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    Abelia Life Sciences - Company Profile

    Uploaded by

    Sakshi Sharma
    Abelia Life Sciences provides turnkey solutions for setting up cGMP-compliant pharmaceutical manufacturing facilities globally. They offer a range of core services including project management, facility design, cleanroom and HVAC design, civil and structural work, water treatment systems, electrical systems, utility systems, GMP trainings, quality management, and continuous improvement consulting. Abelia aims to deliver projects on time and within budget according to national and international regulatory standards.

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    Abelia Life Sciences - Company Profile

    Uploaded by

    Sakshi Sharma
    29 views6 pages
    Abelia Life Sciences provides turnkey solutions for setting up cGMP-compliant pharmaceutical manufacturing facilities globally. They offer a range of core services including project management, facility design, cleanroom and HVAC design, civil and structural work, water treatment systems, electrical systems, utility systems, GMP trainings, quality management, and continuous improvement consulting. Abelia aims to deliver projects on time and within budget according to national and international regulatory standards.

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    Abelia Life Sciences provides turnkey solutions for setting up cGMP-compliant pharmaceutical manufacturing facilities globally. They offer a range of core services including project management, facility design, cleanroom and HVAC design, civil and structural work, water treatment systems, electrical systems, utility systems, GMP trainings, quality management, and continuous improvement consulting. Abelia aims to deliver projects on time and within budget according to national and international regulatory standards.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    29 views6 pages

    Abelia Life Sciences - Company Profile

    Uploaded by

    Sakshi Sharma
    Abelia Life Sciences provides turnkey solutions for setting up cGMP-compliant pharmaceutical manufacturing facilities globally. They offer a range of core services including project management, facility design, cleanroom and HVAC design, civil and structural work, water treatment systems, electrical systems, utility systems, GMP trainings, quality management, and continuous improvement consulting. Abelia aims to deliver projects on time and within budget according to national and international regulatory standards.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    of 6

    INTRODUCTION

    Abelia Life Sciences is an engineering and consulting company with dedicated professionals
    to provide turnkey solutions to highly equipped and cGMP-regulated Pharmaceutical,
    Vaccine, Bio-pharmaceutical, and API manufacturing facilities globally.

    Abelia expertise in conceptualization, basic & detailed engineering/ process engineering


    commissioning, qualification, validation and supervision. We assure our partners, timely &
    within budget completion of project, manufacturing efficiency & compliance, energy saving,
    and improved operational cost without compromising with the safety and quality.

    Abelia provides turnkey consultancy services for projects as per National, WHO, EMA,
    USFDA, MHRA, TGA and cGMP norms and requirements.

    Knowledge and Experience


    CORE SERVICES
    Project Management
    Abelia deliver projects on time, within budget and provide highest quality as per industry requirements to meet
    customer expectations. We provide best alignment of scope between customer and vendor to continuously
    communicate the status, goals, risk assessment, plans, quality control & quality assurance activities.

    Designing & Execution


    Designing of the 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.

    • Site Management • Utility Point of Use (POU) Layout Plan


    • Facility Design (Greenfield & Brownfield) • Decontamination & Reused material flow
    • Basic Conceptual & Detailed Design • Waste & Rejected material flow
    • Process & Personal Flow • Security & safety systems layout plan
    • Equipment layout plan • Wastewater & material treatment
    • Raw material & Packaging Material flow

    Cleanroom and HVAC


    Clean rooms is done considering the process requirements as per cGMP, process flow and manufacturing
    capacity. A risk-based approach used for designing of layout and HVAC system to mitigate any risk.
    Preparation of cleanrooms & HVAC with details as per following:

    o Air classification, Air flow pattern, HVAC zoning & Differential pressure
    o Air Handling Systems design details and duct specifications

    Civil, Structural and Plumbing Work


    Complete civil engineering design, Site Master Plan, Architectural layouts, Plumbing layouts, Bill of Quantity and
    tendering, Floor and wall finishing (Kota, IPS, Epoxy, Cement Concrete floor, Tile work) specification of wall, floor
    ceiling (Modular or Civil).
    Water Generation, Distribution and Treatment System
    Water is an indispensable element to pharmaceutical manufacturing. Pharmaceutical water system includes the pharmacopoeial
    Purified Water (PW), Water for Injections (WFI) & Pure Steam with clear understanding of all aspects with the current technology
    involved in generation of pharmaceutical water system, schematic drawings or P&ID is prepared. The system is designed as per the
    required capacities considering the future expansion for the optimal utilization of manufacturing plant.

    Electrical System
    Detailed designing of the electrical system is performed with primary focus on energy saving and safety to meet the end user
    requirement. Transformer sizing, Drawing of Panel Rooms, Main LT panel, LT panel & Cable Location for power point and luminaries,
    SLD for DB, UPS DB & light DB etc are few in area of work.

    Utility System and Piping


    Utilities such as industrial steam, compressed gases, industrial water, vacuum system, dust extraction system, are an
    important part of the manufacturing process. Abelia provides the economical and consistent operations for these plant
    utilities.
    GMP Trainings
    We provide Good manufacturing practices training to customize the regulatory aspects, authority and to
    meet the requirement for the product as per the industry needs.

    Quality Management System


    We offer quality management services for developing and improving processes to cator the industry needs
    and quality systems.

    Audit & Due Diligence

    Continuous Improvement Consulting


    Abelia provides consultancy services to it's customers in continuous improvement ad business optimization
    focused on change management and delivering strategic results.

    Collaborations for Supply of Products &


    Technology Transfer
    REACH US -

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