Product Overview
The PharmaEvent line (C/280, C/600, C/1300, C/2000) is CSZ’s precision 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 ±0.1–0.2°C in time, the tightest tolerance in the reach-in stability line. The S!MPAC® pharma controller with its 7″ WebSeason® touchscreen serves up to six web users, carries audit trail and electronic signatures per the manufacturer’s 21 CFR Part 11 declaration, and runs continuously at 5°C without defrost. Choose the PharmaEvent when the protocol audits the tightness; for a plug-in single-door chamber at a friendlier budget, see the StableClimate II.
Other CSZ chamber families
StableClimate II Stability — plug-in single-door option, broader humidity, ±0.3°C
Stability Walk-In (WMST) — ICH Q1A batch volumes beyond reach-in capacity
PharmaEvent Photostability — ICH Q1B Option 2 — cool-white + UV-A light testing
BioStore™ Cold Storage — walk-in ultra-low freezer rooms for vaccines and biologics
Temperature / Humidity Reach-In — general-purpose cycling, soak, and conditioning
Key Features & Benefits
- The tightest tolerance in the reach-in stability line — setpoint holds to ±0.1–0.2°C and ±0.2–1% RH in time — the discipline a months-long ICH study audits, held day after day. When the protocol scrutinizes the excursion log, this is the line built for it.
- A pharma controller the whole team can reach — the S!MPAC controller’s 7″ WebSeason touchscreen serves up to six simultaneous web users over Ethernet, with audit trail and electronic signatures per the manufacturer’s Part 11 declaration. The study data is visible from the desk, not just at the chamber door.
- Holds setpoint through the disturbances stability work creates — the control system is tuned to recover fast from door openings and from moisture the specimens and packaging give off — exactly where a general-purpose chamber drifts. Built for the way a stability load actually behaves.
- Runs at 5°C without defrost interruptions — refrigerated-storage conditions run continuously with no defrost cycle to perturb the setpoint — no periodic excursion written into a months-long record. A defrost spike is a protocol deviation this chamber never logs.
- Sterile Steam humidification — the patented system evaporates the humidity water at +140°C to suppress microorganisms — clean moisture into a chamber that may hold drug product for months. Humidity without a contamination question.
Specifications
- Operating principle
- A stable temperature/humidity-conditioned environment held to tight tolerance for pharmaceutical shelf-life work. Precise temperature and humidity sensors feed a control system tuned to correct quickly for the disturbances of stability testing — moisture absorbed or released by the specimens and packaging, and door openings.
- Configuration & access
- Reach-in, front-loading, in single-, double-, and triple-door sizes from the benchtop C/280 through the C/2000. Compact footprints with casters to move through the lab; the C/280 stacks and levels.
- 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. Runs continuously at 5°C without defrosting for refrigerated-storage conditions.
- Humidity range
- 20% to 90% RH (dew point +5°C to +45°C).
- Workspace volume & sizes
- 10, 21, 46, and 71 cu ft (280, 600, 1300, 2000 L) — models C/280, C/600, C/1300, C/2000.
- Load / shelf capacity
- Each shelf carries 88 lb (40 kg) distributed load, with 2 to 18 shelves by model.
- Control tolerance (in time)
- ±0.1°C to ±0.2°C temperature and ±0.2% to ±1% RH in time — the tightest tolerance in the CSZ reach-in stability line.
- Uniformity (in space)
- ±0.3°C to ±1°C in space (±0.5% to ±2% RH).
- 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.
- Controller & software
- S!MPAC® controller with a 7″ multi-user WebSeason® touchscreen — up to six simultaneous web users, audit trail, and Ethernet. 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 is available, 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. A patented Sterile Steam System evaporates the water at +140°C to suppress microorganisms.
- Electrical service
- 220/230 VAC, 1 ph, 50/60 Hz; special 115 V / 60 Hz builds are available on the C/280 and C/600.
- Build & lead time
- CSZ chambers are quote-only; PharmaEvent units are catalog-configured to size, door count, controller options, 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 storage, including continuous 5°C refrigerated-storage conditions
- 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 tight, documented conditions are required
Fit limit: the PharmaEvent is a reach-in for ICH Q1A conditions. For batch volumes beyond reach-in capacity, the WMST/WMSTH walk-in stability rooms apply; for ICH Q1B Option 2 light testing, the PharmaEvent photostability chambers carry the cool-white and UV-A lamps; and where ±0.3°C satisfies the protocol, the StableClimate II line is the budget-friendlier reach-in.
Design & Selection Considerations
- Specify the condition set, not the widest range — a stability chamber only needs to hold the ICH conditions your protocol calls out — long-term, intermediate, or accelerated; asking for range you will not use adds cost without value. Bring the setpoints and we match the chamber. The protocol defines the spec.
- Size to the study, and let the C/280 grow with it — the four models run 10 to 71 cu ft with 2 to 18 shelves; the benchtop C/280 stacks and levels, so a small program can add capacity a chamber at a time instead of buying the big box on day one. Match the volume to the samples, not the lab’s square footage.
- Buy the tightness the protocol audits — the PharmaEvent’s ±0.1–0.2°C is the reason to choose it; if ±0.3°C satisfies the work, the StableClimate II line answers at a friendlier budget with a plug-in single-door option. Buy the tightness you need — no more, no less.
- Map the data and validation path up front — the S!MPAC controller and optional S!MPATI pharma software set what audit trail, signatures, and multi-chamber documentation you get — all per the manufacturer’s Part 11 declaration — and validating the installed system in your GxP environment remains your responsibility. Decide the controller and software against your workflow before you decide validation.
- 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.
- Book the IQ/OQ/PQ with the chamber — qualification documentation and on-site execution are available but are optional, scheduled work; line them up with the order so the chamber is qualified when the study starts, not weeks after it arrives. Qualification is a lead-time item, not a same-day add.
To spec the right CSZ PharmaEvent 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.