PHARMACEUTICAL & CLEAN ROOM SPECIALISATION

When Air Quality is a Compliance Requirement — Engineer It Right the First Time.

Clean room HVAC systems designed, built, and commissioned to cGMP, Schedule M, and ISO standards — by engineers who have done it before.

Specialized Healthcare & Pharma Sub-Sectors

We build air engineering solutions specifically aligned with regulatory compliance, particulate containment, and thermal isolation.

Pharmaceutical Formulation & API

Controlled air distribution preventing cross-contamination in granulating, compression, coating, and sterile filling lines.

cGMP CompliantSchedule MISO 5 - 8

Hospitals & NABH Operation Theatres

Laminar airflow ceilings, positive pressure OT cascades, and negative pressure isolation rooms for infection control.

NABH GuidelinesLaminar AirflowHEPA 99.97%

R&D Labs & Fume Hood Exhaust

Variable air volume (VAV) fume hood exhaust, solvent vapor isolation, and acid-resistant ductwork engineering.

VAV ControlsATEX ExhaustDifferential RH

Regulatory Standards & Validation Framework

Schedule M / cGMP Mandatory air change per hour (ACPH) & pressure cascade control.
ISO 14644-1 Cleanroom particle counts & recovery time testing (Classes 5 through 8).
NABH Standards Hospital infection control, OT temperature 21±2°C, and RH 40–60%.
US FDA / WHO Guidelines Audit-ready DQ, IQ, OQ, PQ documentation and air velocity profiling.

The Air Engineering Challenge

Pharma cleanrooms cannot tolerate leakage, pressure drops, or temperature fluctuations. Cross-contamination between adjacent manufacturing bays can cause batch rejections costing tens of lakhs.

Standard commercial HVAC ducting leaks up to 15% of conditioned air, disrupting room pressure balances and letting unfiltered air enter sterile corridors.

The Phalange Solution

We manufacture our ducting in-house using automated lock-forming machines to guarantee zero leakage. We integrate HEPA filter banks with gel-seal housings, motor-driven pressure dampers, and automated BMS controllers to lock in exact pressure cascades year-round.

PHARMA & HEALTHCARE HVAC FAQs

Frequently Asked Questions

How do you ensure positive pressure cascades between cleanroom bays?
We install precision motorized differential pressure dampers and modulating return air dampers linked to real-time pressure sensors. This maintains a steady +10 to +15 Pascal cascade from cleaner to less clean zones.
Do you provide complete DQ, IQ, OQ, and PQ documentation for US FDA / WHO audits?
Yes. Every pharmaceutical cleanroom project delivered by Phalange Industries includes comprehensive Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) dossiers.
What HEPA filtration efficiency is used for hospital Operation Theatres?
We install H14 grade HEPA filters (99.995% efficiency at 0.3 micron) fitted into custom stainless-steel laminar airflow distribution hoods with terminal DOP test ports.

Planning a Pharma Cleanroom or Hospital OT Project?

Consult with our senior application engineers in Vatva, Ahmedabad today.

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