Flex-Line™
Sterile robotic filling machine for ready-to-use vials and syringes, integrated with isolator

The isolator is a critical component in ensuring the purity and quality of products on an automated filling line. Its meticulous design follows strict cGMP standards and pharmaceutical protocols for handling aseptic materials, ensuring the highest level of quality and safety.

Comecer’s comprehensive package includes an isolator chamber with multi-sided access for easy operation, an advanced ventilation and air filtration system to maintain clean air quality, a state-of-the-art VPHP generator for efficient decontamination, and a specialized VPHP distribution system for even dispersal of the sterilizing agent.

Asepsis

The VPHP generator and the distribution pipes allows the decontamination of the chambers.

The isolator’s performance qualification will consist of the development of a dedicated decontamination cycle with a target of a 6-log microbial reduction.

	Sterile filling in vials for liquid products
	Sterile PFS filling for liquid products
	Sterile filling in vials for lyophilized products
	VPHP decontamination system
	Compact footprint
	Suitable for vaccine production
	Full Laminar Air Flow
	All-in-one isolator integration
	Panel PC HMI Control System fully compliant for CFR21 Part11 and Data Integrity requirements

Main features

Flex-Line™ is designed for aseptic filling of Ready-To-Use nested products such as PFS and vials, for R&D and Pilot Scale sterile production.

All isolators chamber air quality are compliant with ISO5 / Grade A (EU-GMP) and equipped with laminar flow over the entire area.

ROBOTIC HANDLING

A real smart approach

Thanks to its modular design, the filling line is available with different possible configurations in order to fulfil the requirements of different production needs.

Possibility of filling nested syringes and vials.

Aseptic Filling via perfect combination between machine and isolators. Integrated VPHP decontamination system. Full process control by HMI.

• Syringes, PFS 1 ml – Nest 100 position @ 1 ml fill volume: 2500 p/h
• Vials, 6R – Nest 48 position @ 5 ml fill volume: 2000 p/h
• High filling accuracy by peristaltic pump
• IPC with statistical check weighing system
• Nitrogen purging before & after filling for vials and syringes

General process cycle

From nest/tubs to filled aseptic vials or pre-filled syringes by semi-automatic or automatic processing. Flex-Line™ is designed to allow minimal human intervention to reduce contamination risk on your aseptic vaccines production process.

Fully automatic or semi-automatic No-Touch-Transfer procedures grant smooth opening and transfer of the tubs inside the process area.

ONE SOLUTION FITS ALL

De-bagging

Semi-automatic De-bagging

• Superior ergonomics
• Optimized bag cutting system
• Easy reachable bag disposal
• Validated process
• Possibility to integrate camera

Robotic handling

Positive handling of nested products by robotic arm

De-lidding

Fully or semi-automatic Tywek removal & De-lidding

• Foil and lid automatically disposed
• Optimized movement to minimize particle generation
• One Stop operation
• Minimal footprint

Filling & stoppering

Piston or peristaltic filling system available

• Optimum solution for filling different glassware in a nest
• Peristaltic or piston pumps
• Integrated check weighing system
• Nitrogen purging before & after filling

Comecer Aseptic Isolator Main Features

• Grade A (EEC-cGMP) air quality complying and laminar air flow for Delidding and Filling Chambers
• Grade B (EEC-cGMP) air quality complying for Sink
• Filtration system with HEPA H14 absolute filter
• Air outlet with catalyst for VPHP cycle exhaust
• Sealing classification Class 3 ISO 10648-2
• 316L AISI stainless steel work chambers with Mirror-Bright internal surface finish, TIG continuous welds, and widely rounded corners
• 304 AISI stainless steel coverings allow to separate the laboratory area from the technical area
• Box PC HMI Control System fully compliance for CFR21 Part11, GAMP5 and Data Integrity requirements
• Automatic leak test for chambers
• Connection for integrity test for absolute filters
• Particle counter and microbiological sampler in the chambers

Further available options

• Speedy Glove – Automatic glove tester
• RTP Rapid Transfer Port and/or Sterile Liquid Transfer port
• Piston Pumps instead of peristaltic
• Viable and Non-Viable Integrated Monitoring System
• HEPA H14 1st stage exhaust filtration
• HEPA H14 2nd stage exhaust filtration BIBO Safe Change
• Dedicated HVAC
• Scada interface Predisposition