Benefits of working with us:

• Price Certainty -Provides improved budgeting opportunities

• Reduced Change Management Challenges – Streamlined communication

• Reduce Cost Overruns – Team involvement in the design phase prevents delays and cost overruns.

• Condensed Project Timelines – Procurement can occur simultaneously with design finalization.

• Collaborative Approach

• Risk Transference

• Reduced Management Efforts – Reduces the need to manage and supervise numerous contracts

• Consistent Quality – Quality control is integrated into the entire project.

Consultancy

Hexagonal has a team of consultants with extensive professional experience in the production departments, quality, engineering, research, and pharmaceutical industries records.

From the initial concept starting with an idea, to the final approval by national and international regulators, we will guide you safely in the whole process.

Engineering Design

Hexagonal SPM engineering capabilities comprise of proven processes and best practices which guarantee Quality by Design implementation from the outset and looks to provide integrated design, construction and GMP compliance.

Project Execution

When it comes to designing and building custom pharmaceutical machinery, you need a supplier Engineering Design with broad capabilities, experience.

Hexagonal start the project execution from the machinery manufacturing based on the machinery design settled in the engineering design step. After the shipment, workers will arrive onsite for cleanroom, machinery, and auxiliary facilities setup.

Project Management & Validation

During the project validation & qualification, our specialized technicians develop protocols, calibrate, and validate according to ISO, FDA & GMP, standards and national/international regulations.

Process Supervision

Project management a critical element in building complex machinery for the pharmaceutical industries. Project manager, process engineers and designers are assigned to each project. They are involved earlier in the project to define or review the scope of work.

• Weekly project meetings

• Open communications

• Management of FAT & SAT tests

• Installation schedule

• Periodical quality inspection

• Health and safety management and monitoring.

Process Qualification

Hexagonal has a highly qualified team of technicians experienced in the qualification process DQ, IQ, OQ, PQ following the validation master plan and applying the highest standards: ISO, GMP, and FDA.

• Validation master plan

• Standard Operating procedures

• Qualification of FAT & SATs.

• Machine’s user manual

• Qualification documentation: IQ, OQ, PQ, FAT, SAT

The last but not the least before we finish up the project is the production trail run and personnel training. Hexagonal weight our responsibility as our reputation. Hexagonal will accompany our customer to successfully produce three batch of product and provide throughout training program.

Trial and Training