Precision. Purity. Performance – Engineered at Every Stage.

At Silica Healthcare, our IV fluid production is not just about manufacturing—it’s a science of precision, sterility and innovation. We have built a state-of-the-art infrastructure that integrates advanced machinery, automated systems and internationally benchmarked quality controls to ensure that every IV fluid bottle delivers safe, consistent and high-quality therapy to patients across India.

We follow a zero-touch, fully sterile production protocol driven by modern technologies like BFS/FFS Sterile, Sterile Plus and SCADA automation, making our plant one of the most advanced IV fluid production units in the country.

Step-by-Step: IV Fluid Manufacturing Process at Silica Healthcare

Here are the primary reasons IV fluids are used in hospitals and emergency care:

Raw Material Procurement & Quality Check

  • Only medical-grade polypropylene (PP) granules, pharmaceutical-grade APIs and excipients are used.
  • All incoming raw materials undergo QC testing for purity, compliance and certification as per Indian Pharmacopeia (IP) standards.

Water Purification Process

  • Since water constitutes over 99% of IV fluids, we use Italian-engineered multi-stage purification systems, which include:
    • Reverse Osmosis (RO)
    • Electrodeionization (EDI)
    • Ultrafiltration (UF)
    • UV Sterilization
    • 316L Stainless Steel WFI Circulation Loop

The purified water meets WFI-grade requirements and is continuously monitored for pH, TOC (Total Organic Carbon), conductivity and microbial load.

Solution Preparation

  • Precise weighing of ingredients and preparation in closed mixing vessels with automated dosing systems.
  • Real-time temperature and pH control to maintain formulation stability.
  • Filtering through 0.2-micron sterile filters before transfer to the filling unit.

Core Production Technologies at Silica Healthcare

All batches are released only after QC, QA and regulatory approval, ensuring unmatched safety and quality.

Packaging & Storage

  • We currently offer:
    • BFS/FFS Sterile flexible packs (single-use, tamper-proof, recyclable)
    • Rigid PP bottles (with Eurohead or Nipplehead closure)
  • Each pack is:
    • Leak-tested
    • Barcode-labeled for traceability
    • Packed in export-quality shipper boxes for storage & transit stability

Future Expansion: Introducing Non-PVC IV Bags

To meet evolving hospital needs and global compliance trends, we are expanding into Non-PVC IV Bag Technology, which offers several advantages:

Coming Soon: Non-PVC IV Bags

  • DEHP-free, safe for neonates, ICU and oncology
  • Compatible with a wider range of drug infusions
  • More flexible, lightweight and eco-friendly
  • Meets EU & US Pharmacopeia guidelines for high-risk patient care

These bags are ideal for:

  • Pediatric & neonatal care
  • TPN (Total Parenteral Nutrition)
  • Oncology & chemotherapy infusions
  • Export markets & WHO-GMP-based tenders

Why Our Process Matters

Doctors

get sterile, safe and consistently performing IV fluids

Hospitals

rely on long shelf-life and easy-to-use packaging

Distributors

benefit from minimal breakage, high acceptance and timely dispatch

Government buyers

get assurance of regulatory-compliant, large-scale manufacturing capability

BFS/FFS Sterile Technology

  • An advanced European system that forms the bottle, fills the sterile solution and seals it—in a single continuous aseptic environment.
  • Uses multi-layer PP film to form flexible containers in volumes ranging from 100 ml to 1000 ml.
  • No human contact ensures zero contamination risk.

Used For: Large-volume parenterals (LVP), high-demand infusions like NS, RL, DNS and dextrose solutions.

Sterile Plus for PP Bottles

  • PP granules are moulded into preforms, then stretch-blown into rigid, clear, high-strength bottles.
  • These bottles are highly resistant to breakage and suitable for retail and institutional packaging.

Used For: Glycerin-Mannitol, Mannitol, Sodium Bicarbonate and all critical care infusions.

SCADA-Controlled Automation

  • SCADA (Supervisory Control and Data Acquisition) systems control and monitor the entire production process.
  • Ensures electronic batch records, live parameter tracking (temperature, pressure, volume) and alerts in case of deviations.

Result: 100% traceability, zero manual error, 21 CFR Part 11 compliance for regulatory audits.

Quality Control & Assurance at Every Stage

  • In-Process Checks: During manufacturing—monitoring clarity, pH, osmolality and fill volume.
  • Terminal Sterilization: Each batch is autoclaved at 121°C under validated conditions for 30 minutes to ensure sterility.
  • Visual Inspection: Every bottle is checked for particles, leakage, deformation and label accuracy.
  • Microbiology Testing: Each batch is tested for pyrogens, endotoxins and microbial load
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At Silica Healthcare, we don’t just produce IV fluids—we manufacture with purpose, powered by technology and driven by a commitment to quality, safety and care.