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Technical specifications

Materials and finishes

Typical

Product-contact parts: AISI 316L (1.4404), typical Ra < 0.4 µm (16 µin)
Non-contact parts/skid: AISI 304/304L
Seals/elastomers: platinum-cured silicone, EPDM and/or PTFE (material set depends on selection)
Elastomers compliance (depending on selected materials): FDA 21 CFR 177.2600 and USP Class VI
Surface treatments: degreasing, pickling and passivation (ASTM A380 and ASTM A968)
Roughness control on product-contact surfaces

Design conditions

Pressure & temperature

Defined considering non-hazardous process fluids (PED group 2) and jacket steam/superheated water (PED group 5), depending on configuration and project scope.

Reference design envelope

Mode	Element	Working pressure (bar[g])	Working pressure (psi[g])	T max (°C / °F)
Process	Vessel	0 / +2.5	0 / +36.3	+90 / 194
Process	Jacket	0 / +3.8	0 / +55.1	+90 / 194
Sterilisation	Vessel	0 / +2.5	0 / +36.3	+130 / 266
Sterilisation	Jacket	0 / +3.8	0 / +55.1	+150 / 302

Jacket working pressure may also be specified as 0 / +4 bar(g) (0 / +58.0 psi[g]) depending on design selection; final values are confirmed per project.

Pressure control and safeguards

Typical

Designed to maintain a vessel pressure set-point typically in the range 0 to 2.5 bar(g)
Aseptic operation commonly around 0.2 to 0.5 bar(g) to keep the vessel slightly pressurised
Overpressure/underpressure safeguards included per configuration and regulations
Pressure safety device (e.g., rupture disc and/or safety valve) included according to configuration

Agitation

Reference ranges

Working volume	MU (Cell culture), reference	MB (Microbial), reference
10 L	0 to 300 rpm	0 to 1000 rpm
20 L	0 to 250 rpm	0 to 1000 rpm
30 L	0 to 200 rpm	0 to 1000 rpm
50 L	0 to 180 rpm	0 to 1000 rpm

Integrated peristaltic pumps (additions)

Typical

The equipment typically includes 4 integrated variable-speed peristaltic pumps for sterile additions (acid/base/antifoam/feeds). Actual flow depends on selected tubing and calibration.

Parameter	Typical value	Notes
Quantity	4 units (integrated)	In control tower; assignment defined by configuration
Speed	0-300 rpm	Variable control from eSCADA
Minimum flow	0-10 mL/min	Example with 0.8 mm ID tubing; depends on tubing and calibration
Maximum flow	Up to ~366 mL/min	Example with 4.8 mm ID tubing; actual flow depends on calibration
Operating modes	OFF / AUTO / MANUAL / PROFILE	AUTO typically associated to pH/DO/foam loops or recipe
Functions	PURGE, calibration, totaliser, PWM	PWM available for low flow setpoints below minimum operating level

Gas flow control (microbial reference capacity)

Reference

For microbial culture (MB), gas flow controllers (MFC) are typically sized based on VVM targets. Typical reference VVM range: 0.5-1.5 (to be confirmed by process).

Working volume (L)	VVM min	VVM max	Air (L/min)	O2 (10%) (L/min)	CO2 (20%) (L/min)	N2 (10%) (L/min)
10	0.5	1.5	5-15	0.5-1.5	1-3	0.5-1.5
20	0.5	1.5	10-30	1-3	2-6	1-3
30	0.5	1.5	15-45	1.5-4.5	3-9	1.5-4.5
50	0.5	1.5	25-75	2.5-7.5	5-15	2.5-7.5

O2/CO2/N2 values are shown as reference capacities for typical gas blending strategies (10% O2, 20% CO2, 10% N2). Final gas list and ranges depend on process and configuration.

Instrumentation and sensors

Typical

Instrumentation is configurable. The following list describes typical sensors integrated in standard configurations, plus common optional PAT sensors.

Variable / function	Typical technology / interface	Status (STD/OPT)
Temperature (process/jacket)	Pt100 class A RTD	STD
Pressure (vessel/lines)	Pressure transmitter (4-20 mA / digital)	STD
Level (working volume)	Adjustable probe	STD
pH	Digital pH sensor (ARC or equivalent)	STD
DO (pO2)	Digital optical DO sensor (ARC or equivalent)	STD
Foam	Conductive/capacitive foam sensor	STD
Weight / mass balance	Load cell (integrated in skid)	STD
pCO2	Digital pCO2 sensor (ARC or equivalent)	OPT
Biomass (permittivity)	In-line or in-vessel sensor	OPT
VCD / TCD	In-situ cell density sensors	OPT (MU)
Off-gas (O2/CO2)	Gas analyser for OUR/CER	OPT
ORP / Redox	Digital ORP	OPT
Glucose / Lactate	PAT sensor	OPT

Automation, software and connectivity

Typical

The platform incorporates TECNIC eSCADA (typically eSCADA Advanced for ePILOT) to operate actuators and control loops, execute recipes and manage process data.

Main software functions

Main overview screen with process parameters and trends
Alarm management (real-time alarms and historical log) with acknowledgement and comment option
Manual/automatic modes for actuators and control loops
Recipe management with phases and transitions; parameter profiles (multi-step) for pumps and setpoints
Data logging with configurable period and export to CSV; PDF report generation

Common control loops

Temperature control (jacket heating/cooling)
Pressure control (headspace) with associated valve management
pH control via acid/base addition pumps and optional CO2 strategy
DO control with cascade strategies (agitation, air, O2, N2) depending on package and configuration
Foam control (foam sensor and automatic antifoam addition)

Data integrity and 21 CFR Part 11

Support for 21 CFR Part 11 / EU GMP Annex 11 is configuration- and project-dependent and requires customer procedures and validation (CSV).

Utilities

Reference

Utilities depend on final configuration (e.g., AutoSIP vs External SIP) and destination market (EU vs North America). The following values are typical reference points.

Utility	Typical service / configuration	Pressure	Flow / power	Notes
Electrical	EU base: 400 VAC / 50 Hz (3~)	N/A	AutoSIP: 12 kW; External SIP: 5 kW	NA option: 480 VAC / 60 Hz; cabinet/wiring per NEC/NFPA 70; UL/CSA as required
Process gases	Air / O2 / CO2 / N2	Up to 2.5 bar(g) (36.3 psi)	According to setpoint	Typical OD10 pneumatic connections; final list depends on package
Instrument air	Pneumatic valves	Up to 6 bar(g) (87.0 psi)	N/A	Dry/filtered air recommended
Cooling water	Jacket cooling water	2 bar(g) (29.0 psi)	25 L/min (6.6 gpm)	6-10 °C (43-50 °F) typical
Cooling water	Condenser cooling water	2 bar(g) (29.0 psi)	1 L/min (0.26 gpm)	6-10 °C (43-50 °F) typical
Steam (External SIP)	Industrial steam	2-3 bar(g) (29.0-43.5 psi)	30 kg/h (66 lb/h)	For SIP sequences
Steam (External SIP)	Clean steam	1.5 bar(g) (21.8 psi)	8 kg/h (18 lb/h)	Depending on plant strategy

Compliance and deliverables

Typical

Depending on destination and project scope, the regulatory basis may include European Directives (CE) and/or North American codes. The exact list is confirmed per project and stated in the Declaration(s) of Conformity when applicable.

Scope	EU (typical references)	North America (typical references)
Pressure equipment	PED 2014/68/EU	ASME BPVC Section VIII (where applicable)
Hygienic design	Hygienic design good practices	ASME BPE (reference for bioprocessing)
Machine safety	Machinery: 2006/42/EC (until 13/01/2027) / (EU) 2023/1230	OSHA expectations; NFPA 79 (industrial machinery) - project dependent
Electrical / EMC	LVD 2014/35/EU; EMC 2014/30/EU	NEC/NFPA 70; UL/CSA components and marking as required
Materials contact	EC 1935/2004 + EC 2023/2006 (GMP for materials) where applicable	FDA 21 CFR (e.g., 177.2600 for elastomers) - materials compliance
Software / CSV	EU GMP Annex 11 (if applicable)	21 CFR Part 11 (if applicable)

Standard documentation package

User manual and basic operating instructions
P&ID / layout drawings as per project scope
Material certificates and finish/treatment certificates (scope dependent)
FAT report (if included in contract)

Optional qualification and commissioning services

SAT (Site Acceptance Test)
IQ / OQ documentation and/or execution (scope agreed with customer)
CSV support package for regulated environments (ALCOA+ considerations, backups, time synchronisation, etc.)

Ordering and configuration

Project-based

ePILOT BR is configured per project. To define the right MU/MB package, volumes and options (utilities, sensors, software and compliance), please contact TECNIC with your URS or request the configuration questionnaire.

The information provided above is for general reference only and may be modified, updated or discontinued at any time without prior notice. Values and specifications are indicative and may vary depending on project scope, configuration and applicable requirements. This content does not constitute a binding offer, warranty, or contractual commitment. Any final specifications, deliverables and acceptance criteria will be confirmed in the corresponding quotation, technical documentation and/or contract documents.

Cellular configuration

The cellular configuration of the eLab Advanced is equipped with a pitched-blade impeller designed to support efficient mixing for cell culture processes in both laboratory development and early scale-up. The blade geometry promotes mainly axial flow, helping to distribute gases, nutrients and pH control agents uniformly throughout the vessel while keeping shear stress at a moderate level. This makes it suitable for mammalian, insect and other shear-sensitive cell lines when operated with appropriate agitation and aeration settings. In combination with the vessel aspect ratio and baffle design, the pitched blade supports stable foaming behavior and reproducible oxygen transfer, which is essential when comparing batches or transferring processes between working volumes.

Operators can fine-tune agitation speed to balance oxygen demand and mixing time without excessively increasing mechanical stress on the culture.

Technical specifications

Models and working volumes

Tank

The ePlus Mixer platform combines an ePlus Mixer control tower with Tank frames and eBag 3D consumables. Tank can be supplied in square or cylindrical configurations (depending on project) to match the bag format.

Tank model	Nominal volume	Minimum volume to start agitation*
Tank 50 L	50 L	15 L
Tank 100 L	100 L	20 L
Tank 200 L	200 L	30 L
Tank 500 L	500 L	55 L

*Values based on agitation start interlocks per tank model. Final performance depends on the selected eBag 3D, fluid properties and configuration.

Design conditions and operating limits

Reference

Reference limits are defined for the ePlus Mixer and the Tank. It is recommended to validate the specific limits of the selected eBag 3D and single-use sensors for the customer’s process.

Element	Operating pressure	Maximum pressure (safety)	Maximum working temperature
ePlus Mixer (control tower)	ATM	0.5 bar(g)	90 °C
Tank	ATM	0.5 bar(g)	45 °C
Jacket (if applicable)	N/A	1.5 bar	Depends on utilities / scope

The 0.5 bar(g) limit is associated with the equipment design, the circuit is protected by a safety valve. Confirm final limits on the equipment nameplate and project specification.

Materials and finishes

Typical

Control tower housing and frame: stainless steel 304
Product-contact metallic hard parts (if applicable): stainless steel 316 (defined in project manufacturing documentation)
Non-product-contact metallic parts: stainless steel 304
eBag consumable: single-use polymer (supplier dependent, gamma irradiation / sterilisation per specification)
Vent filters: PP (polypropylene), per component list

For GMP projects, the recommended documentation package includes material certificates, surface finish certificates (Ra if applicable) and consumable sterility/irradiation certificates.

Agitation system

Magnetic

Non-invasive magnetic agitation, the impeller is integrated in the eBag 3D Mixer format, avoiding mechanical seals. Agitation speed is controlled from the HMI, with start interlocks linked to the tank model and minimum volume.

Reference speed range

Typical agitation range: 120 to 300 rpm (configuration dependent)
Magnetic drive motor (reference): Sterimixer SMA 85/140, 50 Hz, 230/400 V, 0.18 kW
Gear reduction (reference): 1:5
Actuation (reference): linear actuator LEYG25MA, stroke 30–300 mm, speed 18–500 mm/s (for positioning)

Final rpm and mixing performance depend on tank size, bag format and process requirements.

Weighing and volume control

Integrated

Weight and derived volume control are performed using 4 load cells integrated in the tank frame legs and a weight indicator. Tare functions are managed from the HMI to support preparation steps and additions by mass.

Component	Reference model	Key parameters
Load cells (x4)	Mettler Toledo SWB505 (stainless steel)	550 kg each, output 2 mV/V, IP66
Weight indicator	Mettler Toledo IND360 DIN	Acquisition and HMI display, tare and “clear last tare”

For installation engineering, total floor load should consider product mass + equipment mass + margin (recommended ≥ 20%).

Pumps and fluid handling

Standard

The platform includes integrated pumps for additions and circulation. Final tubing selection and calibration define the usable flow range.

Included pumps (reference)

3 integrated peristaltic pumps for additions (acid/base/media), with speed control from HMI
1 integrated centrifugal pump for circulation / transfer (DN25)

Peristaltic pumps (reference)

Parameter	Reference	Notes
Quantity	3 units	Integrated in the control tower
Pump head	HYB101 (Hygiaflex)	Example tubing: ID 4.8 mm, wall 1.6 mm
Max speed	300 rpm	Speed control reference: 0–5 V
Max flow (example)	365.69 mL/min	Depends on tubing and calibration

Centrifugal pump (reference)

Parameter	Reference
Model	EBARA MR S DN25
Power	0.75 kW
Flow	Up to 42 L/min
Pressure	Up to 1 bar

For circulation and sensor loops, the eBag 3D format can include dedicated ports (depending on the selected consumable and application).

Thermal management (optional jacket)

Optional

Tank can be supplied with a jacket (single or double jacket options). The thermal circuit includes control elements and a heat exchanger, enabling temperature conditioning depending on utilities and project scope.

Jacket maximum pressure (reference): 1.5 bar
Thermal circuit safety: pressure regulator and safety valve (reference set-point 0.5 bar(g))
Heat exchanger (reference): T5-BFG, 12 plates, alloy 316, 0.5 mm, NBRP
Solenoid valves (reference): SMC VXZ262LGK, 1", DC 24 V, 10.5 W
Jacket sequences: fill / empty / flush (scope dependent)

The tank maximum temperature may depend on the thermal circuit and consumable limits. Confirm final values with the selected eBag 3D specification.

Instrumentation and sensors

Optional SU

Single-use sensors can be integrated via dedicated modules. The following references describe typical sensors and interfaces listed in the datasheet.

Variable	Reference model	Interface / protocol	Supply	Operating temperature	IP
pH	OneFerm Arc pH VP 70 NTC (SU)	Arc Module SU pH, Modbus RTU	7–30 VDC	5–50 °C	IP67
Conductivity	Conducell-P SU (SU)	Arc Module Cond-P SU, Modbus RTU	7–30 VDC	0–60 °C	IP64
Temperature	Pt100 ø4 × 52 mm, M8 (non-invasive)	Analog / acquisition module	Project dependent	Project dependent	Project dependent

Measurement ranges and final sensor list depend on the selected single-use components and project scope.

Automation, software and data

Standard + options

The ePlus SUM control tower integrates an industrial PLC and touch HMI. Standard operation supports Manual / Automatic / Profile modes, with optional recipe execution depending on selected software scope.

Software scope (reference)

Standard: eBASIC (base HMI functions)
Optional: eSCADA Basic or eSCADA Advanced (project dependent)
Trends, alarms and profiles, profiles up to 100 steps (depending on scope)
Data retention (reference): up to 1 year

Connectivity (reference)

Industrial Ethernet and integrated OPC server (included)
Remote access option (project dependent)

Utilities and facility interfaces

Typical

Installation requirements depend on jacket and temperature scope and the customer layout. The following values are typical references.

Utility	Pressure	Flow	Connections	Notes
Electrical supply	N/A	Reference: 18 A	380–400 VAC, 3~ + N, 50 Hz	Confirm per final configuration and destination market
Ethernet	N/A	N/A	RJ45	OPC server, LAN integration
Tap water	2.5 bar	N/A	1/2" (hose connection)	Jacket fill and services, tank volume about 25 L
Cooling water	2–4 bar	10–20 L/min	2 × 3/4" (hose connection)	Heat exchanger and jacket cooling
Process air	2–4 bar	N/A	1/2" quick coupling	Used for jacket emptying
Drain	N/A	N/A	2 × 3/4" (hose connection)	For draining
Exhaust	N/A	N/A	N/A	Optional (depending on project)
Stack light (optional)	N/A	N/A	N/A	3-colour indication, as per scope

During FAT, verify in the installation checklist that the available utilities match the selected configuration and scope.

Documentation and deliverables

Project-based

Deliverables depend on scope and project requirements. The following items are typical references included in the technical documentation package.

Datasheet and user manual (HMI and system operation)
Electrical schematics, PLC program and backup package (scope dependent)
P&ID, layout and GA drawings (PDF and/or CAD formats, project dependent)
Factory Acceptance Test (FAT) protocol and FAT report (as per contract)
Installation checklist
Material and consumable certificates, as required for regulated projects (scope dependent)

On-site services (SAT, IQ/OQ) and extended compliance packages are optional and defined per project.

Ordering and configuration

Contact

The ePlus Mixer scope is defined per project. To select the right tank size, bag format, sensors and optional jacket and software, please share your URS or request the configuration questionnaire.

The information provided above is for general reference only and may be modified, updated or discontinued at any time without prior notice. Values and specifications are indicative and may vary depending on project scope, configuration and applicable requirements. This content does not constitute a binding offer, warranty, or contractual commitment. Any final specifications, deliverables and acceptance criteria will be confirmed in the corresponding quotation, technical documentation and/or contract documents.

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Cellular configuration

Cellular configuration

Cellular configuration

Microbial configuration

Technical specifications

Materials and finishes

Design conditions

Pressure control and safeguards

Agitation

Integrated peristaltic pumps (additions)

Gas flow control (microbial reference capacity)

Instrumentation and sensors

Automation, software and connectivity

Utilities

Compliance and deliverables

Ordering and configuration

Cellular configuration

Technical specifications

Cellular configuration

Technical specifications

Models and working volumes

Design conditions and operating limits

Materials and finishes

Agitation system

Weighing and volume control

Pumps and fluid handling

Thermal management (optional jacket)

Instrumentation and sensors

Automation, software and data

Utilities and facility interfaces

Documentation and deliverables

Ordering and configuration

Operating windows microbial vs. cell culture

Indicative operating windows for cellular and microbial processes. Final values depend on bag configuration, impellers, aeration strategy and process targets.

Typical gas line ranges by model and application. Installed ranges and gas setup depend on selected options and project scope.