Indent

Stability Chamber

Touch-screen PLC controlled temperature and humidity chamber that holds ICH storage conditions such as 25 °C/60 % RH and 40 °C/75 % RH, used by pharmaceutical QC and R&D laboratories for long-term and accelerated stability studies. Also printed as Humidity Chamber.

Typical applications

  • ICH long-term stability storage
  • Accelerated stability studies
  • Pharmaceutical shelf-life determination
  • Drug and drug substance testing

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Worth knowing before you order

Stated by the manufacturer as designed to ICH guidelines, but no guideline number is printed anywhere in the brochure. If your protocol has to cite ICH Q1A(R2) or Q1B, ask us to confirm it in writing before you order — we will not assert it for them. No photostability model with UV/visible lux-hour lighting is offered. The manufacturer also prints ISO 9001:2015 (certificate, not a test method) and ISO 9001:2008 (certificate, not a test method). Those are not test methods for this instrument, so they are not listed as conformity above — ask us for the certificate itself if you need it.

Specification

Technical specification for Stability Chamber
Storage conditions fulfilled25 °C / 60 % RH; 30 °C / 65 % RH; 30 °C / 70 % RH; 30 °C / 75 % RH; 40 °C / 75 % RH; 25 °C / 40 % RH; 30 °C / 35 % RH; 40 °C / NMT 25 % RH
Temperature accuracy± 0.1 °C
Temperature resolution0.1 °C
Humidity range40 % RH to 95 % RH
Humidity fluctuationMaximum 3 % RH
Humidity sensorCapacitance type, enables direct display of RH and temperature
Chamber illumination2 or 4 LED lights for lesser power consumption; LED light with door switch
Compressor rating1.5 KW
Dry heater rating2.0 KW
Wet heater rating3.0 KW
Overall power consumption (three phase)2.5 KW per phase (for 3-phase connection)
Power consumption (single phase)7.0 KW (for single phase connection)
Control systemApplication Specific Integrated Programmable Logic Controller (ASI-PLC) with touch screen HMI, fully password protected; two independent PID loops for temperature and humidity control
Controller display7 inch graphics LCD colour TFT touch screen (HMI)
Controller power consumption12 VDC / 15 Watts
Controller panel cut-out140 x 80 x 100 mm (W x H x D)
Controller enclosureOpen frame flush mount type
In-built data loggerSelectable 4, 8, 12, 16 or 32 channels within the LCD colour graphic controller
Controller storage capacityUp to 2 GB inbuilt storage - 38,00000 storage readings (as printed)
Data logging (touch screen model)Storage facility up to 21600 readings logged at 1 minute interval; 4 temperature + 4 RH sensors
Data outputMultipurpose temperature and humidity logger with printout facility; CSV transfer to pen-drive; RS-485 / RS-232 communication port for remote data access via host PC; Ethernet
Compliance software21 CFR compliance software - Part 11 USFDA guidelines; 10 - 20 chambers connectable to one software installation
RedundancyAuto change over to standby systems through PLC - main set to redundant set and vice versa; standby refrigeration and standby humidity system
AlarmsAlarm generated if chamber temperature and/or % RH crosses user defined high/low limits; audio buzzer for alarm annunciation; low water level alarm; door open detection; system cut off in case of gadget failures

Support available

  • Validation & qualification (IQ/OQ/PQ)

Calibration is arranged through NABL-accredited laboratories under the relevant scope. We state the scope and the certificate number on the quotation — see what accreditation actually covers.

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