Thursday   28-Nov-2024

Phone:
+44 (0)161 928 8239
Email:
[email protected]

Introduction

Much of Intuitive's project experience has been in pharmaceuticals and biotechnology. Since the company was formed we have specialised in this business sector and have risen to meet the challenge of its exacting quality and validation requirements and tight project timescales. We are aware of the need to bring new drugs to the market as soon as possible and work hard with our clients to make this happen.

We have been involved in automation and MIS projects for plants employing a wide range of manufacturing processes including chemical synthesis, fermentation, biotechnology, blood products and vaccine manufacture, from pilot plant through small-scale manufacturing to bulk chemicals and finished products.

These projects have enabled to gain expertise in a number of areas unique to pharmaceuticals manufacturing.

Application of S88

Intuitive is highly proficient in the application of IEC 61512 (the ANSI/IEC S88 Batch Standard) to pharmaceuticals processes. We firmly believe that time spent at the start of the project in rigorously defining the physical and procedural models pays dividends later on when detailed design is undertaken. In our experience a consistent control strategy is reflected in a high level of interoperability between plant items and an absence of rework.

Process control

We have wide experience in evolving control strategies for common plant items such as batch reactors, and more complex plant such as fermenters and chromatography columns.

Interfacing

We are familiar with a wide variety of the packaged plant commonly associated with pharmaceuticals manufacturing. Such plant requires both the design and configuration of the necessary interfaces and the provision of suitable control strategies in the main control system. We have experience of both interfacing to and controlling packages such as:

• Filter dryers
• Fluidised bed spray dryers
• Centrifuges
• Desiccant dehumidifiers
• HVAC systems
• ESD and Fire & Gas systems
• Security and paging systems
• Packaged plant such as steam/distilled water packages, multiple effect distillation stills, compressors
• Laboratory, QA and sampling systems

Prototyping

On projects where our "fast-track" project execution strategy is appropriate, we actively promote the inclusion of a prototyping phase into the project. This enables the user requirements to be visualised at an early stage, and ultimately for us to deliver a system with not only reduced schedule and cost but also improved quality of the software and associated documentation produced

For more information on our project execution strategy click here.

Validation

Intuitive is committed to supporting the client's validation aims throughout a project. We have extensive experience of the validation of all phases of a project from design through coding and testing to commissioning and covering project hardware, software and documentation. This includes ensuring that our internal and our client's validation requirements are kept in step.

For more information on our Validation experience and services click here.

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