PRESS RELEASE April 2005

The "ALL NEW" SADE SP Series tablet/capsule Weight Sorters launched by CI Electonics Ltd at Interphex 2005 New York City

Booth No: 455

CI Electronics Ltd, the world's leading manufacturer of tablet/capsule weight sorters for the pharmaceutical industry, has today unveiled its all new SADE SP Series of tablet/capsule weight sorters setting new standards for sorting precision. The range includes floor standing units with hoppers for production and clinical trials batches as well as a bench top model suitable for smaller R&D and formulation batches that sort by weight to an accuracy of +/- 1mg.

Specifically designed for use in GMP environments, the SADE SP Series can sort most standard shapes and sizes of tablets and capsules without the need for change parts. They are very easy to clean and set up between batches and require minimum operator adjustment. All contact parts are made using electro-polished 316 Stainless steel as standard.

SADE SP Series sorters are fitted with the new CI Mk 6 weigh head for improved weighing performance. The design of the new feed and sort mechanisms provides precision handling of the tablets/capsules on and off the weigh pan and assures consistent sorting accuracy over 24/7 operation.

SADE SP Series sorters have a sophisticated control software that allows multiple sorting modes and can calculate statistical data for inclusion in a batch report. With USB and Ethernet connectivity, SP Series sorters can be linked to local or network printers and in Remote Mode can be linked to central Batch Record or Control Systems using an XML interface.

SADE SP sorters are supported by comprehensive validation documentation and a full installation and maintenance service.

SADE SP Series of tablet/capsule weight sorters

PRESS RELEASE November 2004

LATEST VERSION OF CISORP WATER SORPTION ANALYSER LAUNCHED

CI Electronics Ltd, a market leader in microbalance technology, have introduced the latest version of the Cisorp Water Sorption Analyser. It is designed for the study of the physical and chemical properties of solid or liquid samples. It can provide information on material changes that occur as a result of water sorption as well as information on surface porosity and other characteristics. This fully automatic system is suitable for water sorption profiling of material samples including pharmaceuticals, foods, detergents, building materials, fibres, wood as well as many other man-made or natural materials. Applications can range from research and development work through to use within production and quality control departments.

The key feature of the Cisorp is that it incorporates two CI high-accuracy, ultra sensitive microbalance heads which offer versatility in performance not achievable with many alternative makes of analyser. The simultaneous study of two separate samples can be undertaken or, alternatively, larger samples can be investigated by suspending a single sample across both balances. The combined capacity of the heads is 10 grams and the resolution is 0.1 microgram.

User defined test sequences can be run unsupervised for hours or days and viewed in real-time to provide instantaneous current analysis of a sample. Both thermodynamic and kinetic analysis of the performance of materials can be provided. Cisorp is particularly suited to giving rapid control of relative humidity and temperature during kinetic analysis.

CI Electronics has over 40 years experience in balance technology, supplying the pharmaceutical and many other industries. The company manufactures a range of products including Weight Sorters, Checkweighers, Hardness Testers and Dispensary Management Systems for companies throughout the world. Further details can be seen at www.cielec.com

Latest version of CISORP water sorption analyser launched by CI Electronics Ltd

PRESS RELEASE November 2004

NEW STANDARD MODULE FOR SILO DOSING WITH Ci-DMS DISPENSARY MANAGEMENT SYSTEM

CI Systems, the leading specialist developer of Dispensary Management Systems for the pharmaceutical industry, has added a Silo Dosing standard module to its renowned Ci-DMS Dispensary Management System.

PRESS RELEASE 7 October 2004

NEW COMPACT SADE BENCHTOP WEIGHT SORTER

FOR LABORATORIES AND R&D APPLICATIONS

CI Electronics Limited, the leading manufacturer of precision weighing equipment, has introduced the new SADE Benchtop, Tablet/Capsule Weight Sorter. Specifically designed for pharmaceutical research and development departments, it is ideal for 100 per cent weight sorting of small clinical trial batches. This model is the latest addition to the renowned range of SADE tablet/capsule checkweighers and weight sorters with their excellent reputation for high accuracy and consistent, reliable performance.

Typically accommodating 500 to 1000 tablets or capsules, the SADE Benchtop offers the added advantage of being a compact unit. Its small footprint allows it to fit neatly into the sometimes-limited space available in a busy laboratory environment. It incorporates SADE Sorters' proven features and benefits. The feed mechanism allows the user to sort tablets or capsules of different shapes and sizes with minimal adjustment. The initial set-up and operation is simple. Clean down between batches is both quick and easy, typically less than 20 minutes.

CI Electronics' products are accompanied with comprehensive validation packs to save time and money on validation. Available with the SADE Benchtop is the 21 CFR part 11 compliant, WinSort II package for statistical analysis of the sort data on a PC.

PRESS RELEASE 20 September 2004

SADE WEIGHT SORTING TECHNOLOGY

ON SHOW AT EMBALLAGE

CI Electronics/Pharma Alliance
Stand L085, Hall 5a, Emballage, Paris, November 22-26, 2004

CI Electronics, the leading manufacturer of precision weighing equipment, is exhibiting at Emballage 2004 on the Pharm-Alliance Stand L085 in Hall 5a. The company's renowned range of SADE tablet/capsule checkweighers will be highlighted with their reputation for reliability, high accuracy and consistent performance.

SADE sorters are ideal for contract manufacturing or packaging companies who want to offer customers 100% weight sorting for production, clinical trial or pilot batches.

SADE models can weight sort a wide range of products, from small irregular shaped tablets to the large over encapsulated product required for double blind testing. The SADE-P4 tablet/capsule weight sorter will be on show at Emballage, with full details of the complete SADE range available, including the new SADE Benchtop model which is ideal for limited space applications.

CI Electronics has over 35 years' experience in high accuracy weighing and understands the requirement to supply a fully validated process. The comprehensive support documentation and NAMAS traceable performance and calibration checks are an integral part of the company's service.

PRESS RELEASE July 2003

NEW WinSort II

Software for Analysing Tablet/Capsule Weight Sorting Results from SADE Sorters

C I Electronics Ltd, manufacturer of precision weighing equipment, has recently launched WinSort II Software, the new 21 CFR part 11 compliant version of the statistical analysis package for use with CI's SADE range of Weight Sorters.

With a strong emphasis on data security, WinSort II provides pharmaceutical manufacturers with a secure means to store and analyse data from batches sorted on a SADE. All operator actions are recorded in logs and the program can be configured to require an electronic signature as confirmation. For further security, WinSort II can also be configured to prompt a second user to confirm approval. A batch report may be printed, showing batch details, operator name, sort statistics, calibration history, approvals, and with sort data presented as a histogram.

WinSort II is highly configurable, incorporating multi level security. WinSort II integrates with the Microsoft® Windows Security on the PC at local or Network level to limit access to authorised users only. Named users are allocated specific roles within Winsort ll. Roles such as supervisor, operator or administrator can be configured to limit access to specified actions. An auto log-off timeout can be set to increase security. Once a sort process has been started, the sort data is stored on a secure database located locally or on a network server.

WinSort II can capture sort data from up to 4 SADE sorters simultaneously. It is also possible to view and print data from one sort, while running a separate one. There is context sensitive on-line help, and the system is user-friendly. WinSort II is available for retrofit to existing SADE units and is supplied with a comprehensive validation documentation pack, enabling customers to save time and money on validation.

CI's SADE weight sorters have an excellent reputation for high accuracy and consistent, reliable performance. Reasons for sorting a batch of tablets or capsules on a SADE machine include: ensuring weight uniformity by 100% sorting, either for quality control purposes or where the batch is destined for a clinical trial; reclaiming acceptable product from a weight-rejected batch; checking the product made at the start and end of a press run.

C I Electronics was founded on balance technology, and now has 40 years experience supplying the pharmaceutical industry. C I manufactures precision weighing equipment and systems for the worldwide pharmaceutical production departments. Products include Weight Sorters, Checkweighers, Hardness Testers and Dispensary Management Systems.

PRESS RELEASE November 2002

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Pharmaceutical software

Specialist vendors stay nimble, customer focused and ahead of the game.

Paul Stuart of CI Electronics Ltd. explains

The strategic drive for scalability of systems and integrated enterprise solutions for many Pharmaceutical Companies has spawned/engendered/given birth to the Manufacturing Execution System (MES) "one-stop" software vendor, offering a suite of plug-and-play modules. Scaling-up or adding modules alongside one another, has however on occasions led to breadth rather than depth, being the determining factor in vendor selection.

Niche and specialist vendors are better positioned to apply the most advanced techniques and methodologies in software development and have more recently created a new platform enabling their expertise and intimate knowledge of a particular stage in the process to be shared with equal ease across site wide systems. Perceiving benefits, component based development and the Rational Unified Process for software development form the cornerstones of this distinctive approach.

Perceiving benefits

The decision to automate a production process or maybe just a stage in the process, either for the first time or as an upgrade, will be driven by a range of business and operational needs and a clear analysis of what these are, is the best (and only!) place to start. Best practise goes beyond stating the requirements of the system in operational terms to defining how any changes or improvements to the process should benefit the business as a whole. Vendors who actively mine for these business benefits signal a strong partnership approach, one which is borne out of a desire to play a positive role in achieving t a n g i b l e improvements. In additions, such vendors through focus and s p e c i a l i s a t i o n , invariably have an intimate knowledge and understanding of the detail of the operational stage, which is reflected in the broad reach and configurability of their systems.

Take the Dispensary Room as a case in point. The Dispensary is the last of the premixing production stages and the activities undertaken here (i.e. the selection and weighing of ingredients) are widely regarded as mission critical.

Where the activities in a Dispensary are controlled and checked manually by a second operator, costly errors may occur because "hand on heart", we humans do make them. The operational need can be stated as the need to replace the second operator with an automation system. Niche vendors in particular are motivated to look beyond this for the business need, which may be defined (for example might be the reduction) as the need to reduce the risk to consumers of incorrect mixes(or lot) and to reduce waste costs by the elimination of errors in the dispensary. A specialist dispensary vendor would therefore more readily perceive this benefit and would seek to explain how they can deliver it thus providing a detailed insight into their capabilities, covering issues such as :

• 1) software logic that follows operator patterns and pre-emptive logic
• 2) system checks
• 3) system security
• 4) backup/recovery
• 5) test procedures
• 6) annual savings based on number of weighings/campaigns.

Component based development

The component is effectively a black box, which contains a set of characteristics that can be made use of by developers. Each component will perform a specific purpose (e.g. request and validate electronic signatures). Each component will be validated separately and, once validated, cannot be affected by changes to other components (and therefore does not require re-validation). This philosophy is being advanced by Microsoft's .Net solution and is the method by which all state of the art development is taking place. The philosophy is that, when a new product is being developed, existing components on the marketplace may be incorporated.

The benefits to users are that vendors may readily integrate any components into their products. Thus different vendor systems can more readily "talk to each other" and the sourcing of all modules from one vendor is no longer a constraint of the existing MES principle. In other words, an MES can be constructed by picking the "best" modules on the market, meaning those that go down into the heart of the operation and deliver tangible operational benefits. In addition, other benefits of this approach include rapid development, scalability (with components being distributed across a network), ease of upgrade and maintenance and perhaps, most importantly, ease of introducing new technology as it becomes available (eliminating the need for constant product re-writes).

Rational unified process

A robust approach to software development is key to "holding it all together". The Rational Unified Process is a software development process which integrates best practise in project management, Unified Modelling Language (UML) and layered architecture design patterns.

Develop iteratively

In RUP terms, an iteration is a selfcontained, mini-waterfall development cycle with elements of:

• business modelling
• requirements gathering, documentation and prioritising
• object-oriented analysis and design (OOAD)
• implementation or coding
• testing and
• deployment

This is also supported by project management, configuration management and setting up the development environment.

Manage requirements

The single biggest reason for project failure, according to The Standish Group (standishgroup.com) is lack of end user involvement. Requirements management is all about addressing this issue and provides a systematic approach to:

• Finding, eliciting, organising, documenting and managing requirements by
• Establishing and maintaining agreement between customer/user and the project team on the changing requirements

Project success, on the other hand, is defined as meeting all the Customers requirements. It stands to reason, therefore, that getting the requirements correct is a pre-requisite to all successful projects.

Use component architectures

Component based development as described above also represents a cornerstone of the Rational Unified Process.

Model visually

Some years ago, if you were an object oriented analyst or designer, you had a choice of several different modelling notations to use. Nowadays, the most popular of these have been combined (by the original authors Rambaugh, Jacobson and Booch) into the Unified Modelling Language or UML. UML is now the industry standard OOAD notation and is applicable to practically every software development project. Therefore, best practises now tell us that rather than describe our analysis and design decisions in words we should instead use UML. Why? Because UML allows communication between requirements gatherers, analysts and designers in a far less ambiguous and far more condensed form.

There is another benefit to modelling visually. UML tool vendors generally provide the facility to generate code directly from UML Class Diagrams and some from Sequence diagrams. This ensures that effort put into OOAD is productive since it can significantly reduce the amount of coding in a project.

Continuously verify quality

In the classic waterfall development lifecycle, testing is something that is done at the end of the project. Since the results of testing are our only way to prove that functionality has been delivered, this often means that we don't know how complete our application is until the last few weeks of the project. Potentially, a whole string of non-functional tests (like performance) could fail after coding has been completed leading to a significant amount of re-work or, in the worse instance, rewriting.

By developing iteratively, we can design, code and test as we go along. This proves that functionality works well before the end of the project. This is the mechanism we use to reduce risk in the project.

Manage change

The reality is that requirements may change through a project or may not all be definable at the outset. This is part of the nature of software development. Therefore, our approach has to bear this in mind. To a large extent, iterative development lifecycles help to address this because we can choose to leave unstable requirements to nearer the end of the project. Hopefully, by that time decisions will have been made or the delivery of that functionality can be postponed until version 2.

Embracing the best requires a strong cross-disciplinary commitment to achievement. This has long since been and remains today the domain of the specialist vendor who likes to make a difference. Combining a traditional ethos of defining and delivering benefits with the RUP approach is how niche, specialist software vendors are retaining their competitive edge in this age of convergence.

CLEANROOM TECHNOLOGY MAGAZINE, October/November 2002

www.cleanroom-technology.co.uk

View this article in PDF format

PRESS RELEASE April 2002

Water Sorption Analyser

automates complex test sequences.

Salisbury-based C.I. Electronics launches an innovative water sorption analyser which automates gravimetric study of the water sorption behavior of powdered, fibrous, liquid or solid samples to quickly and economically provide precise results in fundamental and applied materials research.

Based on microbalance technology developed by a world leader in its field, the CISorp Water Sorption Analyser represents a major advance over previous analytical methods. In contrast to established techniques which are typically slow, labour intensive, and potentially inaccurate, CISorp allows unattended execution of complex test sequences with high accuracy and dramatically improved productivity.

CISorp measures moisture adsorption and desorption isotherms, plus kinetic and temperature data for evaluation of important physical and chemical parameters in research and development, quality control, and determination of safe storage and handling conditions for materials. Operating at ambient pressures, CISorp is particularly suited to the study of hydrated samples which generate high vapour pressure and cannot be studied under vacuum.

Water sorption studies can reveal crucial information about samples which may not be obtained in any other way, and highlight subtle differences between compounds which may escape other analytical techniques. With its flexibility of operation CISorp yields information such as the general water sorption characteristics of a sample, the physical and chemical affinity of sample surfaces for water, the presence of surface pores, irreversible change resulting from water sorption, special features such as transitions at particular humidities, variations between samples and the effects of mixing them, the effect of compacting powders, the temperature dependence of water sorption, and the thermodynamic and kinetics quantities of water sorption.

CISorp incorporates two microbalances in a chamber in which temperature can be controlled in the range 5 to 65°C with ±0.1°C accuracy, and relative humidity (RH) in the range 0 to 100 percent with 0.1 percent resolution. A test sequence can be programmed with a large number of experimental steps, at which temperature, humidity or equilibration time may be specified and the weight of the samples measured with 0.1µg resolution. The dual balance arrangement enables simultaneous analysis of two samples or comparison of a sample against a standard.

PC Windows-based software controls data acquisition, display and printout of results. Tabular and graphical displays can be viewed in real-time, and recalled for review or printout after a test.