Pharmaceutical Stability Chambers
Pharmaceutical Stability Studies
Are you looking to build, expand or re-structure your pharmaceutical stability chamber? Our projects are engineered to meet the precise and stringent regulatory requirements essential for GxP compliance.​ Not only this, but our pharmaceutical stability chamber design and fit-outs can be tailored to meet your exact needs to conduct effective and efficient pharmaceutical stability studies in-house.
Biopharmaceuticals, vaccines, solid dosage forms, topical formulations, and sterile products, all undergo stability testing for shelf-life evaluation and validation.
Pharmaceutical stability studies ensure individual product safety, quality and efficacy for the assured benefit of the consumer. ​Requiring precise environmental management, a pharmaceutical stability chamber will utilise temperature, humidity, and light sensitivity controls in order to assess product integrity.
We recognise that a pharmaceutical stability chamber can be multi-functional and allows for expansive product assessments against various parameters all within a single unit.
Your pharmaceutical stability chamber application:
Pharmaceutical stability studies
The types of stability testing employed will vary depending on the product characteristics, the regulatory requirements and the intended use. Different types of pharmaceutical stability testing include:
​
-
Longitudinal stability testing
-
Accelerated stability testing
-
Forced degradation studies
-
Microbiological testing
-
R&D stability testing
Pharmaceutical stability chamber storage
Pharmaceutical stability chambers are the ideal environment for product preservation, conditioning and long-term storage. The stored products include pharmaceuticals such as drug formulations, APIs/excipients and finished products, biologics, and packaging materials such as containers and labels.
​
Medical devices such as implantable devices, biodegradable implants, diagnostic reagents and test kits along with sterile packaging will further be stored in a pharmaceutical stability chamber.
GMP compliant pharmaceutical stability chambers
As an essential tool in product quality assurance, pharmaceutical stability studies utilise GMP processes to adhere to stringent regulatory protocols, encompassing guidelines established by authorities such as the ICH, EMA, and the FDA.
All building and structural considerations must be in adherence to the UK’s Building Regulations, British Standards, as well as industry best practices. This ensures that the overall structural integrity, site preparation, appropriate ventilation and additional health and safety components are in line with regulatory expectations.
All pharmaceutical stability chambers are built to include the same structural features which include temperature and humidity control, uniform airflow distribution and monitoring systems for tracking environmental parameters. Pharmaceutical customers we have worked with often look to an advanced stability chamber solution in a bid to meet the highest standards of GXP and quality assurance.
These include:
​
-
High-quality insulation material
-
Corrosion-resistant interior material
-
Appropriate sample storage configuration
-
A reliable air circulation system
-
Safety and protection features, including a power failure recovery system
Our customers also often require pharmaceutical stability walk-in and reach-in chambers where manufacture involves wider structural considerations beyond internal features.
MB3 Technical's expert involvement in compliant stability project delivery ensures that each essential component of a testing or storage chamber is built with compliance. We deliver a wide range of customisable pharmaceutical stability chambers and are confident in our ability to meet your long-term stability, forced degradation and accelerated stability testing needs through our unique chamber portfolio.
Find your pharmaceutical stability chamber solution:
Our design resources accommodate all essential structural considerations for your pharmaceutical stability chamber. Whether it’s GMP-approved uniformity to customised shelving for your various pharmaceutical types, our pharmaceutical stability chambers are crafted through consolidation with the client and design experts to best meet your specific needs.
Our pride lies in going a step beyond structural compliance. Our ability to maximize operational efficiency is the main benefit of our end-to-end pharmaceutical stability service. This is achieved by curating futureproofed stability chambers that deliver larger storage capacity through optimal design.
Expert pharmaceutical stability chamber design, build and installation
At MB3 Technical, we understand and deliver the structural and regulatory expertise needed for the pharmaceutical market. This knowledge has assisted us on several pharmaceutical stability projects both for the NHS and within the Private Sector.
​
Providing turnkey stability storage and testing solutions means we account for the entire construction and management process, including all pre-construction activity, chamber design, supply, build and installation.
​
As a trusted stability provider, we oversee all site preparation and pre-construction phases of a project prior to building and installation. Offering careful planning, coordination, and integration for precise mechanics, electrics and plumbing along with the installation of appropriate flooring, lighting and more.
​
To kick start your consultation, speak to the MB3 Technical team.
Our team were busy building a custom stability chamber for our esteemed pharmaceutical client, providing a secure environment for storing products during their wait for analytical batch testing.
Before project completion, the temperature and humidity were mapped with ultimate precision, confirming operational performance and uniformity of airflow within the storage space.
​
This project was completed to the highest quality, with our turnkey solution covering every aspect of project delivery.
Stability Storage Project