Solution

PharmaBioSolutions project engineering team have been providing Automation Solutions to the Life Science industry. They have extensive experience in all aspects of automation related to manufacturing in API, Biotech and Secondary processes.

 

Over the years PharmaBioSolutions Project Engineers have supplied several projects following GAMP Life Cycles. They have provided solution ranging from Automation of individual equipment (e.g. Sterilisers, Freeze dryers, Tablet coating, Spray Dryers, etc) to plant wide solutions. All the systems supplied have passed regulatory Bodies inspection.

The following are some of the applications provided by our Project engineering team:

    • Reactor control

    • Mixers, Dryers

    • Hydrogenators

    • Bioreactors

    • Purification system

    • Filter systems

    • CIP/SIP

    • BMS for HVAC

    • Environmental monitoring system

    • Purified water & WFI

    • Sterilisers

    • Freeze dryers

    • Blending and Granulators

    • Tablet coating

    • Packaging

    • Waste treatment

 

PharmaBioSolutions Automation team with their vast experience in implementation of Automation solution for pharmaceutical industry globally can provide advice and support in defining their requirement and creating URS.

 

Global standards such as ISA-S88 (IEC 61512), S95 are extensively used as the bases for the definition and design of automation systems. A vast majority of systems provided by PharmaBioSolutions have been designed to satisfy 21 CFR Part11 Electronic Records & Electronics Signatures.

All systems supplied by PharmaBioSolutions have been implemented following GMAP guidelines and have successfully passed EMEA and US FDA inspections

 

PharmaBioSolutions can provides turnkey Automation Systems including installation and complete validation. Its services include:

    • Feasibility studies and assistance in creating URS

    • Assistance in Risk Assessment

    • Creating Quality Plan

    • Creating Design Documents: Functional Specification, Hardware Specification, Software Design    specification, Software Module Specification

    • Build Cabinets, supply of field devices

    • Develop software

    • Create test protocols: Factory Acceptance Test Protocol. Site Acceptance Protocol

    • Execution of protocols

    • Creation of Final documents   

    • Creation of final reports and final handover

    • Provide After sales service: Periodic review, Backup and Disaster Recovery, Data Archive, CAPA, etc

       Besides offering Automation system for new plants, PharmaBioSolutions also offer Automation       system for revamping existing equipment. It also offers replacement for Automation system which       has been made obsolete.   

As an independent supplier of Automation solution they can offer the most suitable hardware solution for your applications. We offering Automation Solutions based on any of the following hardware platforms:

    • DCS systems

    • PLC based systems

    • SCADA based solutions    

    • Data Management systems (local and plant wide) 

    • MES systems

 

Solutions offers include most of major brand names including: Siemens, Invensys, Rockwell, Honeywell, Schneider, etc.

PharmaBio solutions Automation expertise has experience in the following areas:

    • API processes: Reactors, Crystallisers, Filters, Dryers, hydrogenators, solvent Recovery, etc 

    • Biotech processes: Bioreactors/ Frementors, Preperation, purification

    • Automation of equipment: Freeze dryer, Sterilisers, Tablet Coating, Mixers, Blending, mixing,  Granulators, etc

    • Building automation systems

    • Environmental monitoring systems

    • Utility systems: PW, WFI, CIP/SIP

 

Data Management Systems

Data Management is a key requirement for the life Science industry. PharmaBioSolutions has extensive experience in creating and maintaining Data Management system for the Life Science industry. Satisfying Electronics Records and Electronics Signatures (e.g. 21CFR Part 11) is required by regulatory bodies.

 

Central Historian Database and EBR (Electronic Batch Data) are required by most Life Science companies as it will simplifies management and access to regulatory data. PharmaBioSolutions can assist you in defining the requirement for your data management system and supply you with the system. The system will be provided with all the necessary validation documentation following GAMP.  We will also help you to maintain it during its life Cycle.

 

Information Technology

Use of MES (Manufacturing Execution Systems) are becoming very common in the Life Science industry. PharmaBioSolutions project engineering team can help you to define your requirement for MES system and provide a solution which matches the requirement. The MES will be provided with validation documentation following GAMP

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