Industrial · Commercial · Pharmaceutical
GMP cleanrooms, pressure cascades, HEPA H14 filtration, and complete IQ/OQ/PQ validation documentation for ISP licensing — ISO 7 and ISO 8 classification.
Solutions
Active pharmaceutical ingredient (API) synthesis requires ISO 7 or ISO 8 cleanrooms with positive pressure relative to corridors, temperature control ±0.5°C, and relative humidity ±5%. D&Z Building designs HVAC systems with precision air handling units, HEPA H14 filtration, and documented pressure cascades for GMP validation.
Tablet compressing and capsule filling generate API dust that may be toxic or allergenic. The HVAC system must control dust dispersion through local negative pressure, high ventilation rates (15–20 air changes/hour), and HEPA filters on the return. Relative humidity (40–60% RH) directly affects tablet quality — variations >5% can cause friability or punch adhesion.
Film and sugar coating processes involve organic solvents and high process temperatures (50–70°C). HVAC must handle process heat, extract solvent vapors above the LEL, and supply preheated dry air. D&Z Building designs systems with heat recovery and solvent vapor control compliant with NCh 2635 and ATEX standards.
Primary packaging (direct product contact: blisters, ampoules, vials) requires a minimum of ISO 8 with temperature and humidity control to preserve container integrity. Secondary packaging (cartons, labels) has less stringent requirements but still requires controlled environment for label printing quality and carton sealing.
ICH stability chambers (Q1A conditions: 25°C/60% RH long-term, 40°C/75% RH accelerated) are a regulatory requirement for drug registration in Chile. D&Z Building installs walk-in stability chambers with ±0.5°C temperature and ±3% RH humidity control, 24/7 monitoring, and alarms compliant with ICH guidelines Q1A, Q1B, and Q1D.
HVAC system validation (IQ: installation qualification; OQ: operational qualification; PQ: performance qualification) is mandatory for ISP licensing. D&Z Building delivers complete validation protocols: as-built drawings, sensor calibration certificates, smoke studies for airflow visualization, particle counts, and documented pressure differentials compliant with ISPE HVAC guidelines.
FAQ
WHO GMP guidelines (TRS 961) and ISP requirements establish classifications by process type: Zone A (ISO 5, Class 100) for aseptic filling of injectables; Zone B (ISO 7, Class 10,000) for aseptic manufacturing background; Zone C (ISO 8, Class 100,000) for less critical stages of aseptic manufacturing; Zone D (controlled air) for material preparation. Most solid-dose laboratories in Chile operate in Zones C and D. D&Z Building advises on classification based on the process and delivers the validation protocol.
A 100 m² ISO 8 (Class 100,000) cleanroom has a total cost (construction, HVAC, validation) of UF 1,500–4,000 (≈ USD 49,500–132,000) depending on wall materials, temperature and humidity control precision, and required validation documentation. The HVAC system represents 40–55% of total cost. For ISO 7 (Class 10,000) rooms, costs rise to UF 3,000–8,000 due to higher ventilation rates and more demanding HEPA filtration.
Positive pressure (room at higher pressure than the corridor) is used in standard manufacturing zones to prevent external contaminants from entering the product area. Negative pressure (room at lower pressure than the corridor) is used for highly potent APIs, toxic compounds, or allergens, to contain particles within the process zone and protect personnel and other areas. The minimum pressure differential recommended by GMP is 12.5 Pa. D&Z Building designs pressure cascades that maintain the differential under all operating conditions, including door openings.
ISO 14644-2 recommends annual recertification for ISO 7-8 rooms (particle count, HEPA filter integrity test). ISP requires recertification whenever there are changes to the HVAC system, room modifications, or when PQ is part of a registration dossier. Continuous monitoring (temperature, humidity, pressure differential) must be performed with annually calibrated sensors. D&Z Building offers maintenance and annual recertification contracts with ISP-ready reports.
IQ (Installation Qualification) verifies the system was installed according to design drawings and specifications: equipment, materials, connections, and initial calibration. OQ (Operational Qualification) verifies the system operates within specified parameters under empty and loaded conditions: temperature, humidity, airflow, pressure differential, and particle counts. PQ (Performance Qualification) verifies the system reproducibly maintains parameters during the actual manufacturing process. D&Z Building prepares all three protocols with reference to ISPE HVAC guidelines and ISP requirements.
Yes. D&Z Building performs technical audits of existing HVAC systems: as-built drawing review, airflow and pressure measurements, HEPA filter integrity tests, temperature and humidity mapping. If the system needs upgrading to meet current ISP requirements (e.g., due to updated GMP guidelines or a new process), D&Z Building prepares the improvement plan and delivers re-validation documentation.
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