Pharmacuetical Stability Chambers
Stability studies in the pharmaceutical industry
Pharmaceutical stability chambers are engineered to meet the precise and stringent stability storage requirements essential for GxP compliance.
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Biopharmaceuticals, vaccines, solid dosage forms, topical formulations, and sterile products, all undergo stability testing for shelf-life evaluation. This ensures individual pharmaceutical product safety, quality and efficacy for the assured benefit of the consumer.
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Requiring precise environmental management, pharmaceutical stability studies utilise temperature, humidity, and light sensitivity control to assess product integrity. Pharmaceutical testing chambers can be multi-functional, which allows for pharmaceutical product assessment against various parameters using a single unit.
Pharmaceutical stability chamber applications:
Pharmaceutical stability testing
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:
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Longitudinal stability testing
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Accelerated stability testing
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Forced degradation studies
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Microbiological testing
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R&D stability testing
Pharmaceutical stability 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.
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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.
Compliant pharmaceutical stability chambers
As an essential tool in quality assurance, pharmaceutical stability chambers utilised in GMP processes are built 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:
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High-quality insulation material
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Corrosion-resistant interior material
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Appropriate sample storage configuration
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A reliable air circulation system
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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.
Stability chamber portfolio:
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.
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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.
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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.
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To kick start your consultation, speak to the MB3 Technical team.