parameters

A fully instrumented, single punch tablet press is fully Windows compatible and can be interfaced via an internal network card with almost any PC records all activities.

Leading UK distributor of equipment to the medical, healthcare and pharmaceutical sectors, Isopak, is introducing into the UK a fully instrumented, single punch tablet press. The new compact CPR-6 upgrade, which is one of the smallest bench top units in the world, is fully Windows compatible and can be interfaced via an internal network card with almost any PC. It has been developed to allow the user to view exactly what is happening to their product during the pressing process.

The machine records all activities and measures the compression forces needed for transferring the product to larger, full-scale production systems.

Compliant with the Good Management Practise (GMP), the latest version of the CPR-6 can now detect and record compression force on the upper and lower punch, as well as the position of both punches and even the rejection force of the tablet.

Data is displayed as a value of the maximum force in the format of a series of curves on a cartesius axis.

These curves allow the operator to evaluate the quality of the powder granules compaction and therefore the compressing force necessary to obtain the required tablet hardness.

Data can be stored via a computer for many years, enabling users to compare batches of different tablets and also to fully comply with record keeping.

Isopak believes that this new innovative solution will further enhance the UK pharmaceutical industry and could ultimately lead to the development of new drugs.

Designed for small batch runs, the CPR-6 is ideal for laboratories, pharmacies and hospitals needing a compact automatic tablet press.

Capable of producing up to 2500 tablets/h, it is constructed from stainless steel and is very easy to clean and operate.

Even though it is one of the smallest bench top tablet press units in the world, the CPR-6 does not lose out when it comes to power.

Thanks to excellent design, sturdiness and full mechanical driving, it can exercise a compression force of 2.5 tonf.

Tablets with a maximum diameter of 16mm, filled to a depth of 17mm can be produced, at variable speed settings.

Manufactured in two totally separate parts - a compressing area protected by security panels, and a mechanical area, the machine is equipped with independent weight and hardness adjustment capabilities, adding to its flexibility of use.

The CPR-6 is the latest development from Italian manufacturer Dott Bonapace, who also produce an extensive range of other machines including bench top and freestanding, semi-automatic capsule processing and blistering machines, all exclusively sold in the UK by Isopak.

Isopak's managing director Robin Davies comments: 'The new version of the CPR-6 machine is now even more impressive allowing it to be used in even more diverse tablet production type applications'.

'Ideal for anyone wanting an automatic and economical tablet press, this quality machine is particularly suited for use in research establishments and clinical trial laboratories, especially at locations where space is at a premium.' * About Isopak - Isopak is firmly established as a leading UK supplier of equipment to the pharmaceutical, healthcare and converting industries.

Isopak's growing reputation is built on its ability to supply an extensive range of quality products for these sectors.

The company is a distributor of Rotomac machines in the UK.

Rotomac, an Italian based manufacturer, is renowned throughout the world for the provision of competitively priced machinery of the highest quality.

The range includes rewinders, complete packaging lines, aluminium container lines, and dies and is successfully used in more than 40 countries worldwide.

The company is the sole UK distributor of the Dott Bonapace range of equipment, a high quality range of machines suitable for a variety of different applications.

Machines offered include tablet presses, blistering units, capsule processing and filling, suitable for a wide range of applications.

Tuesday, October 24, 2006

Metal detector system meets all 21 CFR regulations

Pharmaceutical metal detector system is believed to be the first and only one that meets all requirements of the 21 CFR regulations, including IQ OQ qualifications.

The new THS/PH21 is the first and only Pharmaceutical Metal Detector System to have been specifically developed to meet all requirements of the 21 CFR regulations, including IQ OQ qualifications. The THS/PH21 is not an upgrade to existing apparatus, both the machinery and software have been designed and manufactured from the ground up to conform to current and future Pharmaceutical Quality Assurance standards. Developed by CEIA and available in the UK solely through Constant Instruments , the THS/PH21 construction complies with 21 CFR requirement Part 210 - current good manufacturing practice in manufacturing, processing, packaging or holding of drugs and Part 211 - current good manufacturing for finished pharmaceuticals.

New software complies with regulation Part 11 - security, integrity and traceability of production data so that electronic records and electronic signatures can be produced.

The THS/PH21 has extremely high detection sensitivity of 0.3mm diameter ferrous, non-ferrous and stainless steel metals and features an innovative deflector for precise ejection of a contaminate at high flow rates.

Pharmaceutical business unit to help cut costs

Pharmaceutical business unit helps pharmaceutical and nutraceutical manufacturers safeguard product security and quality while increasing throughput.

Key Technology announces the launch of its new Pharmaceutical Business Unit, Symetix, and the appointment of Richard Hebel to the position of general manager for Symetix. With world-class automated inspection and specialized conveying systems, Symetix helps pharmaceutical and nutraceutical manufacturers safeguard product security and quality while increasing throughput and reducing manufacturing labor. 'Key Technology is a leading manufacturer of innovative technology with nearly 60 years of experience in the food, tobacco, and pharmaceutical industries'.

' We have over 70 FDA-validated inspection systems installed worldwide for capsules and tablets,' noted Kirk Morton, president and CEO.

'With Symetix, we have built a strong team that is 100% focused on addressing the unique needs of pharmaceutical and nutraceutical manufacturers'.

' We are now poised to be a preferred partner to these manufacturers.' Symetix designs and manufactures a wide range of automated inspection and specialized conveying systems based on GAMP 4 guidelines.

Automated inspection systems meet FDA 21 CFR Part 11 requirements.

Symetix offers validation packages to support pharmaceutical manufacturers' validation documentation needs.

Symetix also offers complete project engineering services'.

''As pharmaceutical and nutraceutical manufacturers increasingly look to take product conformance to a higher level, they need to break out of the lab and rely more on technology that monitors processes in real-time on the production line,' explained Rich Hebel, general manager for Symetix'.

' 'We offer best-in-class technology for bulk-flow tablets, capsules, and softgels as well as blister packs - for regulated and over-the-counter pharmaceuticals as well as nutraceuticals.' Hebel brings more than thirty years of marketing and engineering experience to his position at SYMETIX.

Most recently, Hebel was director, Marketing and Business Development for Key Technology.

Previously, he was vice president, Marketing and Operations for Insight Control Systems International.

From 1993 to 2000, he was vice president, Corporate Marketing and Business Development with Key Technology.

* About Key Technology - Key Technology, an ISO-9001 certified company, is a leading designer and manufacturer of process automation systems, integrated electro-optical inspection and sorting systems, and processing systems.

Key systems help processors to improve quality, increase yield, and reduce cost.

With worldwide sales representation, the company maintains demonstration and testing facilities at its headquarters and manufacturing divisions in Walla Walla, Washington, USA, and at Key Technology BV in Beusichem, the Netherlands.

The company's common stock trades on the Nasdaq National Market tier of The NASDAQ Stock MarketSM under the symbol: KTEC.

Monday, October 23, 2006

Rotary valves meet high pharmaceutical standards

Rota Val has further developed its leading 'Hypergienic' range of rotary valves dedicated for use in exacting pharmaceutical applications. This latest development further enhances the ability of the range of valves to meet increasing demands, particularly on issues such as Occupational Exposure Levels (OELs), explosion and flame containment, and safe handling without compromising design performance. Originally developed through a three-way process between a major pharmaceutical company, Rota Val and a leading supplier of processing equipment to the industry, the 'Hypergienic' range broke completely new ground in providing a rotary valve to perform successfully inside an isolator (glove) box whilst offering full clean-in-place facilities with minimal operator effort.

The new valves incorporated a range of special features to ensure that no crevices could trap product while providing drainage, fluid injection and air blast systems to cope effectively with wash procedures.

Leakage monitoring points permit integration with the users own safety systems.

Unique design provided simple and fast strip down accompanied by long service life even under the demanding conditions of frequent cleaning and arduous duty cycles.

Critical to this, in some cases, is that surface finishes are not compromised through inadvertent component contact during assembly and disassembly.

Since then, Rota Val has continued to research and develop the range.

The advent of EC Directive 94/9/EC (ATEX), has focussed attention on a different aspect of the role of a rotary valve.

Whilst these valves still have a vital function in providing accurate control of powder flow through a pneumatic conveying system, the emphasis has moved on to ensuring totally safe conditions within the working environment.

A key concern in the manufacture of potentially harmful pure chemicals is the Occupational Exposure Level (OEL) to which employees are subjected.

In designing rotary valves for use within isolation boxes, Rota Val had to consider the need to consistently maintain OELs of between 0.01gms/m3 and 0.001gms/m3 under normal production conditions over a very long time.

This involved the design of valves with extremely close operating tolerances and seals to virtually eliminate product loss.

Further reductions in leakage are made possible by the introduction of an inert gas at positive pressure into the seals.

These features have proven value in reducing the waste of expensive pure chemicals, lower disposal costs, and better containment with a subsequent improvement in working conditions.

Ease of manual strip-down without special tools and effortless cleaning can also result in reduced system downtime and a consequent improvement in productivity with lower maintenance costs.

Rotary valves which achieve the relevant international standards are now used increasingly to act as an autonomous safety device in the event of an explosion.

Rota Val submitted representative samples of its wide range via Notified Body Baseefa .

to the Health and Safety Laboratory at Buxton for rigorous testing for explosion and flame containment for St2 Dusts, and has been fully approved.

This means that the valves will withstand a 10barg explosion pressure (actually tested in excess of this level, to more than 11 barg) and have undergone 20 successive full explosion tests using Zinc Stearate with an explosive rating of Kst293.

In addition to type approval with full documentation, every 'Hypergienic' valve is individually tested hydrostatically to 13 barg before leaving the factory as part of the product verification process.

Working conditions are not entirely about meeting international OEL standards, however.

By reducing the manual handling and physical effort required to clean a valve, together with eliminating the need for the operator to wear respiratory protective equipment at all times, Rota Val actively contributed to an improvement in Safety, Health and Environment standards.

Employees have expressed high levels of satisfaction with the 'Hypergienic' valves wherever these have been introduced.

As one production manager said, 'If operators are happy with the equipment, they enjoy using it, clean it regularly and maintain or exceed the very high standards we as a company have set'.

'Removing the need for heavy lifting also means operators are subjected to much less strain, which has a knock-on effect in reducing the number of working days lost through injury.' Rota Val has a long history of innovative development.

Formed in 1970, the company is dedicated to the design, manufacture and servicing of rotary valves, blowing seals, diverter valves and associated equipment.

By specialising in this technology, Rota Val has amassed a vast wealth of experience in the behaviour of different materials within pneumatic and vacuum conveying systems.

From sticky, glassy particulates to abrasive granules or very fine powders, the range of materials handled can present a challenge to the valve designer.

Pharmaceutical applications rarely require large throughput volumes, but the value of the product may be very high and its effect on employees potentially harmful if losses to atmosphere occur.

Acutely aware of these constraints, the company has further developed the original 'Hypergienic' valve designs to enhance performance in these areas.

A crevice-free design is assured by machining the valve body from solid stainless steel, which also has the advantage over cast bodies in that small inclusions, pinhole porosity and other defects often found in castings are completely eliminated.

The optional use of pharmaceutical joint seals further aids the internal crevice-free design.

Minute attention to detail has produced a range of valves which can be washed down under pressure at 75 deg C above ambient without affecting performance.

Rota Val maintains test facilities for high-temperature washdown which permit testing of all valve types for this essential feature.

Despite the close rotor to body tolerances essential for explosion containment, unique design means that the rotor will not make contact and damage the body during strip-down and reassembly.

This feature ensures that valves safely operate over many CIP cycles and still achieve the desired performance characteristics.

Whether supplied for normal environment or isolator box installation, all valves are constructed to make strip-down fast and simple.

Versions with large handles and quick-release toggles can be supplied for applications requiring frequent cleaning, making the process more efficient and reducing downtime.

Connections to the conveying system and other process equipment include flanged, quick-clean and types individually specified by the customer.

Where required, the motor can be totally encased.

FDA-approved seals complete an outstanding design which comes with full validation documentation.

Versions intended for isolator box mounting are equipped with additional seals and remote geared motor with a removable drive shaft.

All models come with full safety interlocks according to customer needs.

Through rigorous testing on prototypes, continuous development and extensive experience in handling products with a very wide range of characteristics, Rota Val have honed the 'Hypergienic' rotary valves to successfully manage the flow of even highly cohesive materials.

For instance, valves may be specified with large inlets to discharge in a precisely controlled manner at low throughputs, ensuring smooth, progressive conveying through the system.

Position indicators provide operators with the essential information to confirm rotor pockets are empty before the valve is opened for cleaning, while true blow-through facilities also ensure full pocket evacuation of product.

Dummy end covers incorporating a spray ball may be supplied for certain CIP applications.

Rota Val's long experience is revealed by the depth and quality of service provided.

Whilst there is a wide range of standard 'Hypergienic' valves already available with inlet sizes from 100mm to 300mm, the Company is always pleased to consider the design and manufacture of valves with special features to meet new application requirements.

Standard or custom-designed, every valve produced has a detailed technical specification record, meaning spares and replacement consumable parts are always available to guarantee long service life.

Indeed, some of the company's early valves first produced around thirty years ago are still working effectively.

Managing director Ian Blackmore commented: 'A clean, well-designed plant is actually looked after better by staff.

There is a significant effect on productivity, and operators feel valued in that their views have been considered closely at the valve design stage.

The new 'Hypergienic' valves allow users to improve containment capability, make the working environment easier and safer, and save time in handling and cleaning.

The rotary valves perform a vital function in the smooth control of product conveying, and are an essential part of modern autonomous safety systems.

Sunday, October 22, 2006

Vision sensor ousts count error, inspects vials

Reported to be the first fully-integrated tray inspection system for the pharmaceutical industry it combines machine vision with automatic tray handling, to enable 100% product accountability.

Quality, accountability and product reconciliation are production mandates at Eli Lilly and Company (Indianapolis, IN, USA), which is why the leading pharmaceutical manufacturer has automated its mechanical vial counting process. The company enlisted Clarke Engineering Services, an Indianapolis-based systems integrator that specialises in vision system integration, commissioning, installation, and validation for the pharmaceutical and diagnostic industries. Together, Eli Lilly and CES co-developed a groundbreaking tray inspection system using a colour visual inspection process powered by In-Sight machine vision sensors from Cognex.

This quality inspection system, dubbed TIS-3000, is reportedly the first fully-integrated tray inspection system for the pharmaceutical industry that combines machine vision with automatic tray handling, to enable one hundred percent accountability of products.

While Eli Lilly's mechanical counter provided only vial count, TIS-3000 uses machine vision to perform a visual inspection that detects fallen vials, identifies missing flip-seals, and verifies cap colour on each vial.

As a result, the tray inspection system improves product quality, in addition to increasing vial-counting efficiency for 100% product reconciliation.

By counting vials in trays at the front end of a packaging line, TIS-3000 helps Eli Lilly eliminate count-related deviations and resultant rework as specific job lots are run.

This saves money, time, and resources required for costly reworks.

'The TIS-3000 establishes the initial count on our packaging line,' explained Rob Stapleton, Operations Team leader at Eli Lilly.

'If the numbers do not reconcile at the end of the line, we have to open up the entire job and find out why a discrepancy exists.

This can be very costly and time consuming considering packaging order sizes range up to 360,000 vials.' Eli Lilly and Company also noted that the existing mechanical counters that were being utilized were prone to jams and that operators could easily miss-handle vials around the counters resulting in a count discrepancy.

This made identification of root causes for mechanical counter errors difficult to identify.

A major benefit to the new tray inspection system is that root causes to count deviations are easier to identify, correct, and explain.

* First a feasibility study - in selecting a vision system, two primary criteria were used, according to CES president Chris Clarke.

'First, the system chosen would need powerful vision tools to meet Eli Lilly's demand for accuracy and repeatability to comply with ever more stringent regulatory requirements,' Clarke explained.

'Second, it had to be very simple to use, so operators with no vision experience could easily modify the inspection on-the-fly during product changeovers.' Several criteria were needed for the system to be successful in meeting Eli Lilly's requirements.

The vision system would have to establish a tray count, look for vials that have fallen over, check that flip seals are in place, and inspect for vials with the wrong colour caps, called strangers.

After evaluating a number of systems, CES selected the In-Sight 1000C colour machine vision sensor from Cognex.

The sensor combines a DSP-based vision-processing unit with a 640 x 480, 8-bit progressive scan digital vision camera in a compact housing with built in communications, and a library of vision software tools.

'We tested several systems to prove which could do the job, then selected the vision system based on the results,' said Clarke.

'Cognex tools were more robust for this application than the other vision tools we evaluated, and the powerful pre-processing filters helped us achieve the desired inspection results.

The Cognex vision tools provided the most robust solution.' The image pre-processing filter tools that other systems offered were not extensive enough to accomplish the inspection goals for the vial trays used by Eli Lilly.

The total count of each tray was not repeatable and therefore not reliable.

Filter tools could not easily be referenced together in order to obtain a refined pre-processed image.

Also, to obtain real-time counts of a tray being inspected, additional front-end programming would be required within the other systems evaluated.

Due to Cognex's unique spreadsheet interface the user can also use one filter to look through another filter resulting in a further pre-processed image for blob counting.

The software is user friendly to navigate through and making changes to the program, or adding a new product.

* System set up - to set up the application, CES used the In-Sight vision spreadsheet interface.

The process involved selecting vision tools and parameters from drop-down menus.

The vision spreadsheet then automatically generated tool results into worksheet cells, which were then linked together to set up the inspection.

CES used In-Sight's blob analysis tools to count the number of vials and determine cap shape, and colour histogram tools to verify cap colour in order to identify strangers.

Additionally, the vision sensor was trained to distinguish specific colours using hue, saturation, and intensity.

The TIS-3000 features Allen-Bradley controls.

A SLC-5/04 PLC handles sequential control and logic.

Communications are handled via hardwired discrete I/O (Input and Output), serial data transfer and Data-Highway Plus.

A PanelView 1000 mounted on a pivoting arm serves as the main operator interface for program selection, fault display and maintenance functions.

At Eli Lilly's request, the TIS 3000 also incorporates an industrial PC from Advantech (Cincinnati, OH).

Mounted within the inspection hood, the industrial PC runs a custom Visual Basic front-end interface developed by CES.

The result is a flexible vial counting and tray inspection system that can be run by a single operator with minimal machine vision knowledge, and handles a wide range of tray sizes with minimal mechanical changeover.

The TIS-3000 can run Lilly's largest tray configuration at over three trays per minute which equates to over one thousand vials per minute.

The system speed capabilities are well within the packaging line speed requirements of 320 vials per minute.

* Easy-to-use tray inspection - during the inspection process, the operator first selects the program and inputs the data required for a given product run and then loads a tray onto the load station.

The TIS 3000 uses three counting programs; each designed to handle a different type of count.

The most common is a fixed tray count where the operator selects tray style, the specific count for that tray type, and cap colour.

'Trays that do not meet these test criteria, would be rejected,' explained Clarke.

Operators can also choose a manual-input program scripted for counting new tray styles that are not yet programmed into the system.

For example, if the manufacturer comes out with a new style tray designed to hold 100 vials, the operator programs the system to handle this count by selecting manual count, and entering 100.

Once again, if the count is not met, the tray is rejected.

The third type of count handles random counts, such as when the operator must establish counts for various tray styles each containing a different number of vials.

In this instance, the system inspects as usual, but accepts all counts, while recording individual tray counts as well as the total count of all of the trays in the production run.

After selecting the count type, and entering the necessary data for a given product run, the operator places a tray onto the load station.

An indexing conveyor belt with cleats carries the tray full of capped vials into the inspection area.

Inside the hood, linear high-frequency fluorescent lamps, complemented by a custom designed dome, provide cloudy day illumination to enhance the features of interest.

A single In-Sight vision sensor, suspended in the hood above the tray, captures the image of the tray and vials.

After applying filters to pre-process the image, an on-board microprocessor analyses the image, compares it with stored data that comprises a standard, and makes the pass-fail decision, which is output to the main system controller.

If the tray contains the correct number of vials, it passes the inspection area, and is indexed to the unload station.

A second PanelView 1000 mounted on the back end of the machine downstream of the unload station displays the actual tray count data.

The operator verifies this count with the expected total, which is printed on a tag attached to the tray.

Once verified, an operator lifts the passed tray off and places it onto an accumulator table for further processing.

If the tray fails, a servo-controlled reject arm transfers it to the reject conveyor, unless cap of the wrong colour is identified.

'If a stranger is detected, the system locks up and requires supervisor intervention in order for the tray to proceed to the reject station,' said Clarke.

'This is an important feature in order to error-proof the process to prevent the wrong medication from being packaged into a lot.

Trays that fail due to a wrong count or downed vial error are automatically cycled back to the load station operator on the reject conveyor.

As the tray returns, the operator can see the cause of failure on the pivot-arm display.

For example, it will say either down vials or incorrect tray count so the operator can correct the problem and send it through again.

'Defective trays do not make it past the inspection station if it does not meet the test criteria,' Clarke said.

* System benefits/applications - the first systems that have been installed are being used for accountability purposes on packaging lines to reconcile incoming lot counts with final order counts.

Additional applications for the TIS-3000 include 100% accountability of vials, syringes, cartridges, and ampoules for controlled substance manufacturers that are required by law to account for any product diversion during the manufacturing and packaging processes.

The TIS-3000 concept can be utilised to establish initial lot counts and monitor lot counts throughout the controlled substance manufacturing/packaging process steps.

The TIS-3000 enables 100% accountability of all product throughout the process.

Where manufacturers have colour coded product vials the system can be utilized for Nude Vial (Bright Stock) Identification.

Clarke Engineering Services has also developed a smaller footprint Tray Inspection System (TIS-2000) that is approximately half the footprint of TIS-3000 but does not incorporate a reject conveyor system.

This system can be used for slower speed lines and off-line inspection activities.

In addition, an on-line printer to print and apply labels to product trays is available as an option.

* System Validation - a comprehensive validation package including engineering, functional and computer system validation documentation was developed for Eli Lilly and Company.

The TIS-3000 has been tested and validated down to unit level testing and has successfully passed Eli Lilly's stringent validation requirements.

Two TIS-3000 systems have been installed and validated at Eli Lilly's Indianapolis, Indiana, USA manufacturing facility.

* Business Benefits - a significant improvement in vial accountability on both lines where the TIS-3000 systems have been implemented has been demonstrated and measured in the parenteral packaging area.

The tray inspection systems have also eliminated the need for in-process 'count checks' required as part of the mechanical counting process resulting in less documentation requirements and improved line efficiencies.

Colour analysis speeds tablet inspection

A high-performance inspection system for tablets, capsules, and softgels achieves 100%, in-line inspection at full production speeds using spatial colour analysis) technology.

Symetix, the Pharmaceutical Business Unit of Key Technology, introduces Vantyx, a high-performance inspection system for tablets, capsules, and softgels. Vantyx achieves 100 percent, in-line inspection at full production speeds using Key's patented SCA (Spatial Color Analysis) technology, which provides the industry's highest color and spatial resolution. With unmatched precision, Vantyx verifies product color, count, shape, position, and presence of print and removes foreigners, color errors, shape defects, and missing doses to assure every dose conforms to product requirements.

Vantyx enables pharmaceutical manufacturers to achieve the highest level of diligence while maximizing throughput.

Vantyx is FDA 21 CFR part 11 compliant, designed to meet GAMP 4 requirements, and benefits from Key Technology's 10-year history of supplying FDA-validated inspection solutions to the pharmaceutical industry and 50-year history of supplying innovative technology to the food industry.

Symetix offers complete engineering services and validation packages.

The compact and flexible Vantyx inspection system can be embedded within other packaging machinery such as blisterpack thermoformers, flat bed printers, and slat fillers.

Symetix can also supply Vantyx as a stand-alone, bulk-to-bulk high volume inspection system.

The technology is capable of inspecting up to 10,000 individual tablets, capsules, or softgels per minute, or as many as 360 complete blisterpacks per minute.

Vantyx ensures accurate product identification and product integrity to maximise pharmaceutical manufacturers' diligence in assuring product quality while running at full production speeds.

Vantyx also serves to monitor upstream production processes, which allows manufacturers to address the FDA's Process Analytic Technology (PAT) guidelines for physical characteristics of the product.

Symetix can equip Vantyx with two to six high-resolution color cameras, depending on the needs of the application.

With up to six cameras, Vantyx can simultaneously inspect up to six different packages or six separate arrays of product.

Each camera uses a dedicated image processor for maximum speed and image resolution.

* About Symetix - Symetix, launched in September 2005, is the Pharmaceutical Business Unit of Key Technology, the leading manufacturer of best-in-class process automation systems with over 50 years of experience in the food, tobacco, and pharmaceutical industries.

Symetix offers worldwide sales representation and maintains demonstration and testing facilities at Key's headquarters and manufacturing divisions in Walla Walla, Washington, USA, and at Key Technology BV in Beusichem, the Netherlands.

Key's common stock trades on the Nasdaq National Market tier of The Nasdaq Stock MarketSM under the symbol: KTEC.