Case Studies > ITS’ Validation Expertise Improves the Performance of a Medical Device Manufacturer

ITS’ Validation Expertise Improves the Performance of a Medical Device Manufacturer

Since 1991, Industrial Technology Systems Ltd (ITS) has carried out over 37 validation projects, mainly prospective, for one particular medical device manufacturer. These have included vendor audits and the validation of software, machinery and systems. The entire process involved ITS validating assembly machines, labelling processes and also the validation of office and laboratory based systems, injection moulding machines, and packaging processes. As validation involves the production of documentary evidence, the company also required process revalidation.

The two parallel activities carried out by ITS and the medical device manufacturer's staff have benefited them by identifying ‘best practice’ and enabling operators to adopt them to improve overall performance. As ITS’ validation manager explained, "ITS aims to provide not only the required paperwork for ‘evidence of operation’ but also real business benefits to our customer by identifying, recommending and installing improved procedures and processes."

During the process, ITS recommended and justified the need for the following requirements, which were recognised as an investment by the medical device manufacturer towards its future growth and continuous improvement:

  • Replacement of several laboratory systems
  • Replacement of  labelling machines
  • Modifications to the moulding machine programs to increase security

The security issues identified by ITS were also taken into consideration by the company’s moulding machine supplier.

The projects also involved the replacement of obsolete vision systems, the replacement of control systems and the validation of systems in the production and assembly area. ITS advised the company to replace its air monitoring system to enable them to maintain their compliance with the regulatory guidelines. This was not only replaced in the production assembly area but also throughout the entire building.


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