Stability Storage

Pharmaceutical Storage

Q1 Scientific offers state of the art environmentally controlled and monitored stability storage facilities to meet all ICH requirements.

Our GMP facility contains rooms and chambers that have been mapped and validated for long- and short-term shelf life studies under various temperature and humidity requirements. This includes intermediate testing and accelerated testing per ICH Q1A (R2).

We make the following stability conditions available for pharmaceutical stability storage:

  • 25°C ± 2°C / 60% RH ± 5% RH
  • 30°C ± 2°C / 65% RH ± 5% RH
  • 40°C ± 2°C / 75% RH ± 5% RH
  • 5°C ± 3°C
  • –20°C ± 5°C
  • Photostability Studies

 

Other Pharmaceutical Storage

  1. API
  2. Vaccines
  3. Retain Samples
  4. Clinical Trial Storage

Medical Device Stability Storage

Due to the integration of active pharmaceutical ingredients (API) and antimicrobial agents, more medical devices are being considered combination products than ever before.
While the stability of these ingredients is often known, it must be tested in conjunction with the device and undergo a complete stability study according to the ICH guidelines.
We make the following stability conditions available for Medical Devices storage:

  • 25°C ± 2°C / 60% RH ± 5% RH
  • 30°C ± 2°C / 65% RH ± 5% RH
  • 40°C ± 2°C / 75% RH ± 5% RH
  • 5°C ± 3°C
  • –20°C ± 5°C

Biological Storage

Q1 Scientific offers all commonly used conditions for Biological Storage including refrigerated and freezer and can offer customised storage as required.

  • 5°C ± 3°C
  • –20°C ± 5°C
  • –80°C ± 10°C

Biological Storage Conditions (Ref Guidelines: ICHQ5C)

Temperature

Because most finished biotechnological/biological products need precisely defined storage temperatures, the storage conditions for the real-time/real-temperature stability studies may be confined to the proposed storage temperature.

Humidity

Biotechnological/biological products are generally distributed in containers protecting them against humidity. Therefore, where it can be demonstrated that the proposed containers (and conditions of storage) afford sufficient protection against high and low humidity, stability tests at different relative humidities can usually be omitted. Where humidity-protecting containers are not used, appropriate stability data should be provided.

Accelerated and Stress Conditions

As previously noted, the expiration dating should be based on real-time/real-temperature data. However, it is strongly suggested that studies be conducted on the drug substance and drug product under accelerated and stress conditions. Studies under accelerated conditions may provide useful support data for establishing the expiration date, provide product stability information or future product development (e.g., preliminary assessment of proposed manufacturing changes such as change in formulation, scale-up), assist in validation of analytical methods for the stability program, or generate information that may help elucidate the degradation profile of the drug substance or drug product. Conditions should be carefully selected on a case-by-case basis.

Sample Types Stored

  • Blood & Plasma
  • Explant Device Storage (e.g. hip replacements)
  • Pathology & Legal samples
  • Bone
  • DNA/RNA
  • Fluids & Urine
  • Agro & Plant samples
  • Serum
  • Other Biological Materials

Heritage & Conservation Storage

The Q1 Scientific storage chambers are also suitable for the preservation of heritage collections. The control of the temperature and humidity keeps future deterioration to a minimum.
Our heritage stability storage service, preserves the integrity, both historic and artistic, of artefacts, original materials and film archives. This helps to prevent them from being compromised through restoration or lost forever.

In the preventative conservation storage rooms temperature is usually at 5°C ± 3°C while humidity can range from 15%RH to 65%RH. However specific temperature and humidity can be accommodated to meet specific requirements.

Sample Items Stored:

  • Documents, books, manuscripts and catalogues
  • Drawings and engravings
  • Historical records
  • Videos, Microfilms, Film archives
  • Painting and pieces of fine art
  • Musical instruments
  • Archaeological artefacts
  • Photographs

Please click the graphic to launch our interactive stability zone explorer.