Stability Studies

Eurofins BioPharma Product Testing Czech Republic s.r.o. prepares stability study plans for each new stability study. The plan is prepared separately for each studied batch and contains identification of the batch, storage conditions, sampling time points, product specification, methods of analysis to be used for particular test, number of packages necessary for each stability time point, study start date and approval of the plan by Eurofins BioPharma Product Testing Czech Republic s.r.o. and the customer.

We also prepare and implement customer designed stability protocols or plans to meet specific needs of our customers.

The protocols and plans conform with the GMP requirements.

CLIMATIC CHAMBERS

Our climatic chambers conditions are constantly monitored and recorded. There is a UPS-backed up Electronic Alarm System advising our managers if conditions go beyond the parameters laid down in specifications. This Alarm System uses PC/ internet / mobile system runs 24 hours per day, which assures that the system will continue to function even in the event of powercut.

We have a 7-days-per-week maintenance/ service agreement with our suppliers. We are ready to manage your stability studies.

STORAGE CAPABILITIES

We have free capacity in our own chambers, walk-in chambers (from Thermotec) with alarm systems and back-ups for following conditions:

1. 25°C / 60 % RH
2. 30°C / 65 % RH
3. 30°C / 75 % RH
4. 40°C / 75 % RH (Accelerated Stabilities)
5. Other conditions
   • 40°C / 20 % RH
   • 25°C / 35 % RH
   • 25°C / 40 % RH
   • -5°C

PHOTOSTABILITY STUDIES

Eurofins BioPharma Product Testing Czech Republic s.r.o. performs the photostability studies according to ICH Q1B using the photostability chamber set at 25°C / 60 % RH with sensors calculating the total illumination and automated turning off of the UV and VIS lamps after reaching the required dose.

For the forced degradation studies of small amounts of samples we use separate instrument with illumination time lower than 24 hours.

FREEZE / THAW STUDIES

We can also perform cyclic studies. We can combine them with our ASAPprime® studies.

ASAPprime® studies

ASAPprime® = how to determine stability of drug product or drug substance – faster and cheaper

ASAPprime® offers:

• FASTER SHELF-LIFE DETERMINATION » 2-4 weeks vs. ICH-based standard of 2-6 months
• OPTIMAL PACKAGING SELECTION » Eliminates screening » Allows for zone packaging selection
• SUPPORT OF REGULATORY FILINGS » Provides better insights into packaging and formulation/process choices » Supports QbD filings » Replaces or supplements ICH-based studies for FDA and other regulatory agencies world-wide
• STABILITY » Accurately assess stability and shelf life variation between product lots