Adam Fabriwerk Processing Skids Presentation Sterile Processing

www.adamfabriwerk.com 1

Vishal WaghDirector

Marketing


Summary

Company OverviewManufacturing Site Product ProfileProjectsInternational Presence

Indian Ethos


Summary


Indian Ethos


Company OverviewAdam Fabriwerk has been delivering quality mixing and processing machinery products to Biopharmaceutical, Pharmaceutical and Cosmetic Industries for the past 26 yearsOur corporate offices are based in Mumbai, India and our Manufacturing Facilities and R&D labs are located at Nashik,160 kms away from MumbaiStrength : 150 people

Mumbai To Nashik

Nashik Works


Company Overview :Board of DirectorsWaman Wagh

Technical Director

Devidas ShirudeFinance Director

Sanjay ShirudeProduction Director Vishal Wagh

Marketing Director


Summary


Indian Ethos


Manufacturing SiteFabrication Facility

In house Design,Manufacturing,FAT facilitiesOrbital Welding machines with Boroscopy for TubesOverhead Cranes covering Complete Factory Bay areas for Material HandlingTotal Fabrication area availability 1800 Sq.MetresMaximum Capacity of Vessel fabrication 30000 LitresPolishing Bays separate from Fabrication and Assembly areasVessel Design as per ASME BPE-2005 and ASME Sec VIII Div 1Qualified Welders as per ASME Sec IX


Manufacturing SiteDisplay FacilityOperator Training Modules

Prospective Clients get a first hand look at the end product

Ease of finalising specific process critical accessories and fitments

Mixing/Blending Vessels,CIP,SIP Modules and Cream Mixers on Display with Full Process Control Options with Production Scale Models

All World Class Bought outs used in Integration of the Skids on Display


Manufacturing SiteFAT Area

Vessel Hydro TestsJacket Hydro TestsVessel/Jacket Vacuum TestsMixing Water TrialsFull BOQ/MOC Documentation Dossiers including DQ/IQ/OQ/PLC Validation Packages availableFull Operational Tests performed under FATWelding Maps with X ray ReportsSurface Finish Test with ProfilometerElectropolishing Reports Riboflavin Tests for Sprayball Efficacy


Manufacturing SiteNew State-of-the-Art Facility

This new facility is designed for the fabrication of 100 percent stainless steel projects.

The plant will boast of a controlled environment ensuring high purity and cross contamination prevention to comply with regulatory standards.

It will also incorporate automated welding processes and advanced finishing processes as well as a designated area for factory acceptance testing.

With a height of 31 feet under hook and a 50 ton lift capacity, it is ideal for large or small tanks as well as super skids.

Unit 2


Summary

Company OverviewManufacturing SiteProduct ProfileProjectsInternational Presence

Indian Ethos


Product Profile : Blending Vessels

Mixing ApplicationsBacteria and Cell CulturesSuspensionsBlood fractions in Cohn fractionationVaccine suspensions containing aluminium hydrogel, salts, antibodiesDissolving glucose in water (LVP solutions)

Capacity5 to 30000 Litres



Sterile Sampling System with In Situ Steam Sterilization

Sterile Flange Connections for Top dish nozzles to enhance CIP,SIP operations

Temperature/pH/Conductivity sensing through sanitary knuckle port on vessel shell

Load Cells for weight measurement

Vessel with CIP / SIP able accessories

PLC system with SCADA available for batch records



General Mixing

The GMP mixer is suitable for general Mixing,Blending,Heat transfer and Shear Sensitive ApplicationsSpeed variation from 20 to 350 RPM

Upstream processing

The USM mixer is a superior alternative to top-mounted mixers in upstream mixing applicationsThe USM mixer creates medium high-shear forces and transfers much more energy into the tank than the GMP mixer, and is ideal for mixing difficult powders into a liquidSpeed variation from 300 to 1440 RPM

GMP Mixer

USM Mixer



High Shear Mixing Applications

Homogenizing-Dispersing activitiesSuspension of Solid Particles in Liquid PhaseDissolving and Downsizing Particles for Suspension ManufacturingEmulsification to achieve small Droplet Size to achieve Stable EmulsionsSpeed variation from 400 to 2800 RPM

High Shear Combo Mixing

A HS mixer creates the High Shear Forces needed to create an Emulsion, while the GMP mixer is used to break the vortex and create additional agitation and balance in the tankA variety of powerful results can be achieved this way, such as controlling vortex to prevent foaming, increased agitation, etc.

Combo Mixing

HS Mixer

Rotor

Stator

Drive

Tank Plate



Valve Configurations

Take Off ValvesUsed in PW and WFI Loops, free of Dead Legs and No Pressure Drop over the valve in the main line

Tank Outlet ValvesTruly Zero Dead Leg with Multiple ports and Actuation options

Shut Off ValvesPositive Sealing with no cavities, Full Drainability and Low Pressure Drop

Flow Through ValvesManifold, Take Off and Drainage Valves in Aseptic Applications

Take Off

Shut Off Flow Through

Tank Outlet


LVP Project Profiling

Photo Courtesy:Charak Pharmaceuticals




LVP Project Profiling


LVP Preparation tanks

Jacketed/Insulated/Cladded VesselBottom Entry Propeller Mixer for vigorous MASS MOVEMENT within the vesselBottom Entry Magnetic mixer mounted within the vesselLug Mounted Vessel on Platform with Load cells


Mixing of 10000 litres of water


Transfer Panels

Panel Design

Jumper DesignJumper HoldersPort CapsDrain PanProximity SwitchesPanel SupportPanel and Port Labeling

Photo Courtesy: Johnson & Johnson



Applications : Cleaning In Place of

Cream Manufacturing VesselIntermediate Preparation VesselsStorage Vessels Product Transfer lines

Photo Courtesy: Encube Ethicals

Product Profile : CIP System


Completely Automated Process Cycles of Pre Wash/Air blow/Detergent Wash/Rinse /Drying

On line display of process parameters with P & I of Operating System

Real Time Recording and Print /Communication of Process Parameters

Detergent / Acid / Alkali Automated Dosing system

On Line pH,Conductivity, TOC Sensing

CIP is designed in accordance with ASME BPE guidelines

PLC-based, with Touch Screen MMI and SCADA Packages



Key Benefits of CIP Process

Validatable process for cleaning of process equipment

Lower facility operating costs

Minimal dismantling of equipment and piping

Reduced turnaround time for cleaning

WFI requirements for cleaning reduced significantly

Exposure to hazardous activities or entry into tanks, is eliminated


Cleaning In Place Cycle


Key Benefits of CIP Process

Validatable process for cleaning of process equipment

Lower facility operating costs

Minimal dismantling of equipment and piping

Reduced turnaround time for cleaning

WFI requirements for cleaning reduced significantly

Exposure to hazardous activities or entry into tanks, is eliminated



Flow Characteristics and Measurement

Sanitary Flow meter



PIDOf

Plant wideCIP

System



HMI Screens : Manufacturing Vessel

Automation


HMI Screens : Phase Preparation Vessel

Automation


HMI Screens : Product Preparation Steps

Automation


HMI Screens : CIP System

Automation


HMI Screens : CIP System Steps

Automation


Summary

Company OverviewManufacturing Site Product ProfileProjectsInternational PresenceTrade Shows

Indian Ethos


Sterile Processing Projects






ProjectsReliance Lifesciences

IndiaBlood Plasma Products

Sanofi AventisEgypt

Semi Solids Processing Plant


ProjectsSerum Institute Of India

IndiaDSP Area Blending Vessels for

HIB Vaccine Project

EIMCEgypt

Vaccine Formulation Vessels


ProjectsJohnson & Johnson

IndiaFully Integrated SCADA Controlled Semi Solids-Liquids

Facility

Encube EthicalsIndia

Fully Automated Semi Solid/Emulsions Processing Facility


Summary


Indian Ethos


International PresenceInterphex Singapore 2005 CPHI India 2006 Interphex New York 2007

Interphex India 2007 Interphex Philadelphia 2008 Interphex Canada 2008

Documents

Adam Fabriwerk Processing Skids Presentation Sterile Processing