In industries where quality takes precedence, meeting precise specifications for accurate, reliable and compliant stability storage is essential. Even minor deviations from specified conditions can compromise product integrity, making precision in stability chamber design and construction critical.
To meet the diverse individual and industry needs of various operations, many businesses make the obvious choice: turn to a custom solution. Here, custom stability chamber manufacturers must not only possess a thorough understanding of the technical requirements and regulatory standards that govern stability testing, but also offer tailored designs that align with specific commercial goals and operational demands.
As expert stability chamber manufacturers, MB3 Technical discuss the various design considerations and specifications needed to develop a compliant, efficient and commercially beneficial stability chamber for any industry.
The diverse needs of a stability chamber
Offering the exact environment required by stability storage protocols, the stability chamber provides strict parameter control to accurately assess product behaviour under various environmental conditions.
Each enclosure is constructed to guarantee that its pharmaceuticals, food products, biological samples, seeds, medical devices and more are stored within strict specifications established by regulatory bodies (e.g. ICH, FDA and EMA).
Its precision in design ensures that manufacturers can test product stability to accurately confirm shelf-life, identify degradation pathways, optimise storage conditions and confirm regulatory compliance.
When it comes to product storage, stability chambers are just as essential for ensuring that raw materials, consumables and ready-to-market products, are stored and preserved correctly, with integrity assured.
Given their significant value in providing precise environmental control, stability chambers are an essential component in many pillar industries. The main sectors include:
Pharmaceutical
Agricultural
Food and beverage
Biotechnology
Electronics
Naturally, the stability chamber needs of each target sector will vary. That’s not forgetting the individual facility or commercial operational demands that a business may also need to meet.
Pharmaceutical manufacturers, for example, require product volume to maximise profit. However, floor space can often be limited, making strategic stability storage solutions that can be accommodated by your current facility the most beneficial.
In contrast, a food and beverage manufacturer often deal with highly perishable items that require rapid and large-scale storage solutions. These will likely require high-capacity chambers which prioritise ease of access and quick turnover.
Understanding the external governance factors of stability chambers
As mentioned, the environmental specifications of a stability chamber are determined by the regulatory requirements specific to its industry. Whether it be a walk-in chamber, reach-in chamber, or cold room, your stability solution must always comply with the relevant standards.
Regulatory requirements extend beyond just operational and storage protocols such as set temperature and humidity parameters, impacting various aspects of stability chamber management.
Bodies like the ICH, FDA, and EPA, as well as industry standards such as ISO and GMP, play a role in shaping the chamber’s installation process, its maintenance schedule, and ongoing management practices. This is embedded in regulations governing calibration, data integrity, environmental and safety considerations, and requirements for training and documentation.
These external governance factors play a crucial role in shaping the design, construction, and operation of your stability chamber, influencing everything from the selection of optimal materials for ease of cleaning and maintenance, to the integration of precise environmental controls that ensure compliance with stringent regulatory requirements.
Building a custom stability chamber
Beyond the standard customisable parameters of your stability chamber such as temperature and humidity, various structural components can be customised entirely to your chamber build. Each component must be modified in a way that ensures safety, efficacy, and compliance depending on sector requirements.
Modifiable elements include:
· Size and dimensions
· Insulation
· Lighting
· Shelving and racking
· Heating and cooling mechanisms
· Air circulation systems
· Control systems
· Safety features
How do MB3 embed customisation in their turnkey solution?
To accommodate a customer's exact needs based on industry requirements, unique business needs, and current facility considerations, the best solution is an end-to-end consultative and construction service for custom manufacture.
Embodied in our core services, stability chamber manufacturers, MB3 Technical, offer the four-tiered approach to custom chamber design and execution:
Phase one: Initial consultation
This stage of the project offers strategic advice for optimal chamber design. MB3 Technical will gather all the custom requirements of the research organisation, manufacturer or laboratory and develop a project program which covers:
Costs and budgeting: To ensure a solution fits in within the client's budget
Feasibility assessment: To investigate whether the proposed solution is likely to meet regulatory and operational requirements
Facility assessment: Assessing the current facility and its available space, including its structural and MEP features.
Phase two: Design
The chamber design conceptualises the above, including design features that meet commercial requirements by either maximising capacity, reducing operational costs or improving sustainability.
The MB3 team curate CAD design with accurate dimensions to offer visualisation of your proposed solution. Continuous collaboration is conducted to ensure client requirements and chamber design remain aligned with project objectives.
The design stage ensures that all project constraints are accounted for whilst planning the execution. This is entirely tailored to the client, with risk assessment integrated.
Phase three: Manufacture, construction and infrastructure
All site preparations, building modifications, infrastructure preparation or alterations are identified and managed. As a turnkey solutions provider, all considerations of the client's specific site, as well as the appropriate logistics, are addressed by the MB3 team.
Features outside of the standard stability chamber, including energy and sustainability reviews, power supply installations, steel/metal construction requirements and more are all accounted for.
Phase four: Installation and testing
The final stage involves an onsite commissioning service by our engineering team. The installation of your stability storage chamber will be executed in a way that ensures minimal downtime and limited risk to your everyday operation.
The last deliverable will involve rigorous testing to ensure the functionality of the chamber. Performed by our technical team, qualification methods such as multi data point temperature and humidity mapping will be conducted to offer verification over the precise parameter conditions necessary. Additional testing methods include power failure recovery and door open recovery tests.
The benefits of customising your stability storage chamber
Beyond the standard benefits, such as custom temperature and humidity control, a custom stability chamber serves as a highly beneficial and transformative solution for your stability process.
Custom stability chamber manufacturers design a solution that fits exactly into your operational workflows. By aligning the chamber's features with your specific needs, unique product types, or specific storage conditions, the chamber maximises productivity and reduces disruptions.
Choose MB3 as your trusted stability chamber manufacturer
As specialist stability chamber manufacturers, MB3 Technical builds solutions that actively enhance efficiency, from optimal space utilisation to energy efficiency, helping you to meet commercial goals as well as operational demands.
We understand the pivotal role stability chambers play in each sector, which is why we deliver capital investments which can be customised to our client's exact requirements.
To begin the build of your new custom stability chamber, get in touch with our team.
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