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Insight-Agambix Project consultancy

  "Agambix boasts a seasoned team proficient in conceptualization, basic and detailed engineering, process engineering commissioning, qualification, validation, and supervision. We guarantee our partners on-time and within-budget project completion, enhanced manufacturing efficiency and compliance, energy savings, and reduced operational costs— all while upholding safety and quality standards. Our turnkey consultancy services align with National, WHO, EMA, USFDA, MHRA, TGA, and cGMP norms and requirements." 

Project Management

Civil, Structural and Plumbing work

Conceptual Engineering

 Agambix ensure to deliver projects on time, within budget and provide highest quality as per industry requirements to meet customer expectations. Agambix excel in aligning project scope between customers and vendors, fostering continuous communication regarding status updates, goals, risk assessments, plans, and quality control and assurance activities." 

Conceptual Engineering

Civil, Structural and Plumbing work

Conceptual Engineering

 Designing of site and facilities, bulk production unit (RM/API), fill finish unit, quality control, quality assurance, animal house, warehouse and utility area as per manufacturing demand, ease of operations, latest cGMP guidelines and other international regulatory compliance. 

Civil, Structural and Plumbing work

Civil, Structural and Plumbing work

Civil, Structural and Plumbing work

 Site Master Plan Architectural layouts for Bulk Production Unit (RM/API), Fill Finish Unit, QC, QA, Animal House, Warehouse and Utility Area Structural layouts for Bulk Production Unit (RM/API), Fill Finish Unit, QC, QA, Animal House, Warehouse and Utility Area. Plumbing layouts (Clean room and industrial) for Bulk Production Unit (RM/AP

 Site Master Plan Architectural layouts for Bulk Production Unit (RM/API), Fill Finish Unit, QC, QA, Animal House, Warehouse and Utility Area Structural layouts for Bulk Production Unit (RM/API), Fill Finish Unit, QC, QA, Animal House, Warehouse and Utility Area. Plumbing layouts (Clean room and industrial) for Bulk Production Unit (RM/API), Fill Finish Unit, QC, QA, Animal House, Warehouse and Utility Area. .

Cleanroom Design

HVAC System Design

HVAC System Design

 Clean rooms designing shall be done taking into consideration of cGMP, process flow and manufacturing capacity. A risk-based approach to be used for designing of layout and HVAC system. Air classification, Air flow pattern, HVAC zoning & Differential pressure Infiltrations/exfiltration’s according to room pressure differential Cleanroom 

 Clean rooms designing shall be done taking into consideration of cGMP, process flow and manufacturing capacity. A risk-based approach to be used for designing of layout and HVAC system. Air classification, Air flow pattern, HVAC zoning & Differential pressure Infiltrations/exfiltration’s according to room pressure differential Cleanroom door, Emergency door and view panels Preparation of Modular panel specification and BOQ Preparation & review of technical specification of cleanroom sandwich wall, ceiling panels, doors, and view panels 

HVAC System Design

HVAC System Design

HVAC System Design

 Preparation & review of system design details for Air Handling Systems and duct specifications Location, type and number of HEPA filter as per air changes, grade, temperature, humidity, and pressure. Heat load calculations Preparation & review of supply and return duct layout Technical overview of major HVAC components Preparation & revi

 Preparation & review of system design details for Air Handling Systems and duct specifications Location, type and number of HEPA filter as per air changes, grade, temperature, humidity, and pressure. Heat load calculations Preparation & review of supply and return duct layout Technical overview of major HVAC components Preparation & review of different utilities (electricity, steam, soft water, cooling water, chilled water, and hot water) Preparation & review of clean room monitoring system (Temperature, RH, Pressure & Alarm system) Preparation & review of specification of clean room lights and electrical accessories Building Management System details & 

Electrical System

HVAC System Design

Electrical System

 Transformer sizing Drawing, Panel Room, Main LT panel LT panel & Cable SLD for DB, UPS DB & light DB Location for power point and luminaries Power outlets Preparation & review of specification of clean room luminaries and switch sockets Preparation & review of specification of Illumination system & control 

Preparation & review of specifi

 Transformer sizing Drawing, Panel Room, Main LT panel LT panel & Cable SLD for DB, UPS DB & light DB Location for power point and luminaries Power outlets Preparation & review of specification of clean room luminaries and switch sockets Preparation & review of specification of Illumination system & control 

Preparation & review of specification of Wiring and controls 

Preparation & review of specification of Earthing and Lightning protection system 

Preparation & review of specification of communication system in cleanroom and other areas Preparation & review of specification of Conduiting and wiring system Schedule of quantities/material 

Water generation & treatment system

Regulatory & Process Performance Qualification (PPQ)

Water generation & treatment system

  Preparation & review of Schematic Drawings or P&ID Clean Steam Generation and Distribution System Purified Water Generation & Distribution System WFI Generation & Distribution System Effluent Treatment Plant (ETP) and Sewage Treatment Plant (STP) Preparation & review of design, capacity of Clean Steam Generation and Distribution system 

  Preparation & review of Schematic Drawings or P&ID Clean Steam Generation and Distribution System Purified Water Generation & Distribution System WFI Generation & Distribution System Effluent Treatment Plant (ETP) and Sewage Treatment Plant (STP) Preparation & review of design, capacity of Clean Steam Generation and Distribution system Preparation & review of design, capacity of Purified Water Generation & Distribution system Preparation & review of design, capacity of WFI Generation & Distribution system Preparation & review of design, capacity of Soft water Generation & Distribution system Preparation & review of design, capacity of ETP & STP  

Utility System and piping

Regulatory & Process Performance Qualification (PPQ)

Water generation & treatment system

 Preparation and review of technical specification of boiler Preparation and review of technical specification Compressed air generation and distribution system Preparation and review of technical specification of Nitrogen and oxygen generation and distribution system Preparation & review of Schematic / P& I Drawings Preparation & review 

 Preparation and review of technical specification of boiler Preparation and review of technical specification Compressed air generation and distribution system Preparation and review of technical specification of Nitrogen and oxygen generation and distribution system Preparation & review of Schematic / P& I Drawings Preparation & review of material of construction of pipes Preparation & review Piping rack and support Review of pressure rating & pipe sizing to minimize the energy losses Preparation and review of shortest route of pipe to minimize the energy losses Design of condensate recovery system to increase the boiler efficiency 

Regulatory & Process Performance Qualification (PPQ)

Regulatory & Process Performance Qualification (PPQ)

Regulatory & Process Performance Qualification (PPQ)

 Agambix is having the Regulatory Experts and technical collaboration globally to handle the client specific regulatory needs with respect to specific regulatory agencies - EU regulatory, US regulatory, and Indian Regulatory submissions. Regulatory path clarification for pharmaceuticals, biologics, and devices Effective preparation and fi

 Agambix is having the Regulatory Experts and technical collaboration globally to handle the client specific regulatory needs with respect to specific regulatory agencies - EU regulatory, US regulatory, and Indian Regulatory submissions. Regulatory path clarification for pharmaceuticals, biologics, and devices Effective preparation and filing of regulatory submissions Problem-solving expertise for compliance across product lifecycle stages Maintenance of compliance at every stage of product development 

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