pharmaceutical & biotech over 25 years of experience · over 25 years of experience as a...

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over 25 years of experience As a technology supplier to the biotechnological and pharmaceutical industry, we design, manufacture, and install customized solutions for well-known and respected companies around the world. PHARMACEUTICAL & BIOTECH CHEMICALS FOOD & BEVERAGES PROCESS TECHNOLOGY SOLUTIONS DEDICATED EFFICIENT AND TAILOR-MADE SOLUTIONS www.ipros.si 1 12

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Page 1: PHARMACEUTICAL & BIOTECH over 25 years of experience · over 25 years of experience As a technology supplier to the biotechnological and pharmaceutical ... • Now contribute to the

over25 yearsof experienceAs a technology supplier to the biotechnological andpharmaceutical industry, we design, manufacture,and install customized solutions for well-known andrespected companies around the world.

PHARMACEUTICAL & BIOTECH

CHEMICALS FOOD & BEVERAGES

PROCESS TECHNOLOGY SOLUTIONS

D E D I C A T E D E F F I C I E N T A N D T A I L O R - M A D E S O L U T I O N S

www.ipros.si

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Page 2: PHARMACEUTICAL & BIOTECH over 25 years of experience · over 25 years of experience As a technology supplier to the biotechnological and pharmaceutical ... • Now contribute to the

ABOUT US :

• Company Profile

• Founded in 1989 by senior executives coming froma larger company operating in pharmaceutical,chemical and food & beverage industry.

• Leading system provider for Pharma, Food andEnergy processes within southern Europe.

• Over 60 professionals (strong engineering andconstruction department with over 25 engineers).Additionally we are steadily outsourcing knownengineers and design offices in the area to beable to satisfy the ever-growing demands of ourprojects + additional capacities 25 in electrical &

automation, 35 in vessel production which can makeus a capable player.

• Company Evolution

• Originally involved in sales and installation ofequipment components and installation.

• Evolved over time to ‘turn key’ solutionsdevelopment ... Design (composing specificationsand P&ID), manufacture, installation, technicaldocumentation and validation.

• Now contribute to the writing of User RequirementSpecifications.

• Technical Certificates

• ISO 9001:2008, PED 97/23/EC (AD 2000-Merkblatt)

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Page 3: PHARMACEUTICAL & BIOTECH over 25 years of experience · over 25 years of experience As a technology supplier to the biotechnological and pharmaceutical ... • Now contribute to the

GMP Media Distribution

PHARMACEUTICAL INDUSTRY:

• Specialized Units

• CIP/WIP• SIP Units• GMP Media• Vessels & Reactors• Solution Preparation• Sterile Filtration• TFF Units• Single-Use Units• Chromatography

• State-of-the-art Components

• Tube heat exchangers

• Plate heat exchangers

• Pall filters• Gemü valves• Grundfos pumps

ASSESSMENTS•RISK MANAGEMENT • SYSTEM/SOFTWARE QUALITY ASSURANCEPROCESS • SYSTEM/SOFTWARE CONFIGURATION MANAGMENT PROCESS •SYSTEM/SOFTWARE PROBLEM RESOLUTION PROCESS • OPERATIONS AND

MAINTENANCE LIFECYCLE • SYSTEM DISPOSITION/RETIREMENT

VALIDATION PLANNINIG

VALIDATIONSUMMARY REPORT

USERREQUIREMENTS

PERFORMENCEQUALIFICATIONS

FUNCTIONALSPECIFICATIONS

OPERATIONALQUALIFICATIONS

DESIGNSPECIFICATIONS

INSTALLATIONQUALIFICATIONS

CONSTRUCTION

VE

RI

FI

CA

TI

ON

TR

AC

EA

BIL

ITY

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Complex Mixing Vessels Piping & Installation

Page 4: PHARMACEUTICAL & BIOTECH over 25 years of experience · over 25 years of experience As a technology supplier to the biotechnological and pharmaceutical ... • Now contribute to the

• Preparation and dosing of clean, sterile and non-sterile solutions, suspensions, syrups...

• Cleaning; WIP (washing in place), CIP (cleaning inplace) systems

• Cooling and heating (tempering stations) for theproduction for various types of products

• Pasteurization units

• Filtration units

• Preparation and distribution of clean and GMPmedia (process water, PW – purified water, WFI –water for injections, PS – pure steam, nitrogen, air...)

• Design of all mentioned above, preparation of:

• Basic and detail designs • specifications of material and labour• URS• 3D modelling• Construction• Detailed drawings for manufacture• ‘As built’ design/project• Technical documentation• Validation documentation• Validation execution.

PROCESS SYSTEMS FOR THE USE IN THE PHARMACEUTICAL INDUSTRY:

Preparation & Dosing Cleaning WIP/CIP Heating/Cooling Systems Automation

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Page 5: PHARMACEUTICAL & BIOTECH over 25 years of experience · over 25 years of experience As a technology supplier to the biotechnological and pharmaceutical ... • Now contribute to the

SYSTEMS

• CIP or WIP systems for solidforms production (cleaning ofprocess and preparation vesselsand FBDs or coaters)

• Solution preparation withpreparation and mixing vesselsfor solid forms production (alsoacc. to ATEX, also mobile)

• CIP/SIP systems for sterile liquidforms production and biotechproduction

• Sterile solution preparation linesfor sterile filtration and dosing

PROCESS VESSELSOR UNITS• As previously mentioned mixing

and preparation vessels forcoating (also acc. to ATEX, alsomobile)

• Sterile solution preparationvessels

• Syrup preparation vessels withanchor, high – speed propeller,homogenizer mixers and H/Csystems

• Special homogenizing vesselswith scraper and homogenizermixer with H/C system,automated dosing and weightcontrol, vacuum system…

INSTALLATION ONSITE• GMP, clean media installation

(PW, WFI, CS, comp. AIR,NITROGEN)

• Installation of above mentionedequipment

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Page 6: PHARMACEUTICAL & BIOTECH over 25 years of experience · over 25 years of experience As a technology supplier to the biotechnological and pharmaceutical ... • Now contribute to the

CIP SYSTEM

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Page 7: PHARMACEUTICAL & BIOTECH over 25 years of experience · over 25 years of experience As a technology supplier to the biotechnological and pharmaceutical ... • Now contribute to the

STERILE SOLUTIONPREPARATION LINE WITH MIXING VESSELS

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Page 8: PHARMACEUTICAL & BIOTECH over 25 years of experience · over 25 years of experience As a technology supplier to the biotechnological and pharmaceutical ... • Now contribute to the

HOMOGENIZERSFOR GELS,CREAMS ANDOINTMENTS

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Page 9: PHARMACEUTICAL & BIOTECH over 25 years of experience · over 25 years of experience As a technology supplier to the biotechnological and pharmaceutical ... • Now contribute to the

WIP FORPREPARATIONVESSEL ANDFBD

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Page 10: PHARMACEUTICAL & BIOTECH over 25 years of experience · over 25 years of experience As a technology supplier to the biotechnological and pharmaceutical ... • Now contribute to the

ATEXSOLUTIONPREPARATIONANDCONNECTIONTO FBD

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Page 11: PHARMACEUTICAL & BIOTECH over 25 years of experience · over 25 years of experience As a technology supplier to the biotechnological and pharmaceutical ... • Now contribute to the

• Project management• Engineering

Process engineering • Equipment design• Production• Installation• Automation• Qualification

OUR SPECIALIZED TEAM OFFERS: • Experience

• More than 25 years in pharmaceutical process equipment engineering

• Long term relationship with Sandoz, Teva, Krka, Pfizer...• Perfect size

• Flexible• Quicker• Price competitive

• Know How• Cost-effective plant engineering• Validation process• Design and qualification

WHY IPROS ?

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Page 12: PHARMACEUTICAL & BIOTECH over 25 years of experience · over 25 years of experience As a technology supplier to the biotechnological and pharmaceutical ... • Now contribute to the

IPROS ENGINEERING

A: Cesta v gorice 30, LjubjanaT: +386 1 200 26 29Web: www.ipros.siE-mail: [email protected]

Best regards,

Michael MarkovBusiness developmentM: +386 41 828 031

THANK YOU FOR YOUR TIME!

CONTACT US:

LjubljanaZagreb

Belgrade

Bucharest

Skopje

Munich

PragueFrankfurt

Brussels

AmsterdamBerlin

Warsaw

Paris

London

Bern

RomaMadrid

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