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The CambTEK Rapid Extraction System (RES)

RES-CG and RES-Sonics: Fully Automated Sample Preparation instrument for rapid extraction of solid dose forms, gels, and liquids.

FlowCell Consumables

Proprietary Technology designed to enhance tortuous and turbulent flow for rapid extraction of dosage forms.

Introducing RES

The fully automated approach to solid, semi-solid, and liquid dosage form sample preparation.

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1 Health & Safety – Automated sample preparation and enclosed system reduces user exposure to harmful substances

2 Easy-load System – Minimal setup and instrument touch-time maximizes productivity

3 Barcode Workflow – Reduces errors, simplifies operation, and facilitates sample custody tracking

4 Patented Turbulent Flow Extraction – Accelerates extraction and delivers highly homogenous samples

5 Patented Crush and Grind or Sonication Technology – Provides a wide range of method flexibility for all sample types

6 Large Volume Range – Wide range of extraction volume maximises method flexibility

7 Accurate Dispensing – Gravimetric confirmation of dispensed solvent volumes ensures accuracy, provides in-process data, and comprehensive reporting

The RES uses patented turbulent flow technology, with optional ultasonication or crush and grind mechanical force to accelerate sample preparation extractions. Samples are quickly extracted, filtered, and diluted, ahead of analysis.

The RES is suitable for testing content uniformity (CU), impurity (imps), composite and bulk assay, ICH stability assay, blend and granulation uniformity, and other applications requiring a liquid extracted sample preparation.

From analytical R&D through to QA/QC laboratories, the RES improves quality of data, productivity, compliance, process standardization, and simplicity, whilst also delivering health & safety, environmental, and economic benefits.

Ease of use

Step one:

Load the sample into the FlowCell

Step two:

Load the FlowCell into the Puck

Step three:

Scan the barcode and input the data

Step four:

Load the puck onto the Carousel

Step five:

Process the sample

Step six:

Result out

The CambTEK RES: an in-depth look

RES Technology

The selected extraction eluent is dispensed to ASTM Class A dispensing accuracy, with gravimetric verification of solvent arrival. The extraction eluent is then circulated around the closed loop system, the turbulent flow quickly extracting the sample contained within the FlowCell.

An aliquot of solute is filtered and dispensed into a septa-sealed 22 mL primary vial. If required, the filtrate is then automatically diluted to ASTM Class A dispensing accuracy, to achieve the required concentration from 1:1 to 1:100000 dilution range.

After mixing to achieve homogeneity, a volume can be automatically dispensed into a septa-sealed 2 mL HPLC vial, or directly injected into your analyser.

Sample Type Demonstrations

Normal release tablet

Prolonged release tablet

Capsule

Bulk assay extraction

Powder extraction

Liquid extraction

Quality Control

Designed to highest standards to ensure regulatory and quality compliance of data integrity, validity, and repeatability.

CambTEK has worked with analytical chemists from leading Pharmaceutical Companies in the design and testing of the RES, to ensure the common concerns within the industry were addressed.

  • Designed to highest standards to ensure regulatory and quality compliance of data integrity, validity and repeatability
  • Sanitary design of fluidic path, minimising leeching and carryover : studies with difficult to clean compounds show < 0.1% carryover is achievable with minimal wash steps
  • Developed to exceed ASTM Class A volumetric requirements with sophisticated gravimetric feedback for closed loop confirmation of dispensing processes
  • Eliminates potential variability due to analyst technique or human error
  • Sample barcode tracking provides improved chain of custody to improve compliance
  • 21 CFR Part 11 compliance
  • In-process data for checking and conformity, answering ‘who?’, ‘when?’, and ‘what?’ queries
  • Comprehensive post-extraction report allows for detailed Out Of Specification (OOS) investigations
  • On-line video monitoring* assists method development and atypical OOS investigations
  • Sealed vials maintain sample integrity
  • Enclosed system for additional safety and sample integrity

* Optional Features / Additional Cost Features

Productivity

Requires low user touch-time, and 24/7 workflow increases laboratory productivity.

Support and improve your lean sigma initiatives and gain productivity.

  • Minimal user touch-time and fast setup and operation
  • Robust design and component specification for minimal downtime and maximum reliability
  • Work 24/7 with 30 sample capacity, plus batch load operation
  • Smart carousel load and scan
  • Easy maintenance design and software control
  • Suitable for At-line testing

Process Control

Full in-process data, not just end-point analytical data.

Reproducible Processes

Fully automated sample-in to prepared sample-out workflow, passes highly consistent results to any downstream analytical instrument.

Health & Safety

Automated sample preparation and enclosed system reduces user exposure to harmful substances.

User:

Automated closed system reduces analyst exposure to solvents, excipients and active pharmaceutical ingredients.

System:

  • Main pump has a physical safety feature to prevent over-pressurizing of the system
  • Leak sensor increases safety of operation, and minimizes wasted samples
  • Pump revolutions are monitored and an on-screen message advises when tubing needs replacing
  • ‘Watchguard System’ monitors the entire system in operation, and where possible, recovers instrument to a working state after any stop event

Process Standardization

Platform technology aids compliance and consistent results, independent of user proficiency or laboratory location.

Platform technology for site and user independent standardization of results, from R&D through to manufacturing.

  • Supporting R&D laboratories performing DoE and new product developments supporting Quality by Design (ICH Q8)
  • Pressure monitoring allows end-point confirmation, aiding method development
  • Fluidics and Sonication provides good equivalency to manual methods, minimizing re-validation from manual processes to automation
  • Comprehensive encrypted and secure documentation complies with 21 CFR Part 11
  • User access rights control method approval and status

Versatility

Processes a wide range of sample types in both single sample and bulk assay, including more challenging formulations such HPMC, PEG, PEO and laser-drilled.

Flexibility

Provides sample preparation front-end to any dosage form analytical workflow.

The CambTEK RES is at the cutting edge of fully automated sample preparation of dosage forms, in development and quality assurance laboratories, and manufacturing environments. From Phase 1 Development through to Manufacturing Quality Assurance, the RES will improve quality of data, and increase productivity.

The RES has been designed to prepare a vast range of dosage forms, including:

  • Tablets (both normal and prolonged release)
  • Capsules
  • Powders
  • Liquids
  • Gels
  • Pastes
  • Swabs
  • Stents
  • Beads
  • Intermediate Granulations
  • Pellets
  • Solid & Semi-solid Matrices
  • Suppositories

The RES uses turbulent fluidic flow with solvent quantities from 50 mL-500 mL with optional ultrasonic energy to extract samples. Pump speed is adjustable from 70 mL/min to 1 L/min approximately, giving full control of the extraction process, allowing the RES to perform a wide range of functions, including:

  • Content Uniformity Testing (CU)
  • Impurity Testing (imps)
  • Composite and Bulk Assay Testing Stability Assay Testing (ICH)
  • Blend and Granulation Uniformity Testing

After extraction, the solution is filtered and the filtrate delivered to a primary 20 mL vial ready for dilution or directly to an HPLC vial for analysis. All dilution and dispensing steps are performed with gravimetric feedback, delivering high repeatability and ASTM Class A dispensing accuracy. The RES then automatically performs a cleaning and drying cycle, ready to process the next sample.

Other features include:

  • 5-channel solvent selection allows for complex extractions
  • Off-line and adaptable for on-line with HPLC or UV/MS analysis
  • Powerful extraction for unstable compounds with or without ultrasonics
  • Robustness testing/design space of analytical test methods to investigate the envelope of extraction and dilution process
  • Highly variable working sequence giving random access workflow
  • System achieves clean & dry state between samples allowing for full flexibility of consecutive sample types

Accuracy

Highly repeatable liquid delivery process conforms to ASTM Class A dispensing accuracy.

Re-Validation

Fluidics and sonication provide good equivalency to manual methods, minimizing validation requirements when transferring from manual processes to RES automation.

Economic

Automated sample preparation increases laboratory productivity, leading to greater efficiency and economic benefits.

RES delivers economic benefits by reducing manual sample preparation tasks, standardizing processes, reducing errors, and increasing laboratory productivity.

  • Intuitive ease of use to increase productivity and reduce cost per test
  • Reduction in associated solvent purchase and disposal costs
  • Flexible payment options to overcome common laboratory budget constraints

Ease of Use

Intuitive instrument & software, with barcode-driven workflows, simplifies operation for all types of users.

All aspects of the instrument are easily configured using the intuitive Graphical User Interface (GUI), from setup to method development to operation.

  • Designed for intuitive operation with simple walk-up, scan, load, and run features
  • Press “Play & Go” design concepts Barcode workflow removes need for sample placement cross-referencing by the operator
  • Consumable set designed for prescriptive operation and user error reduction, independent of user experience or ability

Data Tracking

Unique sample record stored in encrypted database, for integrity and protection of raw data.

User Control

21 CFR Part 11 compliant, with full user and instrument operations log. Login rights assigned depending on required permissions: Standard User, Method Developer, and Administrator.

Reliability

Robust design and high component specification delivers minimal downtime and maximum reliability.

Find out more

Book a presentation for a more in-depth look at the technology and application areas, and an opportunity to ask any questions you have about the system.

Book a presentation

Download the brochure

Download the full RES brochure for a full overview of the advantages offered by the RES (PDF download).

Get the brochure

Contact us

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