Pharma — process systems, engineering and validation

Product lines

Systems for pharmaceutical production

PW system units, CIP/SIP systems, systems for sterile solutions, clean media preparation, storage and distribution, mobile mixing vessels and duplicators, and SKID units for utilities or process.

Aseptic vial solution preparation lineMobile and fixed vessels with CIP and SIP loops, for preparing and storing sterile solutions next to the filling line.150 L and 3,000 LPharma
PW systems — purified waterGeneration, storage and distribution of purified water, with reverse osmosis and electrodeionisation — fully automated.200–1,000 L/hPharmaBiopharma
Clean media: preparation, storage, distributionThe utilities a clean production depends on: purified water, process and clean gases, and the user points in the clean room.PW, process and clean gasesPharmaBiopharma
CIP/SIP systemsFully automated cleaning in place, with optional sterilisation and rinsing with purified water (SIP/WIP).1,000–3,000 L/hPharmaFoodBiopharma
Process and utility SKIDsPre-tested, documented SKID units for PW and WFI distribution, tempering, filtering, media preparation, mixing and dosing.FAT in RENI’s workshopPharma
Process vesselsHygienic mobile mixing vessels of 100, 200 and 600 L, with bottom magnetic mixers and double jackets for tempering.100, 200 and 600 LPharma
Mobile duplicators60 L double-jacketed vessels for preparing suspensions, with autonomous control of pH, oxygen and temperature.60 L; batches 10–100 %Pharma
ATEX mobile mixing unitsMobile mixers with adjustable height and a suction hood, for the ATEX-safe preparation of coating suspensions.30, 60 and 90 LPharma
Transfer panels and valve manifoldsClean room transfer panels and valve manifolds that direct the flow of product and cleaning media, safely.Dosing, sampling, distributionPharmaBiopharmaFood

Engineering, implementation, validation

Complete engineering, implementation and validation services

Committed to safety

We take safety seriously. Our equipment and systems comply with legislative requirements and current industry standards. Above all, we assess, manage and minimise design and operational risks, and we always provide information, instruction, supervision and training for employees and clients.

Documentation matters

We prepare and hand over the complete project documentation, and we make sure it follows the cGMP and ISPE guidelines.

Automation means security

All our systems are built with a high level of automation. The aim is a system that gives complete control over the process and a satisfactory, repeatable quality of the final product; SCADA visualisation allows complete and precise control of the equipment.

Extensive control

From the incoming goods inspection, through quality assurance in production, to the final as-built documentation, nothing slips by unchecked.

Fast-track projects

Experienced with fast-track projects

When the schedule is tight, detail engineering and execution run at the same time, and the client’s design changes are implemented while the project is under way — with the same consistent quality of workmanship.

Ongoing, simultaneous execution and detail engineering
Client design changes implemented during execution
Consistent quality of workmanship
On schedule and in budget

The seven steps in detail

A valve manifold with pneumatic valves, built by RENI, in black and white

Standards and certification

Built to the standards pharma works to

The standards and certifications we name for our pharmaceutical equipment and systems.

ASME BPEStandardisation
EN ISO 3834-2Fusion welding
EN 1090-1Conformity assessment for structural components
AD 2000-Merkblatt and EN ISO 3834-2Design and manufacture
PED 2014/68/EUPressure equipment
GAMP 5GxP computerised systems — quality maintenance
Orbital weldingQuality and precision
ATEXCertified for the assembly of ATEX equipment — safety and regulations

Reference project

Krka: 13 ATEX mobile mixing units

Pharma · Krka

ATEX mobile mixing units for coating suspensions in tablet production

Client: Krka
Country: Slovenia
Year: 2019–2021
RENI’s scope: Engineering, design, production, testing and commissioning

The task

Delivery of 13 mobile mixing units in three sizes — 30, 60 and 90 litres — for a hygienic, ATEX-safe mixing environment.

The mixers have an adjustable height and a suction hood over the mixing chamber that prevents cross-contamination. The top cover and the container separate easily from the base unit, an operating-position switch stops the agitator outside the permitted mixing position, and the shape of the mixing rotor can be changed.

Outcome

More efficient mixing, a 5 % increase in production, a unit standardised for future projects, and ATEX documentation.

Product lines in this project

ATEX mobile mixing units

The team

Experience builds trust. And trust builds a successful partnership.

We are a team of highly devoted professionals, experienced in process engineering for the life-science and pharmaceutical industries.

With our knowledge we deliver high-quality products and solutions, while keeping an open mind for our clients’ suggestions.

Send a project enquiry

An operator at a RENI mobile mixing unit in a pharmaceutical clean room

Trusted by

Pharmaceutical companies on our reference list

Krka d.d.
ATEX mobile mixing vessels for preparing coating suspensions in tablet production.
Lek d.d.
A mobile pressure duplicator for pharmaceutical products.
Pfizer
Novartis
MSD
GSK
Hemofarm
Pannoc

All references

Describe your process

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Project enquiry

A pharmaceutical project in preparation?

From the URS to qualification, we work as one team. Tell us where your project stands — idea, concept, basic design, tender or execution.

Send a project enquiry Call +386 1 500 81 64

URS, P&ID or layout drawings: please send them by e-mail to info@reni.si

Effective, innovative, safe