Our Services

Pharmaceutical Storage

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).

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-80°C

Ultra Low
Temperature


Biological and Clinical Trial Samples, DNA, RNA, Urine, Serum, Plasma. Legal and pathology samples

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).

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Thermal Cycling gives an indication as to how a product will react to adverse conditions, usually encountered during transportation. The storage conditions and the lengths of studies chosen should be sufficient to cover storage, shipment and subsequent use (ICH Q1 A 2.1.7)

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Disaster recovery stability storage

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).

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Q1 Scientific offers a complete stability study sample management service. The Q1 Scientific QMS is set up to manage stability samples from the initial protocol development through to defining pull points and delivering samples to the laboratory for analysis. Clients are provided with full visibility of actual monitoring data and details on all their samples on stability

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The ICH Q1B guideline is the harmonized effort to standardize photostability testing on new pharmaceutical drug substances and drug products.

Photostability Guidelines

Testing is carried out on a single batch of material selected. Whether studies should be repeated depends on the photostability characteristics determined at the time of initial filing and the type of variation and/or change made. The guideline primarily addresses the generation of photostability information for submission in Registration Applications for new molecular entities and associated drug products. It does not cover the photostability of drugs after administration (i.e. under conditions of use) and those applications not covered by the Parent Guideline.

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Need ultra low storage? Ensuring the integrity of ultra low temperature sensitive medicine and pharmaceutical products is important.

Q1 Scientific is the ideal solution for storing your products at ultra low temperatures down to -80˚C.

At our facility we offer all commonly used conditions for biological or vaccine storage:

  • 5°C ± 3°C
  • –20°C ± 5°C
  • –70°C ± 10°C
  • –80°C ± 10°C
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Stability Studies Conference 2023

Join us to hear the latest trends and best practices in stability studies and product development

Killashee Hotel, Naas, Co. Kildare, Ireland
Wednesday 18th October 2023

Quality Assured

Quality & Compliance

Compliance with GMP is a mandatory aspect of pharmaceutical manufacturing, the ultimate goal being the safe-guarding of patient health and the provision of high quality and efficacious medicines. Read more…

OUR FACILITY

Complete stability sample management service.

Complete stability sample
management service.

Unique stability study calendar

Unique stability
study calendar.

Remote sample access

Remote sample
access.