The AC20 is a benchtop fully automated vial and cartridge bottle capping and sealing machine designed for biotechnology and pharmaceutical R&D, cell and gene therapy (CGT), ADC, clinical trial batches (Phase I/II/III), and high-value small-batch production. Addressing the needs of various container sizes and high-quality sealing, the AC20 features a compact, modular, and quick-release design, achieving a high-precision, extremely low-dust fully automated roller capping process on a single benchtop platform. It can be seamlessly integrated into aseptic isolators, biosafety cabinets (BSCs), or aseptic laminar flow systems.

I. Wide compatibility with various container sizes and cap types: Fully compatible with RTU vials (2–100 mL) and cartridges/refills (1.5–3 mL), supporting Ø13 mm, Ø20 mm and Ø32 mm pure aluminum caps and Flip-Off aluminum-plastic composite caps.

II. Low-dust precision rotary roller cap technology: Utilizing a servo precision multi-roller rotary forming mechanism, it can significantly suppress the generation of metal debris and particles compared to traditional stamping dies (compliant with Grade A / ISO Class 5 specifications), ensuring excellent container seal integrity (CCI).

III. Servo Precision Pressure and Height Closed-Loop Monitoring: Servo drive precisely controls the vertical downward pressure and lateral roller forming stress, effectively preventing bottle mouth cracking and excessive pressure deformation of the rubber stopper, ensuring a flat and consistent seal and stable airtightness.

IV. Capacity efficiency and quick changeover design: Cap capacity up to 20 pcs/min (1,200 pcs/hr); modular snap-on quick-release design enables tool-free specification switching and disassembly/cleaning within minutes.

V. Aseptic protection and isolation device integration: Streamlined body with no dead angles and SUS316L pharmacopoeia-grade material, compatible with ISO Class 5 / Grade A vertical unidirectional flow, can be directly integrated into Isolator / RABS / BSC, the whole machine can withstand VHP space sterilization and high concentration IPA wiping.

VI. Computerized Compliance and Complete Validation: Equipped with audit tracking and electronic signatures, compliant with FDA 21 CFR Part 11, EU GMP Annex 11 and GAMP 5, and providing complete DQ/IQ/OQ/PQ validation documentation.

Equipment Introduction

• Wide-range container and cap compatibility.

  • A single unit can accommodate a variety of commonly used sterile container types, including RTU (ready-to-use) vials (2 - 100 mL) and cartridges/pen refills (1.5 - 3 mL).

  • It fully supports standard pure aluminum caps of Ø13 mm, Ø20 mm and Ø32 mm as well as Flip-Off aluminum-plastic composite caps, meeting the needs of multi-pipeline R&D and flexible production.

• High-efficiency Automated Capping Performance

  • Designed specifically for laboratory research and development, clinical trials (Phase I/II) and high-value small-batch manufacturing processes, capping capacity can reach up to 20 pcs/min (1,200 pcs/hr).

  • The automated and precise positioning and sealing process significantly reduces human intervention and the risk of contamination in aseptic operating areas.

• Low-Particle Precision Roller Crimping Technology

  • The servo-controlled multi-roller rotary capping mechanism significantly reduces the generation of metal debris and particles during the capping process compared to traditional stamping dies (compliant with Grade A / ISO Class 5 particle specifications).

  • Precise control of vertical downward pressure and lateral roller forming stress effectively prevents bottle neck breakage and stopper deformation, ensuring excellent container seal integrity (CCI).

• Tool-less Quick-Change Modular Design

  • The modular design allows for easy switching between different bottle sizes (2-100 mL) and cap diameters without the need for special tools, and the process can be completed in minutes.

  • The operation settings and daily maintenance process are greatly simplified, significantly reducing downtime between different production batches.

• High Isolator & BSC Compatibility

  • The ultra-compact benchtop design allows for independent use in general operating environments, or it can be seamlessly integrated into a biosafety cabinet (BSC), clean bench, or dedicated ISO-100 isolator (Grade A / ISO Class 5 chamber).

  • The entire machine has excellent sealing and protection levels, and can fully withstand vaporized hydrogen peroxide (VHP) space sterilization and high-concentration IPA wiping disinfection.

• Pharmacopeia-Grade Sanitary Materials with Corrosion-Resistant Design

  • All structural and contact parts are made of AISI 316L medical-grade stainless steel, and all non-metallic sealing components meet USP Class VI biocompatibility standards.

  • The surface is smooth and flat, with no dead corners, making it easy to clean and completely preventing dust accumulation, thus meeting the strict anti-contamination standards of cGMP aseptic process.

• cGMP and 21 CFR Part 11 Intelligent Control & Compliance

  • It adopts an industrial-grade PLC control system and an intuitive color touch human-machine interface (HMI) to support multiple product parameter recipe management and one-click retrieval.

  • Fully compliant with FDA 21 CFR Part 11, EU GMP Annex 11 and GAMP 5, with built-in multi-level user access control, electronic signatures and an unalterable complete audit trail.

  • We provide complete and valid documentation and technical support for original equipment manufacturer (OEM) standards DQ/IQ/OQ.