PHARMACEUTICAL & BIOTECH over 25 years of experience · over 25 years of experience As a technology...
Transcript of PHARMACEUTICAL & BIOTECH over 25 years of experience · over 25 years of experience As a technology...
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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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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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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
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• 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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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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CIP SYSTEM
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STERILE SOLUTIONPREPARATION LINE WITH MIXING VESSELS
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HOMOGENIZERSFOR GELS,CREAMS ANDOINTMENTS
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WIP FORPREPARATIONVESSEL ANDFBD
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ATEXSOLUTIONPREPARATIONANDCONNECTIONTO FBD
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• 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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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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