Facility Engineering and Construction

Design and construct contamination-controlled environments (Cleanrooms) and related systems and utilities. 

Design and implementation of process engineering tools for API production. 

Qualification and validation of various equipment, instruments, and computerized systems in API production, finished production for direct and indirect critical systems. 

Support for efficient energy management and proper waste disposal. 

Expertise in turnkey implementation, including engineering management services (EPCM & EPC solutions), from feasibility studies to commissioning and qualification, with a high level of customization through design/construction and project management in compliance with GMP and GEP. 

Clean rooms and contamination control areas  

RABS and Isolator applied technologies 

HVAC systems 

Black and white utility installations 

Clean Water Systems (PW, WFI, PS) 

Electrical and BMS installations 

Civil works for production facilities 

Development of digitalization of processes  

SW Validation (Management systems, production control systems, laboratory systems)  

Compliance assessment and remediation plan  

Data integrity solutions  

Assessment and qualification of IT infrastructures  

IT quality system development 

Our expertise in turnkey implementation, including engineering management services (EPCM & EPC solutions), starts from feasibility studies up to commissioning and qualification, with a high level of customization.  

The main benefits for the customers are: 

Project schedule reduction; 

System integration in GMP/GEP environments; 

Budget-oriented solutions in accordance with client’s requirements; 

Customized approach and flexibility. 

In a nutshell, our job is like tailoring work: we talk to the client, we hold him in front of a mirror where he can see the effect of what is being sewn on him until he gets the result he needs, with his “taste” and our experience. 

Client Challenges:

A multi-national client needed to revamp the structures and utilities of new machines in the “Solid Oral Forms” department with a multi-annual program. Each revamping phase involves a programmed production outage, following product stock accumulation to fulfill the production plan.

Project Details:  

• Project completion in 2011
• Gross floor area: 700 m2
• PLG supplied a general contractor and project management
• Works amounted to: €1,500,000.00 

Results:  

PLG provided definitions and plans for individual steps according to realization priority, the production capacity of the plants, resource usage, and market demand. 

We further included the individuation of intervention strategies to ensure a physical delimitation of the department sector affected by the restructuring to guarantee total compliance of the productive area unaffected by the intervention. We strictly adhered to the construction times of the individual sub-phases to allow subsequent validation, training, and production start-up phases. 

Ensured complete respect for the estimated cost and expected qualitative result.