Is the line compatible with cartridges?

Yes, quick-change tooling modules allow nested cartridges and vials to be processed.

How is fill volume accuracy maintained?

Volume is set by servo-driven pumps and verified at start-up and at defined intervals through the run. Machines can be specified with 100% inline checkweighing, which rejects out-of-tolerance units and records each weight against the batch.

Is the machine suitable for aseptic filling?

Aseptic configurations are supplied for installation under Grade A protection, with RABS or isolator interfaces, sterilisable product path and steam-in-place connections. The qualification package addresses EU-GMP Annex 1 expectations.

How are changeover and cleaning handled between products?

The product path is designed for clean-in-place and steam-in-place where the process requires it. Where a full CIP is not justified, the wetted assemblies are removable as a set for offline cleaning and autoclaving.

What warranty applies to this machine?

Machines are supplied with a 12-month warranty from commissioning covering manufacturing defects, with wear parts and tooling excluded. Extended cover is available under an annual maintenance contract, which also fixes response times for breakdown attendance.

What documentation is supplied at handover?

Handover includes the operation and maintenance manual, electrical and pneumatic schematics, the spare parts list with part numbers, material test certificates for contact parts, sensor calibration certificates and the completed qualification dossier.

APS-60 Aseptic Pre-Filled Syringe (PFS) Filling Line

Name: APS-60 Aseptic Pre-Filled Syringe (PFS) Filling Line
Brand: GentlemanPharmed
Availability: InStock

Robotic nest-based pre-filled syringe (PFS) filling and vacuum stoppering line operating inside a Grade A closed RABS isolator.

Call Us

Overview

About the APS-60 Aseptic Pre-Filled Syringe (PFS) Filling Line

The **APS-60 Pre-Filled Syringe Line** is engineered for high-value biologics, vaccines, and sterile injectable solutions packaged in nested ready-to-use (RTU) syringes (0.5 mL to 20 mL). Operating under an integrated Restricted Access Barrier System (RABS) or full isolator, the APS-60 uses multi-axis robotic arms for automated tub debagging, lid peeling, and nested filling.

Nested Tub RTU Processing: Direct processing of pre-sterilized nested tubs eliminates on-site washing and depyrogenation.

Vacuum-Assisted Stoppering: Stoppers are seated under deep vacuum, eliminating air bubbles above the liquid.

Servo-Driven Volumetric Dosing: Fill volume is set electronically and held across the run, removing the drift associated with mechanically set cam systems.

Drainable, Sanitary Product Path: The wetted path is fully drainable with sanitary fittings throughout, supporting clean-in-place and, where specified, steam-in-place.

Specifications

Technical Specifications

Technical specifications for the APS-60 Aseptic Pre-Filled Syringe (PFS) Filling Line
Syringe Formats	0.5 mL to 20 mL (Nested RTU)
Filling Accuracy	± 0.5% nominal volume
Output Speed	Up to 60 syringes / min

* Specifications may vary by model. Contact us for exact configuration.

Validation Support

Full IQ/OQ/PQ documentation packages available. Our validation team works with your QA department to ensure regulatory acceptance.

Design Qualification (DQ)
Installation Qualification (IQ)
Operational Qualification (OQ)
Performance Qualification (PQ)
Factory Acceptance Test (FAT)
Site Acceptance Test (SAT)

Compliance Standards

Built and tested to international pharmaceutical manufacturing standards.

WHO-GMPISO 9001CE MarkedCDSCO

See it in Action

Video Demonstration

Machine demonstration video

APS-60 Aseptic Pre-Filled Syringe (PFS) Filling Line — Product Brochure

Technical specs, dimensions & ordering guide · PDF

Download Brochure

Gallery

Product Gallery

FAQ

Product FAQs

Common questions about our pharmaceutical machinery.

Ready to Order?

Get a custom quote, technical specifications, and delivery timeline from our experts.

+91 98311 97931

About the APS-60 Aseptic Pre-Filled Syringe (PFS) Filling Line

Syringe Formats

0.5 mL to 20 mL (Nested RTU)

Filling Accuracy

± 0.5% nominal volume

Output Speed

Up to 60 syringes / min