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Quality Control & Assurance

Comprehensive quality management ensuring every product meets the highest international standards.

QUALITY FIRST
Our Quality Philosophy

At Divine India, quality is not just a department—it's embedded in our culture. Every member of our team is committed to maintaining the highest standards of quality in every aspect of our operations.

Our comprehensive quality management system encompasses everything from raw material procurement to final product delivery, ensuring consistent quality and compliance with international regulatory requirements.

Our Commitment:

Zero-defect manufacturing approach

Continuous process improvement

Regular staff training and qualification

Compliance with international standards

Transparent quality documentation

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In-House Testing Laboratory

Our well-equipped laboratory conducts comprehensive testing to ensure product quality and compliance.

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Comprehensive Testing Capabilities

Our laboratory is equipped with modern testing equipment and staffed by qualified technicians who perform rigorous testing on raw materials, in-process samples, and finished products.

Physical dimension testing

Absorbency rate testing

Tensile strength testing

Sterility assurance testing

Microbial Testing

Pyrogen Testing

Particle Count Testing

Residual EO Testing

Sterility Assurance Program

For all sterile products, we implement a comprehensive Sterility Assurance Level (SAL) program that ensures complete elimination of viable microorganisms.

Pre-Sterilization Controls:
  • Environmental monitoring of clean rooms

  • Bioburden testing of products

  • Personnel hygiene monitoring

  • Equipment cleaning validation

Post-Sterilization Testing:
  • Biological indicator results

  • Sterility testing as per USP/BP

  • Residual EO testing

  • Package integrity testing

Sterility Assurance Level
10
-6
Batch Testing
100%
Environmental Monitoring
24/7
Batch Documentation

Complete batch manufacturing records with full traceability from raw materials to finished products.

Adherence to international standards including ISO, WHO-GMP, and country-specific regulations.

Regulatory Compliance
Certificate of Analysis

Detailed CoA provided with every batch including all test results and specifications.

Documentation & Compliance

We maintain comprehensive documentation systems that provide complete traceability and ensure regulatory compliance for all our products.

Every batch is accompanied by complete documentation including:

    Manufacturing batch records

    Certificate of Analysis (CoA)

    Test reports and data

    Manufacturing licenses

    Sterilization certificates

    Material safety data sheets

    Technical documentation files

Certifications & Licenses

Our certifications demonstrate our commitment to quality and compliance with international standards.

ISO 13485 : 2016
Medical Device Quality Management
CE Marking
European Conformity
WHO - GMP
Good Manufacturing Practtices
Drug License
100+ Manufacturing Licenses
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DIVINE INDIA

Medical Manufacturing

Licensed OEM manufacturer of medical equipment.

Quick Links

Our Brand

100+ Licensed Products

Class 10,000 Clean Room

EO Sterilization

Export Quality

Contact Us

143 HSIIDC IE Rai, Sonipat

+91 96508 56677

divineindiaoffice@gmail.com

© 2025 Divine India. All rights reserved.

Licensed OEM Manufacturer | Vivon® is a Registered Trademark

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