Himalayan Steel Industries
HomeProductsClean Room Equipment Suite
Clean Room Equipment Suite
Cleanroom Transfer
Finish: Electropolished (Ra < 0.4 µm)100% Traceable SS
Himalayan Steel Precision Series

Clean Room Equipment Suite

A comprehensive turnkey suite of certified cleanroom machinery engineered for complete formulation, sterile injectable, and active pharmaceutical ingredient (API) facilities. Designed for seamless validation compliance under US FDA and EU-GMP regulatory audits.

Available Metallurgies
AISI 316L / AISI 304 Combined
Regulatory Compliance
Turnkey cGMP ComplianceISO 14644-1 Suite CertificationUS FDA 21 CFR Compliant
✓ Direct factory prices•✓ Material Test Certificate (MTC 3.1) included•✓ Pan-India Delivery

Engineering Overview & Fluid Dynamics

Active contamination barrier and laminar downflow principles

The Himalayan Steel Clean Room Equipment Suite offers complete, integrated facility solutions for turnkey pharmaceutical projects. Rather than procuring disparate equipment from various suppliers, our unified engineering suite combines dynamic pass boxes, static airlocks, high-velocity air showers, terminal HEPA filter housings, and continuous laminar flow hoods under a single, cohesive DQ/IQ/OQ validation and metallurgy traceability protocol from our Baddi manufacturing facility.

Technical Engineering Specifications

Standard dimensional tolerances, electrical parameters, and air quality ratings

Engineering ScopeTurnkey equipment package for ISO Class 5 to Class 8 cleanrooms
Core EquipmentDynamic & Static Pass Boxes, Air Showers, Terminal Filter Boxes, VLAF/HLAF Benches
Filtration StandardCertified H14 / U15 mini-pleat HEPA filters tested to EN 1822
AutomationInterlocking microprocessor logic with centralized BMS monitoring capability
Metallurgy Purity100% spectrometer-verified AISI 316L and 304 with EN 10204 3.1 MTC
Surface ProfileUniform electropolished Ra < 0.4 µm finish across all product contact points
CustomizationEngineered directly to architectural civil wall panel thicknesses (50 to 100 mm)
Validation ScopeComplete DQ/IQ/OQ validation protocols and FAT/SAT testing documentation

Standard Dimensional Matrix

Fabrication schedule comparison in Imperial and Metric standards

Custom dimensions available on request
Size (Feet)Metric (MM)Internal Chamber (W x D x H)External Footprint (W x D x H)
Pilot Plant PackageCustom Turnkey ScopeEngineered to room layoutTurnkey CAD drawing
Full Commercial BlockFacility Wide DeploymentTailored to production throughputFacility master plan
Note:External dimensions include top motor plenum and side return ducting. Himalayan Steel Industries custom-tailors flange profiles to fit any wall panel thickness (50 mm, 80 mm, 100 mm).

Cleanroom Construction & Architectural Design

cGMP sanitary fabrication details from our Baddi engineering works

Unified Metallurgy Standards

All equipment is built using certified premium stainless steel batches with verified chemical composition and zero surface pitting.

Coordinated Electrical Architecture

Interlocks and controls utilize compatible 24V DC logic with unified LED indicator color coding across all airlocks.

Standardized Flange Architecture

Wall mounting flanges are engineered to snap-fit cleanroom sandwich panels with identical sanitary RTV joint details.

Factory Acceptance Testing (FAT)

Every machine undergoes full operational and HEPA aerosol testing in Baddi before dispatch to ensure zero site punch-list delays.

Comprehensive Documentation Binder

Supplied with indexed multi-volume validation binders containing all drawings, MTCs, filter scans, and calibration certificates.

On-Site Installation Supervision

Factory-trained engineers supervise leveling, wall integration, electrical hookup, and on-site SAT aerosol audits.

Standard Operating Protocol (cGMP SOP)

Standard operating guidelines and contamination control sequence

SOP REFERENCE GUIDE
Objective
To establish project commissioning and handover protocol for the Himalayan Steel Clean Room Equipment Suite.
Scope
Applies to turnkey cleanroom machinery commissioning across pharmaceutical facilities.
Responsibility
Project Managers, Commissioning Engineers, and Facility Heads.

Step-by-Step Material Transfer Sequence

1
Uncrate and inspect all machinery against approved shipping manifests and GA drawings.
2
Verify structural wall openings match provided equipment perimeter trim flanges.
3
Position and level each unit using precision digital spirit levels.
4
Connect primary electrical feeds and verify earthing continuity (< 1 Ohm).
5
Perform DOP/PAO HEPA integrity scans on all pass boxes, terminal boxes, and laminar flow hoods.
6
Execute OQ cycle operational tests and sign off qualification protocol binders.

Sanitization & Wipe-Down Protocol

  • Perform post-installation gross cleaning with neutral detergent followed by 70% IPA wipe-down.
  • Follow individual machine SOP guidelines for shift and monthly sanitization.

Fail-Safe Interlock Protection

  • Central emergency power disconnect isolates all equipment in facility safety alerts.

Optional Engineering Customizations

Site-specific hardware adaptations

  • Central cleanroom status annunciator panel linking all airlock states
  • Spare parts turnover package (pre-filters, HEPA filters, UV tubes, magnetic locks)
  • Automated aerosol generator challenge equipment for facility maintenance teams
  • Flameproof electrical upgrades for explosive solvent processing zones
  • BMS Modbus integration gateway for remote facility compliance monitoring

Quality Validation Package (DQ/IQ/OQ)

Audit-ready documentation for US FDA and EU-GMP inspections

  • Facility Master Validation Plan (VMP) Support Documentation
  • Design Qualification (DQ) Binder with CAD Layouts & P&ID Drawings
  • Installation Qualification (IQ) Protocols across All Delivered Units
  • Operational Qualification (OQ) Test Protocols & Calibration Logs
  • Material Test Certificates (EN 10204 Type 3.1) for Every Batch
  • Factory Acceptance Test (FAT) & Site Acceptance Test (SAT) Reports

Cleanroom Design Highlights

  • Complete turnkey integration eliminates vendor coordination mismatch on site
  • Single-source traceability for all steel heats, certificates, and validation protocols
  • Standardized aesthetic finish across all cleanroom transfer hatches and airflow hoods
  • Backed by over a decade of precision fabrication experience in Baddi, Himachal Pradesh

Target Pharmaceutical Applications

Greenfield Pharmaceutical Formulation Plant Projects
Sterile Injectable & Ophthalmic Cleanroom Upgrades
Biotechnology Vaccine & Monoclonal Antibody Facilities
Active Pharmaceutical Ingredient (API) Powder Blocks
Medical Device & Orthopedic Implant Cleanrooms

Explore Other Equipment Divisions

SS Dynamic Pass Box (HEPA Filtered)

SS Dynamic Pass Box (HEPA Filtered)

Active Class 100 laminar downflow pass box with electromagnetic interlocking, Magnehelic gauge, and UV germicidal sterilization.

Static Pass Box (Wall Mounted)

Static Pass Box (Wall Mounted)

Precision wall-mounted transfer box with mechanical or electrical interlocking, UV lamp, and double-wall silicone gasketed doors.

Cleanroom Air Shower Decontamination Chamber

Cleanroom Air Shower Decontamination Chamber

High-velocity 25 m/s air jet decontamination tunnel with 360° rotating stainless nozzles and microprocessor interlocked doors.