Shubham Corporation

 

Quality & Compliance

At Shubham Corporation and Soxa Formulations & Research Pvt. Ltd., quality is not just a process—it is a commitment. Every dialysis consumable we manufacture undergoes stringent checks at every stage of production to ensure safety, reliability, and global acceptance.

✅ Our Standards & Certifications

• Certified under ISO 13485 for medical device quality management

• CE marking for compliance with European regulatory requirements

• Licensed by CDSCO (Central Drugs Standard Control Organization, India)

• Adherence to BP/USP/Ph. Eur. standards where applicable

✅ Our Quality Practices

• Raw Material Inspection: Only medical-grade, traceable raw materials are sourced and verified.

• In-Process Monitoring: Continuous quality checks during molding, assembly, and packaging.

• Sterilization Validation: In-house EO (Ethylene Oxide) sterilization with full validation and monitoring.

• Microbiology & Biocompatibility Testing: Ensuring patient safety and product compatibility.

• Final Product Testing: Leak tests, flow rate analysis, burst pressure tests, and functional checks.

• Traceability: Each batch is fully traceable with complete documentation and regulatory records.

✅ Global Compliance

Our products are designed to meet or exceed international standards, enabling us to successfully supply dialysis consumables across Asia, Africa, the Middle East, and Latin America. Regulatory documentation and technical files are prepared to support product registrations worldwide.

✅ Our Philosophy

We believe that quality is life—and for dialysis patients, this means absolute reliability. Our compliance-driven approach ensures that every product we deliver reflects our core values of safety, innovation, and trust.

 

Quality Standards

At Shubham Corporation and Soxa Formulations & Research Pvt. Ltd., we follow globally recognized quality and regulatory standards to ensure the highest level of safety and performance in every dialysis consumable we manufacture.

✅ Certifications & Compliance

• ISO 13485:2016 – Certified Quality Management System for Medical Devices

• CE Marking – Compliance with European Union directives for product safety and performance

• CDSCO License (India) – Licensed by the Central Drugs Standard Control Organization for medical device manufacturing

• WHO-GMP Guidelines – Adhered to for good manufacturing practices

• BP / USP / Ph. Eur. Standards – Raw materials and finished products meet international pharmacopeia specifications

✅ Manufacturing Practices

• Class 10,000 & Class 100,000 Cleanroom environments for sterile product assembly

• EO Sterilization with full validation and monitoring

• AHU & HEPA filtration systems for contamination-free production

• In-process & final product testing including leak test, burst pressure test, microbiology, and biocompatibility

✅ Traceability & Documentation

Every product batch is backed with complete traceability, COA (Certificate of Analysis), and regulatory documentation, supporting global product registrations and exports.

“Certified. Trusted. Globally Compliant.”

Testing Facilities

At Shubham Corporation and Soxa Formulations & Research Pvt. Ltd., every product undergoes rigorous testing in our dedicated quality-control laboratories to ensure safety, consistency, and compliance with international standards.

🔬 Mechanical & Functional Testing

• Leakage Test – Ensures no fluid leakage under simulated dialysis conditions

• Burst Pressure Test – Verifies strength and durability of tubing and components

• Flow Rate Test – Confirms correct flow and pressure as per specifications

• Tensile Strength Test (UTM) – Checks the breaking strength of joints and assemblies

🧪 Microbiological Testing

• Bioburden Testing – Monitors microbial load before sterilization

• Endotoxin Testing (LAL Test) – Ensures products are free from pyrogenic contamination

• Sterility Testing – Validates EO sterilization effectiveness

• Environmental Monitoring – Routine checks in cleanrooms (airborne particles, surface swabs, HEPA efficiency)

⚗️ Chemical & Compatibility Testing

• Extractables & Leachables Analysis – Confirms material safety for patient use

• pH & Conductivity Checks – For solutions like bicarbonate and acid concentrates

• Biocompatibility Testing – Ensures raw materials meet medical safety standards

📑 Validation & Documentation

All test results are documented in accordance with ISO 13485 & CE requirements and are fully traceable to each product batch. Certificates of Analysis (COA) and Quality Control Reports accompany every shipment for global compliance.

“Every product tested. Every standard validated. Every patient protected.”