Aseptic Filling Isolator

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  • Aseptic Filling Isolator with Integrated VHP
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Aseptic Filling Isolator with Integrated VHP

Description: In-house engineered aseptic filling isolator with proprietary VHP bio-decontamination. Grade A (ISO 5) in C/D background. Proven in PFS filling lines.

In-house engineered rigid isolator delivering continuous Grade A (ISO 5) aseptic environment for PFS, vial, and cartridge filling. Proprietary VHP bio-decontamination system, 316L stainless steel chamber, ergonomic glove-port operation.Safeguarding product, personnel, and your contamination control strategy. Aseptic containment, engineered around your fill-finish line.

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Description

Overview

Our aseptic filling isolators are designed to enclose critical filling, stoppering and container transfer operations in a validated barrier environment. Negative-pressure configuration protects the operator from potent or cytotoxic compounds. Pressure regime is selected per your formulation and facility classification.


Key Features

VHP bio-decontamination​ — automated vaporized hydrogen peroxide cycle with cycle data recording.

RABS / Isolator options​ — oRABS, cRABS or fully enclosed isolator, matched to your risk level.

RTP transfer​ — rapid transfer ports for stoppers, components and waste without breaking containment.

Format flexibility​ — PFS, vials and cartridges supported with changeover tooling.

Environmental monitoring ready​ — particle, differential pressure, airflow and glove-integrity monitoring available.

Documentation package​ — DQ/IQ/OQ, FAT/SAT and material certificates aligned with GMP expectations.


Applications

Sterile injectables: small-volume parenterals, biologics, vaccines

Potent compounds: ADCs, HPAPIs, cytotoxic or sensitizing formulations.

Advanced therapies: cell & gene therapy intermediates, Clinical trial / tech-transfer batches where containment and traceability matter.


Isolator vs RABS

RABS limits operator access but usually runs in a Grade B background. An isolator is a fully enclosed barrier with automated decontamination, allowing Grade A conditions even in a Grade C/D room. If your product is potent, toxic or high-value, isolator architecture usually gives higher assurance — and our engineers will help you choose.

FAQ

  • What products are your filling lines designed for?

    We offer two dedicated lines: Vacuum Filling Lines for small-volume sterile injectables (0.2–20 mL), including biologics, vaccines, and aesthetic formulations (HA series, PDRN, collagen, Gel, PLLA, Hydroxyapatite, Cross‑linked products, Mesotherapy injectable series, etc.), and Catheter Flush Syringe Lines for high-throughput production of saline and heparin flush syringes. For specific formulation compatibility.

  • Are your machines GMP and FDA compliant?

    All equipment is designed in compliance with GMP specifications and can be implemented with reference to relevant FDA general standards. Our quality management system is certified to ISO 9001 and CE. We provide complete documentation support to assist customers in completing the validation procedures.

  • Can you customize lines for our facility?

    Yes. Our modular lines support adjustable head counts, multiple container formats (PFS, cartridges, vials), and flexible layouts (linear, L-shape, U-shape) to fit your cleanroom.

  • What is the typical lead time?

    Standard lead time ranges from 16 to 28 weeks depending on configuration and current order backlog. Expedited options may be discussed for urgent projects.

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About Us
Leggenda (Shanghai) Technology Co., Ltd.

Leggenda (Shanghai) Technology Co., Ltd. was founded in 2019 and is headquartered in Shanghai. It is a supplier of automated pharmaceutical equipment systems and related services, serving pharmaceutical enterprises with products including small-volume pre-filled water syringes.

With a mission to deliver professional services for the pharmaceutical industry, Leggenda Technology prioritizes quality-driven development. Through continuous innovation, it safeguards pharmaceutical production with safer, greener and more advanced professional technologies.

The company consistently upholds the product philosophy of technological innovation and quality first, and attaches great importance to talent training and development. It keeps increasing R&D investment for new products. Within just a few years, the company has filed for and obtained multiple patents. It has finished the product development of high-speed production lines for pre-filled flush syringes, delivering high-speed and turnkey solutions for numerous clients. We are a pioneer in the technical field of vacuum filling and vacuum stoppering for high-viscosity products.

In response to the rapid growth of the pharmaceutical industry and the complex, unique features of production processes, the company vigorously develops core products and concentrates on the R&D of syringe filling equipment. At present, technical staff account for approximately 80% of its total workforce. Most are design and technical engineers with over 10 years of hands-on experience in the pharmaceutical equipment sector.

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