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Introduction

Denca Controls is well experienced in the unique requirements of the pharmaceutical sector having worked with several pharmaceutical companies to provide integrated automated control systems.

Denca uses imaginative software engineering to provide full validation documentation for FDA and MHRA approval. This is particularly relevant to the process automation requirements of the pharmaceutical sector, as the following case study demonstrates:

Problem

Evans Vaccines converts pure water to steam and distils it back down to sterile water for injections (WFI). Increased product demand meant that they could not produce sufficient volume at the high quality level required by the FDA and the MHRA (formerly the MCA).

Solution

To maximise production volume at the required quality the plant's manual control system for the vial transfer production process needed to be converted to a fully automated control system. The solution which Denca implemented provided full validation documentation and included the following elements:

  • Design of two automated handling systems - one each for the pure water and the WFI.
  • Each system monitored and recorded the quality criteria at each stage of production via traceable electronic documentation in accordance with CFR21 Part 2 and as required by the FDA and the MHRA.
  • The design of the automated control systems needed to tightly control both the conductivity and heat of the pure water and WFI, plus ensure a constant availability of pure water for production and WFI at four separate feeding points.
  • Manufacture of the specialised control equipment required.
  • Coding the control programs for the programmable logic controllers (PLCs) and the human machine interface (HMI) touch screen.
  • Installation and commissioning of the automated control systems.

Benefits

The automated handling and control systems for the vial transfer production process provided the following main benefits to Evans Vaccines:

  • bespoke packaged plant delivered more volume of WFI at the required quality
  • full validation documentation provided to facilitate FDA and MHRA approval
  • tight control of production parameters reduced product wastage
  • increased functionality and product availability meant less production time lost.

Technical

Following a competitive tendering process, Denca Controls were contracted by Thermal Transfer Ltd for Evans Vaccines to:

  • provide a detailed electrical & instrumentation design package
  • software engineering - configure automation software for PLCs & HMI
  • manufacture and assemble bespoke control equipment
  • install & commission the full control system.

The primary components of the automated handling and control system included:

  • 2 x Allen Bradley SLC 500 PLCs
  • 1 x Allen Bradley Panel View 1000 HMI.

In addition, the contract included the design and implementation of the following elements:

  • Full sequencing for start-up and shut-down, including full sanitising and sterilising
  • Manual overrides for safety and maintenance.

The above installation provided Evans Vaccines with an automated handling and control system for the vial transfer production process which increased production volume, attained FDA and MHRA approval status, reduced product wastage, and reduced production time lost.

For further details, please contact Andy Vogan on 0151 257 9010

 

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