My Engineering follows a « Quality by design » approach during all stages of the projects, to ensure the integration of all quality requirements.

Following the guidance given by the Project Management Institute (PMI), in order to meet the quality requirements, the project managers at My Engineering follow the guidelines:

– Identifying project goals, needs, and scope 

– Planning, monitoring, and documenting tasks throughout a project 

– Ensuring all tasks, deliverables, and project materials are delivered promptly 

– Managing all resources necessary for project execution 

– Fostering effective communication with stakeholders concerning project status 

– Foreseeing, managing and strategically eliminating blockers and potential risks

– Documenting each step of the process

– Ensuring results and success 

« Good manufacturing practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product. The main risks are: unexpected contamination of products, causing damage to health or even death; incorrect labels on containers, which could mean that patients receive the wrong medicine; insufficient or too much active ingredient, resulting in ineffective treatment or adverse effects. GMP covers all aspects of production; from the starting materials, premises and equipment to the training and personal hygiene of staff. Detailed, written procedures are essential for each process that could affect the quality of the finished product. There must be systems to provide documented proof that correct procedures are consistently followed at each step in the manufacturing process – every time a product is made. » (World Health Oorganization – 20th of November 2015) 

At My Engineering, we advice you at each step of the facility design to reach thos international standards.

Biosafety levels (BL or BSL) are used to identify the safeguards needed in a laboratory to protect workers, the environment and the public according last regulation.

There are four BLs: from BL-1 to BL-4, the fours being the highest containment level. 

The BLs classify the pathogens according to:

– spread, 

– mortality rate, 

– existence and effectiveness of treatment 

– the capacity of immune response

We have the expertise in the design of HVAC in controlled environments :

– The control of contamination, cleanliness and air purity

– The environmental parameters control (pressure, temperature and humidity) 

– The implementation of specific filtration, devices and air handling systems 

– The rnergy recovery systems

Our expertise in these fields allows us to provide turnkey solutions for:

– Cleanrooms 

– BSL laboratories 

– Radio protection environements

– Clinical controlled envirronments

The clean room is a room or a series of rooms where the concentration of particles is controlled in order to minimize the introduction, generation and retention of particles, generally for a specific industrial or scientific research purpose.

They are governed by the ISO 14664 standard. At My Engineering we are capable to advice your for every single part of it :

– Walls and ceiling

– Finishes

– Furnitures

– Doors equipment

– Pass Boxes

– PALS and MALS

– Stainless steel  accesories

My Engineering helps you to define the best technical solution that meets your needs for the production and distribution of clean utilities.

According to the customer’s requirements, a centralised or distributed system can be installed for the following utilties :

– (Higlly) Purified water ((H)PW)

– Water for injection (WFI)

– Clean Steam / Pure Steam

– Clean Gases / Clean compressed air

In order to exploit the clean room to its full potential, My engineering ensures the control of all the infrastructure equipment of the clean room and meets the legal requirements for a safe and clean process. 

– Decontamination stations

– chemical hood, 

– Laminar flow

– Autoclaves

– Biosafety cabinets

My Engineering houses the competences of design, study, follow-up of realization, commissioning and qualification of electrical installations in compliance with the last regulations.

The electrical engineer works to ensure that the high and low current electrical distribution is efficient at all times.

– Medium voltage distribution: extension, renewal, connection of sites and installations with power distribution from the external network.

– Low voltage distribution: fire detection system, access control, CCTV, anti-intrusion system, interlocking, instrumentation, process alarm system, equipment.

The automation systems ensure the good functioning of your installations, improves the collection and the management of your datas, simplifies the human operational tasks by the development of the systems aiming to make automatically a succession of operations. 

My Engineering designs the automation of the control and supervision systems from the clean room installations as well as the infrastructure necessary to host these systems.

– Implementation of a supervision system.

– Development or improvement of the SCADA computer system.

– Creation of an intuitive HMI interface for users.

– Data collection and analysis.

– Qualification and validation (GAMP5, 21cfrpart11, Data Integrity, FAT/SAT/IQ/OQ qualification test protocols.)

In every pharmaceutical production plant, Black utilities are essential. Our engineers master also those essential competences :

– Heating and cooling systems 

– Wastewater treatment 

– Waste collection and disposal systems

– Compressed air

– Industrial steam