Stability Testing Solutions offering Flexibility with Compliance**
The Amebis Stability Testing & Monitoring System is a highly flexible and inexpensive means of performing small-scale stability testing. The system can be set up in minutes with a full range of environmental conditions available.
These are just some of the areas of use which maybe of interest to you:
- Accelerated Stability Assessment Programme (ASAP)**
- Forced Degradation
- Stress Testing
- Chemical Stability
- Exploratory & early development stability studies (NCEs, APIs, Excipients)
- Pre-formulation and formulation development stability studies
- Recrystallisation Kinetic Studies
- Phase Changes (glass transitions, hydrate formation, deliquescence)
- Polymorph Screening Studies
- Pre-conditioning of Samples for Thermal and Moisture Sorption (DVS) Analysis
- Controlled Stability Testing (small-scale) for any condition: 0-80⁰C /0-95%RH
- Shelf-life Studies
- Biofilm Formation/Spoilage
- Monitoring & Mapping of rooms or cabinets to ensure appropriate storage conditions
- Recording of Environmental Conditions in process operations
**Contract analysis can be provided through a specialist testing laboratory which has expertise in performing very fast (2-4 week) shelf-life determinations using the Amebis system and ASAPprime software – please contact us for further information.
To ensure that new materials brought to market are stable in their storage environments, it is important to subject the material to known temperature and humidity conditions. Also, if the material is for the pharmaceutical market this is a legislative requirement and the process needs to be undertaken in a fashion so as to meet the regulations. Traditionally this has been done using large humidity cabinets in centralised facilities with many projects vying for space. In addition, due to the large Capex cost of a traditional humidity chamber, only the conditions prescribed within the legislation are investigated thus stopping other investigative work being done at different conditions earlier in the R&D chain.
Amebis Ltd – based in Ireland – has developed the unique small-scale system to allow chemists at all stages of the R&D process to determine the stability of their material at a wide range of conditions while collecting GAMP V compliant data (via CFR accredited software) to be used in the product licensing stages of the pipeline.
With humidity and temperature affecting the shelf-life and performance of materials and products in many non-pharmaceutical sectors, the Amebis system is also very suitable for studies on:
- Chemicals (adhesives, agrochemicals, catalysts, desiccants)
Small Scale Stability Testing System
The Stability Testing System is based around individual closed sample chambers into which samples of material are placed and subjected to a target temperature and humidity (0-95%RH, 0-80⁰C). The temperature and humidity within the chamber is measured and logged using Rotronic manufactured and calibrated probes.
This data is then wirelessly transmitted back to the controlling PC via a wireless hub and is then stored within 21 CFR part 11 compliant software. This data is analysed by the software and will warn the user if there is a problem with the sample conditions. The number of sample chambers that can be associated with a single PC is unlimited and the system can be expanded as user requirements grow.
Temperature and humidity generation
Using well understood physical chemistry, the humidity is generated by means of a range of salt solutions supplied in foil sealed capsules which once pierced are placed inside the sample chamber. The unit is then placed in a thermostated oven to achieve the desired test conditions. As the humidity is generated from physical phenomenon compared to the unreliable humidity generators found in the traditional cabinets, there is not the issue of loss of conditions which can be encountered.
For further information and prices, please contact us.