The CambTEK Rapid Extraction System (RES) is a fully automated solid dosage form sample pretreatment extraction system designed for pharmaceutical quality control (QC), R&D analysis, and high-throughput stability testing laboratories. It can be used for fully automated sample pretreatment of tablets, capsules, soft capsules, implants, and various solid dosage forms for content uniformity (CU), principal component analysis (Assay), and impurity detection. This instrument fully complies with international regulations such as the United States Pharmacopeia (USP) <905>, USP <621>, the European Pharmacopoeia (EP) <2.9.40>, and ICH.

I. The system integrates high-shear homogenizer, programmed ultrasonic vibration and dynamic solvent extraction technology, which can rapidly pulverize poorly soluble matrices within minutes and completely release active pharmaceutical ingredients (APIs).

II. Equipped with a high-precision multi-channel solvent automatic dispensing module and multi-stage precise quantitative dilution function, it supports the precise automatic addition of single or multiple organic/aqueous solvents, eliminating cumbersome manual quantitative errors.

III. Equipped with a multi-stage online automatic filtration module (supporting 0.2 µm / 0.45 µm filter membranes), it can automatically dispense the extracted sample directly into standard HPLC / UPLC sample vials or connect directly in series with analytical instruments, significantly reducing pretreatment time and improving analytical reproducibility.

IV. The closed-loop, fully automated sample handling process completely eliminates the risk of solvent exposure and highly reactive dust contact for personnel; the proprietary operating software has complete method editing, multi-level user access control, and audit trail functions, fully complying with GMP and 21 CFR Part 11 data integrity regulations.

Equipment Introduction

• High-Shear Homogenization

  • Rapidly breaks down stubborn matrices : The high-performance stainless steel homogeneous cutter head generates extremely high shearing force, which can completely crush high-hardness tablets, controlled-release formulations (SR/CR/OROS) and high-viscosity matrices within seconds to minutes.

  • 100% complete release of main components : The sample is extremely finely refined and brought into deep homogeneous contact with solvent molecules, greatly overcoming the bottleneck that traditional stirring or pure ultrasound cannot completely extract.

• Programmable Ultrasonic Extraction

  • Molecular-level assisted dissolution : For poorly soluble drugs (BCS Class II/IV) and hydrophilic polymer gels (such as HPMC and PEO), programmable ultrasonic energy is provided to assist in accelerating dissolution.

  • Dynamic temperature control to prevent degradation : The ultrasonic treatment time and interval can be customized to avoid degradation and deterioration of heat-sensitive APIs caused by prolonged high-temperature vibration.

• Multi-Solvent Automated Dispensing

  • Flexible switching between multiple solvents : The system can connect to up to 4 different extraction solvents and automatically complete the dispensing of solvent in fixed volume, fractional or multi-step manner according to the experimental formula.

  • High-precision volume control : Equipped with a high-resolution metering pump and micro-valve control, ensuring extremely accurate volume dispensing for each injection, eliminating human error caused by manual measuring cylinders/pipettes.

• Multi-stage online automated precision filtration and quantitative dilution (In-Line Filtration & Secondary Dilution)

  • Direct online micron-level filtration : The extract is automatically filtered through a standard 0.2 µm or 0.45 µm filter membrane and directly dispensed into HPLC/UPLC sample vials.

  • Fully automated multi-stage quantitative dilution : Built-in automatic quantitative dilution station, which can automatically perform secondary or multi-stage dilution according to the required analytical concentration. Samples can be directly analyzed after pretreatment.

• Fully Automated Active Cleaning System for Probe Cleaning and Cross-Contamination Prevention

  • Ultra-low residue between samples (Carryover < 0.1%) : After extraction, the high-pressure multi-solvent cleaning tank and probe rinsing process are automatically activated to completely eliminate sample residue.

  • Eliminates tedious manual cleaning : Saves a lot of traditional glassware cleaning and verification work, significantly improving the operational efficiency of the quality control laboratory.

• High-throughput walk-away operation

  • Batch processing capability : The sample tray can continuously accommodate up to 30 sets of samples for unattended batch processing (supports overnight or weekend continuous operation).

  • Significantly reduces manpower and time : Sample pretreatment time is reduced by up to 70% to 90% compared to traditional manual grinding, shaking and filtration.