Standards & compliance.
FC ENERGIE works in compliance with the strictest standards in the sector — pharmaceutical, hospital, aerospace, food & beverage and data center.
Pharmaceutical & cleanrooms.
Standards governing controlled-contamination environments and pharmaceutical production — particles, classes, qualifications.
ISO 14644
International standard defining cleanliness classes ISO 1 to ISO 9 — particle concentrations, measurement methods and cleanroom qualification.
EU GMP — Annex 1
European good manufacturing practice for sterile medicinal products — 2023 revision.
BPF / GMP
Good Manufacturing Practice — the Moroccan and international standard for the production of medicinal products for human use.
ICH Q1A (R2)
Stability of new active substances — long-term, accelerated and intermediate conditions for stability studies.
CFR 21 Part 11
FDA — electronic records and signatures. Traceability, audit trail and data integrity for computerized systems.
Hospital, aerospace, food & beverage.
NF S 90-351
Hospital — operating theaters with contamination risk, zone classification and airflow performance.
EN 9100
Aerospace — quality management system for aviation, space and defense organizations.
HACCP
Food & beverage — hazard analysis and critical control points for food safety.
Uptime Tier III / IV
Data center — redundancy and availability levels for critical computing infrastructure.
Standards of airflow engineering.
ASHRAE
American Society of Heating, Refrigerating and Air-Conditioning Engineers — the global reference for HVAC standards.
EN 1822
HEPA and ULPA filtration — classification, performance and test methods for very-high-efficiency filters (H13 → U17).
Fire rating EI 60 / EI 90
Fire resistance of partitions and doors — integrity (E) and insulation (I) in minutes (60 / 90).
DQ · IQ · OQ · PQ.
Four documented and validated stages — from design to operational performance, in line with GMP / FDA requirements.
Design qualification
Validation that the design meets the URS — User Requirements Specifications.
Installation qualification
Documented verification that the installation conforms to the drawings and specifications.
Operational qualification
Tests proving the installation operates within the defined operating ranges.
Performance qualification
Performance validation under real conditions, with real processes and operators.