Quality Control

DissoSpec QC Dissolution Monitoring System

Dissolution data – now live!

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PAMPA

Pion’s PAMPA is an in vitro, high throughput screening assay highly correlated to biological membrane permeability.

LOREM IPSUM

Screening excipients, solvents, and APIs to rank order formulations and drug candidates on the basis of permeability.

LOREM IPSUM

Each PAMPA well uses artificial lipid membranes that mimic drug uptake in the gastrointestinal tract (GIT) or the blood-brain barrier(BBB) to provide robust, reliable, bio relevant results.

Integrated, in situ UV-Vis dissolution testing system for efficient and compliant method development and Quality Control (QC) dissolution analysis.

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In Situ UV Probe-Based Dissolution System

Dosage to Data, Simplified

  • Real-time data analysis with fiber optic probes
  • High resolution dissolution profiles
  • Develop methods for transfer to QC
  • Simplified data collection and interpretation
In Situ UV Probe-Based Dissolution System

THE PION PAMPA ADVANTAGE

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In Vivo Correlation

Gut-Box controls stirring speed to match the hydrodynamics of the intestinal tract or the blood brain barrier. The adjustable stirring allows you to mimic the ABL (aqueous boundary layer), allowing for higher accuracy and reducing assay time.[1].

High Throughput

The STIRWELL plates in Pions’ PAMPA sandwich kits contain a pre-loaded stir bar in each well, providing dynamic stirring for each assay, allowing for high-throughput screening of multiple compounds simultaneously.

Easy Data Interpretation

PAMPA Explorer software for easy data
interpretation. SW includes a plate-reader
data wizard, results visualization, and reporting. Data output is the complete mass balance including membrane retention.

Reproducible Results

While orbital shakers can lead to edge
effects in the assay plates, GutBox provides consistent agitation across the whole plate, allowing for more reproducible data.

Complete Solution

The complete PAMPA system includes our 96well STIRWELL plates, the Gut Box™ stirring system and PAMPA Explorer™ software.

Pion’s PAMPA is an in vitro, high throughput screening assay highly correlated to biological membrane permeability
Screening excipients, solvents, and APIs to rank order formulations and drug candidates on the basis of permeability.
Each PAMPA well uses artificial lipid membranes that mimic drug uptake in the gastrointestinal tract (GIT) or the blood-brain barrier(BBB) to provide robust, reliable, bio relevant results.

DissoSpec is engineered to meet USP 1 / 2 / 5 / 6 dissolution methods, ensuring compliance while reducing operational costs.

DissoSpec is engineered to meet USP 1 / 2 / 5 / 6 dissolution methods, ensuring compliance while reducing operational costs.

Advanced UV-Vis Technology:

  • In situ analysis ensuring stable and reliable data collection.
  • In situ data acquisition: Acquire full spectral readings as fast as every 5 seconds.
  • 2nd derivative spectroscopy: Quantify and resolve dual-component dosages accurately, without filtration or physical separation of sample components.

Long-Acting Injectable (LAI) Adapters

  • Simplify sample introduction, improve reproducibility and discrimination, and increase resolution with LAI devices from Pion.
  • Enables dissolution testing of long-acting injectables and other extended-release dosage formulations
Long-Acting Injectable (LAI) Adapters
Long-Acting Injectable Adapter, USP 2 Dissolution Apparatus

Volume range from 5 μL – 100 μL

Filler Cap *
Sample Holder *
Long-Acting Injectable Adapters, USP 4 Flow-through cells

Samples 50 μL and 1 mL in volume

50 μL adapter
1 mL adapter v2
* Can be used with Pion’s DissoSpec QC Dissolution Monitoring System.
DissoPRO™ Software with 21 CFR Part 11 Compliance

DissoPRO™ Software with 21 CFR Part 11 Compliance

Enhanced Data Security:
  • Full access controls, audit trails, electronic signatures, and ALCOA++ compliance.
User-Friendly Interface:
  • Simplified dissolution run protocols with secure login roles that meet current GMP/GLP standards.
Automatic Report Generation:
  • Receive a single, consolidated report upon dissolution completion, covering standard system suitability test, dissolution parameters and data analysis.