Services and Consultancy India
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Diagnosis, Repairs & Spares
Equipment SAT & Qualification
One of the key strengths of PharmaNXT Biotech team is post-sales services for systems in process development and manufacturing. The team has vast experience of supporting customers across Asia in setting-up their plant machinery and performing equipment qualification and documentation as per the recent regulatory requirement.
The team also has strength in supporting the customers in determining critical spares that need to be on stock so that any breakdown calls can be attended immediately without any downtime.
Our service team has substantial experience performing preventive maintenance activities to ensure that the equipment has long life and do not fail during critical operations. This is always done in association with the customers’ Production and Engineering teams so that the services can be delivered on time and with minimal disruption of work.
-Extensive experience of thorough diagnosis enables customers to take right decision to either repair or replace a component
-Component level repair capability, reduces overall maintenance cost
-Suggestion of concrete list of spare parts to be stocked helps reduce inventory
-Extensive experience in the industry of performing preventive maintenance activities
-Each component is thoroughly checked, if required repaired / replaced and all-encompassing documentation completed to meet GMP requirements.
-On schedule and on time delivery guaranteed.
-Exhaustive documentation prepared for each equipment based on the system specific configuration
-Flexible documentation format to meet the stringent demands of customers and regulators
-Thorough tests performed and extensive documentation delivered
PharmNXT Biotech team has vast experience of working with customers across industry segments, from process development to manufacturing. The experience of PharmNXT Biotech is enabling the scientists in the Biologics industry to develop their processes, perform mass balance calculations, define automation strategy keeping in view the recent data compliance requirements, do equipment sizing and perform tech transfer from PD to manufacturing, all this with high efficiency and economically.
Following are the services offered by PharmNXT Biotech for Process Engineering Consultancy:
1. Process Development
2. Mass Balance Calculations & Equipment Sizing
3. Single Use equipment arrangement
4. Overall Project Management
-On site support for process development
-Scale-up requirements inbuilt from PD
-Using chemicals suitable for scale-up
-Process Parameter optimization making scale-up easy
-Complete Tech. transfer
-Mass Balance simulation based on customer data
-Buffer volume calculations
-Rate of buffer consumption
-Tank scheduling to optimize tank purchase
-Equipment sizing to meet current and future demands
-Facility fit where existing facilities to be used
-Philosophies of piping management, transfer between unit operations and between rooms have changed.
-PharmNXTbiotech has the experience and knowledge to design efficiently & economically
-Management of suppliers – Responsibilities from DQ to Qualification
-Perform equipment qualification – Turnkey or only supervision
-Support first few mfg. batches