Product Overview
The StableClimate® II line (ST/STH 24, 52, 82) is CSZ’s practical reach-in for pharmaceutical shelf-life work to ICH Q1A — long-term (25°C/60% RH), intermediate (30°C/65% RH), and accelerated (40°C/75% RH) conditions — holding ±0.3°C with the broadest humidity range of the pair (20–95% RH plus a low-humidity option). Single-door models plug into 115 V / 20 A, full heated glass doors show the product without opening the chamber, and the EZT-570S touchscreen carries audit trail and electronic signatures per the manufacturer’s 21 CFR Part 11 declaration; the chamber is UL/CUL 61010 Listed with IQ/OQ/PQ included on request. Choose the StableClimate II for straightforward ICH work at a friendlier budget; when the protocol audits tenth-of-a-degree control, see the PharmaEvent.
Key Features & Benefits
- Plug-in installation on the single-door sizes — a single-door StableClimate II runs on 115 V / 20 A — a standard circuit, not an electrical project — so a regulated chamber goes where the work is with the least site preparation in the line. Order to running condition without waiting on an electrician.
- The broadest humidity range of the reach-in pair — 20 to 95% RH with a low-humidity option covers protocols the tighter-tolerance line does not reach — one chamber family for the whole humidity spread of the lab’s methods. Range where range is the requirement.
- See the product without disturbing the study — full heated glass doors give a clear, fog-free view of the shelves, so a visual check does not become a door-opening excursion in a months-long record. Look in as often as you like; the setpoint never knows.
- Airflow built for loaded solid shelves — the horizontal airflow design washes conditioned air across each solid shelf, holding uniformity around a real specimen load and recovering fast after the door does open. Uniformity specified with the shelves full, which is how a stability chamber actually runs.
- Listed, documented, and audit-ready as delivered — UL/CUL 61010 listing, an EZT-570S controller with audit trail and electronic signatures per the manufacturer’s Part 11 declaration, and an IQ/OQ/PQ protocol included on request. The paperwork a regulated buy needs, without a custom-engineering line item.
Specifications
- Operating principle
- A stable temperature/humidity-conditioned environment for pharmaceutical shelf-life work, with a horizontal airflow design across solid shelves that holds uniformity high and recovers fast after a door opening — the disturbance a stability lab creates many times a day.
- Configuration & access
- Reach-in, front-loading, in three sizes and single-, double-, or triple-door configurations, with full heated glass doors for product viewing without opening the chamber. Casters move it through the lab.
- Temperature range
- +2°C to +70°C — covering ICH Q1A long-term (25°C/60% RH), intermediate (30°C/65% RH), and accelerated (40°C/75% RH) conditions.
- Humidity range
- 20% to 95% RH, with a low-humidity option — the broadest humidity range in the CSZ reach-in stability line.
- Workspace volume & sizes
- 24, 52, and 82 cu ft — models ST/STH 24, 52, and 82.
- Load / shelf capacity
- Each solid shelf carries 75 lb (34 kg), up to 300 / 600 / 900 lb total by size.
- Control tolerance (in time)
- ±0.3°C temperature and ±3% RH in time.
- Uniformity (in space)
- ±1°C in space (±0.6°C from 25–50°C), ±4% RH — the horizontal airflow across solid shelves keeps uniformity high and recovers fast after a door opening.
- Standards & protocols
- Built for ICH Q1A stability testing for drug substances and products, and meets the requirements of USP, ISO, IEC, ISTA, and ASTM methods within the chamber’s performance range. UL/CUL 61010 Listed.
- Controller & software
- EZT-570S touchscreen — 21 CFR Part 11 compliant per the manufacturer’s declaration (audit trail, electronic signatures), with optional S!MPATI® pharma software for multi-chamber documentation; validating the installed system in your GxP environment remains the end user’s responsibility.
- Validation documentation
- IQ/OQ/PQ qualification protocol included on request, with optional on-site execution by the factory-trained service group — optional scheduled work, quoted with the chamber.
- Humidity water supply
- Built-in demineralized-water reservoir for automatic and manual supply, or connect to a local supply through the demineralization unit.
- Electrical service
- Single-door models run on 115 V / 20 A for plug-in installation; larger sizes on 230 V.
- Build & lead time
- CSZ chambers are quote-only; StableClimate II units are catalog-configured to size, door count, humidity option, and documentation, with lead time confirmed at quotation.
Common Applications
- ICH Q1A pharmaceutical stability and shelf-life testing — long-term, intermediate, accelerated
- Drug-substance and drug-product stability storage
- Medical-device, packaging, and shipping-container conditioning to ASTM and ISTA methods in range
- Personal-care, consumer-product, and nutraceutical stability and accelerated-aging studies
- R&D and clinical-trial stability storage where documented conditions are required
Design & Selection Considerations
- Choose it when ±0.3°C satisfies the protocol — the StableClimate II holds ±0.3°C and ±3% RH — enough for most ICH Q1A work at a friendlier budget; where the study audits tenth-of-a-degree control, the PharmaEvent line is the tighter answer. Buy the tightness you need — no more, no less.
- Specify the condition set, not the widest range — the chamber only needs to hold the ICH conditions your protocol calls out — long-term, intermediate, or accelerated — plus the low-humidity option only if a method demands it. Bring the setpoints and we match the chamber. The protocol defines the spec.
- Size by batch volume and shelf load together — the three sizes run 24 to 82 cu ft with 75 lb per shelf and 300 / 600 / 900 lb totals by size — a dense load of packaged product can hit the weight total before the volume. Count the samples and weigh the load; the model follows.
- Plan the power by size — single-door models plug into 115 V / 20 A; the larger sizes take 230 V service — decide the size early and the site work is either trivial or scheduled. The electrical answer is part of the size choice.
- Plan the humidity water and the demineralizer — humidity control needs a clean demineralized-water supply — the built-in reservoir or a local supply through the demineralization unit — and water quality drives both humidity accuracy and maintenance. The water system is part of the spec, not an accessory.
- Ask for the IQ/OQ/PQ with the order — the qualification protocol is included on request and on-site execution is optional scheduled work; line both up with the order so the chamber is qualified when the study starts. Qualification is a lead-time item, not a same-day add.
To spec the right CSZ StableClimate II stability chamber:
To configure the right chamber, the application drives every choice — so the more of this you can give us up front, the tighter the quote:
- the test standard or protocol you are working to (ICH Q1A / Q1B Option 2, IEC 62660-2, SAE J2464, a UL battery method, an internal spec);
- the test article — size, weight, quantity, and (for powered tests) the heat it dissipates;
- the required temperature and humidity range and how tightly you need them held;
- whether the work is regulated (21 CFR Part 11 audit trail, IQ/OQ/PQ qualification) — and, for battery work, the hazard scope (cell chemistry and the abuse you intend to run);
- your site — available power, water, drainage, doorway and ceiling clearance, and floor loading.
Talk to an engineer directly — Scott Prater, Principal · 917-580-0878 · scott@pratertechnical.com
Specifications compiled by Prater Technical Partners from Cincinnati Sub-Zero published product specifications.