11-Jun-2003

The modular concept

Abstract

There can be considerable advantages in opting for modular, turnkey pharmaceutical production suites built off-site, as Romaco IPM explains

Romaco IPM's modular technology allows the design, assembly and qualification of turnkey plants for pharmaceutical production with complete control of quality, lead time and construction costs.

The compact, stand-alone units are made of inter-connected "ISOdules", pre-assembled and tested at IPM's premises in France prior to installation at the production site. The modular concept makes them easy to validate and to relocate at a later stage should this be required. ISOdules are ideally suited for start-up production in remote locations, upgrades to ensure compliance with new regulations, or in circumstances where capacity increases are required without disruption to existing production. The first step is the preparation of engineering studies. These are carried out by the in-house engineering department, which is equipped with the required resources and experience necessary to design industrial pharmaceutical projects. The appropriate ISOdules, process equipment and utilities are selected according to the medicines to be manufactured, taking into account all the requirements of current pharmaceutical standards. The design is then finalised in accordance with production site specifications.

Choice of materials and finishes The ISOdules are constructed from composite materials and the materials and surface finishes can be adapted to best suit the process requirements and on-site environment. Once built, the units are positioned in the assembly hall according to the final site layout. Each piece of process equipment is then integrated into the ISOdules every machine is positioned according to the pre-agreed design, site services are connected and everything is fixed securely in place. Once installed, the equipment remains in place, secured throughout transport, installation and into production. Air treatment is a critical step in any pharmaceutical process and very close attention is paid to its implementation. The unit is essentially a self-contained HVAC module complete with full ducting for air delivery and recovery and the air treatment systems conform to all GMP and ISO norms applicable to the cleanroom class specified. Filtered air is blown into the process area and the staff air-lock via the integral ducting and subsequently recovered and returned to the HVAC module. Pressure differentials between the various zones are maintained throughout. A complete portfolio of optional utilities is available, depending on the process requirement, including hot water production, air compressor, HVAC module and primary water treatment. Before shipment to the production site, all process equipment and utilities are tested and qualified in pharmaceutical production conditions. Following factory acceptance tests, the unit is packed, shipped by any appropriate means of transport, installed and started up by IPM's qualified staff. Within six weeks of the inception of the project, the unit is ready for its first production run. IPM also provides a number of services, including qualification files for the whole modular unit and staff training in various areas. For pharmacists, theoretical training is available on techniques specific to the process implemented. Practical training on QC lab apparatus used for GMP testing can also be given. For engineers, training on maintenance and operating procedures is available for every piece of equipment supplied with the modular unit.

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