PROJECT MANAGER ENGINEER
YOUR SINGLE
POINT OF
CONTACT
From engineering to reception
ISALYS CLEANROOM is a single point of contact, a project manager engineer.
6
5
4
3
2
1
-
Your needsClean rooms are fundamental in pharmaceutical production. Isalys CleanRoom masters the normative references and ensures that the "clean room" solution is consistent with your drug manufacturing processes.
-
Our engagementsIntegration of functional expectations Analysis and design of traffic flows and utility networks Compliance with ANSM, EMA, FDA, ANVISA, PLVA authorities Control of building and security constraints according to GMPc/BPF Management of regulatory qualifications Selection of pharmaceutical laboratory equipment
1 - PRODUCT / PROCESS ENGINEERING
​
-
Intervention of our network of experts;
​
-
Convergence of needs with clients, definition of processes and equipment;
​
-
Construction of a initial technical and economic study of the decision support project.
3 - BUILDING ENGINEERING
-
Preliminary design study (APS) and detailed design study (APD).
​
-
Integration of constraints and normative requirements.
​
-
Preparation of the engineering file.
2 - PROJECT MANAGEMENT
-
Our project manager pilots the Quality, Cost, and Delivery issues of your laboratories.
​
-
He provides the required skills at the right time
​
-
As a single point of contact from the upstream definition to the final acceptance, he ensures regular communication of project's progress
6 - COMPLIANCE /
DELIVERY
-
Consolidation and transmission of the "Construction work file"
​
-
Staff training
​
-
Final validation good for use
5 - FUNCTIONAL QUALIFICATIONS
-
Steering of qualifications (IQ, OQ, PQ, MQ) by our Isalys experts.
​
-
Qualifications of equipment, installations and utilities
4 - EXECUTION OF WORKS
-
The work is carried out by the Isalys group or a selected partner under the guidance of our project manager.
​
-
With almost 20 years of experience in the execution of works in a clean environment, our know-how is a guarantee of quality.