A Sai Tanvi Group Domains

In today’s challenging regulatory and competitive environment, no pharmaceutical business can risk losing time or paying costly fines due to lack of regulatory compliance. Non-compliance and quality lapses - even a warning letter - can potentially devastate a brand. In the high-stakes business of biopharmaceutical manufacturing, Delta sigma has distinguished itself as a world leader in process automation control and software solutions assisting users in the total validation effort and helping minimize costs related to regulatory compliance. In addition to helping users conform to Current Good Manufacturing Practices (CGMP), Delta sigma’s products and services assist them in compliance with 21 CFR Part 11 regulations as well as global, European and local protocols.

As the biopharmaceuticals industry focuses on driving down production costs, maximizing unit production and flexibility and rationalizing assets, achieving consistent product quality, improving efficiencies and reducing waste is essential.

DeltaSigma’s Batch Manufacturing solutions improve production reliability and supply chain agility, while ensuring that the safety, compliance, reliability and efficiency targets in the plant are met or exceeded. Users in industries ranging from Bio-Pharmaceuticals and Food and Beverage to Specialty Chemicals benefit from a stronger competitive position with on time, on budget execution and are able to deliver greater value to their customers.

DeltaSigma’s Validation Services are provided using unparalleled experience in both process automation and environmental control, which are critical elements in regulatory conformance. Users are supported through every state of validation, including the writing of functional design specifications for factors such as temperature and humidity, development and documentation of standard operating procedures and ongoing support.

DeltaSigma Integrated Tabletting Automation Including phases of

  • Granulating
  • Milling
  • Blending
  • Coating
  • Encapsulation
  • Packaging

Integrated Utility Monitoring System
Integrated Crystallization Automation
Integrated Reactor Automation
Intelligent Dryer Automation
Intelligent Centrifuge Automation
Intelligent Clean Room HVAC Automation
Intelligent Distillation
Integrated PB Alarm

IT – a Electronic Batch Process Recording [EBPR]
Equipment Time Cycle Monitoring
Validation

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