Cleanroom Technology
ISO-classified cleanroom zones, HEPA-filtered air, pressure cascades, controlled access, and environmental monitoring are designed around a documented contamination control strategy.
Learn about sterile manufacturingOur World-Class Facility
State-of-the-art sterile infrastructure designed for precision, compliance, and scale.
Facility Overview
Integrated Sterile Manufacturing Infrastructure
Our facility at SICOP Kathua, Jammu & Kashmir is purpose-built for sterile API manufacturing with dedicated zones for every function.
Manufacturing Unit
Dedicated sterile blocks for cephalosporins, penicillins, carbapenems and general products with ISO-classified cleanrooms.
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Quality & Compliance
Fully equipped QC and microbiology laboratories with HPLC, GC, and advanced analytical instruments for comprehensive testing.
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Warehouse
GMP-compliant cold-chain enabled warehouse with real-time temperature and humidity monitoring for raw materials and finished goods.
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Packaging & Dispatch
Dedicated secondary packaging lines compliant with cGMP, USFDA, and EU-GMP standards, with full dispatch traceability.
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Utilities
Robust utility systems including WFI plant, clean steam, HVAC, nitrogen generation, and 24x7 power backup ensuring uninterrupted production.
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Lyophilizer Unit
Industrial-scale freeze-drying equipment for thermolabile APIs, ensuring long-term stability without compromising potency.
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Manufacturing Infrastructure
Purpose-Built for Sterile API Production
Our Kathua manufacturing campus brings production, quality, engineering, warehousing, and dispatch functions into one coordinated pharmaceutical environment. Segregated process areas and controlled material and personnel flows are designed to support contamination control, repeatability, and scalable delivery.
- Dedicated production zones for key sterile API categories
- Qualified utilities supporting critical manufacturing operations
- Controlled receipt, quarantine, storage, and dispatch workflows
- Lifecycle approach to equipment qualification and process validation
Controlled Environments
Cleanroom Technology & Quality Control
Infrastructure and analytical controls work together to protect sterile integrity from incoming material through final release.
Quality Control Laboratory
Our analytical and microbiology capabilities support raw material, in-process, finished product, stability, and environmental testing through controlled methods and data review.
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Research & Development
Translating Science into Scalable Processes
R&D teams work across process development, analytical method support, scale-up, technology transfer, and lifecycle improvement. The aim is to build robust processes that can move efficiently from laboratory learning to controlled manufacturing.
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Environmental & Sustainability Practices
Responsible Growth by Design
Our environmental program focuses on efficient utilities, responsible water management, waste segregation, pollution prevention, energy awareness, and continual improvement as manufacturing capacity grows.
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Operational Excellence
Safety Standards & GMP Compliance
A strong pharmaceutical facility depends on trained people, disciplined systems, and a culture that treats quality and safety as shared responsibilities.
Safety Standards
Risk assessments, permit-to-work practices, emergency preparedness, occupational hygiene, preventive maintenance, and role-based training support safe daily operations.
- Documented incident and corrective action processes
- Equipment, chemical, fire, and personnel safety controls
- Routine drills, inspections, and competency programs
GMP Compliance
Our quality systems are built around documented procedures, controlled records, qualification, validation, deviation management, change control, CAPA, supplier oversight, and continual review.
- Data integrity and traceable batch documentation
- Audit readiness and regulatory documentation support
- Quality risk management across the product lifecycle
Facility Gallery
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Inside Our Manufacturing Ecosystem
Key Features
Features of Our Sterile Facility
Every aspect of our facility is engineered to maintain sterile integrity, regulatory compliance, and operational efficiency.
Cleanrooms
Grade A, B, C and D ISO-classified cleanrooms for aseptic manufacturing operations with validated particle count limits.
Positive Air Pressure
Cascading positive air pressure differentials between rooms to prevent contamination ingress and cross-contamination.
HEPA Filtration
100% HEPA-filtered unidirectional airflow in Grade A zones ensuring particle-free sterile environment at all times.
Smooth Surfaces
Coved floors, rounded corners, and smooth wall finishes enabling effective cleaning and sanitization throughout all areas.
Specialized Equipment
Lyophilizers, crystallizers, isolators, and aseptic filling equipment qualified to the highest pharmaceutical standards.
Aseptic Processing
Validated aseptic processing lines with media fill qualification ensuring sterility of all injectable API products.
Personnel Gowning
Dedicated gowning rooms with stepwise gowning procedures, air showers, and personnel qualification programs.
Environmental Monitoring
Continuous viable and non-viable particle monitoring across all cleanroom grades with alert and action limits.
Sterilization Methods
Steam sterilization, dry heat, filtration, and chemical sterilization methods validated for all sterile processes.
Validation Procedures
Comprehensive IQ, OQ, PQ validation protocols for all critical equipment, utilities, and cleaning procedures.
Quality Assurance
Critical Sterility Control Aspects
Particle Control
Continuous particle monitoring with automated data logging. Grade A areas: ≤3,520 particles/m³ (≥0.5μm) as per EU GMP Annex 1.
Pyrogen Control
Bacterial endotoxin testing (BET/LAL) for all water systems, equipment, and final API batches ensuring pyrogen-free products.
Stability Testing
ICH-compliant stability studies conducted in calibrated stability chambers for long-term, accelerated, and intermediate conditions.
Quality Control
Comprehensive in-process and finished product QC testing including HPLC, GC, IR spectroscopy, and microbiological analysis.
Future Expansion Plans
Building Capacity for the Next Generation of Sterile APIs
Our long-term roadmap focuses on capacity expansion, advanced automation, digital quality systems, stronger sustainability performance, and new product capabilities aligned with evolving global pharmaceutical needs.
Facility Enquiry
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