Pharmaceutical

Process technology supplier to the biotechnological and pharmaceutical industry.

We supply our customers with all process- and operations – relevant services and key components for professionally seeing projects through to their completion – all from a single source. Our specialists have years of experience in all the necessary disciplines, and systematically implement our customers’ specifications and the project targets they set.

PROCESS VESSELS

All vessels are made out of stainless steel and can be supplied as stand-alone equipment or as automated process units delivered as fully-functional modules installed on-site that include: agitators, homogenisers, metering and regulating technology, control units, valves and pipe connections. Options for hazardous environments are also available. Our products are in accordance with the Pressure Equipment Directive, and optionally acc. to ATEX, the European directive for systems operating in potentially explosive environments.

OPEN PROCESS VESSELS BROCHURE

DESIGN + VALIDATION + DOCUMENTATION

The design of all the above-mentioned processes, the preparation of: basic and detailed designs, specifications of material and labour, URS, 3D modelling, construction, detailed drawings for manufacture, ‘as built’ design/projects, technical documentation, validation documentation, validation execution.

Preparation and execution of projects and equipment according to ATEX.
Automation of all mentioned above including electrical connections, design documentation, technical documentation, and validation documentation and execution.

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Process and product safety is always a priority for us.

We ensure compliance with GxP’s and other official requirements (FDA, EMA, etc.) in accordance with current standards in construction and conversion of entire plants or plant components in the pharmaceutical industry.

We aim for the complete and comprehensible documentation of all GMP-relevant processes or process steps and the assistance of our customers beyond project completion.

An overview of our services:

  • Determining qualifiers
  • Risk analysis definition
  • Qualification schedule generation
  • Implementing DQ, IQ, and OQ
  • Extending qualification phases with FAT and SAT
  • Assisting in PQ
  • On-site operator training
  • Formulating SOPs
  • Change control

Years of experience, continual further training, and know-how in pharmaceutical plant construction ensure that qualification will be treated extensively and with the utmost quality.

OPEN DIAGRAM

SOLUTIONS AND SUSPENSIONS PREPARATION

Our systems optimise these operations, which are vital to a final solid- or liquid-form pharmaceutical process. We provide a range of manual and automated preparation and dosing equipment, creating systems designed to optimise the dosing of ingredients.

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Units for controlled and repeatable distribution and dosing of various media (WFI, PW, alcohol, solvents, nitrogen, air, dust…) and solution preparation.

Our dosing units for solution preparation are designed and built ensuring a reliable and repeatable process of dosing. During the switch between the dosing media in the recipe the exact separation between media is ensured by emptying the system with compressed air. Minimal product loss is ensured during the dosing media and recipe switches. The unit enables a controlled mixing of powders, heating and cooling of the process vessels (part of the H/C systems), mixing with variable speeds (part of the process vessels)… Our units fulfil the strict pharmaceutical norms and we can provide all the necessary validation protocols and documentation in accordance with GMP.

Basic features:

  • Various capacities, sizes and levels of sophistication depending on the requirements of the process and the user
  • All parts in contact with the product are made of AISI 316L
  • Surface roughness up to Ra < 0,2µm
  • State of the art equipment: Endress & Hauser, Gemü, Dockweiler
  • Automated process control via Siemens PLC or manual
  • CFR part 11 reporting
  • All the required documentation: P&IDs, 3D design, FDS, HDS, SDS, DQ/IQ/OQ/PQ, technical documentation, certificates, statements, ATEX…

WIP/CIP/SIP

An essential part of high-quality production is an integrated WIP/CIP/SIP system. Ipros provides efficient cleaning and sterilisation concepts adapted to consumer’s actual demands and for timely supply of the correct cleaning media to the points-of-use. From mobile and independent cleaning systems up to diverse CIP satellites fed with conditioned cleaning solutions, the range of customized solutions for your process plant is large.

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Clean-in-Place (CIP) and Sterilize-in-Place (SIP) systems are designed to both automate essential cleaning and disinfection processes and remove the need for time-consuming disassembly and assembly work.

Process optimisation depends on efficient, effective cleaning. Clean-in-Place (CIP) systems can be incorporated into all the equipment produced for the pharmaceutical industry, including both solid and liquid dosage formulation systems. Automating the cleaning process ensures repeatability, allows validation and minimizes downtime.

The most effective way to implement CIP technology is to design it into a process. Incorporating spray systems, tank cleaners, nozzles and seals to automate the cleaning process, we consider every aspect of your system when applying CIP features, from inlet to discharge.

Automating the cleaning cycle essentially converts batch pharmaceutical processes into a continuous operation of production and cleaning cycles.

The advantages of CIP include

  • reduced cleaning cycle times
  • optimized use of detergent and water
  • eliminates manual cleaning

At the heart of our CIP system is an advanced Wash Liquid Preparation Unit, which handles all preheating, mixing and pumping detergents and PW. It provides continuous monitoring and control of cleaning parameters, including flow rate, detergent concentration, temperature and wash time for full process validation.

Our CIP/WIP system skids are designed, engineered, fabricated, automated and tested in-house. The integrated approach allows for open communication between disciplines, enabling rapid response times to any variances that occur during the project lifecycle. A qualified Project/Process Engineer is assigned to your project to facilitate discussions regarding site-specific requirements, integration concerns and final FAT protocols.

In addition to defining and configuring your system skid, we further assist you to integrate CIP into your hygienic process and plant.

HEATING & COOLING SYSTEMS

Temperature control and agitation during the process are crucial for achieving a successful and repeatable outcome. Ipros ensures that the temperature of products in the vessel can be controlled within narrow limits (+/ 0.5° C) to avoid product variation during production.

This high degree of temperature control throughout production processes and product homogeneity is achieved using the latest heat exchanger technology and careful agitation. Precise instrumentation measures all the key parameters of pH, O2, temperature, agitator speed, and weight throughout processing.

GMP INSTALLATION

We design, install, commission, and qualify/validate the operation, performance, and maintenance of the storage and distribution system, to ensure reliable, consistent production of media of required quality, in order to prevent recontamination after treatment.

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Competent specialists guarantee consistent implementation.

Competent specialists ensure consistent implementation.

High-quality piping requires high quality standards, especially in the pharmaceutical, biotechnological, food, and chemical industries.

Perfect organization, many years of experience, state-of-the-art equipment, and the continuous optimization of various welding techniques are fundamental prerequisites for a project’s successful completion. We have made it our business to ensure our customer’s that these requirements will be filled.

Our installation portfolio comprises:

  • Installation planning
  • Piping
  • Quality control/documentation
  • Commissioning service
  • Calibration
  • Full Service Installation
  • Planning and manufacturing of stainless steel components.

The customer takes centre stage in all our activities. Our portfolio of services comprises the planning, coordination, assembling, and documenting process systems, as well as quality assurance inspections and commissioning.

In addition to stainless steel structures, frames and special components, we also supply our customers with completely pre-built skids.

We provide appropriate packaging and transportation as well, if required.

In order to be able to produce the required quantities of water in the quality laid down in USP and Ph Eur a water plant has to meet very exact demands. A large number regulations and standards have to be respected. The GMP water system is subject to very stringent control and inspection. We ensure these requirements are met.

We will design, assemble, deliver and install a hot (WFI) or cold (PW) water storage system, depending on your requirements. Every sampling point in the loop can be equipped with a sampling valve and fittings for loop sterilization. The necessary metering technology for throughput and TOC are provided as standard. We incorporate all the units required for the production of highly purified media into these systems.

Essential features:

  • zero dead-leg design
  • systems that can be completely drained and sterilized
  • TOC metering technology
  • diaphragm valve technology
  • tubular heat exchangers in DTS design

AUTOMATION

Automation technology is much more than programming and electrical engineering. In addition to our know-how in automation technology, this technology requires a qualified understanding of process engineering and process plants, and extensive experience in implementing the requirements.

For modern production plants in the pharmaceutical industry Ipros supplies automation solutions for the entire process chain, from upstream to downstream, from standalone single station systems (skid units) to complex central process management systems.

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The diverse processes in the food industry, for example in a creamery, are customized and tailored for the production of the various dairy products.

Consequently the automation of these processes is just as diverse and varied.

For production plants’ automation requirements, Ipros developed the concept of operation and control.

Our services:

  • Project organization
  • Demand analysis & concept
  • Engineering
  • Switchgear & electrical installation
  • Functional tests
  • Commissioning & verification
  • Life cycle management
  • Service & maintenance
  • Systems & products
  • Process control systems
  • Operating systems
  • Batch-SCADA server
  • PLC controls
  • Client server systems
  • Switch cabinet
  • Construction
  • Automation Made to Measure

We are trusted by the following
companies, among others:

Pfizer, HR – preparation and storage of GMP media and of sterile solutions, process mixing jacketed vessels for the preparation of sterile solutions with WIP

Sandoz (Lek), SLO – preparation and storage of GMP media and of sterile solutions, process vessels for the preparation of sterile solutions, several WIP systems and CIP systems

Krka, SLO – preparation and storage of non-sterile solutions, process vessels for preparation of sterile solutions, installations (acc. to ATEX), manufacture and installation of a process mixing vessel with peripheral systems (vacuum system, H/C systems, inertisation, lifting, turning…) for the preparation of gels, ointments, creams, pastes… (acc. to ATEX)

Contact

Ipros – Inženiring Procesne Opreme in Sistemov d.o.o.
Cesta v Gorice 30, 1000 Ljubljana, Slovenija, EU

Phone: +386 1 200 26 20
Fax: +386 1 423 18 24
ipros@ipros.si

SALES MANAGER
PHARMA

Peter Požar
peter.pozar@ipros.si
+386 41 361 122

HEAT EXCHANGERS
SALES & PRODUCT MANAGER

Boris Deršek
boris.dersek@ipros.si
+386 51 346 901

DAIRY, BEER, FOOD & BEVERAGE

Nejc Zor
nejc.zor@ipros.si
+386 41 911 936

DIRECTOR OF OPERATIONS

Tomaž Zor
tomaz.zor@ipros.si
+386 41 271 432

TECHNICAL DIRECTOR

Frenk Plevnik
frenk.plevnik@ipros.si
+386 41 751 545

HEAD PROJECT MANAGER

Damir Škrobot
damir.skrobot@ipros.si
+386 41 393 560

SENIOR BUSINESS DEVELOPER

Michael Markov
michael.markov@ipros-sourcing.com
+386 41 828 031

PURCHASE AND LOGISTICS

Andreja Davidović
andreja.davidovic@ipros.si
+386 41 323 502

SERVICE

service@ipros.si
+386 40 669 277

BENELUX

Olivier Burguet
o.burguet@beaupain.be
+32 475 708 983

EGYPT

Wahid Abdel-Malik
ecat@ecat-international.com
+20 122 2126359

MACEDONIA

Ina Miloševska
ina@ecotip.com.mk
+389 76 346 363

SERBIA

Dragan Brenesel
dragan.brenesel@ipros-rs.com
+381 63 513 819

BULGARIA

Dimitar Yordanov
office@maycom.eu
+359 2 8583 152

GERMANY

Branimir Djukic
b.dukic@gmx.de
+49 (0) 162 6566543

POLAND

Łukasz Berbeć
info@craftech.pl
+48 667 344 377

SOUTH KOREA

JK(Jin-Kook) Lee
jklee@joowon.co.kr
+381 63 513 819

CROATIA

Vjekoslav Piljek
vjekoslav.piljek@ipros-hr.com
+385 98 356 349

GREECE

George Katsaounis
sales@thesciencesupport.com
+30 211 8005090

PORTUGAL

José Amaral
jeamaral@jeamaral.org
+351 962996943

TAIWAN

Robert Lin
bonrace@ms15.hinet.net
+8862 22609855

DENMARK (Nordic)

Bo Frederiksen
bfr@mech-e.dk
+45 21 74 14 71

INDONESIA

Rifan Ahmad
rifan@biosm-indonesia.com
+62 812 872 4464

ROMANIA

Alin Daniel Popa
alin.popa@ipros-ro.com
+40 748 060 708