Stability rooms need a clear brief: the study conditions, usable capacity, loading pattern and documentation requirements must fit the intended application. Discuss your project requirements with Bronson Climate before selecting a configuration.
Experience with pharmaceutical stability rooms
Bronson Climate has previously built stability rooms for a pharmaceutical customer. In that project, qualification was carried out by the customer. This distinction matters when planning a new installation: equipment supply and the qualification of its intended use need clearly assigned responsibilities.
For each new project, define the required operating conditions, acceptance criteria and qualification responsibilities before agreeing the supply scope.
Start with your protocol and operating conditions
- Required temperature and relative humidity, including simultaneous operating conditions and tolerances.
- Usable storage capacity, shelf layout, sample packaging and expected loading changes.
- Access frequency, door openings and the recovery behaviour the study requires.
- Site dimensions, utilities, access for installation and any facility constraints.
- Monitoring, alarm handling, records and the documentation your quality team requires.
Define qualification and documentation responsibilities
Agree who will prepare the specification, approve the design, perform acceptance tests, arrange mapping and calibration, and carry out qualification. State the documents and evidence required at each stage. Confirm the engineering, documentation and service scope for your installation with Bronson Climate.
Planning an ICH stability study
If your study follows ICH guidance, provide the applicable protocol and required conditions as part of the enquiry. Equipment selection alone does not demonstrate compliance of the study or the complete installation. Your quality team should review the requirements and qualification approach. See the EMA information on ICH Q1A(R2) and confirm which guidance applies to your project.
Discuss a stability room
Send your required conditions, capacity, available space and documentation brief through our enquiry form. For a practical checklist, read the Stability Chamber Selection Guide. You can also explore our project examples.