FPC60 Unique Configurable Filling/Refilling System

Flexicon Aseptic aLiquid Filling

Industrial equipment

Built upon our highly accurate peristaltic filler-pump, the FPC60 is a unique solution for small batch aseptic filling/refilling of liquids with a wide variety of modules designed to work together and provide the ultimate filling solution.

The FPC60 system can be designed and modified to meet specific project requirements thanks to a range of optional solutions allowing adaptation of each stage of the filling and refilling process, from vial infeed, filling, stoppering and capping to automatic rejection and unloading of the final product.
Flexicon has over 30 years of experience in implementing projects with guaranteed optimal and reliable equipment delivery time including factory acceptance testing (FAT) and confirmation of installation and operational qualifications (IQ/OQ) for laboratory equipment without interrupting the manufacturing process, thus avoiding costly time and resource delays in project implementation.

Flexicon offers comprehensive FPC60 turnkey solutions for aseptic filling/refilling systems that are suitable for use in laminar air flow (LAF) systems or restricted access barrier systems (RABS). Flexicon also offers the FPC60 configuration that is fully integrated with a barrier isolator manufactured by one of the company's partners.

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FPC60

About the Product

The Flexicon FPC60 is a fully automatic, modular Fill & Finish system designed for manufacturers of biopharmaceuticals, vaccines, diagnostic reagents, and sterile pharmaceutical products in small- and medium-scale production. Unlike conventional filling lines, the FPC60 is individually configured to match each customer's manufacturing process, enabling tailored automation from vial feeding through to finished product discharge.

At the core of the system is the high-precision Flexicon peristaltic filling technology, delivering filling accuracy of better than ±1% across a volume range of 0.2–100 mL. A single-use aseptic fluid path eliminates the risk of cross-contamination between production batches while reducing cleaning time and simplifying validation.

The modular platform can be equipped with automated vial feeding, nitrogen flushing, in-process fill-weight control, stoppering, roller crimping or press-on capping, automatic reject handling, and a variety of product discharge options. A servo-driven automatic changeover system minimizes the need for format parts across the ISO 2R–100H vial range, significantly reducing downtime between production batches.

The FPC60 is fully compatible with LAF cabinets, oRABS, and isolator systems. Its advanced control platform supports electronic batch records, recipe management, remote access, and compliance with FDA 21 CFR Part 11, making it an ideal solution for modern GMP-compliant pharmaceutical manufacturing.

Lyophilized Drug Production

Support for partial stoppering and lyophilization stoppers, enabling seamless integration with freeze-drying processes for sterile injectable products.

Biopharmaceutical & Pharmaceutical Manufacturing

Aseptic filling of protein therapeutics, vaccines, monoclonal antibodies, sterile injectables, and diagnostic solutions for small- and medium-scale production.

Research & Pilot Production

Production of clinical trial batches, pilot-scale manufacturing, and process development to support scale-up from laboratory to commercial production

Contract Manufacturing (CMO/CDMO)

Modular system architecture and rapid recipe changeovers enable efficient production of multiple pharmaceutical products in short manufacturing runs.

Применение

FPC60

Suitable for use in restricted access environments

Minimization of contamination risk thanks to automatic setup and no operator intervention

Highly accurate and precision filling from volumes of 0.2-100 ml with an accuracy of up to ±0.5 %

Reduced downtime, increased uptime due to no tools and minimal setup between the batches

Installation of a zero-waste system and no component elements for the entire range of vials

Full control over changes made by the operator

Remote digital access and separate service account

FPC60

Specifications

Loading and Unloading Trays
loading tray width: 185–360 mm, unloading tray width: 180–360 mm. Feeding pre-sterilized adaptiQ + EZfill RTU vials into the trays is optional.

Stoppers
ISO standard or lyophilized, 13 mm and 20 mm

Maximum Capacity
1500 dose/hour

Accuracy
up to ±0,5%

Filling Volume Range
0,2–100 ml