top of page

Clean Room HVAC Design in Saudi ArabiaEngineering.

2 days ago
14 min read

Engineering Guide for Pharmaceutical, Healthcare, Biotech and High-Hygiene Facilities in KSA

Direct answer


Clean room HVAC design in Saudi Arabia is an environmental contamination-control system, not an upgraded comfort cooling package. To achieve ISO 14644-1 particle classification and SFDA / EU-GMP or CBAHI compliance, the design must integrate eight engineered layers: high-air-change airflow (20 to 60+ ACH or unidirectional laminar flow), terminal H13/H14 HEPA or ULPA filtration, multi-stage pre-filtration against fine Saudi silica dust, a stable 10–15 Pa inter-room pressure cascade across airlocks, decoupled sub-dewpoint dehumidification and steam humidification, Eurovent/DIN 1946-4 hygienic Air Handling Units (AHUs), high-integrity DW/144 Class C/D ductwork, and full 3D CFD, TAB, DOP filter scanning and IQ/OQ validation.


When a pharmaceutical plant, hospital sterile compounding pharmacy, semiconductor lab or high-hygiene food facility is planned in Saudi Arabia, the HVAC system is frequently the single largest determinant of whether the facility passes regulatory licensing. Unlike commercial buildings—where temperature swings only cause occupant discomfort—a 5 Pa pressure reversal, a 10% relative humidity drift or an unsealed return-duct joint inside a cleanroom can contaminate an entire production batch or halt surgical and compounding operations.


Designing cleanrooms in Riyadh, Jeddah, Dammam, Tabuk and across KSA introduces severe external stresses that standard European or North American templates rarely account for: 48°C–52°C summer dry-bulb temperatures on make-up air intakes, high coastal wet-bulb humidity along the Red Sea and Arabian Gulf, ultra-fine airborne desert dust that rapidly blinds HEPA filters if pre-filtration is undersized, and strict local energy and mechanical codes. A defensible cleanroom HVAC design therefore starts with the User Requirement Specification (URS) and contamination risk profile — not with a rule-of-thumb cooling load.


Why conventional HVAC design logic fails in Saudi cleanrooms ?


Cleanroom classification is governed internationally by ISO 14644-1 (airborne particulate cleanliness from ISO Class 1 to ISO Class 9) and, for sterile medicinal manufacturing in Saudi Arabia, by SFDA Good Manufacturing Practice (GMP) guidelines aligned with EU-GMP Annex 1 and WHO TRS standards. ISO 14644-4 – Cleanrooms and Associated Controlled Environments (Design, Construction and Start-up)


  • Airflow is dictated by particle dilution and recovery rate (20 to 60+ Air Changes per Hour), resulting in supply air volumes 4 to 10 times higher than what sensible cooling loads alone require.


  • Standard thermostat deadbands allow wide relative humidity swings, promoting microbial growth (>60% RH) or electrostatic particle attraction and powder clumping (<35% RH).


  • Without automated supply/return airflow tracking or VFD compensation, progressive dust loading across HEPA filters reduces supply CFM and collapses room pressurization.


  • Conventional commercial AHUs contain internal insulation fibers, flat drain pans and thermal bridges that harbor bacteria, mold and condensation.


  • Untreated Saudi outdoor make-up air carries heavy fine-particulate loads during shamal dust events, choking expensive terminal HEPA filters within weeks unless staged G4/F7/F9 pre-filtration is engineered.


  • Leaky ductwork or unsealed ceiling penetrations prevent the room from holding its 10–15 Pa differential pressure cascade during airlock door openings.


To pass qualification at handover, every component from the fresh-air intake louver to the low-level return grille must be engineered as a sealed, verifiable pressure and psychrometric loop.



Figure 1. Cleanroom HVAC architecture: hygienic AHU psychrometric treatment and multi-zone pressure cascade in KSA.
Figure 1. Cleanroom HVAC architecture: hygienic AHU psychrometric treatment and multi-zone pressure cascade in KSA.


The 8 core engineering pillars of clean room HVAC design in Saudi Arabia.


1. Airflow regime, Air Changes per Hour (ACH) and low-level return geometry


Cleanliness classes ISO 6, 7 and 8 (GMP Grades B, C and D) typically rely on turbulent dilution mixing using ceiling-mounted terminal HEPA diffusers paired with low-level return air grilles installed 150–300 mm above the floor across opposite walls. ISO 5 (GMP Grade A) critical zones require unidirectional (laminar) vertical or horizontal airflow at a uniform velocity of 0.45 m/s ±20% to sweep particles continuously away from the exposed product or patient zone.


Engineering checks: Target ISO 14644-1 particle concentration (at rest and in operation); 15–20 minute 100:1 clean-up recovery time; low-level return grille distribution to eliminate dead corners.


2. Room differential pressure cascades and airlock philosophy


Cleanrooms protect sterile processes by maintaining positive pressure steps—typically 10 Pa to 15 Pa between adjacent classified rooms—flowing outward from the cleanest core zone through gowning/material airlocks to unclassified corridors. Where potent compounds, cytotoxic drugs, BSL-3 pathogens or dusty powder dispensing are handled, the pressure cascade is engineered with negative-pressure containment sinks or bubble/sink airlocks so hazardous aerosols cannot escape.


Engineering checks: Room-by-room ΔP matrix; door-opening leakage allowance; interlock logic with time delays on airlock doors; visual Magnehelic gauges and BMS differential pressure transmitters.


3. Multi-stage filtration engineered for Saudi desert dust


Terminal H13, H14 HEPA (99.95% to 99.995% MPPS efficiency per EN 1822) or U15 ULPA filters are polishing devices—not bulk dust collectors. In Saudi Arabia, fresh-air handling systems must incorporate heavy-duty sand-trap louvers followed by washable G4 pre-filters, F7 medium filters and F9 rigid bag filters inside the AHU so terminal ceiling HEPA filters achieve a 3-to-5-year service life.


Engineering checks: EN 1822 / ISO 29463 filter classification; dirty-filter static pressure allowance (2x initial ΔP); room-side replaceable gel-seal or knife-edge terminal HEPA housings with upstream PAO/DOP aerosol injection ports.


4. Precision psychrometric control: sub-dewpoint dehumidification and clean steam


Pharmaceutical tableting, effervescent lines, diagnostic reagent production and surgical suites require tight temperature (18°C–22°C) and relative humidity (typically 45% ±5% RH, or <25% RH for moisture-sensitive powders). In KSA, make-up air must be pre-cooled and deep-dehumidified via chilled-water coils, DX heat recovery or desiccant dehumidification wheels, followed by SCR-modulated electric reheat and clean-steam humidification.


Engineering checks: Coastal latent load vs. inland dry ambient extremes; sub-dewpoint chilled-water coil rows and fin spacing; desiccant rotor regeneration heat source; RO-fed clean steam humidifier selection.


5. Hygienic Air Handling Unit (AHU) construction (DIN 1946-4 / EN 1886)


Cleanroom AHUs must prevent internal microbial colonization and air leakage. Hygienic units specify smooth stainless-steel (SS 304/316L) or antibacterial powder-coated inner skins, double-skin acoustic/thermal panels (T2/TB2 thermal bridging, L1 casing leakage per EN 1886), 3-way sloped stainless condensate trays, UVGI coil irradiation, and fans mounted downstream of the primary cooling coil criteria.


Engineering checks: EN 1886 mechanical strength (D1), casing air leakage (L1), filter bypass leakage (F9), thermal transmittance (T2) and thermal bridging factor (TB2); sight glasses and marine access doors.


6. Computational Fluid Dynamics (CFD) validation of particle trajectories


Adding high ACH on drawings does not guarantee clean air at the work table. Overhead lighting fixtures, process machinery, operator movement and poorly placed return grilles create recirculation eddies that trap contaminants over critical zones. A 3D CFD study models velocity vectors, age-of-air, temperature stratification and particle sweep paths before ductwork fabrication.


Engineering checks: 3D room geometry including process autoclaves/filling lines; unidirectional velocity uniformity (0.45 m/s ±20%); stagnant eddy identification; return-grille resizing.


7. High-integrity ductwork, Duct Pressure Leak Testing and Duct Cleaning


Cleanroom supply and exhaust ducts operate at high static pressures (750 Pa to 1500+ Pa). Standard commercial duct seam sealing leaks conditioned air into ceiling voids, destroying room pressure balance and wasting fan energy. Ducts must be fabricated, sealed and tested to DW/144 Class C or Class D (or SMACNA Seal Class A) and thoroughly cleaned prior to HEPA installation.


Engineering checks: DW/144 / EN 1507 high-pressure duct leakage testing; stainless or zero-spangle galvanized construction; closed-cell antimicrobial external insulation; NADCA-standard pre-commissioning duct cleaning.


8. Automated airflow tracking, TAB, HEPA integrity scanning and IQ/OQ validation


A cleanroom cannot be handed over on a standard comfort TAB report. Commissioning requires automated supply/extract VAV or Venturi valve tracking, certified Testing, Adjusting and Balancing (TAB), in-situ PAO/DOP aerosol photometer scan testing of every installed HEPA filter and housing seal, room clean-up recovery time testing, and formal IQ/OQ documentation.


Engineering checks: ISO 14644-3 test procedures; calibrated hood CFM readings; PAO/DOP filter leak scan (<0.01% penetration); non-viable airborne particle counts; acoustic and lighting verification.

Field-proven pharmaceutical & clean-industry precedent in Saudi Arabia.


ASPAR Engineering’s project track record across Saudi Arabia includes delivering specialized clean-industry HVAC and precision steam humidification solutions (such as Condair EC and CP3 systems) for Tabuk Pharmaceuticals and major pharmaceutical distribution hubs including Nahdi Warehouse in Riyadh, alongside hygienic Air Handling Units (AHUs), Condair DA desiccant dehumidifiers, and certified Duct Pressure Leak Testing, Duct Cleaning, CFD and TAB services.



Figure 2. Cleanroom HVAC delivery: five engineering, testing and qualification gates from URS to IQ/OQ handover.


Technical reference matrix:

ISO 14644-1 & GMP cleanroom HVAC design parameters.

Cleanliness Class (ISO / GMP)

Max Particles ≥0.5 µm / m³ (At Rest)

Typical Airflow & ACH Range

Terminal Filter & ΔP Target

Typical Saudi Sector Application

ISO Class 5 (EU-GMP Grade A)

3,520

Unidirectional laminar flow (0.45 m/s ±20%)

H14 HEPA / U15 ULPA (+45 to +60 Pa)

Aseptic filling lines, isolator zones, microelectronics

ISO Class 6 (EU-GMP Grade B)

35,200

Turbulent / mixed flow (40 – 60+ ACH)

H14 terminal HEPA (+30 to +45 Pa)

Background room for aseptic Grade A, bone-marrow/hybrid ORs

ISO Class 7 (EU-GMP Grade C)

352,000

Turbulent dilution flow (25 – 40 ACH)

H13 / H14 terminal HEPA (+15 to +30 Pa)

Sterile compounding pharmacies, API solution prep, general ORs

ISO Class 8 (EU-GMP Grade D)

3,520,000

Turbulent dilution flow (15 – 25 ACH)

H13 HEPA (+10 to +15 Pa)

Oral solid dosage (OSD) packaging, gowning airlocks, clean corridors

Negative Containment (Potent / BSL)

Class-dependent (ISO 7/8)

Once-through 100% exhaust + Bag-In/Bag-Out

Dual H14 HEPA supply & BIBO exhaust (-15 to -45 Pa)

Oncology/cytotoxic compounding, infectious isolation, hormonal lines



The cleanroom design should start with a “User Requirement Specification (URS) data pack”


Before sizing hygienic AHUs or routing ceiling plenums, freeze a formal URS data pack between the process owner, QA/validation lead and MEP consultant. Ambiguous room classifications or unverified process heat loads cause costly mid-construction AHU replacements.

URS Input Category

Minimum Engineering Information Required

Classification & regulatory basis

Target ISO 14644-1 class (at rest and in operation); SFDA / EU-GMP Annex 1, WHO, USP <797>/<800> or CBAHI healthcare standard; recovery time target.

Room zoning & pressure regime

Architectural layout with personnel and material airlocks (PAL/MAL); positive vs. negative pressure cascade direction; door-interlock logic.

Psychrometric & process loads

Indoor temperature & RH tolerances (e.g., 20°C ±2°C, 45% ±5% RH); autoclave, lyophilizer, tablet press and lighting sensible/latent heat loads; occupancy count.

Make-up air & local extract

Process exhaust hood/biosafety cabinet CFM; once-through (100% fresh air) vs. recirculated air permissions; Bag-In/Bag-Out (BIBO) filtration needs.

Architectural & ceiling envelope

Flush modular cleanroom panel system; walkable vs. non-walkable ceiling grid; clear interstitial service void height for ducts, VAVs and HEPA plenums.

Validation & EMS monitoring

Environmental Monitoring System (EMS) vs. BMS segregation; 21 CFR Part 11 data logging; continuous particle counters; DQ/IQ/OQ/PQ witness protocols.



Why high ACH and Saudi ambient extremes demand dedicated energy & psychrometric engineering.


Because a cleanroom circulates 20 to 60+ air changes per hour while rejecting make-up air exhausted by process hoods, its cooling and fan energy footprint is several multiples of a commercial office. In Saudi Arabia, conditioning 50°C outdoor make-up air down to a 9°C–11°C apparatus dew point—and then reheating it to maintain 45% RH—creates a massive thermal load that must also respect Saudi Building Code mechanical (SBC 501) and energy conservation (SBC 601) principles.

High-performance cleanroom designs in KSA overcome this penalty by separating the Dedicated Outdoor Air System (DOAS) from the high-volume recirculation AHU: the DOAS handles deep latent dehumidification, sand/dust pre-filtration and energy recovery, while the recirculation AHU handles sensible heat and high-ACH particulate dilution using variable-speed EC fans and hot-gas or condenser-water heat recovery for reheat.

Critical regulatory & qualification boundary.


This article is an engineering planning guide, not a certified GMP validation protocol. Final cleanroom classification, pressure cascade matrices, cross-contamination risk assessments, hazardous exhaust treatment and IQ/OQ/PQ qualification must be approved by the facility’s Quality Assurance (QA) unit, licensed MEP design consultants and relevant Saudi authorities (SFDA, MOH/CBAHI, MODON and Civil Defense).


Saudi-specific engineering considerations for cleanroom HVAC projects

  • SFDA & EU-GMP Annex 1 alignment: Pharmaceutical and sterile medical-device plants in KSA must satisfy Saudi Food and Drug Authority (SFDA) inspections, including continuous differential-pressure monitoring, alarm logging and documented Contamination Control Strategies (CCS).

  • Sandstorms and 4-stage fresh-air filtration: During seasonal dust storms, outdoor PM10 and PM2.5 levels spike dramatically. Fresh-air intakes require inertial sand louvers, G4 washable panels, F7 pocket filters and F9 cartridge filters ahead of the main AHU coils.

  • Red Sea / Arabian Gulf latent loads vs. Riyadh dryness: Cleanrooms in Jeddah, Yanbu, Dammam or Jubail require double-cooling coils or desiccant dehumidifiers to handle extreme coastal dew points, whereas facilities in Riyadh or Tabuk require high-purity RO steam humidification to prevent electrostatic charges.

  • 52°C high-ambient chiller redundancy (N+1): Loss of chilled water causes cleanroom temperature and RH to breach GMP limits within minutes. Chiller plants must be sized at 50°C–52°C ambient with N+1 pump and chiller redundancy and automatic lead/lag switchover.

  • DW/144 Class C/D duct pressure leak testing: High-pressure supply and contaminated exhaust ducts concealed above flush cleanroom ceilings must pass certified duct pressure leak testing before ceiling panels are closed.

  • Life-safety and smoke-purge interlocks: Cleanroom airlocks with electromagnetic door interlocks must fail-safe unlock immediately upon fire-alarm activation, and smoke dampers must isolate zones without violating hazardous containment rules.


Cleanroom HVAC delivery workflow: from URS and Design Qualification (DQ) to OQ handover


1. Freeze the User Requirement Specification (URS): define ISO 14644-1 class, GMP grade, room T/RH tolerances, process exhausts and regulatory authority (SFDA / CBAHI).

2. Develop the room zoning, personnel/material airlock layout and 10–15 Pa differential pressure cascade matrix.

3. Run a 3D CFD airflow and particle-sweep simulation to optimize ceiling HEPA diffuser placement and low-level return grille locations.

4. Engineer the psychrometric cycle: separate DOAS latent treatment from high-ACH recirculation and size hygienic AHUs (EN 1886 / DIN 1946-4) and 50°C+ chillers.

5. Complete Design Qualification (DQ) review to verify that P&IDs, equipment submittals, EMS sensors and material finishes meet GMP and code requirements.

6. Install high-integrity ductwork and execute certified Duct Pressure Leak Testing (DW/144) and internal Duct Cleaning while terminal HEPA housings remain blanked off.

7. Flush and chemically treat chilled-water and reheat hydronic loops, then verify hygienic AHU casing leakage and drain-pan slopes (Installation Qualification – IQ).

8. Unseal and install terminal H13/H14 HEPA filters only after the cleanroom architectural envelope (walls, floors, ceiling silicone joints) is dust-free and sealed.

9. Perform certified Testing, Adjusting and Balancing (TAB) to lock in supply CFM, ACH rates, room pressure cascades and VFD/Venturi door-opening recovery.

10. Execute Operational Qualification (OQ): in-situ PAO/DOP HEPA leak scans, airborne particle counts (at rest), recovery time tests, airflow visualization (smoke studies) and EMS alarm sign-off.


Copy-ready consultant checklist: clean room HVAC design & qualification in KSA



  • ISO 14644-1 particle class and SFDA / EU-GMP / CBAHI standard frozen in the project URS.

  • Room-by-room differential pressure cascade (10–15 Pa steps) and airlock airflow direction mapped.

  • ACH dilution rate (20–60+ ACH) or laminar flow velocity (0.45 m/s ±20%) verified against recovery time.

  • Low-level return air grilles positioned to prevent stagnant corners and short-circuiting.

  • 3D CFD simulation completed for critical ISO 5 / 6 / 7 zones and equipment heat plumes.

  • Hygienic AHUs specified to EN 1886 (L1 leakage, T2/TB2 thermal) and DIN 1946-4 with SS 304/316 drain pans.

  • 4-stage sand and dust pre-filtration (Sand louver + G4 + F7 + F9) engineered ahead of terminal HEPA filters.

  • Sub-dewpoint dehumidification (chilled water / desiccant) and clean-steam humidification sized for KSA climate.

  • High-ambient chiller plant rated at 50°C–52°C outdoor design temperature with N+1 redundancy.

  • Supply and extract ductwork pressure-leak tested to DW/144 Class C/D and cleaned prior to HEPA load.

  • Terminal HEPA housings equipped with room-side PAO/DOP aerosol challenge ports and gel/knife-edge seals.

  • Automated VFD / constant-volume Venturi airflow tracking configured to compensate for filter loading.

  • Independent EMS sensors calibrated for temperature, RH and ΔP with audiovisual local and BMS alarms.

  • Airlock door electromagnetic interlocks integrated with emergency fire-alarm fail-safe release.

  • Full DQ, IQ, TAB, PAO/DOP scan and OQ particle-count validation protocols included in contractor scope.

How ASPAR Engineering can support clean room HVAC projects in Saudi Arabia

Cleanroom projects fail when design, hygienic equipment selection, ductwork integrity and validation testing are split across uncoordinated vendors. ASPAR Engineering provides an integrated engineering and product platform in Saudi Arabia that bridges the gap between cleanroom MEP design and field-verified commissioning.

Depending on your project stage, ASPAR supports consultants, pharmaceutical manufacturers, hospitals and industrial clients with: MEP Engineering Design and 3D Computational Fluid Dynamics (CFD) airflow modeling; supply of hygienic Air Handling Units (AHUs), high-ambient Chillers, and precision Condair steam humidifiers and desiccant dehumidifiers; pre-commissioning Duct Pressure Leak Testing, Duct Cleaning, and Flushing & Chemical Treatment; and certified Testing, Adjusting & Balancing (TAB), Indoor Air Quality (IAQ) testing, Commissioning, and 24/7 Operation & Maintenance (O&M).

From pharmaceutical manufacturing plants and GMP warehouses in Riyadh and Tabuk to hospital isolation suites and research laboratories, ASPAR ensures your cleanroom HVAC package is engineered for Saudi ambient realities and ready for regulatory sign-off.

Planning a new cleanroom or upgrading a GMP/healthcare facility in Saudi Arabia?Share your target ISO class, architectural layout, room T/RH matrix and equipment schedules with ASPAR Engineering’s technical team in Riyadh.

Discuss Your Cleanroom Project with ASPAR Engineering —


https://www.asparengineering.com/contactaspar  |  info@aspar.engineer  |  +966 59 662 9319


Relevant ASPAR Engineering pages


Frequently asked questions


What is the difference between ISO 14644-1 classes and EU-GMP / SFDA Grades A, B, C and D?


ISO 14644-1 classifies cleanrooms from ISO 1 to ISO 9 based on non-viable airborne particle counts only. SFDA and EU-GMP Annex 1 use Grades A, B, C and D for sterile pharmaceutical manufacturing—mapping roughly to ISO 5 (Grade A/B at rest), ISO 7 (Grade C at rest) and ISO 8 (Grade D at rest)—while adding strict viable microbiological limits (CFU) and mandatory ‘at rest’ versus ‘in operation’ state verification.


What differential pressure should be maintained between cleanroom zones?


Industry standards (ISO 14644-4 and EU-GMP Annex 1) specify a minimum differential pressure of 10 Pa to 15 Pa between adjacent rooms of different cleanliness grades, with air flowing from the cleanest zone toward less clean zones. Where hazardous, potent or infectious materials are handled, negative-pressure airlocks (sinks) are used to contain airborne hazards.


Why do cleanrooms in Saudi Arabia require Hygienic AHUs instead of standard commercial AHUs?


Standard commercial AHUs use internal fibreglass insulation, unsealed panel joints and flat drain pans that shed fibers, leak air under high static pressure and breed mold or bacteria. Hygienic AHUs (built to DIN 1946-4 and EN 1886 L1/T2/TB2 standards) feature smooth stainless or antibacterial interiors, sloped self-draining pans, zero-bypass filter frames and walk-inwashable access for GMP sanitization.


How do you protect expensive terminal HEPA filters from Saudi desert dust?


Terminal H13/H14 HEPA filters should never be exposed directly to poorly filtered outdoor air. In KSA, the fresh-air intake must include an inertial sand-trap louver followed by staged G4, F7 and F9 filtration inside the AHU. In addition, ductwork must be pressure-tested and internally cleaned before terminal HEPA filters are unboxed and installed.


When is a 100% once-through (fresh air) HVAC system required instead of recirculated air?


Most ISO 7 and ISO 8 cleanrooms recirculate 70% to 85% of their conditioned air through terminal HEPA filters to save energy. However, 100% once-through fresh air with Bag-In/Bag-Out (BIBO) exhaust filtration is required where cross-contamination risks are unacceptable—such as multi-product potent API facilities, cytotoxic compounding, BSL-3 labs, or rooms with heavy solvent vapors.


What information should I send ASPAR Engineering to start a cleanroom HVAC design or review?


Share your project location in KSA, facility type (pharma, healthcare, lab, food/industrial), architectural floor plans and ceiling heights, target ISO class or GMP grade for each room, process equipment heat/exhaust schedules, and any existing URS or consultant specifications.


What tests are required to validate a cleanroom HVAC system before handover?


A complete qualification package includes: DW/144 duct pressure leak test reports, hydronic flushing certificates, certified air and water TAB reports, room differential pressure cascade verification, in-situ PAO/DOP HEPA filter integrity scan reports, airborne particle count certification (ISO 14644-1), airflow velocity/uniformity tests, and clean-up recovery time tests.


Conclusion.


Successful clean room HVAC design in Saudi Arabia requires treating airflow, filtration, pressure cascades, psychrometric dehumidification/humidification and commissioning validation as one continuous engineering chain. When extreme 50°C+ summer temperatures, coastal humidity and desert dust are accounted for at the URS and CFD stage—and backed by hygienic AHUs, Class C/D leak-tested ductwork and rigorous TAB/OQ testing—the facility achieves reliable regulatory approval and stable long-term operation.

Whether you are developing a greenfield pharmaceutical plant, upgrading a hospital sterile suite or troubleshooting pressure and humidity alarms in an active cleanroom, early coordination between MEP design, hygienic equipment selection and field testing is the surest path to compliance.


Sources and technical references.

  • ISO 14644-1 & ISO 14644-4 – Cleanrooms and Associated Controlled Environments (Classification of Air Cleanliness & Design, Construction and Start-up)

  • ISO 14644-3 – Cleanrooms and Associated Controlled Environments: Test Methods & Metrology

  • SFDA (Saudi Food and Drug Authority) & EU-GMP Annex 1 – Manufacture of Sterile Medicinal Products (Good Manufacturing Practice Guidelines)

  • DIN 1946-4 & EN 1886 – Ventilation and Air Conditioning in Healthcare/Hygienic Buildings & Mechanical Performance of Air Handling Units

  • Saudi Building Code – SBC 501:2024 (Mechanical Code) & SBC 601:2024 (Energy Conservation for Nonresidential Buildings)

  • DW/144 & EN 1507 – Specification for Sheet Metal Ductwork (High-Pressure Class C & Class D Air Leakage Testing)

  • ASPAR Engineering – MEP Engineering Design, CFD Analysis, Hygienic AHUs & Humidification Solutions

  • ASPAR Engineering – Duct Pressure Leak Testing, Duct Cleaning, TAB & Commissioning Services

Technical note:


Cleanroom HVAC design parameters, ACH rates and pressure cascades are process- and regulation-specific. The matrices and schematic diagrams in this guide support engineering planning, but final system design, hazardous containment, fire-smoke interlocks and IQ/OQ/PQ validation protocols must be engineered and approved for the specific facility’s URS, QA requirements and Saudi statutory authorities.


 
 
 

Comments


bottom of page