Services

With your process in mind, we guide you through a fast track Front End Engineering phase

Pharmadule's Front End Design team consists of multi skilled professionals with extenstive experience from pharmaceutical manufacturing, design and process technology. We focus on moving quickly and effectively through the front end design phase ensuring that your requirements, time schedule, and budget are met, all in compliance with cGMP.

Our expertise covers, among other areas:

Aseptic processing
Upstream- and downsteam biopharmaceutical processes
Single use technology
Lyophilization
Barrier- & isolator technology
BSL and containment requirements

DESIGN & ENGINEERING

When you are planning for a new manufacturing facility, upgrade of process equipment or expansion, it all starts with the process design.
Understanding the process and being able to translate it into a cGMP compliant facility design is key.

Once the manufacturing process is determined our project design & engineering process starts. We will mature the project design through Conceptual Design, Basic Design and Detailed Design. Our design process uses state-of-the-art design softwares and Building Information Management (BIM) systems to ensure a stringent design process.

Process Design

The core of any project is the manufacturing process. The process design is fundamental for the design of a manufacturing facility and its process equipment.
The starting point is the user requirement specification (URS) or a high-level process description. We develop Process Flow Diagrams (PFDs) describing the manufacturing process, capacity calculations and unit operations.
The purpose of the Process Design is to:

• Characterize and visualize the current process
• Determine gaps and bottlenecks, suggest improvements
• Choose suitable equipment
• Establish production schedule and capacity calculations
• Baseline layout development and modularization

Conceptual Design

Based on the User Requirement Specification (URS) we conceptualize your project. During the Conceptual Design we develop Process Flow Diagrams describing the unit operations in the manufacturing process. Once the process is defined our process architects start the layout development, including area classification, equipment arrangement and personnel- and material flows.
A draft project execution approach is developed together with a delivery schedule and a price estimate.
We help you identify risks early securing a predictable project execution and address flexibility to guarantee that your best operating criterias will be met. Properly executed this phase provides the key to a cost-effective and successful facility project implementation.

Basic Design

In the Basic Design the design is taken to the next level. PI&Ds, providing more details on process, instrumentation and utilities are developed together with detailed specifications and drawings for each design discipline. This is all included in the BIM (Building Information Modeling) 3D model. A detailed project execution plan and a constructability study are developed.
The time schedule is further detailed, as well as the procurement plan to support and control the project execution.
Throughout the design process, we will have multiple reviews to make certain that the design satisfies the requirements.

Detailed Design

In Detailed Design, all detailed specifications, shop drawings and installation drawings needed for fabrication and documentation of the facility are developed based on the approved Basic Design.
The time schedule and the procurement plan are further detailed to control the project execution.
We finalize the 3D model (Building Information Modelling) with a single point of entry for all data for objects. Our integrated Enterprise Resource Planning (ERP) system allows full digital flow of engineering data throughout the project from start to end.

COMMISSIONING & QUALIFICATION

Our quality and validation team have extensive practical knowledge and experience in current regulatory requirements (FDA/EMA/Chinese NMPA/cGMP) and local regulations.

In combination with the modular facility delivery, commissioning and parts of the IQ/OQ are performed at the equipment suppliers' workshop, and in our own assembly facilities.

The final steps of qualification are performed at the final site, often together with the client's QA and validation team. This allows for a fast delivery without compromising quality.

We have developed an extended V-model. This V-model offers seamless integration of Quality by Design (QbD) as defined by ICH Q8 Pharmaceutical Development and a modern risk-based approach as defined in ICH Q9 Quality Risk Management and GAMP 5 Risk-Based Approach to Compliant GxP Computerized Systems.

VALIDATION & QUALITY ASSURANCE SERVICES

Pharmadule Morimatsu is offering consultant services to manage your commissioning, qualification, validation and Quality Management System (QMS) projects for all types of pharmaceutical and biopharmaceutical facilities. We can provide the following services:

GMP audits
GAP analysis
Validation Master Plan
Commissioning, Qualification and Validation
GMP Risk Assessment and Control Strategies
Design Qualification
Quality Management System development and implementation
GMP consultancy and training

Quality Management System

We have developed a Quality Management System (QMS) which is aligned with ICH Q10 Pharmaceutical Quality System.

Our approach to build a world class QMS is to provide auditing, consulting, tools, methods, training, review and coaching for client to develop and implement the QMS.

We also provide Quality Manuals, including management and supporting SOPs.

TRAINING

Starting up a new manufacturing building often requires training of operators and maintenance personnel.

Pharmadule can provide tailor-made training programs for your new facility covering areas such as:

Hands-on training on process and utility equipment
Maintenance training
How to work in a GMP facility

AFTER SALES SUPPORT

Pharmadule Morimatsu continues to serve you even after your project is installed and in operation. We can be your partner when it comes to keeping your facility and equipment in good working order and your production running smoothly.

Should you require technical assistance, Pharmadule Morimatsu's After Sales Support Department can help you with:

Spare parts
On-site service
Service contracts
Documentation
Training
Upgrades, renovations, etc.
Warranty issues

Dive deeper into our modular concept and explore the wide range of process systems we offer. Download brochures here: Resource Center