CambTEK
Brand Introduction
Founded in Cambridge, United Kingdom in 2012, CambTEK Limited is a leading global brand specializing in fully automated sample preparation systems for solid and semi-solid pharmaceutical formulations.
In the overall workflow of modern pharmaceutical analysis (content homogeneity (CU), content assay, related substances/impurities, stability testing), up to 70% to 80% of analytical errors and time consumption stem from traditional, cumbersome manual sample pretreatment. CambTEK is committed to using forward-thinking automation engineering to completely eliminate the variations caused by manual grinding, ultrasonic oscillation, volumetric flask filling, manual filtration, and pipetting. CambTEK provides high-capacity, high-precision automated extraction solutions with complete data integrity to leading global multinational pharmaceutical companies, generic drug development giants, contract research organizations/CDMOs, and regulatory testing agencies.
Core values
Revolutionizing traditional sample pretreatment processes (Automated Transformation) :
The traditional manual pretreatment process (crushing, cutting, multiple extractions, volume adjustment, membrane filtration, and sample vial dispensing) that takes hours or even days has been integrated into a standardized one-click unattended fully automated workflow.
Revolutionary "Dual-Energy Extraction Technology" :
Integrating a dual-power mechanism of high-shear homogenization and high-frequency ultrasonic extraction , it can efficiently break down insoluble matrices, high-viscosity polymers, osmotic pump (OROS) structures, or soft and hard capsule shells within minutes, achieving an extreme recovery rate of nearly 100%.
Zero Cross-Contamination :
Employing an innovative, patented disposable/closed flow path design and self-cleaning mechanism, it completely eliminates cross-contamination between samples (Carryover < 0.01%), eliminating the heavy costs of cleaning, baking, and validation of glassware.
Ultimate EHS laboratory occupational safety protection (Closed Architecture) :
The closed, slightly negative pressure operating chamber and sealed pipelines significantly reduce the occupational safety risks to laboratory analysts exposed to volatile organic solvents (VOCs) and highly active, toxic drug molecules (HPAPIs / hormones / cytotoxic drugs).
Strict adherence to international regulations and data integrity compliance :
The entire process is precisely controlled by intelligent software, and all solvent volume, ultrasonic power, homogenization speed, and extraction time are accurately recorded, fully complying with FDA 21 CFR Part 11, EU GMP Annex 11, ALCOA+ , and International Pharmacopoeia (USP/EP/JP/ChP) regulations.
Product direction
CambTEK's core flagship system is the RES (Rapid Extraction System), which extends to automated modules suitable for different dosage forms and high-throughput requirements:
1. Core flagship: CambTEK RES (Rapid Extraction System, fully automated sample pretreatment system)
Walk-away automated workstations specifically designed for solid and semi-solid drug analysis:
High-throughput continuous sample processing :
Equipped with a rotatable sample tray, it supports unattended fully automated extraction and continuous sample vial collection of up to 30 samples per batch, significantly increasing laboratory utilization by more than 300%.
Patented extraction chamber and dual-power system :
Ultrasonic System : High-frequency destruction of microcrystals and matrix compounds.
High-Shear Homogenizer : The blade speed is precisely adjustable, which can quickly shred extremely tough tablet outer membranes, polymer sustained-release backbones (such as HPMC, PEO, PEG), gelling agents or capsule shells.
Multi-solvent precision automatic dispensing and continuous dilution :
It supports the programmed automatic addition of up to 3 different extraction solvents (aqueous phase, polar and non-polar organic solvents such as methanol, acetonitrile, etc.); after extraction is completed, it can automatically perform online gradient dilution to avoid over-range problems.
In-line Filtration & Vial Filling :
The system automatically filters the extracted clarified solution through a 0.2 µm or 0.45 µm standard injection filter (Syringe Filter) and dispenses it directly into a standard 2 mL HPLC/UPLC chromatographic vial , allowing the sample to be analyzed directly on the instrument.
2. Compatibility of Universal Dosage Form with Special Prescriptions (Universal Dosage Form Application)
The RES system is specifically designed to tackle the most difficult "difficult reagents" to handle in traditional laboratories:
Oral solid dosage forms (OSDs) : regular tablets, double/triple tablets, chewable tablets, coated tablets, pellets, granules, and powders.
Poorly soluble and controlled-release systems : Osmosis pump formulations (OROS), polymeric hydrophilic gel matrix tablets (PEO / HPMC Matrix), wax matrix tablets.
Capsule formulations : hard gelatin capsules, HPMC plant capsules, liquid/softgels.
Semi-solid and topical preparations : high-viscosity ointments, creams, suppositories, and transdermal patches.
3. CambTEK Intelligent Control and Compliance Software System
Intuitive formulation management and visual monitoring : An intuitive GUI interface allows for the customized storage of multiple extraction methods (including immersion time, homogenization speed, ultrasonic time, solvent volume, and dilution ratio) for different project products.
Complete Audit Trail : Unalterable electronic records and log tracking with multi-level user access control and electronic signature functionality, fully compliant with cGMP / 21 CFR Part 11 requirements.
Brand advantages
Solving the analytical bottleneck at its root : While the operational cycle of high-performance liquid chromatography (HPLC/UPLC) has been drastically reduced to minutes, the analytical bottleneck is entirely due to manual sample pretreatment. CambTEK RES reduces manual operation time by 70% to 90% , truly achieving a fully automated closed-loop process in the chromatography laboratory.
Unparalleled data reproducibility (RSD < 1.0%) : Completely eliminates operational errors caused by different experimenters, such as "shaking force, cutting size, volumetric parallax, and filtration flow rate", achieving the best batch reproducibility in content uniformity (CU) and relative standard deviation (RSD) of impurity detection.
Green Analytical Chemistry and Solvent Reduction : Compared to traditional volumetric flasks that require 100 mL to 250 mL or even more solvent, CambTEK uses micro-volume high-concentration extraction and online automatic dilution technology to reduce solvent consumption by up to 80% to 90% , significantly reducing the generation and treatment costs of organic waste liquid.
The standard trusted choice of top global pharmaceutical companies : The CambTEK system is widely used by the R&D development centers and commercial release QC laboratories of international pharmaceutical giants such as AstraZeneca, Pfizer, Novartis, GSK, Johnson & Johnson, and Takeda. It is the gold standard benchmark in the field of global solid dosage form sample pretreatment automation.
