Modular Solutions for Processing Equipment

Increased specialization and ever-more complex regulatory requirements have increased pressures on pharmaceutical companies to achieve ‘right first time’ when building new facilities and installing process equipment.

This in turn has increased international interest in the modular solutions for processing equipment provided by Pharmadule Morimatsu AB (Pharmadule).

The Swedish-based specialist in modular facilities and process equipment has seen its modular design and construction vision and methodology embraced by key players in the pharmaceutical industry.

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 offers a unique value that it calls “The Power of Certainty”. Modular design and engineering, combined with off-site construction, deliver very high predictability. The client can be sure of delivery on time, on budget and with consistent high quality.

While set up costs may be higher for modular solutions in process equipment, modular design and construction offer a far more cost-effective route overall, with more than sufficient overall cost savings over the overall duration of the project to outweigh increased initial investment.

Timeframes for modular projects tend to be much shorter than those of traditional engineering and construction projects. Also commissioning, qualification and validation are all part of the modular design process rather than separate stages as in a traditional project.

Fundamental differences between modular and traditional construction in installation approaches make it imperative to work with a partner who understands and is experienced in the initial design and planning stage in modular construction.

For more than two decades, Pharmadule has focused on the Pharma & Biopharma industries. Now, as part of the Morimatsu Group, this Swedish-based design build and turnkey plant specialist is able to broaden its offerings to related industries where the Pharmadule-Morimatsu values are equally appreciated.

As a result, Pharmadule is well positioned to help support 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.

Modular Facilities

Modularization of construction entails rational use of prefabrication, to simplify and streamline the work.

The success of prefabrication lies within the adoption of a manufacturing philosophy rather than a traditional philosophy.

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.

Off-Site Fabrication

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 preprocess equipment is built, excavations, foundations and onsite 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 our efforts in the workshop to a maximum, drastically reducing time spent on-site.

As part of the Morimatsu Industry Group, Pharmadule can supply specialized process equipment; including bioreactors, vessels, CIP-skids, formulation systems and many other process systems; from within its own organisation.

Modular solutions for biopharma processing

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

Modular solutions for pharmaceutical processing

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

Basic and Detailed Design

All detailed specifications, shop drawings and installation drawings needed for fabrication and documentation of the facility are developed based on a mutually-approved Basic Design.

The time schedule is further detailed, as well as the procurement plan to support and control the project execution.

Full digital flow of engineering data is enabled end-to-end throughout the project, starting at the P&ID and data sheets, into the 3D model. Then on to procurement, construction and validation, where non-critical systems are checked out via handhelds (PDA’s), with single point of entry for all data.

Documents created are automatically put in document management system, where they are electronically signed. Reviews are made in 3D. Digital data and documents can be transferred to the client’s maintenance systems.