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Kapisa Healthcare · Delhi NCR

Cleanroom Solutions - Precision Environments for Critical Healthcare & Pharma

Kapisa Healthcare designs, builds, and validates ISO-classified cleanrooms for hospital pharmacies, pathology laboratories, pharmaceutical manufacturing units, and critical care environments across Delhi NCR and India. From ISO Class 5 aseptic suites to ISO Class 8 controlled environments — we deliver every cleanroom to specification, fully documented and ready for regulatory inspection.
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ISO 14644 Classification

Cleanroom Classifications - From ISO Class 5 to ISO Class 8

Each ISO class has a defined maximum particle count. The lower the class number, the cleaner and more tightly controlled the environment – and the more demanding the HVAC, filtration, and construction specification.

Grade A / B

ISO Class 5 (Grade A/B)

Aseptic filling environments, laminar flow hoods, and critical aseptic processing zones. Used in hospital pharmacy sterile preparation units and pharmaceutical aseptic manufacturing.

≤3,520 particles/m³ at 0.5µm · HEPA H14 · 100% recirculation

Grade B Background

ISO Class 6 (Grade B Background)

Background environment for aseptic operations. Used as the surrounding room for ISO Class 5 laminar flow stations in sterile pharma manufacturing.

≤35,200 particles/m³ at 0.5µm · HEPA H14

Grade C

ISO Class 7 (Grade C)

Preparation and support areas for sterile manufacturing. Used in hospital pharmacy preparation rooms, microbiology lab support areas, and less critical sterile processing zones.

≤352,000 particles/m³ at 0.5µm · HEPA H13

Grade D

ISO Class 8 (Grade D)

Controlled but less critical environments. Used in gowning areas, component preparation, and general support areas adjacent to higher-classification cleanrooms.

≤3,520,000 particles/m³ at 0.5µm · HEPA H13

Where We Build

Cleanroom Applications - Healthcare & Pharmaceutical

Hospital Pharmacy Aseptic Suites

ISO Class 5 cleanrooms for IV admixture preparation, cytotoxic drug compounding, and sterile pharmaceutical preparation in hospital pharmacies.

Pathology & Microbiology Labs

Controlled environments for sensitive diagnostic procedures requiring low-particulate, temperature-stable conditions with contamination prevention.

Pharmaceutical Manufacturing

GMP-compliant cleanroom suites for small and medium pharma manufacturers — designed to WHO-GMP and Schedule M requirements.

Medical Device Manufacturing

ISO-classified environments for medical device assembly, packaging, and quality control - meeting ISO 13485 facility requirements.

IVF & Fertility Labs

Specialist cleanroom environments for IVF laboratories with precise temperature, humidity, and VOC control to protect embryo culture conditions.

Research & Biotech Labs

Controlled laboratory environments for biotech research, cell culture, and biosafety level 2 applications requiring contamination-free conditions.

Complete Scope

Turnkey Cleanroom Delivery - Design to Validated Handover

01

Cleanroom Layout & Design

AutoCAD layout with ISO classification zoning, personnel and material flow separation, gowning room design, and airlock positioning.

02

Modular Wall & Ceiling Panels

Flush-jointed, seamless, non-shedding panel systems - polyurethane or GRP sandwich panels with integrated ceiling grid.

03

HEPA / ULPA Filtration

Ceiling-mounted HEPA (H13/H14) or ULPA fan filter units providing the required air cleanliness classification.

04

Pressure Cascade Design

Positive pressure cascades from highest to lowest classification - preventing contamination ingress at every transition point.

05

Epoxy / Resin Flooring

Seamless, chemical-resistant, anti-static epoxy flooring with coved skirting - no particle-trapping joints anywhere.

06

Airlock & Gowning Rooms

Personnel and material airlocks with interlocked doors, preventing simultaneous opening and maintaining pressure integrity.

07

Temperature & Humidity Control

Dedicated AHU maintaining precise temperature and humidity within classification-specific tolerances throughout the cleanroom.

08

Environmental Monitoring

Particle counters, temperature and humidity sensors, and differential pressure gauges with alarm systems and data logging.

09

Validation & IQ/OQ/PQ

Installation Qualification, Operational Qualification, and Performance Qualification documentation provided for GMP and regulatory submission.

Frequently Asked Questions

Common Questions About
Cleanroom Installation

Hospital pharmacy aseptic preparation areas typically require an ISO Class 5 environment (Grade A) for the critical filling zone, within an ISO Class 7 (Grade C) or ISO Class 8 (Grade D) background room. The exact requirement depends on the type of preparation and whether the pharmacy is seeking NABH or regulatory approval.
ISO Class 5 allows a maximum of 3,520 particles per cubic metre at 0.5 microns — used for the most critical aseptic environments. ISO Class 7 allows up to 352,000 particles per cubic metre — used for less critical preparation and support areas. The lower the ISO class number, the cleaner the environment.
Cleanroom cost depends on the ISO classification, size, and complexity. A small ISO Class 7 hospital pharmacy preparation room can start from ₹12–20 lakhs. A multi-room ISO Class 5/7 aseptic suite for pharma manufacturing typically ranges from ₹40 lakhs to ₹1.5 crore depending on scale and specification.
Yes. All Kapisa cleanrooms are delivered with Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) documentation — formatted for GMP, NABH, CDSCO, and WHO regulatory submissions.
A small single-room cleanroom typically takes 6–10 weeks from design approval to validated handover. A multi-room cleanroom suite for pharmaceutical manufacturing typically takes 12–20 weeks. Validation adds 2–4 weeks to the construction timeline.

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