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Pharmadule Morimatsu AB
Pharmadule Morimatsu designs and builds turnkey production facilities and process equipment’s for the pharma and biopharma Industries and also for the FMCG area (Fast Moving Consumer Goods). Pharmadule services extend from conceptual design to IQ/OQ qualifications completion, offering a one-stop-shop suite of services that include: Front-End Design & Pre-Engineering, Detailed Design, Fabrication, Quality Assurance (QA) and Validation Management.
The company was founded in September 1986 by engineer Clas Wallenborg whose vision was to use the same basic modular design techniques and technology used to build specialized spaces for offshore oil platforms to be able to deliver ‘ready-made’ hygienic pharmaceutical production and laboratory facilities worldwide. These could be designed and fabricated centrally under hi-tech controlled conditions and transported to pharma sites all over the world for final assembly and erection.
Since then, Pharmadule has successfully delivered more than 70 production facilities worldwide for clients including Eli Lilly, Merck, Baxter, GlaxoSmithKline, Genentech, Pfizer, AstraZeneca, forging The Pharmadule Way as a way of offering unique value and reassurance to customers, with off-site construction and modular design concepts to provide very high predictability of on time, on budget delivery and consistent high quality, regardless of final location.
Since 2011, Pharmadule has been part of the Morimatsu Group of Japan, which specializes in process equipment, forming Pharmadule Morimatsu AB, headquartered in Stockholm, Sweden. The company also has a strong presence in Asia with engineering and manufacturing facilities in Shanghai, providing an enhanced service for clients in new markets.
Pharmadule Morimatsu offers a one-stop-shop suite of services that include:
Front-End Design & Pre-Engineering
With customer and process in mind, Pharmadule develops an optimised design for any pharmaceutical or biotech facility project.
Pharmadule’s Front End Design team consists of multi-skilled professionals with direct experience from pharmaceutical manufacturing, design and process technology. The team focuses on moving effectively through the front-end design phase ensuring that client requirements, time schedule, and budget are met.
Pharmadule is an expert in securing a predictable project execution and addressing flexibility to guarantee that best operating criteria are achieved. When properly executed, this phase provides the key to a cost-effective and successful facility project implementation.
Quality Assurance and Validation Management
The Pharmadule Quality Assurance and Validation team has extensive practical know-how on current regulatory requirements (FDA/EMA/CFDA/WHO/GMP), and relevant local regulations. The work-model takes into account the latest developments in the field, incorporating Quality Risk Management principles into all parts of the workflow.
Commissioning and parts of the installation and operational qualification (IQ/OQ) process are combined with the modular facility delivery at the vendor workshop and in Pharmadule’s own assembly facilities. The final steps of Qualification and Process Validation are performed on site, together with the client’s QA and Validation team. This allows for fast delivery without compromising quality.
Pharmadule can also act as a consultant, managing turnkey QA and/or validation projects for all types of pharmaceutical and biotech facilities. The team can also perform related tasks such as GMP audits, Risk Management (deriving CQA/CPPs), write Validation Master Plans and design GMP-compliant Quality Systems.
After Sales Support
Pharmadule continues to serve clients even after their original projects are installed and operating. A partnership approach can assist in keeping the facility and equipment in good working order, with production running smoothly.
Pharmadule’s After Sales Support Department can help with technical assistance, including: spare parts, on-site service, service contracts, documentation, training, upgrades, renovations and warranty issues.
Pharmadule can offer specialised design and construction advice across the broad range of life science production and research facilities.
Pharmadule has established a solid track record of designing and delivering pharmaceutical production facilities including process steps such as product formulation, vials & syringe filling and lyophilisation. Specialised expertise extends to fields including:
- Aseptic and sterile fill and finish processes for injectable solutions
- Lyophilisation 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 and tableting
- High containment for processes of high potency products
- API production plants
Pharmadule’s expertise in biopharma processes can guide clients through the whole process of achieving an efficient production flow, optimising the layout and ensuring regulatory compliance. The company has specialised knowledge of key upstream aspects including:
- Mammalian cell culture (bioreactor) processes for therapeutic proteins
- Bacterial and yeast fermentation processes and recovery operations
- Blood plasma fractionation processes
Downstream processing expertise includes:
- Membrane separation and cell culture recovery
- Liquid chromatography operations
- Solvent based recovery and purification processes
- Media & Buffer prep and hold systems
- Layout optimisation
- BSL Technology