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Automated Sample Preparation

Description

For Content Uniformity, Blend Uniformity, Potency, and Related Substances Testing

Sample preparation can be a very general term. When we talk about sample preparations at SOTAX, we are referring to the volumetric preparations of API, solid/liquid oral dosage forms, creams, and pastes.
Automated Sample Preparation enhances laboratory productivity by minimizing resource allocation for repetitive tasks such as sample weighing, extraction, filtration, dilution, and transfer to analysis devices. This enables the re-purposing of lab staff to mission critical tasks such as data analysis, reporting, and notebook documentation. Automated procedures can also reduce solvent usage and hazardous waste generation while improving analyst safety by minimizing exposure to hazardous reagents and samples. With 100's of installations globally, processing thousands of samples, SOTAX Automated Sample Preparation systems have proven to be reliant and compliant solutions to enhance your laboratory's efficiency and streamline your workflows.

Manual
Manual sample preparation in volumetric glassware for tablet, capsule, and blend evaluations have long been the industry standard. Unfortunately, so have bottlenecks, OOS investigations, and excessive solvent costs.

Automated
Automate your sample preparations so that they are performed the same way every time. Each method step is confirmed gravimetrically, reported volumetrically, and documented electronically.

Why Automate Sample Preparations?

Streamline your laboratory workflow. Automation facilitates processing labor-intensive samples for a broad spectrum of challenging formulations including tamper-resistant, osmotic pump, modified, extended, and delayed release.
With robust, focused extraction techniques, the samples are consistently prepared across a variety of analysts and laboratories. Recent initiatives to incorporate QbD and Continuous Process Improvement principles into the drug product life-cycle management process have increasingly raised laboratory productivity expectations. This demand for more sample throughput with the same or reduced head count is being imposed on laboratories across the industry.

Extract Difficult Formulations
Products such as ER, CR, MR, osmotic pump, and tamper resistant formulations present a difficult challenge to the manual sample preparation method. The limited efficiency of traditional stirring, shaking and sonication mechanisms result in in increased method complexity and raise the risk of OOS results. The physics of the homogenizer and extraction vessel geometry enable the TPW and CTS to quickly break and extract even the most difficult formulations. The APW uses a focused sonication probe coupled with a UV temperature sensor to deliver sample disintegration without over-heating.

Automate Your Method Development
Our user-friendly software interface provides rapid assimilation of SOTAX Automated Sample Preparation platforms in environments from academic to industry AR&D to the QC lab. Advanced developer options accelerate the method development design process to facilitate Analytical Quality by Design. The TPW and APW platforms include our powerful dEsign™ variables function that fully automates AQbD to ensure robust, fit-for-purpose methods that deliver consistent results throughout the method lifecycle. These powerful software functions allow you to plan and execute method development DOE activities quickly and efficiently.
Deficiencies in laboratory investigations are a major source of warning letters in the pharmaceutical industry, recently accounting for 12%-15% of 483s annually. With APW, TPW and CTS, each method step is gravimetrically confirmed and recorded in the secure database to ensure high quality consistent results. The audit trail provides a compliant and comprehensive history of the entire sample preparation process. In the event of an unexpected result, this audit trail ensures a well-defined assignment of the root cause to simplify the laboratory investigation process.

Product list

APW™ Automated Sample Preparation Workstation

Assay and content/blend uniformity for up to 300 samples
10 mL initial extraction volume using a focused Sonication Probe
Waters Empower™ interface
Powerful dEsign™ variables for streamlined DoE studies

TPW™ Automated Sample Preparation Workstation

Assay and content/blend uniformity for up to 100 samples
20 – 520 mL initial extraction volume
Waters Empower™ Interface
Powerful dEsign™ variables for streamlined DoE studies

CTS Automated Sample Preparation Workstation

Assay and content/blend uniformity for up to 240 samples
High-throughput, multi-sample processing
25 – 1000 mL initial extraction volume
Extraction from large dosage forms (up to 30 mm)