Quality Assurance at Silica Healthcare

At Silica Healthcare, quality is the cornerstone of our manufacturing philosophy. We believe that every drop of IV fluid that enters a patient’s body must meet the highest standards of purity, sterility and safety. That’s why our Quality Assurance (QA) and Quality Control (QC) processes are designed to comply not just with Indian Pharmacopoeia (IP) norms, but also with global pharmaceutical quality benchmarks like WHO-GMP, USFDA, ISO and EU GMP standards.

Rigorous Batch Testing & Validation

Every batch of IV fluids produced at our facility undergoes a multi-stage quality check protocol:

Raw Material Testing: All input materials (water, APIs, excipients, packaging materials) are tested for purity and consistency.

In-Process Checks: At every critical stage of production — from compounding, filtration and filling to sealing and labeling — our QA team performs documented checks to ensure compliance with validated procedures.

Final Product Testing: The finished product is tested for pH, particulate matter, volume accuracy, clarity, endotoxins, sterility and leachability.

Modern Analytical Laboratories

Silica Healthcare is equipped with state-of-the-art analytical labs featuring:

HPLC, UV-Vis Spectrophotometers, FTIR, TOC analyzers

Sterility testing isolators, incubators and endotoxin testing systems

Real-time environmental monitoring systems
These tools enable precise testing and ensure consistency across batches.

Advanced Manufacturing Technologies

We employ Form-Fill-Seal (BFS/FFS Sterile) and PP bottle technologies in a Class 100 cleanroom environment, minimizing human intervention and eliminating contamination risks. Our quality assurance system is deeply integrated into this automated process, ensuring traceability and audit-readiness at every step.

Documentation & Regulatory Compliance

SOP-driven operations ensure consistency across all teams and shifts.

Every batch is supported by Batch Manufacturing Records (BMRs) and Certificates of Analysis (COA).

Regular internal audits and third-party audits ensure continued regulatory compliance.

Training programs keep QA/QC personnel updated on current best practices and new regulations.

Zero-Compromise Policy

Our motto is clear: “If it’s not perfect, it doesn’t leave the plant.”
We implement a zero-defect policy and any deviation – no matter how minor – is investigated, documented and addressed with CAPA (Corrective and Preventive Actions).

Global Quality, Indian Commitment

As a part of the 900 Cr Silica Group, Silica Healthcare combines global quality systems with Indian values of care, responsibility and affordability. Whether our products are destined for Indian hospitals or global markets, we maintain a single standard of uncompromised quality.

Advanced Manufacturing at Silica Healthcare

Where Innovation Meets Precision – Ensuring Quality from Molecule to Market
Silica Healthcare’s manufacturing facility represents the forefront of sterile pharmaceutical production. Located in a pollution-free industrial zone, our plant is built to meet both current and future demands of the Indian and international healthcare markets. Every product leaving our plant reflects world-class technology, uncompromising quality control and a commitment to human safety.

Facility Overview

Plant Area: Spread over 5+ acres with future expansion capability

Total Built-Up Area: 100,000+ sq. ft. with separate zones for production, QC/QA and warehouse

Production Lines: Dedicated lines for FFS IV fluids, PP Bottles and LVP (Large Volume Parenterals) up to 1000 ml

Technology Platforms

  1. Form-Fill-Seal (FFS) Technology

One of the most sterile and automated production systems

Uses pharma-grade multi-layered plastic film to form containers inside sterile chambers

In a single continuous process:

Container is formed

IV solution is filled

Container is sealed

Eliminates human touch — zero risk of contamination

Higher productivity and uniformity compared to glass ampoules or PVC bottles

Widely accepted in institutional and export markets for quality assurance

  1. Polypropylene (PP) Blow-Fill-Seal (BFS) Bottles

Used for IV fluids and large-volume sterile products

Advantages:

Lightweight, break-resistant

Tamper-evident closures

100% recyclable and environment-friendly

Compatible with most IV drugs, diluents and electrolyte solutions

Designed for high stability under Indian climatic conditions

Quality Systems & Certifications

WHO-GMP certified facility with all operations as per Schedule M guidelines

In-process Quality Checks at every stage: raw material → mixing → filling → sealing → labeling → final inspection

Sterility assurance through:

Validated sterilization processes (autoclave, dry heat, filtration)

Controlled class 100 cleanroom zones with HEPA filtration

QC Laboratories:

Microbiology Lab

Instrumentation Lab (HPLC, UV, IR)

Packaging Material Testing

Stability Chambers (as per ICH guidelines)

Regulatory Roadmap:

Facility and processes aligned with USFDA, EU-GMP, PIC/S and TGA norms for future international audits and exports

Water Systems (WFI & PW)

In-house Water for Injection (WFI) generation and distribution system

Stainless steel piping with loop design

24×7 monitored for microbial load, conductivity and TOC

Dedicated Purified Water (PW) systems for cleaning and non-sterile applications

CIP (Clean-in-Place) and SIP (Sterilize-in-Place) ensure equipment cleanliness and validation compliance

Environmental Controls

HVAC Systems with 100% air changes, positive pressure differentials

Real-time environmental monitoring for:

Airborne particles

Temperature and humidity

Microbial presence

Differential pressure-controlled clean rooms: ISO Class 7 (Grade C) and ISO Class 8 (Grade D)

Cleanroom personnel movement under SOP-guided garmenting and entry procedures

Batch Manufacturing & Traceability

End-to-end documentation via:

Batch Manufacturing Records (BMRs)

SOP-driven validation protocols

Electronic traceability from raw material to finished goods

QR-coded and barcode-enabled packaging supports Track & Trace, compliant with government & institutional supply norms

Production Capacity

FFS IV Fluids: Over 10 million bottles/month (100 ml to 1000 ml)

PP Bottles & LVPs: Over 6 million bottles/month

Multiple shifts to manage institutional tenders, bulk exports and channel stock requirements without delay

Safety & Sustainability

ETP (Effluent Treatment Plant) and Zero Discharge policy

100% solar backup for critical functions

Fire-safety systems with smoke detectors, sprinklers and fire hydrants installed across the plant

Safe handling & disposal SOPs for chemicals, solvents and packaging waste

Packaging & Dispatch

Automatic labeling and tamper-evident packing

UV inspection & vision system for label accuracy

Temperature-controlled warehouses to maintain product integrity

Integrated with the logistics system for direct dispatch to distributors, hospitals and government depots

Feature Silica Healthcare Advantage
Technology Fully automated BFS/FFS Sterile & PP
Compliance WHO-GMP, aligned with USFDA & EU-GMP
Quality End-to-end QC with zero contamination
Speed High-capacity lines for fast delivery
Sustainability Green practices and energy-efficient systems
Future-Ready Built for export, global audits & institutional contracts

Logistics & Distribution

Nationwide Reach. Timely Delivery. Trusted Access.
At Silica Healthcare Pvt. Ltd., our logistics and distribution system is one of our core strengths, enabling us to maintain a reliable, responsive and compliant supply chain that supports the uninterrupted delivery of life-saving products like IV fluids and critical care medicines across India.

Comprehensive Distribution Network

We have built an extensive distribution footprint covering 29 states and union territories, supported by:

Central & Regional Warehouses strategically located in North, South, East and West India.

Over 150+ Super Stockists and Channel Partners connected with local distributors and hospital suppliers.

Presence in urban, semi-urban and rural markets, ensuring accessibility even in the remotest healthcare setups.

End-to-End Logistics Management

Our integrated logistics ecosystem includes:

Vendor Managed Inventory (VMI) and Just-in-Time (JIT) supply mechanisms to reduce inventory burden on hospitals and partners.

A dedicated Logistics Coordination Team that ensures real-time communication between manufacturing, warehousing and last-mile delivery teams.

Advanced ERP-based inventory and dispatch tracking system for real-time visibility, forecasting and planning.

Last-Mile Delivery Excellence

We specialize in last-mile delivery to:

Government Institutions like Railways, Defence, State Medical Services Corporations and ESI Hospitals.

Leading Private Hospitals, Nursing Homes and Clinics.

Retail Pharmacy Chains, Hospital Pharmacies and Tender-based Supply Channels.

Our fleet and partner carriers are equipped for:

Temperature-sensitive product handling (especially for IV fluids and sterile injectables).

Prompt delivery within 24–72 hours of dispatch, depending on location.

Zero-breakage packaging standards with tamper-evident seals.

Regulatory Compliance & Quality Assurance

Silica’s logistics operations are fully aligned with:

Good Distribution Practices (GDP)

Indian Drugs & Cosmetics Act

State and Central FDA requirements

Track & Trace standards for pharmaceutical transport and documentation

We maintain audit-ready documentation and transport validation records for all supply chain partners to ensure complete regulatory adherence.

Institutional & Government Supply Expertise

With rich experience in government and institutional business, we are empaneled with:

State Medical Service Corporations (MSMCs)

Central Government Health Schemes (CGHS)

Railways, ESIC, Defence and Municipal Hospitals

Public Procurement Platforms like GeM

We understand the compliance, documentation and delivery timelines critical to public sector procurement and have a specialized division to handle these requirements.

Emergency & Priority Dispatch Capabilities

We recognize the urgency of medical product supply and have provisions for:

Emergency dispatches for critical care institutions

Dedicated transport in outbreak or disaster response situations

Custom dispatch planning during festivals, lockdowns, or transportation strikes

Technology-Enabled Monitoring

Our supply chain is integrated with barcode scanning, batch tracking, auto-replenishment alerts and dispatch scheduling tools, helping us maintain 99%+ service levels and avoid stockouts or overstocking.

Why Silica Healthcare’s Distribution Makes the Difference

Speed with Accuracy

Fast-moving logistics with near-zero error rates.

High Availability

Consistent supply across all SKUs and volumes.

Customer-Centric Approach

Tailored distribution support for hospitals, institutions and partners.

Nationwide Reliability

Trusted delivery partner for both private and public healthcare systems.

Innovation-Driven: Advancing the Future of Infusion Therapy

At Silica Healthcare, innovation isn’t just a department—it’s embedded in our DNA. From our inception, we’ve been driven by a singular vision: to redefine the standards of infusion therapy in India and globally through cutting-edge solutions, technology and patient-centric design.

As part of the 900 Cr Silica Group, we leverage strong infrastructure, scientific expertise and strategic foresight to build a robust innovation ecosystem. Every new product, process and system is born out of a commitment to quality, safety, efficiency and accessibility.

Next-Generation Infusion Solutions

Our core focus is on delivering the next generation of IV fluids and infusion therapies tailored for modern healthcare needs. This includes:

BFS/FFS Sterile (Form-Fill-Seal) Technology – For contamination-free, aseptic manufacturing

Polypropylene Bottles (PP Bottles) – Lightweight, break-resistant and eco-friendly

Closed-System Packaging – Enhancing sterility and patient safety in hospital settings

Ready-to-Use Formulations – Reducing preparation time and human error in critical care

These innovations help hospitals and clinicians provide safer, faster and more effective care.

Therapeutic Expansion Beyond IV Fluids

While IV fluids remain at the heart of our operations, we are actively expanding into high-potential therapeutic areas, guided by market needs and medical insights:

Critical Care & Emergency Medicine

High-demand injectable formulations and electrolytes for ICUs and trauma care

Nephrology & Dialysis Support

Electrolyte-balanced solutions and specialized formulations for renal patients

Nutritional Infusions & TPN

Total Parenteral Nutrition and amino acid combinations for surgical and post-op care

Oncology Supportive Therapy

Infusion solutions designed to complement chemotherapy and reduce treatment-related complications

Anti-infectives & Antibiotics

Developing high-purity injectable antibiotics for infection control in hospital settings

Tech-Driven Product Development

Our team of scientists, clinicians and technical experts works tirelessly on:

Process optimization for faster turnaround and reduced cost

Smart manufacturing practices including real-time batch monitoring and digital QA

Research collaborations with hospitals and academic institutions to address unmet medical needs

Stability and bio-compatibility research for new delivery systems

This ensures our innovation is not only safe and scalable, but also globally competitive.

Sustainability & Future Readiness

Our innovation roadmap also focuses on sustainability and environmental stewardship. By adopting recyclable packaging materials, minimizing water usage and reducing carbon footprint across our plants, Silica Healthcare is building a future that is as responsible as it is advanced.

The Silica Promise

At Silica Healthcare, we don’t just manufacture IV fluids—we innovate solutions that heal, protect and transform care delivery. As we scale up across India and international markets, our innovation engine will continue to drive the development of reliable, affordable and smarter therapies for tomorrow’s healthcare needs.

Ethical & Transparent

Built on Trust. Sustained by Integrity.

At Silica Healthcare, ethics and transparency form the bedrock of our identity. In an industry that directly impacts human life, we recognize that doing the right thing is not optional—it is fundamental. Our operations, from manufacturing to marketing and distribution, are governed by the highest standards of compliance, integrity and openness.

We are committed to building a business that not only delivers high-quality pharmaceutical products but also upholds the trust of healthcare professionals, patients, regulators and partners across the ecosystem.

Governed by Compliance, Guided by Ethics

Every product that leaves our facility carries not just our name, but our responsibility. We strictly adhere to:

Indian Pharmacopoeia (IP) and WHO-GMP guidelines for every step of production.

Comprehensive Standard Operating Procedures (SOPs) to ensure consistency and traceability.

Regular internal audits and third-party inspections to ensure full regulatory compliance.

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Robust systems to maintain data integrity, batch traceability and documentation accuracy.

We operate in full alignment with the Drugs & Cosmetics Act, Schedule M and global best practices, ensuring that our processes are audit-ready at all times.

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Transparent Documentation & Reporting

Transparency at Silica Healthcare extends to our meticulous documentation:

Electronic and manual batch records are maintained for every lot with real-time updates.

Deviation reports, change controls and CAPA (Corrective & Preventive Actions) are documented and acted upon without exception.

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Certificates of Analysis (CoAs) are issued for every consignment, ensuring customers receive full visibility into product quality.

Our documentation practices ensure not only compliance but also full accountability at each operational stage.

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Ethical Marketing Practices

We take a scientific, responsible and respectful approach to all customer interactions and promotional efforts:

All communication to healthcare professionals is evidence-based, balanced and approved by our medical and regulatory teams.

We avoid any form of exaggerated claims or unverified therapeutic promises.

Promotional materials and interactions are in full compliance with the Uniform Code for Pharmaceutical Marketing Practices (UCPMP).

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No inducements, unethical incentives, or misleading messages are used in our business promotions.

We firmly believe that prescriptions must be based on clinical merit, not marketing influence.

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Transparent Partnerships & Institutional Relationships

Whether it’s a hospital, government agency, distributor, or private healthcare provider, Silica Healthcare ensures:

Clear pricing structures with no hidden costs.

Transparent supply chain and delivery timelines.

Proper documentation in tenders, institutional contracts and commercial agreements.

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Open and honest communication across all touchpoints.

Our ethical reputation allows us to be considered a trusted long-term partner in both public and private healthcare projects.

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Patient-First Business Values

Every product is ultimately meant for a patient’s wellbeing—and we never lose sight of that.

We ensure accurate labeling, appropriate usage instructions and complete safety warnings.

Products are priced to ensure accessibility without compromising quality.

In case of any reported adverse events, our pharmacovigilance team ensures prompt and transparent investigation.

Internal Culture of Integrity

Ethics at Silica Healthcare is not limited to external conduct—it is an internal commitment:

All employees go through regular ethics training and compliance workshops.

A zero-tolerance policy is maintained for any unethical behavior or violation of code of conduct.

An internal whistleblower mechanism ensures accountability and empowers our teams to speak up.

The Silica Promise: Ethics You Can Trust

In an era where ethical lapses can damage lives and reputations, Silica Healthcare stands firm in its belief:

Quality means nothing without integrity.

We’re not just building a pharmaceutical company—we’re nurturing a legacy of trust, transparency and ethical leadership in healthcare.