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Ultimate modular design in biopharma process solutions
Pharmadule’s systems and solutions embrace modular design and engineering, combined with prefabricated off-site construction, to deliver very high predictability and Pharmadule’s “Power of Certainty” in which the client can be sure of delivery on time, on budget and with consistent high quality.
Since it was founded, Pharmadule has focused on supporting the pharma and biotech industries with specialty process equipment backed by expert advice on specification, installation, commissioning and regulatory compliance.
Modular Solutions in Process Equipment
Pharmadule Morimatsu provides complete biopharmaceutical process solutions ranging from bioreactors and fermenters through media/buffer preparation to formulation, bio-waste and clean or sterilize in place (CIP/SIP) systems. These are fully engineered solutions designed and configured to minimize waste and product loss and fully CIP/SIP capable while being easy to install, operate and maintain.
As an end-to-end from upstream to downstream solutions provider, Pharmadule can streamline interfaces across the whole system for easiest possible project management and delivery.
All Pharmadule biopharma process solutions share common attributes in design, automation, materials handling and documentation. These features include design using PDMS 3D software to ASME BPE standards and ISPE guidelines, modular concepts, multiple powder adding and lifting solutions and flexible material transfer systems. In automation, Pharmadule emphasizes user friendly man-machine interfaces, protective safety interlocks, programing to ISA 88, standards for batch production, full electronic recording. And compliance with GAMP 6 and 21 CFR Part 11 guidelines. Process systems can be fabricated to specific material specifications, including super austenitic stainless steel, Hastelloy or titanium, supported by fully traceable FDA, EMA and WHO compliant documentation.
Pharmadule applies a similar approach to modular design and total quality assurance to provision of preparation systems, sanitary vessels and CIP/SIP systems.
The Pharmadule modular approach
Pharmadule sees modern construction as emphasizing use of prefabrication, to simplify and streamline the work. The success of this methodology depends on following a holistic and modular manufacturing philosophy in which different types and hierarchies of components: skids, process modules, control panels, clean room systems and panels, pipe racks, facility modules, etc. can be combined in almost infinitely variations while achieving predictable results due to their inherent quality and interconnectability.
This approach also increases flexibility, accelerates response times and removes most of the risks of on-site fabrication.
Within this overall approach there is a role for fully-integrated modular design in perfecting basic interchangeable and systemically equivalent modules to perform functions that are constant across a range of overall processes and applications.
Since more than three-quarters of the actual fabrication and assembly is performed and finalized indoors under controlled conditions in a modern manufacturing manner, these modules can be assured of performing flawlessly within final on-site application.
The modular, remotely fabricated approach allows a parallel approach to the project, with excavation, foundation and services work on site performed at the same time as the actual facility is largely constructed off-site, allowing the modular plant to be assembled, commissioned and validated quickly after components arrive on site.
Since validation and qualification are also incorporated into an overall modular design process that incorporates QbD methodology, these, too, can be performed much more easily and quickly than with a ‘traditional’ linear project.
The full module design philosophy place more of the emphasis in project planning and delivery on the initial specification and planning stages and it is useful to work with partners who appreciate the fundamental differences between modular and traditional construction in installation approaches and who are experienced in the front end stages in modular construction.