By Pharmadule Morimatsu…
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Modular Solutions for pharma & biotech industries
Swedish-based facility and process construction specialist Pharmadule-Morimatsu founded the concept of modular facility solutions and has also become a world leading provider of process equipment and modular skids for the pharma & biotech industries.
Its integrated and holistic approach to design, engineering and construction, combined with sophisticated off-site modular construction capabilities add up to ‘The Pharmadule Way’ of delivering advanced solutions for pharma, healthcare and life sciences companies.
These capabilities appeal to life sciences industries that need assured ‘right first time’ quality facilities and processes in the face of increasingly rigorous regulation, combined with the ability to project worldwide to meet the trend for specialization.
Modular solutions for pharma & biotech applications
These trends have increased international interest in the modular solutions for processing equipment provided by Pharmadule Morimatsu AB (Pharmadule).
Key players in the pharmaceutical and biopharma industries have embraced Pharmadule’s modular design and construction vision and methodology as enabling the best solutions for rapid construction of high quality in overseas markets. Meanwhile Pharmadule modular solutions in process equipment have been recognized as providing clients with faster project delivery, lower risk, predictable implementation and enhanced flexibility.
Modular Solutions in Process Equipment
The Pharmadule Way creates ‘The Power of Certainty’ by combining modular design and engineering with off-site pre-construction to deliver very high predictability. The client can be sure of delivery on time, on budget and with consistent high quality.
Initial investment and set up costs may be somewhat higher when using the modular approach. However, minimization of risk and the greater integration between design, manufacturing and onsite construction add up to offer a far more cost-effective overall process, usually resulting in comparable or lower costs over the scope of the entire project.
Furthermore, modular projects tend to offer much shorter overall timeframes between commissioning and delivery when compared with traditional engineering and construction approaches. The commissioning, qualification and validation stages in particular are usually far quicker as they have been ‘paid forward’ as part of the modular design process rather forming separate stages as in a traditional project.
The Pharmadule Way
For more than three decades, Pharmadule has focused on the modular solutions for pharma and biopharma applications. Now, as part of the Morimatsu Group, this Swedish-based design build and turnkey plant specialist can continue to work with global projects with a stronger approach to deliver turnkey projects worldwide.
The partnership with the pharma and biotech industry has been synergistic with clients sharing an appreciation of a rational approach to projects, incorporating values like Quality by Design (QbD) and a rigorous approach to planning and process.
This leaves Pharmadule ideally placed to support life sciences partners with their modular construction and design enquiries. Pharmadule’s success over more than quarter of a century has been based on a value proposition that combines predictability and assured quality for the client with flexibility and rapid time to market with cost and schedule control.
Modular pharma & biotech facilities
Success in facilities construction lies within a manufacturing philosophy that seeks to minimize risk and variable factors at every stage. Modularization of construction entails rational use of prefabrication, to simplify and streamline the work.
Pharmadule offers a wide range of basic module types to achieve this, including process modules, production rooms, pipe racks, facility modules, and clean rooms. This approach increases predictability and flexibility while shortening delivery time
Modular fabrication minimizes risks by allowing some 75% of construction to take place indoors under controlled conditions with rational and effective working procedures in an assembly line manner by highly trained staff who are specialized in the disciplines of pharmaceutical engineering.
While facilities and pre-process equipment are manufactured off-site, on-site excavations, foundations and platforms can be completed onsite, ready for final installation. This parallel process allows much faster and error-free assembly, commissioning and validation.
The Pharmadule approach to integrated qualification leverages inputs from the workshop to a maximum, drastically reducing time spent on-site.
Pharmadule’s association with the Morimatsu Industry Group allows it to supply specialized process equipment; including bioreactors, vessels, CIP-skids, formulation systems and many other process systems from in-house sources.
Modular pharma solutions
With a solid track record from designing and delivering pharmaceutical production facilities including process steps such as product formulation, vials & syringe filling and lyophilization, Pharmadule can help identify the best modular process solutions, taking all relevant aspects into account.
Specific expertise includes:
- Aseptic and sterile fill and finish processes for injectable solutions in vials, ampoules and syringes
- Lyophilization of products filled in vials or syringes
- Traditional infusion solution products (IV-solutions) with liquid delivery
- Isolator/barrier technology for containment and filling operations
- Oral solid dosage including weighing, dispensing, blending, granulation, spray drying, sieving, tableting and encapsulation
- High containment for processes of high potency products
- API production plants
- GMP Laboratories
Modular biopharma solutions
Pharmadule can guide clients through the whole process of achieving an efficient biopharmaceutical production flow, optimizing the layout and ensuring regulatory compliance for any manufacturing facility.
Specific Pharmadule expertise covers a wide range of applications, including:
- Mammalian cell culture (bioreactor) processes for therapeutic proteins
- Bacterial and yeast fermentation processes and recovery operations
- Blood plasma fractionation processes
- Downstream Processing, including membrane separation technologies, continuous (perfusion) cell culture recovery, liquid chromatography operations for protein recovery and downstream purification, solvent-based recovery and purification, media & Buffer prep and hold systems
- Layout optimization
- BSL Technology