Service 01 / 04

Clean rooms.

FC ENERGIE's extensive experience in cleanrooms and controlled environments has built deep technical expertise — from design to operational qualification.

Salle blanche pharmaceutique
Controlled contamination ISO 14644
A · Sources of contamination

The 5 M of contamination.

Five families of contamination sources — each must be controlled through a combination of design, procedure and continuous qualification.

M.1
Environment
Atmosphere, temperature, humidity, differential pressure, airborne particles.
M.2
Manpower
Operators — gowning, movement, training, personal hygiene.
M.3
Material
Raw materials, consumables, packaging, process fluids.
M.4
Method
Operating procedures, sequences, flows, cleaning, disinfection.
M.5
Machinery
Process equipment, instrumentation, furniture — their design and qualification.
B · Objectives

Quatre controls to guarantee.

Every FC ENERGIE cleanroom is designed to meet these four levels of control simultaneously — without compromise.

B.01

Particle contamination

HEPA/ULPA filtration, ISO classes 5 to 9, continuous particle-count monitoring.

B.02

Cross-contamination

Pressure cascade, airlocks and pass-boxes, separation of operator / material flows.

B.03

Microbial contamination

Scheduled disinfection, cleanable surfaces, microbiological environmental monitoring.

B.04

Chemical contamination

Activated-carbon filtration, solvent management, detection of volatile organic compounds (VOCs).

C · Project cycle

From audit to qualification.

01

Study & design

URS, layout drawings, CFD simulations, airflow calculations.

02

Fabrication

Workshop prefabrication of partitions, plenums and AHUs — functional testing.

03

Installation

On-site integration, automation, BMS/BAS, commissioning.

04

Qualification

DQ · IQ · OQ · PQ — complete validation file for audit.