Humidity is not a critical stability parameter with vialed sterile products
Tony Cundell
On Sat, May 12, 2012 at 9:44 AM, Trupti Bhagat <[log in to unmask]>wrote:
> Dear All,
>
> For dry powder injectables (sterile powder in a glass vial, capped with a
> rubber stopper and sealed with a Aluminium flip off seals), how critical it
> is to charge the samples for stability at x% Humidity in addition to
> temperature i.e charging of samples at 40C / 75% RH and so on?
>
> Thanks,
> Trupti Bhagat
>
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High quality controlled environmental walk-in rooms and reach-in chambers
Full installation, validation and spare parts also available
Environmental Specialties - http://www.eschambers.com/
Manufacturer of Quality Stability Chambers and
Provider of Complete Validation & Calibration Services
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