Taming the paharmaceutical validation process

A Modular Automation International product story

Edited by the Engineeringtalk editorial team Apr 10, 2001

Modular Automation, describes how the application of their tried and tested modular approach to pharmaceutical manufacturing can significantly reduce the headaches involved.

The validation process for the pharmaceutical industry makes the implementation of change a laborious process.

Companies are reluctant to change systems and manufacturing processes because the validation consequences can be too severe.

However, here, Modular Automation, describes how the application of their tried and tested modular approach to pharmaceutical manufacturing can significantly reduce the headaches.

In the world of assembly automation there is no such thing as a standard system.

Every application, every product, is different and requires a different approach and different techniques to produce an assembly machine with the right accuracy, speed and flexibility.

But to start designing each new system from a blank page would be a mistake.

Machine components are rarely identical to previous models, but they do have similarities.

And it is these similarities that Modular Automation capitalises on to achieve accuracy, speed and flexibility together with the quickest possible development and validation time.

The Modular Design library contains the company's approved designs for a wide range of automatic, semi-automatic and manual assembly stations.

This will include loading stations such as bowl or blow feeders; handling units; robots; and test stations.

Each will have been refined through many years of experience and then adapted, through minimal changes, to suit each application.

When it comes to the validation process, this proven modular approach really pays dividends.

Greg Hurst is the Pharmaceutical Project Manager for Modular Automation.

It's his job to oversee the whole project from initial concept right through to commissioning.

His first task is to write the Quality Plan, Project Plan and Functional Requirement Specification (FRS) - a technical document that identifies the verifiable parts of the project.

"The modular system makes the whole process much easier because we always know exactly how a piece of equipment will perform even before we assemble it," he commented.

Next comes the Design Specification covering the mechanical design, method of operation, choice of machine, safety and ergonomics.

This is a joint exercise with customer before the commitment to manufacture.

Again the modular system of manufacture helps by reducing the design time to a minimum.

The same principle is used when producing the Software Requirement Specification (SRS).

Greg Hurst explains: "The SRS defines the way in which the software will perform.

The software used is usually just an adaption of trusted technology we have used before, which significantly reduces the writing and validation time.

Similarly, Factory Acceptance Tests, the last part of the validation process before systems are despatched, also become much quicker, with fewer unwelcome surprises, as all the component parts of the machine are working within well-understood parameters.

Modular Automation also provides assistance during the Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) processes.

IQ provides documented verification that all key aspects of hardware installation have been carried out correctly in accordance with the recommendations of the manufacturer.

OQ is documented verification that the equipment performs as intended throughout anticipated operating ranges.

PQ is documented verification that the process produces components of the correct quality and with the required cycle times.

Again, Modular Automation's experience in production line technology can ease pharmaceutical companies through these essential parts of the validation process as quickly as possible.

By building machines with maximum built-in flexibility, Modular Automation can often shorten the time from clinical trials to mass production.

"We can also help the customer by building in safeguards such as automatic back up data and a short-term uninterrupted power supply to guard against product loss in the event of a power failure," explains Greg Hurst.

Moving from manual to automatic assembly can be a daunting experience for many pharmaceutical companies.

In addition to the time taken for validation, they must be confident that new automatic systems will perform well, be reliable and have the necessary flexibility to accept product variants or even product changes without fundamental redesign.

Modular Automation has shown that its use of proven technology provides that reliability and flexibility and demonstrates that the validation process need not be an obstacle to progress.