Area of Application: Pharmaceutical
Product Type: Pharmaceutical Stability Test Room
Weiss Technik UK installed a number of Pharmaceutical Stability Test Rooms at pharmaceutical manufacturer, TEVA UK Ltd based in Runcorn, Cheshire, United Kingdom.
The company are part of the worldwide TEVA Pharmaceutical Industries Group. TEVA UK Ltd supply medicines to pharmacies and hospitals including painkillers, antibiotics, cholesterol reducers and lifesaving injectable medicines to fight cancer. They specialise in generic medicines which ordinarily are those with expired patents and respiratory medicines, in particular asthma inhalers.
The PSRs are unique as they are built on steel skids. The steel skids enable the rooms to be moved easily; being able to be lifted onto an open top lorry. Each room has individual chilled water systems located externally. In the event of a malfunction the chillers are easily replaceable with a simple 'plug and play' operation. There is an additional stand-by chiller which in the event of a malfunction of any of the other chillers, will instantly replace them.
Each room has a stainless steel interior and shelving and a painted, corrosion-resistant exterior. The rooms also contain dryers to achieve conditions of 25°C and 40%RH and 40°C and 25%RH.
- meets the conditions required for continuous, long-term stability tests defined in ICH Guideline Q1A
- ensures the maximum room volume provides useable sample space within the specified tolerances for the test conditions
- enables ease of access for maintenance without the need to disturb samples under test
- incorporates recording of independent test data as an option
- can be provided with additional back-up facilities to meet individual requirements