Applications by Sector
Pharmaceutical Industry HVAC
Validatable systems for clean rooms, GMP production and controlled environments
Precision HVAC systems for pharmaceutical, cosmetic and veterinary industries. ISO 5 to ISO 8 classified clean rooms with HEPA H13/H14 filtration, ±0.5°C temperature control, 30-65% RH and differential pressure cascade. 100% validatable systems per ANVISA RDC 658/2022, GMP, FDA 21 CFR Part 11, ISPE Baseline Guides and WHO Technical Report Series. Complete documentation for IQ/OQ/PQ qualification and regulatory audit support.
Talk to SpecialistTechnical Specifications
Process Requirements
Aseptic filling area for injectables, eye drops and sterile products. Unidirectional laminar flow (0.45 m/s ±20%), minimum positive pressure of +15 Pa relative to anteroom, and particle count ≤3,520/m³ (≥0.5 μm) in operation.
Background for aseptic operations, solution preparation and sterile component handling. Particle count ≤35,200/m³ (≥0.5 μm) in operation with controlled turbulent flow.
Production area for solid pharmaceutical forms (tablets, capsules, dragees). Strict humidity control to prevent powder flow and adhesion issues. Minimum 20 air changes per hour.
Primary pharmaceutical packaging area, blistering and wrapping. Positive pressure environment relative to corridors and unclassified areas.
Physicochemical, microbiological and stability analyses. Analytical balance rooms with vibration and temperature control. Microbiology areas with negative pressure.
Microbiological testing area with negative pressure relative to corridor. Class II laminar flows for microorganism handling. Anteroom with door interlocking.
Environment for weighing raw materials and active ingredients. Vibration, temperature and humidity control for analytical balance precision. Containment systems for potent products.
Wet granulation and granule drying area. Critical humidity control for granulate quality. Exhaust systems with HEPA filters for powder containment.
Tablet compression and capsule filling area. Controlled humidity to prevent powder adhesion and flow issues. Integrated dust collection systems.
Tablet coating application area (sugar coating, film coating). Temperature and humidity control of inlet air for coating pans.
Storage of pharmaceutical inputs per product specifications. Calibrated dataloggers at multiple points with deviation alarms. Segregation of controlled materials.
Storage of vaccines, immunobiologicals, insulins and thermolabile medications. Mandatory redundancy with 24/7 alarms. Validated thermal mapping and calibrated dataloggers.
Accelerated and long-term stability studies per ICH Q1A. Controlled temperature and humidity conditions with validated continuous recording.
Handling of high-potency APIs (OEB 4-5) with containment systems. Negative pressure, airlocks with interlocking and HEPA filtration on exhaust.
Technical Analysis
Pharmaceutical Air Conditioning: Science, Regulation and Good Practices
The pharmaceutical industry operates under the most rigorous quality and safety standards in the industrial world.The HVAC system is considered a critical production support system, with a direct impact on product quality, patient safety and regulatory compliance.Unlike other industries, pharmaceutical HVAC systems must be designed, installed, qualified and validated following specific methodologies established by regulatory agencies such as ANVISA, FDA, EMA and WHO.
ISO 14644 Cleanroom Classification
The ISO 14644-1 standard establishes the classification of clean rooms based on the concentration of particles suspended in the air.The pharmaceutical industry mainly uses classes ISO 5 to ISO 8:
\n\n| ISO class | Federal Class (USA) | Particles ≥0.5μm/m³ | Typical Application |
|---|---|---|---|
| ISO 5 | Classe 100 | 3.520 | Aseptic filling, sterile handling |
| ISO 6 | Classe 1.000 | 35.200 | Aseptic background, preparation |
| ISO 7 | Classe 10.000 | 352.000 | Production of solids, non-sterile liquids |
| ISO 8 | Classe 100.000 | 3.520.000 | Primary packaging, aisles |
Pressure Cascade in Pharmaceutical Environments
\nThe pressure cascade is essential to prevent cross-contamination between areas of different classifications.Typical differentials are:
\n- \n
- Between adjacent classified areas:+10 to +15 Pa \n
- Between classified area and corridor:+15 to +20 Pa \n
- Between corridor and non-classified area:+10 to +15 Pa \n
- Containment areas (potent products):-15 to -30 Pa \n
Qualification of Pharmaceutical HVAC Systems
\nQualification is a formal, documented process that demonstrates that the HVAC system operates according to specifications and is suitable for its intended use:
\n- \n
- DQ (Design Qualification):Verification that the project meets user requirements and applicable standards. \n
- IQ (Installation Qualification):Verification that the system was installed according to approved specifications. \n
- O'QUE (Operation Qualification):Functional tests demonstrating operation within specified parameters. \n
- PQ (Performance Qualification):Prolonged monitoring demonstrating the ability to maintain conditions in real operation. \n
Data Integrity (ALCOA+)
\nEnvironmental monitoring systems must meet ALCOA+ principles for data integrity:
\n- \n
- Attributable:Data traceable to the person responsible \n
- Readable:Readable and permanent data \n
- Contemporary:Registered at the time of the activity \n
- Original:Original data or certified copies \n
- Accurate:Accurate and correct data \n
- Complete, Consistent, Enduring, Available:Extensions of the basic principle \n
Sector Challenges
ISO 5 to ISO 8 classified environments require strict control of viable and non-viable particles, temperature, humidity and differential pressure. Maintaining classification during operation is critical for regulatory compliance.
HVAC systems must be qualified (DQ/IQ/OQ/PQ) and validated per GMP standards. All documentation must be available for regulatory audits and demonstrate continuous compliance.
Tablet, capsule and powder processes are extremely sensitive to relative humidity. Variations can cause flow problems, adhesion, active ingredient degradation and product instability.
Maintaining pressure differentials between environments to prevent cross-contamination. Systems must respond quickly to disturbances such as door openings and occupancy changes.
Critical production areas cannot be without climate control. N+1 or N+2 redundant systems are mandatory to ensure operational continuity and protection of in-process products.
Monitoring systems must meet data integrity requirements (ALCOA+) per FDA 21 CFR Part 11. Electronic records must be secure, traceable and tamper-proof.
High-potency APIs (OEB 4-5) and cytotoxics require containment systems with negative pressure, airlocks and HEPA filtration on exhaust for operator and environment protection.
Clean rooms consume 10-100x more energy than conventional offices. Energy optimization must be balanced with quality requirements and regulatory compliance.
HEPA filters must be periodically tested (leak test) and replaced without compromising room classification. Replacement procedures must be validated and documented.
Frequent inspections by ANVISA, FDA and clients require complete documentation, maintenance records, instrument calibration and deviation and CAPA history.
Our Solutions
Air handling units designed for clean rooms with HEPA H13/H14 filtration, humidity control by dehumidification and humidification, and precise pressurization. Stainless steel or anodized aluminum construction.
View ProductChilled water cooling with high precision (±0.5°C) and N+1 redundancy for critical systems. Silent operation and superior energy efficiency for operational cost reduction.
View ProductPrecision climate control for laboratories, stability chambers and storage areas. ±0.5°C temperature and ±3% RH humidity control with integrated redundancy.
View ProductClimate control for support areas, technical corridors and anterooms. Models with high-efficiency filtration and construction for pharmaceutical environments.
View ProductTemperature control for reactors, process tanks, coating equipment and purified water systems. ±0.1°C precision for critical processes.
View ProductHumidity control for solid production areas, granulation and hygroscopic raw material storage. Capacities from 5 to 500 kg/h moisture removal.
View ProductDehumidification for environments requiring relative humidity below 30% RH, such as effervescent production, vitamins and moisture-sensitive APIs.
View ProductHelioCloud platform for continuous monitoring of temperature, humidity and differential pressure. 21 CFR Part 11 compliant, real-time alarms and audit reports.
View ProductRegulations and Standards
Benefits for Your Business
Success Case
National Pharmaceutical Laboratory - Oral Solid Production
Complete HVAC project for a new oral solid medication production plant (tablets and capsules) with capacity of 500 million units/year. The scope included ISO 7 and ISO 8 clean rooms for granulation, compression, coating and packaging, plus quality control laboratories and climate-controlled warehouses. The system was designed with focus on energy efficiency, using heat recovery, free-cooling and demand-based control, resulting in 35% savings compared to the original conventional system design.
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