Are you Securing the Integrity of Samples for Safe Use?
Astoriom ICH sample stability storage and assessment solutions provide our global R&D customers with an industry-leading comprehensive portfolio of ambient storage temperatures, humidity-controlled environment and ICH global climatic zone capabilities.
ICH Q1A Sample Stability Storage
- Validated ambient and humidity-controlled environments (Standard Offering)
- 21°C/45% RH – Zone 1
- 25°C/60% RH – Zone II
- 30°C/35% RH – Zone III
- 30°C/65% RH – Zone IV
- 30°C/75% RH – Zone IVb
- 40°C/75% RH – Accelerated ambient
- Ambient and humidity-controlled environments (Custom Request)
- 25°C/40% RH
- 30°C/25% RH
- 40°C/NMT 25% RH
- Cabinet storage – (50°C, 55°C, 60°C)
- Intermediate trial conditions for climatic zones (I, II, III and IVa)
- Long term trial conditions for climatic zones (I, II, III, IVb)
- Accelerated trial conditions for Zones (I – IV)
Our customers trust us to storage their samples in highly controlled environments so they may meet international regulatory agency requirements for their scientific research and consumer products.
Some of our top areas of sample stability expertise includes:
Biological pre-clinical and clinical research samples
Drug and device samples
Consumer product samples
Industrial manufacturing samples
Reference sample batches – check a sample or reagent to ensure compliance with market authorization.
Retained sample batches - verify batch integrity of samples in case of downstream issues such as contamination.
Disaster recovery samples - Disaster planning & recovery solutions
Our ICH Sample Stability Assessment Solutions
Astoriom offers both photostability and thermal cycling testing within our facilities to support the evaluation of environmental impact conditions, such as storage temperatures, humidity and light conditions on samples in storage or transport over time.
Our stability assessment experts will partner with you to discuss your regulatory compliant sample stability needs and advise you on our in-house referral laboratory solutions.
Learn more about our in-house stability assessment capabilities:
The Value of Partnering with Astoriom for ICH Sample Stability Storage
Global Sample Stability Storage Design Expertise
Our sample storage design team with over 30 years of sample stability storage expertise ensures you receive the best outsourcing partner to manage your valuable sample assets.
Broadest Range of Controlled-Temperature Stability Storage
Our comprehensive portfolio of temperature-controlled stability storage solutions provides you more flexible options for storing your sample assets in a single location.
Storage Redundancy and Back-Up
Our global regulatory compliant facilities, trained staff and validated back-up sample storage walk-in rooms and cabinets are validated, ready as needed and provide you greater sample security and maximum protection of your sample assets.
Cost-Saving CAPEX vs. OPEX Model
Instead of large Capital Expenditure Projects, manage your stability projects as part of an operational budget. Typically, a customer pays only for the space used against a pay per use model. Reinvest savings back into advancing your R&D initiatives.
Improves Focus on Core R&D Priorities
Stability studies are typically long-term projects whereby required investments must be made in sizeable facility storage space, staffing, ongoing equipment maintenance, inventory tracking and data monitoring across the length of a project. Outsourcing stability storage enables you to reallocate internal staff and investment savings into higher revenue generating core activities.
Photostability Testing
Stress-test the impact of UV light on sample stability and integrity.
Explore our comprehensive photostability testing solutions:
Photostability chamber/s operate at validated ambient temperatures
ICH Q1B Photostability Testing Compliance
Meet D65/ID65 emission standards for indirect indoor daylight environments
Meeting ISO 9001 standards for exposure to a cool white fluorescent or near UV indoor environments
Benefit from constant monitoring of lux and ultraviolet levels
Validated testing procedures
Benefit from elapsed time meters constantly monitoring lamp life
Single batch testing of samples and studies could be required to be repeated depending on the photostability characteristics determined at the time of initial filing and the type of variation or change made.
Thermal Cycling Testing
Reproduce transportation conditions safely and securely
Thermal Cycling allows the appropriate tests to be carried out to assess the impact of temperature fluctuation on samples during production, transport and storage and to assess how to best avoid adverse effects that could reduce sample life. The completion of this study will uncover the potential effects of temperature deviation that any product or substance can experience during shipment, shelf-life and storage.
It is important to understand the effects the various environments may have on your products; factors such as unforeseen weather conditions, natural disasters, general traffic congestion and aeronautical travel can all be an element of changes in conditions for a product being transported.
For example, a temperature profile of -20˚C to +40˚C could be selected, this is considered the average min/max temperatures for a UK/Germany/Ukraine route. The Ukraine and Germany have temperate continental climates, with warm and humid summers and cold winters.
Maximum temperatures in the range -10˚C to 30˚C. UK has a temperate oceanic climate, with mild wet summers and mild, wet winters with Mean Maximum temperatures in the range -10˚C to 29˚C.
Cycling studies using Astoriom cycling equipment can reproduce these conditions in a validated state and cycle at various hour periods without the disruption of moving product from one chamber to another.
Secondary accelerated aging time
The introduction of new or modified medical devices requires evidence that they can be stored or used without any deleterious effects on performance that may impact patient safety and efficacy.
Note: Real-time studies should be performed in parallel to Accelerated Studies
By exposing or “stressing” the product to higher temperatures than would be used for ambient aging, an increased reaction rate is correlated to normal ranges.
A simplified protocol based on the Arrhenius equation, also called the 10-degree rule, is used where it is assumed that a ten-degree temp increase results in a 2 fold increase in reaction rate.