BIOPROCESS EQUIPMENT

Bionet has more than fifteen years of

experience in process design and in the
construction of bespoken equipment for the
pharmaceutical, food and biotechnology
industries. Backed by this experience,
Bionet has developed a complete range of
laboratory, pilot and industrial equipment for
bioprocesses.

Our equipment is innovative, with state of

the art solutions and technologies, and with
a design focused on reliability and easy
maintenance.
PA G E 10 PA G E 12 PA G E 14 PA G E 16
F1 F2 F3 FS

Autoclavable bench Pilot scale SIP Pilot and small Large volume industrial
scale Bioreactors/ Bioreactors/Fermentors industrial production Bioreactors/Fermentors
Fermentors Bioreactors/Fermentors
 INDEX

PA G E 18 PA G E 22 PA G E 24 PA G E 26
M CIP ROSA + ACCESORIES
SOFTWARE

Cross-Flow Filtration Cleaning-In-Place ROSA+ Advanced Accesories and spare

Systems from lab to Systems Software for control parts for Bioreactors and
industry and automation of Filtration Units
Bioprocesses
T H E CO M PA N Y

We are an independent company, founded in 1999,

dedicated with passion and professionalism to bioprocess

engineering. We offer state-of-the-art technology, with a

practical approach and tailored to the particular needs of

your project and company.

We understand the project as a whole, thanks to the

experience accumulated in multiple projects and an

international team that comes from a variety of activities

(R&D, engineering, production, maintenance, quality

control).

Therefore we can help not only providing equipment

but also developing processes, designing and building

complete plants and training your operation and

maintenance personnel.
 T H E CO M PA N Y 7

Bionet is a specialist in bioprocesses engineering.

We provide equipment (Bioreactors, Cross-Flow
Filtration Systems and Cleaning-In-Place Systems) and
advanced technical services. Our clients are industries
and R&D organizations which work with bioprocesses
in the chemical, food and pharmaceutical sectors.

QUALITY

In Bionet, quality is part of our core culture and we work We have a commissioning and FATs (Factory Acceptance

under a certified quality management system, based on Test) area that allows us to deliver tested and ready-to-

ISO 9001:2008. start equipment, according to a Plug & Play concept.

This reduces risk, shortens periods of commissioning of

We work in a full documented engineering environment
equipment and is useful to train future users.
and provide our equipment with IQ (Installation Qualifica-

tion), OQ (Operation Qualification) and PQ (Performance

Qualification). On demand, the design and qualification

may be executed according to cGMP standards.

8 BIOPROCESS EQUIPMENT

Bionet has developed a complete range of

Bioprocess Equipment including series of Bioreactors
/ Fermentors, Cross-Flow Filtration Systems and
Cleaning-in-Place Systems (CIPs).

Each of these series includes models throughout the range

of use. From small R&D equipment, both in laboratory and
pilot plant, to industrial scale equipment.

These different units share a design philosophy we believe

makes our current technological proposal unique.
The designs incorporate the latest mechanical,
instrumentation and control technology, being at the
forefront of the industry. Bionet units are an up-to-date
solution that will offer many years of service.
 BIOPROCESS EQUIPMENT

Since its initial conception (QbD), Bionet units have been
designed to ensure availability and simplify maintenance
and operation.
For this purpose, the units include not proprietary
components from leading vendors. This ensures
manufacturing excellence, and allows quick and easy
access to consumables and spare parts, allowing working
with local suppliers.
Furthermore, our equipment shares proven engineering
solutions common to all models in a serie and also
shared between different series. This reduces the need for
maintenance and simplifies your procurement tasks.
All bioreactors and filtration units are available for both,
cell culture and microorganisms (bacteria, yeasts and
fungi) and in cGMP version.

The 3D design is open and orderly, facilitating access to

all system components and the supply of utilities to the
equipment interfaces.
 F1

F1 models are autoclavable bench-scale Bioreactors

designed to meet the R&D requirements in
biotechnological and biopharmaceutical processes.

The system is user friendly, flexible, and
incorporates the latest technology of the sector
microbial and cell culture processes
>
| Available in five models (F1-1, F1-3, F1-5, F1-8 and
F1-10) with working volumes from 0,7 to 10 liters. All
five are compatible with the same control unit (FCU) and
agitator motor.
>
| Product-contact surfaces made entirely of stainless
steel A316L, borosilicate and jacketed for optimum
temperature control steel.
>
| Noiseless servo top-mounted agitator with broad
speed range (10-1200 rpm). Available with Rusthon or
marine impellers.
>
| 3-4 addition pumps, 1 with variable speed for fed-batch
or continuous fermentation.
BIOREACTORS / F1 11
with a high-quality service.
F1 units are the right tool for
initiating and developing your
in stirred reactors.
>
| Controlled parameters: pH, dissolved O2, temperature
and level (foam). Other parameters (OD, exhaust
gas...) can be easily added on demand even after the
equipment delivery and commissioning.
>
| Gas supply, temperature control , monitoring and
additions are all integrated in Bionet FCU through an
industrial PLC (Siemens) and a 12 HMI Panel PC, with
ROSA+ control software installed.
>
| Ethernet port with LAN and VPN communication.
>
| cGMP version bioreactors and manufacturing under
ASME-BPE standards available on demand. It includes CFR
21.11 version of ROSA+ SW.
 F2

Bionet F2 models include

Steam-In-Place (SIP)
Bioreactors made
of stainless steel,
incorporating the latest
technology and practical
conception.
 BIOREACTORS / F2 13

A modular system designed and constructed under

the highest quality standards, equipped for a simple
operation that will be easily integrated into your
facilities. F2 Bioreactors are used for both R&D
and industrial production due to its high level of
automation, control and flexibility on a robust and
reliable design and construction.

>
| Two models (F2-15 and F2-30) with max working >
| Controlled parameters: pH, dissolved O2, temperature
volumes of 15 and 30 liters, respectively, and possibility and level (foam). Other parameters (OD, exhaust
to work with volumes between 6 and 30 liters. gas...) can be easily added on demand, even after the
equipment delivery and commissioning.
>
| Vessel and product-contact surfaces made of stainless
steel A316L. >
| 3-4 addition pumps, 1 with variable speed for fed-batch
or continuous fermentation.
>
| 15+ ports for instrumentation, addition, and outgassing.
>
| Monitoring and additions integrated in Bionets FCU
>
| Sterilisable (SIP) harvest valve.
through an industrial PLC (Siemens) and a 12 HMI Panel
>
| Noiseless, maintenance free, 1,1kW top-mounted
PC, with ROSA+ control software installed.
agitator, brushless servomotor, speed range of 20-1200
>
| cGMP version bioreactors and manufacturing under
rpm. Available with Rusthon or marine impellers.
ASME-BPE standards available on demand. It includes
>
| Ethernet port with LAN and VPN communication.
CFR 21.11 version of ROSA+ SW.

>
| Available in self-sterilisation version with integrated
steam supply.
 F3

Bionet F3 models are a unique

concept for those seeking for a
Steam-In-Place (SIP) Bioreactor/
Fermentor of industrial scale and
conception, with the quality of
a standardized product but with
the flexibility of a local vendor.

>
| Available in five models (F3-50, F3-100, F3-200, F3-300
and F3-500) with working volumes from 50 to 500 liters, and
possibility to work with volumes between 30 and 500 liters.
>
| Vessel and product contact surfaces made of stainless
steel A316L.
>
| Controlled parameters: pH, dissolved O2, temperature
and level (foam). Other parameters (OD, exhaust gas) may
be easily added on demand, even after the equipment is
delivered and working.
>
| Ethernet port with LAN and VPN communication.

>
| 20+ ports for instrumentation, addition, and outgassing. >
| Monitoring and additions integrated in BionetS FCU
through an industrial PLC (Siemens) and a 12 HMI Panel
>
| Sterilisable (SIP) harvest valve.
PC, with ROSA+ control software installed. cGMP version
>
| Bottom agitation system from 2,2 kW to 5,5 kW, servo or and other multiple options and accessories available on
electrical motor with gear reduction motor. Available with demand.
Rusthon or marine impellers.
>
| cGMP version bioreactors and manufacturing under
>
| 3-4 addition pumps, 1 with variable speed for fed-batch ASME-BPE standards available on demand. It includes CFR
or continuous fermentation. 21.11 version of ROSA+ SW.
 BIOREACTORS / F3 15

A system with state-of-the-art technology meant to

be the reference in industrial fermentation and cell
culture. As all our products it comes with practical
conception and the premium Bionet quality service.
 FS
Bioreactors entirely built at the workshop, with a
self-supporting frame and assembled and fully tested
prior to shipment to the customer. After the FATs
(Factory Acceptance Test), the bioreactors are stripped
out to be assembled in its final location.
It is a unique plug and play concept for large
bioreactors. A safe and quick alternative to reduce risks in
projects which, until now, were performed as unique with
the limitations and risks that entails.
>
| Available in three models (FS-1000, FS-2000, and FS-3000)
with working volumes from 1000 to 3000 liters, and possibility
to work with volumes between 150 and 3000 liters.
>
| Larger volume bioreactors available on demand.
>
| Vessel and product-contact surfaces made of stainless
steel A316L.
>
| 25+ ports for instrumentation, addition and outgassing.
>
| Sterilisable (SIP) harvest valve.
>
| Bottom agitation system from 5,4 kW to 7 kW, servo or
electrical motor with gear reducer. Available with Rushton or
marine impellers and higher power input.
 BIOREACTORS / FS 17

The FS Bionet models are

thought to fill a market gap
so far unresolved: medium
and large volume Fermentors
which being competitive with
local suppliers, provide the
great advantages of carefully
engineered equipment and
mass-manufactured.

>
| Controlled parameters: pH, dissolved O2, temperature
and tevel (foam). Other parameters (OD, exhaust gas) may
be easily added on demand, even after the equipment is
delivered and working.
>
| Ethernet port with LAN and VPN communication.
>
| All monitoring and additions integrated in BionetS FCU
through an industrial PLC (Siemens) and a 12 HMI Panel
PC, with ROSA+ control software installed. Available in
cGMP version and other multiple options and accessories.
>
| cGMP bioreactors and manufacturing under ASME-BPE
standards available on demand. It includes CFR 21.11
version of ROSA+ SW.
18 C R O S S - F LO W F I LT R AT I O N

Cross-Flow Filtration is a widespread technology in

industrial separation, clarification and
concentration processes.

At Bionet we strive to understand your technology,

production and regulation needs, to design and build
the optimal solution for your cross-flow filtration processes.

We offer a flexible relationship, adapted to your needs,

including process development, process engineering,
production, equipment, turnkey projects and training.

Our goal is to partner with you to provide you with a

production capacity according to your needs and status
of your project.
Production and process development
 C R O S S - F LO W F I LT R AT I O N

The design of cross-flow filtration processes, and Bionet has a department dedicated to process
equipment that run them, is a complex process that development, composed of highly qualified staff that has
requires knowledge and experience, in addition to the extensive experience working in many projects of high
necessary technological capabilities. complexity.

Reach the optimal solution requires a methodical process Our laboratory and pilot plant is equipped with several
that may include different tests, such as: filtration units to perform tests with different membrane
technologies and from multiple vendors. We can work
>
| Screening of the most suitable membrane technology
from small batches (2-3 liters) up to hundreds of liters.
(ceramic vs organic, flat, tubular or HF membranes...) and
cut-offs for your filtration process.
All this work reduces project risks ensuring that the
>
| To optimize working conditions. equipment you are buying responds to a process
execution tested and validated.
>
| Physical/chemical conditioning of the products to be
filtered to enable the process and optimize yields.
We can produce commercial or validation batches in our
>
| Study of multi-stage processes. pilot plant so you can advance your technical and
commercial development.
>
| Development and validation of cleaning processes.
 Bionet has developed de M and R series,
a complete range of pilot and industrial scale
Cross-Flow Filtration systems.

Our models cover all filtration levels (microfiltration,

ultrafiltration, nanofiltration and reverse osmosis). In
addition, most market leaders available technologies (flat
ceramic tubular, hollow fiber, spiral...) can be integrated.

>
| Bionet owns Backpulse systems, for cleaning
enhancement and/or for delaying fouling episodes.
>
| All units are available in several sizes and from pilot
units, with working volumes between 30 and 100 liters
(M50, R50), to units for small and medium industrial
production (M500 and R500) and customized industrial
units to filter thousands of liters per hour (MR and RS).
>
| All models may be fully automated with process and
control instrumentation through ROSA+ SW. Software
implemented in 12 Touch Panel PCs.
>
| ATEX compliant version for organic solvent filtration-
extraction processes available.
>
| Based on standard capacity most units can incorporate
further membranes units to increase filtration surface.
C R O S S - F LO W F I LT R AT I O N / S E R I E S M - R 21
>
| Alternative pump technologies depending on the
medium rheology.
>
| All models may incorporate temperature control through
temperature exchange jackets or heat exchangers integrated
in the filtration circuit.
>
| cGMP versions of all models and manufacturing under
ASME-BPE standards available on demand. It includes CFR
21.11 version of ROSA+ SW.
BIONET offers, as a service, cross-flow filtration process
development. Our laboratory and pilot plant house the
right-scale equipment to select and optimize processes
with all technologies we install. This reduces project risks
ensuring that the unit we deliver responds to a process
performance already tested and validated.
22 CLEANING IN PLACE

Bionet CIP (Cleaning-In-Place) systems are

engineered to guarantee an effective and
efficient cleaning of your lines, vessels, reactors and
process units. They are designed based on proven
engineering solutions (process, equipment and
control SW) and we adapt them to specific
project and client needs.
 CLEANING IN PLACE
Our CIP units are designed to work integrated with both
Bionet equipment or other manufacturer equipment
and processes.
With this equipment you will have the security and
confidence of a complete and traceable cleaning for
all your systems. In addition, you will be able to easily
configure different operation recipes to adress process
changes or new requirements.
>
| Models to clean process vessels from 30 to 50,000 litres
of volume, plus piping and ancillary equipment.
>
| Portable or stationary design.
>
| One-tank (Wash & Rinse) or multi-tank version for
shorter process cycle. Single tank versions imply reduced
capital costs, limited footprint and are easy to transport.
Multi-tank
| versions save water and chemicals, reducing
operating costs, environmental impact and cleaning cycle time.
>
| All systems performance can be qualified through a
Riboflavin Test.
>
| Bionet specialized staff, in addition to supplying
equipment, can provide support to design and optimize
your cleaning recipes.
>
| All models may be fully automated with process and
control instrumentation through ROSA+ SW. Software
implemented in 12 Touch Panel PCs.
>
| cGMP versions of all CIP models and manufacturing
under ASME-BPE standards available on demand. It
includes CFR 21.11 version of ROSA+ SW.
24 ROSA + SOFTWARE

ROSA+ is the advanced SW solution created by

Bionet to automate Bioprocess equipment and complete
Bioprocess lines.

The core module is designed ROSA+ is installed as standard in each Bionet FCU

for fermentation and cell
culture process control, and
it is installed in all Bionet F
Series. It is a powerful tool that
incorporates all the necessary
functions for integrated process
(Fermentor Control Unit). The FCU is the unit where all
the operations (utility supply, process and automation
control) are centralized and has been designed to be
compatible with each particular model of the F series.
ROSA+ also offers filtration and CIP automation modules,
guaranteeing an optimal integration of all processes
under single software.

control, process qualification All software modules are available in 21CFR Part11

and validation, and data compliant version.

analysis and data management. ROSA + may be installed in multi-language version. The
application allows users to work on different languages
for every work session.
 ROSA + SOFTWARE

ROSA+ main features include:

>
| 7 screen modes: >
| 3 types of data logging:

> Process synoptics. > Alarms and messages of the system.

> System alarms. > Process data.

> Process tendency curves. > Audit trail, regarding the change of status of
process variables.
> Loading and programming of recipes.
>
| 2 user levels (operator and administrator).
> Instruments and pumps calibration.
>
| VPN connection via ethernet port.
> Controls and control programming.
>
| MODBUS communication to process hardware
> Batch reports.
(instruments, pumps, etc).
 ACCESSORIES

Bionet is not limited to the supply of complete

equipment but also provides accessories, spare parts
and consumables for Bioreactors / Fermentors
and Filtration Plants.

Accessories and spare parts meet the established Fermentation

international standards and are available in different sizes

and micron ratings to ensure proper adjustment to the
Accessories integrated in bioreactors/ fermentors, such as:
scale and equipment considered.
>
| Sterile sampling and addition devices.

>
| Foam level probes. Sliding probe for the establishment
of different level maximums.

>
| Manual aseptic addition accessories (septums, septum
needles).

>
| Automatic aseptic dosing accessories (double-dosing nozzles,
dosing bottles,) and peristaltic pumps.

>
| Aeration and agitation; impellers, baffles, spargers, mass-
flow controllers.

>
| Contention accessories (0,22 m filters, filter housings).

>
| Safety accessories (burst discs, overpressure relief valves).

>
| Probes; temperature, pH, dO2 or turbidity.

>
| Steam line accessories: Steam contention valves and
steam tramps.

>
| Aseptic fittings: nuts and screws, lids, caps and plugs,
adaptors, connections

Cross-flow Filtration
Common cross-flow filtration systems accessories:
>
| Different technology membranes (ceramic, hollow fiber,
spiral ...) and characteristics (pore size, filtration area ...) to
encompass all levels of filtration (microfiltration, ultrafiltration,
nanofiltration and reverse osmosis). Besides all the parts
required for installation.
>
| Harvest and concentration tanks of different volumes.
>
| Recirculation pumps (peristaltic, centrifugal, lobe)
CIP
>
CIP units accessories and related peripherals, such as;
chemical dosing pumps, chemical storage tanks ...
ACCESSORIES 27
General Accessories
Common accessories to different Bionet units, such as:
>
| Different type of aseptic valves (ball valves, diaphragm
valves, butterfly valves, needle valves...) manual or
pneumatic. Different ends (clamp, threaded, welded).
>
| Water recirculation valves for jacketed tanks.
>
| Indicators (tank level, load cells, temperature, pressure
gauges, flowmeters).
>
| Different type (clamp, flange, threaded) and different
shape (grooves, elbows, crosses, reducers, hose nipples,
tube adaptors, end caps, fittings).
| Consumables made of different materials such as; hoses,
aseptic tubes, o-rings, gaskets, seals...
Bionet Engineering

Parque Tecnolgico Fuente lamo

Fuente lamo (Murcia) Spain
Tel.: +34 902 170 704 / Fax: +34 968 197 543
sales@bionet.com