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Storage and Stability

Storage and Stability

Stability testing is not only a regulatory requirement but a critical aspect of ensuring the highest standards of product integrity and patient care. It plays a crucial role in protecting patient health by establishing the appropriate shelf life, storage conditions, and labeling instructions.

Eurofins BioPharma Product Testing Italy has over 30 years of experience in stability storage management. We have now doubled our GMP facility with over 140 m3 of storage capacity,  offering 15 different temperature and humidity conditions. 

This expansion comes in response to the increasing client demand for both stability storage and stability programs that include testing. 

Our fully validated stability chambers operate at ICH conditions for stability studies on large & small molecules (DS & DP), veterinary medicinal products, ATMPs, medical devices and biocides - even in the most complex dosage forms. We are also authorised to store and test GMMO and narcotics products.

The installation of new state-of-the-art stability walk-in chambers and climate cabinets, strongly amplifies our portfolio of services and fuels our ongoing commitment in providing our clients with cutting-edge, timely and safe product development solutions.

We provide a complete range of temperature and humidity conditions. Customised temperature and relative humidity conditions can be accommodated upon request.

All storage areas are CFR 21 part 11 compliant with continuous monitoring (temperature and humidity). Onsite alarm and backup system is active 24 hours a day, 7 days a week. 

Climatic chambers are fully qualified with a maintenance program in place. Double engines climatic chamber, back up organisation and a power back-up generator on site ensure a prompt management of any possible disaster recovery.

Study management is performed through elimsBPT and all documentation is available on LabAccess.

  • Experienced guidance on protocol design and management of Client's stability study program
  • Stress studies
  • Photostability studies
  • In-use stability studies
  • Cycling studies
  • Development and validation of analytical methods
  • Aging studies on medical devices
  • Sample Storage
  • Strictly controlled conditions from sample receivement to shipment
  • Dedicated staff and personnel
  • Logistic and Sample transportation

Condition

Capacity (m3)

25°C ± 2°C/ 60% RH ± 5%

45

25°C ± 2°C/ 40% RH ± 5%

1,5

30°C ± 2°C/ 65% RH ± 5%

10

30°C ± 2°C/ 75% RH ± 5%

27

30°C ± 2°C/ 35% RH ± 5%

1,5

40°C ± 2°C / 75% RH ± 5%

6

2-8°C

42,5

-20°C ± 5°C

1,1

-40°C ± 5°C

0,7

-70°C

1,4

-80°C

0,7

55±2°C

0,8

Costumizable 25-80°C

0,8

Costumizable 0-70°C / 10-90 RH

0,8

Vapour Nitrogen Storage(-180°C)

0,01
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