
Automation Solutions for the Pharmaceutical & Life Science industry
The Pharmaceutical and Life science industry is characterized by extensive global competition and stringent quality norms. In order to lead the competition, manufacturers need to reduce the costs of production and at the same time offer improved & consistent quality of product in terms of purity and efficacy. Our offerings for the Pharma and Life science industry are well integrated based on our rich experience and deep understanding of the processes, safety and quality standards, GAMP practices and batch executions.
Solutions for Pharmaceutical & Life Science Industry:
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Industry Expertise across Pharma manufacturing processes |
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Receiving
the ingredients |
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Checking
the ingredients
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Formulations |
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Mixing
and granulation |
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Drying |
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Pressing |
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Coating |
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Packaging |
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Process Expertise |
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ChemAPI |
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BioAPI |
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Comminution process |
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Trituration, levitation process |
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Colation ,Filtration, Centrifugation, Precipitation, Heating process, Formulations involving SIP plant |
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CIP plant |
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Fermentation and Extraction process |
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Ethanol process |
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Sterilization,Fermentation, extraction |
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Neutralization,Filtering,
Freeze drying, Centrifuging |
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Industry Standard
Compliance |
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21 CFR part 11 of FDA |
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S88 standards for batch execution |
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S95 |
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GAMP practices |
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Development of Standard Library
1. Standardization of Control Modules and Library for New Drug Substance Facility. |
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Expertise across Pharma Machine Units |
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Purified water system |
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Fluid bed system,Centrifuge machine, |
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8 head ampoule filling machine, Comber machine, Compression machine, |
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Ultrasonic washing machine |
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Super coater, Flux recovery unit, Reactor automation control, membrane plant, |
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Bulk drug API plant |
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Titanium dioxide plant, polymer plant |
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Our expertise ranges right from the initial process of receiving the ingredients to the final process of packaging. Our automation solutions adhere with all the industry standards including GAMP practices, compliance & validation of 21 CFR Part 11 for electronic records and signatures, S88 standard for batch execution and S95 standards. Our validation documents include Quality Plan, Functional Specifications, Hardware Design and Test Specifications, Software Design and Test Specifications, Installation Qualification Specifications (IQ) and Operational Qualification Specifications (OQ).
We understand the vital Lifecycle – “V” Model practice and automate every bit of your processes involving preparation of process intermediates; introduction of functional groups; coupling and esterification; separation processes such as washing and stripping; purification of the final product. We have expertise across product preparation processes including granulation, drying, tablet pressing, printing, and coating, filling and packaging.
Project Reference:
Design and configuration of RS Batch System for leading Pharma company in Ireland
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