Which containers can Malys Multiformat fill?

Vials, bottles, syringes and nest formats (nest-and-tub), for volumes from 0.01 ml to 50 ml. Format changeover is done by recalling a stored recipe, with no mechanical reconfiguration.

Which volumetric pumps are compatible?

Every volumetric pump on the market: Corima, Syntegon (Bosch), Groninger and Bausch+Ströbel as standard, other references on request. That is the machine main differentiator — you develop in R&D with the exact pump of your production line.

Is Malys Multiformat 21 CFR Part 11 compliant?

Yes: audit trail, electronic signatures and cycle traceability. The machine is also CE marked and GMP/cGMP compatible, with aseptic 316L stainless steel materials for sterile use.

Does it integrate into an isolator or RABS?

Yes. The dosing module is designed for integration into isolators, RABS or frames with a centralised remote HMI. SPC Group adapts it to your existing environment, as a stand-alone unit or as a revamping of a machine already in place.

What after-sales service is provided?

After-sales support is provided directly from the Rillieux-la-Pape site (Lyon), with a network of European distributors: Netsteril in Spain, Francelab in Hungary, profcontrol in Germany. Maintenance stays limited thanks to the robust, hygienic design.

Malys Multiformat, SPC benchtop volumetric filling machine, main view

Packaging machine

SPC MACHINES

Benchtop Volumetric Filling Machine 0.01 to 50 ml | Malys Multiformat

Benchtop volumetric dosing module compatible with every pump on the market, for pharmaceutical R&D, clinical batches and tech transfer.

Who is it for?

Malys Multiformat is aimed at pharmaceutical R&D teams, biopharma CDMOs and industrial sites in transfer phase. Its distinctive feature: it accepts every volumetric pump on the market — Corima, Syntegon (Bosch), Groninger, Bausch+Ströbel — so labs can develop with the exact pump of the future production line, with no method change between pilot and production.

How does Malys Multiformat work?

The module is semi-automatic and sits on a bench: 234 × 234 × 708 mm, with an integrated carry handle. It is driven from a touch screen with unlimited recipe storage and integrates into isolators, RABS or remote-HMI frames. The cycle runs in 4 steps:

Recipe selection on the touch screen — volume, speed, dosing profile
Container positioning — vial, bottle, syringe or nest format
Volumetric dosing by the fitted pump, from 0.01 to 50 ml, at ±0.1% repeatability
Cycle logging under a CFR 21 Part 11 audit trail

Key features

Compatible with every pump on the market: Corima, Syntegon (Bosch), Groninger, Bausch+Ströbel
Dosing range from 0.01 ml to 50 ml, ±0.1% repeatability
Vials, bottles, syringes and nest formats on the same module
CFR 21 Part 11 compliant: audit trail, electronic signatures, traceability
Benchtop footprint 234 × 234 × 708 mm, integrated carry handle
316L stainless steel, hygienic design for sterile use
Integrates into isolators, RABS or remote-HMI frames
Available as a stand-alone unit or as a revamping module

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Specifications

Technical specifications

Dosing range: 0.01 ml to 50 ml
Repeatability: ±0.1%
Accepted formats: vials, bottles, syringes, nest formats (nest-and-tub)
Compatible pumps: Corima, Syntegon (Bosch), Groninger, Bausch+Ströbel — others on request
Dosing technology: volumetric, interchangeable pump
Throughput: up to 6,000 vials/hour
Format changeover: fast, by recalling a stored recipe
Footprint (L × W × H): 234 × 234 × 708 mm
Direct product-contact materials: aseptic 316L stainless steel
HMI: touch screen, unlimited recipes, CFR 21 Part 11 audit trail
Integration: stand-alone, isolator, RABS, remote HMI, revamping
Options: foot pedal, needle gripper, PTFE spreader
Manufacturing: France — Rillieux-la-Pape (Lyon)

Compliance

Machinery Directive 2006/42/EC
CE marking (Machinery, EMC, Low Voltage)
Design compliant with GMP
FDA 21 CFR Part 11 (audit trail, electronic signatures)
Aseptic 316L stainless steel, hygienic design for sterile use
IQ/OQ qualification file delivered with the machine
Designed and manufactured in France

Use cases

Typical use cases

Pharmaceutical R&D, syringe formulation: 500 × 1 ml syringes of an experimental formulation filled in under an hour under ISO 5 laminar flow, with a stored recipe for batch-to-batch reproducibility.
Biopharma CDMO, clinical batches in an isolator: revamping integration on an existing isolator station for 1 to 10 ml batches in RTU nest vials, controlled under CFR 21 Part 11 via remote HMI.
Industrial site, scale-up validation: successive testing of several pumps (Corima then Syntegon) on the same machine, to qualify in R&D the one that will equip the line.
Quality control laboratory: filling of very small volumes, from 0.01 ml, with repeatability compatible with analytical requirements.
Multi-product pilot unit: switching from one formulation to another by simply recalling a recipe, with no mechanical reconfiguration.